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Title: A Phase 1, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of SQZ-PBMC-HPV as Monotherapy and in Combination With Atezolizumab or Other Immune Checkpoint Inhibitors in HLA-A02+ Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors \| Condition: Adult Solid Tumor \| Keywords: recurrent cancer, metastatic, locally advanced, cancer, cervical, head and neck, anal, penile, SQZ-PBMC-HPV, atezolizumab, HPV16, APC, cell therapy, ipilimumab, nivolumab, checkpoint inhibitors, immunotherapy, solid tumor, HLA-A02, therapeutic vaccine, advanced solid tumor, rectal, vulvar, vaginal, PBMC, human papillomavirus strain 16, peripheral blood mononuclear cells, antigen presenting cells \| Summary: \| Description: N/A \| ArmGroups: [{'label': 'Part 1 Monotherapy Dose Escalation Phase', 'type': 'EXPERIMENTAL', 'description': 'In Part 1, SQZ-PBMC-HPV as a monotherapy is administered on Day 1 of every 3 week cycles for up to a year. In Cohort 3 (double-priming), SQZ-PBMC-HPV is also administered on Day 2 of Cycle 1. There are at least 3 groups ("Cohorts") in this Phase as follows:\n\n* Cohort 1: specified dose SQZ-PBMC-HPV\n* Cohort 2: specified dose SQZ-PBMC-HPV\n* Cohort 3: specified dose SQZ-PBMC-HPV double-priming', 'interventionNames': ['Biological: SQZ-PBMC-HPV']}, {'label': 'Part 2 Combination Safety Phase', 'type': 'EXPERIMENTAL', 'description': 'In Part 2, SQZ-PBMC-HPV in combination with immune checkpoint inhibitors (1) atezolizumab, (2) ipilimumab, (3) nivolumab, or (4) nivolumab and ipilimumab, is administered every 3 weeks for up to a year except atezolizumab may be given up to 2 years; and ipilimumab will be administered four times (in a timeframe less than a year) if safety allows. There are 4 groups ("Cohorts") in this Phase as follows:\n\n* Cohort 4: SQZ-PBMC-HPV RP2D (Recommended Phase 2 Dose) plus atezolizumab\n* Cohort 5: SQZ-PBMC-HPV RP2D plus ipilimumab\n* Cohort 6: SQZ-PBMC-HPV RP2D plus nivolumab\n* Cohort 7: SQZ-PBMC-HPV RP2D plus nivolumab and ipilimumab', 'interventionNames': ['Biological: SQZ-PBMC-HPV', 'Drug: Atezolizumab', 'Drug: Ipilimumab', 'Drug: Nivolumab']}, {'label': 'Part 3 Monotherapy Dose Expansion Phase', 'type': 'EXPERIMENTAL', 'description': 'In Part 3, SQZ-PBMC-HPV is administered at the RP2D to patients enrolled in HPV16+ cancer-type specific cohorts. There are 4 groups ("Cohorts") in this Phase as follows:\n\n* Cohort 8: SQZ-PBMC-HPV RP2D in HPV16+ head and neck cancer patients\n* Cohort 9: SQZ-PBMC-HPV RP2D in HPV16+ cervical cancer patients\n* Cohort 10: SQZ-PBMC-HPV RP2D in HPV16+ anal cancer patients\n* Cohort 11: SQZ-PBMC-HPV RP2D in other HPV16+ cancer patients', 'interventionNames': ['Biological: SQZ-PBMC-HPV']}] \| Interventions:[{'type': 'BIOLOGICAL', 'name': 'SQZ-PBMC-HPV', 'description': 'antigen presenting cell therapy; therapeutic vaccine consisting of peripheral blood mononuclear cells (PBMCs) manufactured with immunogenic epitopes of HPV16', 'armGroupLabels': ['Part 1 Monotherapy Dose Escalation Phase', 'Part 2 Combination Safety Phase', 'Part 3 Monotherapy Dose Expansion Phase']}, {'type': 'DRUG', 'name': 'Atezolizumab', 'description': 'programmed cell death ligand 1 (PD-L1) blocking antibody', 'armGroupLabels': ['Part 2 Combination Safety Phase']}, {'type': 'DRUG', 'name': 'Ipilimumab', 'description': 'cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) blocking antibody', 'armGroupLabels': ['Part 2 Combination Safety Phase']}, {'type': 'DRUG', 'name': 'Nivolumab', 'description': 'programmed cell death 1 (PD-1) blocking antibody', 'armGroupLabels': ['Part 2 Combination Safety Phase']}] \| PrimaryOutcomes: [{'measure': 'Number of participants with treatment-related adverse events (TEAEs; all, related, serious, and of special interest) as assessed by CTCAE version 5.0', 'description': 'For SQZ-PBMC-HPV as a single agent (Part 1 and Part 3) and in combination with immune checkpoint inhibitors (Part 2)', 'timeFrame': "Through 6 weeks after the patient's last dose of investigational product"}, {'measure': 'Number of participants with dose-limiting toxicity (DLT)', 'description': 'For SQZ-PBMC-HPV as a single agent (Part 1 and Part 3) and in combination with immune checkpoint inhibitors (Part 2)', 'timeFrame': 'Up to 1 year after LPFV'}, {'measure': 'Objective response rate (ORR) [Part 3]', 'description': 'Proportion of patients with best response of complete response \\[CR\\] and/or partial response \\[PR\\] as defined by RECIST v1.1 criteria. For SQZ-PBMC-HPV as a single agent (Part 3 only)', 'timeFrame': 'Through progression per RECIST v1.1 or start of new anticancer therapy, up to 2 years after first dose of investigational product'}, {'measure': 'Best overall response (BoR) [Part 3]', 'description': 'Evaluation of the BoR defined as CR, PR, Stable Disease \\[SD\\], Progressive Disease \\[PD\\] or Not Evaluable \\[NE\\] as defined by RECIST v1.1 criteria. For SQZ-PBMC-HPV as a single agent (Part 3 only)', 'timeFrame': 'Through start of a new anticancer therapy, up to 2 years after the first dose of investigational product]'}, {'measure': 'Progression-free survival (PFS) [Part 3]', 'description': 'Defined as the time from first dose of study treatment to first overall response of PD by RECIST v 1.1 or to death by any cause. This will be censored at the last RECIST v1.1 assessment if PD/death is not observed. For SQZ-PBMC-HPV as a single agent (Part 3 only)', 'timeFrame': 'Through progression per RECIST v1.1 or start of new anticancer therapy, up to 2 years after first dose of investigational product'}, {'measure': 'Duration of Response (DoR) [Part 3]', 'description': 'Defined as the time from overall response of CR or PR to first overall response of PD by RECIST v1.1 or to death by any cause. This is defined only for patients who have a CR or PR and will be censored at the last RECIST v1.1 assessment if PD/Death is not observed. For SQZ-PBMC-HPV as a single agent (Part 3 only)', 'timeFrame': 'Through progression per RECIST v1.1 or start of new anticancer therapy, up to 2 years after first dose of investigational product'}, {'measure': 'Disease-control rate (DCR) [Part 3]', 'description': 'Proportion of patients with best response of CR or PR or SD as defined by RECIST v1.1 criteria. For SQZ-PBMC-HPV as a single agent (Part 3 only)', 'timeFrame': 'Through progression per RECIST v1.1 or start of new anticancer therapy, up to 2 years after first dose of investigational product'}, {'measure': 'Overall survival (OS) [Part 3]', 'description': 'Defined as the time from first dose of study treatment to death by any cause. This will be censored at the last date patient is known to be alive if death is not observed. For SQZ-PBMC-HPV as a single agent (Part 3 only)', 'timeFrame': 'Through study completion, up to 2 years'}] \| SecondaryOutcomes: [{'measure': 'Objective response rate (ORR) [Part 1 and 2]', 'description': 'Proportion of patients with best response of complete response \\[CR\\] and/or partial response \\[PR\\] as defined by RECIST v1.1 criteria. For SQZ-PBMC-HPV as a single agent (Part 1) and in combination with immune checkpoint inhibitors (Part 2)', 'timeFrame': 'Through progression per RECIST v1.1 or start of new anticancer therapy, up to 2 years after first dose of investigational product'}, {'measure': 'Best overall response (BoR) [Part 1 and 2]', 'description': 'Evaluation of the BoR defined as CR, PR, Stable Disease \\[SD\\], Progressive Disease \\[PD\\] or Not Evaluable \\[NE\\] as defined by RECIST v1.1 criteria. For SQZ-PBMC-HPV as a single agent (Part 1) and in combination with immune checkpoint inhibitors (Part 2)', 'timeFrame': 'Through start of a new anticancer therapy, up to 2 years after the first dose of investigational product]'}, {'measure': 'Progression-free survival (PFS) [Part 1 and 2]', 'description': 'Defined as the time from first dose of study treatment to first overall response of PD by RECIST v 1.1 or to death by any cause. This will be censored at the last RECIST v1.1 assessment if PD/death is not observed. For SQZ-PBMC-HPV as a single agent (Part 1) and in combination with immune checkpoint inhibitors (Part 2)', 'timeFrame': 'Through progression per RECIST v1.1 or start of new anticancer therapy, up to 2 years after first dose of investigational product'}, {'measure': 'Duration of Response (DoR) [Part 1 and 2]', 'description': 'Defined as the time from overall response of CR or PR to first overall response of PD by RECIST v1.1 or to death by any cause. This is defined only for patients who have a CR or PR and will be censored at the last RECIST v1.1 assessment if PD/Death is not observed. For SQZ-PBMC-HPV as a single agent (Part 1) and in combination with immune checkpoint inhibitors (Part 2)', 'timeFrame': 'Through progression per RECIST v1.1 or start of new anticancer therapy, up to 2 years after first dose of investigational product'}, {'measure': 'Disease-control rate (DCR) [Part 1 and 2]', 'description': 'Proportion of patients with best response of CR or PR or SD as defined by RECIST v1.1 criteria. For SQZ-PBMC-HPV as a single agent (Part 1) and in combination with immune checkpoint inhibitors (Part 2)', 'timeFrame': 'Through progression per RECIST v1.1 or start of new anticancer therapy, up to 2 years after first dose of investigational product'}, {'measure': 'Overall survival (OS) [Part 1 and 2]', 'description': 'For SQZ-PBMC-HPV as a single agent (Part 1) and in combination with immune checkpoint inhibitors (Part 2)', 'timeFrame': 'Through study completion, up to 2 years'}, {'measure': 'Amount of investigational product (IP) from individual patient blood collection [Part 1]', 'description': 'To determine manufacturing feasibility (Part 1 only)', 'timeFrame': 'From leukapheresis through manufacture, a maximum of 28 days'}]
Title: Russian Multicenter Comparative Low-intervention Study of the Impact of Perioperative High-protein Nutritional Support on Postoperative Outcomes in the Treatment of Primary Lung Cancer \| Condition: Lung Cancer \| Keywords: \| Summary: \| Description: The study enrolled 114 patients with primary non-small cell lung cancer and nutritional deficiencies or at risk of developing them, admitted for surgical treatment and meeting other inclusion/exclusion criteria. Patients were randomly divided into two groups: the study group of 57 people and the control group of 57 people. Patients in the study group, in addition to the usual diet, received nutritional support. During the hospital stay, additional nutritional support was added to the patient's standard hospital diet. On an outpatient basis, patients received the required amount at their disposal and will take it as a supplement to his usual and habitual diet. Patients in the control group followed the standard hospital diet, and at discharge - the usual habitual diet. The study was conducted using Enrollme.ru electronic platform. In total, the study comprised screening and 5 visits. \| ArmGroups: [{'label': 'The Study Group', 'description': "Patients in the study group (N=57), in addition to the usual diet, received nutritional support with the Oral Nutrition Supplement (ONS) Nutridrink Compact Protein in the amount of 2 bottles per day for 14 days prior to surgery and 14 days following surgery. During the hospital stay, additional nutritional support was added to the patient's standard hospital diet. On an outpatient basis, the patient received the required amount of ONS at his/her disposal and took it as a supplement to his/her usual and habitual diet. The ONS was recommended to be taken between main meals", 'interventionNames': ['Dietary Supplement: Nutridrink Compact Protein']}, {'label': 'The Control Group', 'description': 'Patients in the control group (N=57) followed the standard hospital diet, and at outpatient basis - their usual habitual diet'}] \| Interventions:[{'type': 'DIETARY_SUPPLEMENT', 'name': 'Nutridrink Compact Protein', 'description': 'Oral Nutritional Supplement, a liquid, ready-to-drink, high protein, high calorie blend. Intended for adult patients (from 18 years of age) with malnutrition or risk of its development. Produced by Nutricia', 'armGroupLabels': ['The Study Group']}] \| PrimaryOutcomes: [{'measure': 'Weight', 'description': 'The weight was measured at each visit', 'timeFrame': 'during observation up to 6 weeks'}, {'measure': 'Days in hospital', 'description': 'Count of hospital stay after surgery', 'timeFrame': 'during observation up to 6 weeks'}, {'measure': 'Six Minute Walk Test', 'description': 'A test to count walk distance a patient can afford during 6 minutes', 'timeFrame': 'during observation up to 6 weeks'}, {'measure': 'Hand strength', 'description': 'A hand strength was measured using hand dynamometer at each visit', 'timeFrame': 'during observation up to 6 weeks'}, {'measure': 'Lung complications', 'description': 'Number of lung postoperative complications, e.g. lung infections, atelectasis were registered', 'timeFrame': 'during hospital stay for about 2 weeks'}] \| SecondaryOutcomes: [{'measure': 'Serum total protein', 'description': 'Serum total protein was measured at each visit', 'timeFrame': 'during observation up to 6 weeks'}, {'measure': 'Serum albumin', 'description': 'Serum albumin was measured at each visit', 'timeFrame': 'during observation up to 6 weeks'}, {'measure': 'Total lymphocyte count', 'description': 'Serum albumin was measured at each visit', 'timeFrame': 'during observation up to 6 weeks'}, {'measure': 'EORTC QLQ-C30', 'description': 'EORTC QLQ-C30 (The European Organization for Research and Treatment of Cancer core quality of life questionnaire) questionnaire was completed at visits. The questionnaire incorporates five functional scales, three symptom scales, a global health status, and a number of single items assessing additional symptoms commonly reported by cancer patients. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale and global health status represents a high / healthy level of functioning, but a high score for a symptom scale / item represents a high level of symptomatology / problems', 'timeFrame': 'during observation up to 6 weeks'}]
Title: Phase III Study of Hyperfractionated Radiation Therapy With or Without Simultaneaous Application of CIS-Platinum in Patients With Moderately Advanced to Advanced Cancers of the Head and Neck \| Condition: Head and Neck Cancer \| Keywords: stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx \| Summary: \| Description: OBJECTIVES: I. Assess the time to treatment failure (local and regional) in patients with moderately advanced and advanced squamous cell carcinoma of the head and neck (no distant metastases) when treated with hyperfractionated radiotherapy with vs. without 2 courses of simultaneously administered cisplatin. II. Assess the time to distant metastatic relapse, overall survival, and toxicity in patients receiving these treatments. III. Evaluate whether the potential tumor-doubling time is an indicator for risk of treatment failure in patients receiving these treatments. OUTLINE: Randomized study. Arm I: Radiotherapy plus Single-Agent Chemotherapy followed, as indicated, by Surgery. Hyperfractionated external-beam tumor irradiation using photon energies of 4-6 MV or electrons of 6-12 MV (interstitial brachytherapy boost to lesions of the oral cavity allowed); plus Cisplatin, CDDP, NSC-119875; followed, in patients with persistent disease (at the discretion of the surgeon), by resection of primary tumor or involved nodes. Arm II: Hyperfractionated radiotherapy followed by Surgery. Tumor irradiation as in Arm I; followed by resection as in Arm I. PROJECTED ACCRUAL: At least 400 patients will be accrued over 5 years. Interim analyses to allow for early stopping will be carried out after entry of 50 and 100 patients. \| ArmGroups: N/A \| Interventions:[{'type': 'DRUG', 'name': 'chemotherapy'}, {'type': 'DRUG', 'name': 'cisplatin'}, {'type': 'RADIATION', 'name': 'low-LET cobalt-60 gamma ray therapy'}, {'type': 'RADIATION', 'name': 'low-LET electron therapy'}, {'type': 'RADIATION', 'name': 'low-LET photon therapy'}] \| PrimaryOutcomes: N/A \| SecondaryOutcomes: N/A
Title: Transversus Abdominis Plane Block Compared to Local Anesthetic Wound Infiltration in Gynecologic Oncology Surgery \| Condition: Analgesia, Surgery \| Keywords: laparotomy \| Summary: \| Description: Primary Objective * To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on pain control in subjects undergoing laparotomy. Secondary Objectives * To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on subject-rated perception of pain in subjects undergoing laparotomy. * To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on length of hospital stay in subjects undergoing laparotomy. * To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on postoperative anti-emetic use and number of recorded episodes of emesis in subjects undergoing laparotomy. * To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on return of bowel function in subjects undergoing laparotomy. * To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on subject satisfaction in subjects undergoing laparotomy. * To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on postoperative complications in subjects undergoing laparotomy. * To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on readmission rates in subjects undergoing laparotomy. * To evaluate the cost of care associated with TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on readmission rates in subjects undergoing laparotomy. \| ArmGroups: [{'label': 'TAP Block plus Laparotomy', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Drug: TAP Anesthesia']}, {'label': 'Laparotomy plus Local Wound Anesthetic', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Drug: Surgeon-Initiated Local Anesthetic']}] \| Interventions:[{'type': 'DRUG', 'name': 'TAP Anesthesia', 'description': 'ultrasound guided TAP block, 133 mg of liposomal bupivacaine and 15 mL of 0.25% bupivacaine deposited into the TAP on each side for a total of two injections', 'armGroupLabels': ['TAP Block plus Laparotomy'], 'otherNames': ['bupivacaine', 'liposomal bupivacaine']}, {'type': 'DRUG', 'name': 'Surgeon-Initiated Local Anesthetic', 'description': '266 mg of liposomal bupivacaine and 30 mL of 0.25% bupivacaine diluted in 130 mL of normal saline (160 mL of solution), 40 mL fascial injection and 40 mL skin injection on either side of the wound', 'armGroupLabels': ['Laparotomy plus Local Wound Anesthetic']}] \| PrimaryOutcomes: [{'measure': 'Total opioid use measured in oral morphine equivalents for the first 24 hours post-surgery', 'description': 'Total opioid use measured in oral morphine equivalents for the first 24 hours post-surgery (including intraoperative and Post Anesthesia Care Unit (PACU) opioid utilization).', 'timeFrame': '24 hours post-surgery'}] \| SecondaryOutcomes: [{'measure': 'Mean postoperative pain score for the first 24 hours post-surgery', 'description': 'Mean postoperative pain score for the first 24 hours post-surgery, measured by the Numeric Rating Scale (NRS), which rates pain on a 0-10 scale (collected routinely on the post-operative floor). Higher numbers indicate worse pain.', 'timeFrame': '24 hours post-surgery'}, {'measure': 'Length of hospital stay, measured in whole hours from admission to PACU to time of discharge order placement', 'timeFrame': 'estimated to be up to 3 days'}, {'measure': 'Post-operative anti-emetic use', 'description': "A study team member will review the patient's medical chart to record the number of times an anti-emetic was given to the subject.", 'timeFrame': 'estimated to be up to 3 days'}, {'measure': 'Number of recorded episodes of emesis', 'description': "A study team member will review the patient's medical chart to record number of times the hospital staff observed a participant vomit.", 'timeFrame': 'estimated to be up to 3 days'}, {'measure': 'Return of bowel function measured in whole hours from completion of surgery to passage of flatus', 'timeFrame': 'estimated to be up to 3 days'}, {'measure': 'Participant Satisfaction at Postoperative Visit measured by two pain questions from the QoR-15 Patient Reported Outcomes Survey Score', 'description': 'Scores are from 0-10 where 0 is pain all of the time and 10 is pain none of the time.', 'timeFrame': 'post-operative visit (up to 60 days)'}, {'measure': 'Readmission rate measured by readmission in the 30 days following surgery', 'timeFrame': 'up to 30 days'}, {'measure': 'Cost of care measured by aggregate cost of hospitalization following discharge from surgical hospital stay', 'timeFrame': 'estimated to be up to 3 days'}, {'measure': 'Summary of Post-operative Complications', 'description': 'Postoperative complications, as defined by urinary tract infections, thromboembolic events, pneumonia, blood transfusion, cardiac events, falls, and electrolyte disturbances will be summarized by type and number of complications.', 'timeFrame': 'up to 30 days post-operatively'}, {'measure': 'Time to First Ambulation measured in hours', 'description': "A study team member will review the participant's medical chart to record the interval (in hours) from completion of surgery to first ambulation after surgery.", 'timeFrame': 'estimated to be within 72 hours post-surgery'}]
Title: Diagnosis and Survival Prediction of Pancreatic Cancer by Machine Learning of Image Data \| Condition: Pancreatic Cancer \| Keywords: Pancreatic Cancer, Machine Learning, Radiomics, CT, MRI, Ultrasound \| Summary: \| Description: In this study, investigators aimed to investigate the diagnostic performance and prediction accuracy of pancreatic cancer by radiomics data and clinical data, which include CT scan, MRI, PET-CT, PET-MR, ultrasound, and clinical data. \| ArmGroups: N/A \| Interventions:N/A \| PrimaryOutcomes: [{'measure': 'Patient overall survival', 'description': 'Patient overall survival, from the time of diagnosis of pancreatic tumor to the death of the patient.', 'timeFrame': 'up to 3 years'}] \| SecondaryOutcomes: [{'measure': 'Pathology diagnosis', 'description': 'Pathology diagnosis of the patient, such as adenocarcinoma, pancreatic neuroendocrine tumors, intraductal Papillary Mucinous Neoplasm, et al.', 'timeFrame': 'intraoperative'}]
Title: Phase II Study of Regorafenib as Single Agent for the Treatment of Patients With Metastatic Colorectal Cancer (mCRC) With Any RAS or BRAF Mutation Previously Treated With FOLFOXIRI Plus Bevacizumab \| Condition: Colorectal Neoplasms, Metastatic Disease \| Keywords: metastatic colorectal cancer, RAS/BRAF mutation, Regorafenib, FOLFOXIRI, Bevacizumab \| Summary: \| Description: N/A \| ArmGroups: [{'label': 'Regorafenib', 'type': 'EXPERIMENTAL', 'description': 'Regorafenib will be administered orally at the initial dosage of 160 mg per day for 3 weeks, followed by one week of rest, according to the 3/1 regimen', 'interventionNames': ['Drug: Regorafenib']}] \| Interventions:[{'type': 'DRUG', 'name': 'Regorafenib', 'armGroupLabels': ['Regorafenib']}] \| PrimaryOutcomes: [{'measure': 'Progression free survival rate at 6 months', 'timeFrame': '6 months'}] \| SecondaryOutcomes: [{'measure': 'Objective response rate based on the Response Evaluation Criteria in Solid Tumors criteria', 'timeFrame': '36 months'}, {'measure': 'Disease control rate', 'timeFrame': '36 months'}, {'measure': 'Response according other criteria (Appendix 9)', 'timeFrame': '36 months'}, {'measure': 'Time to response', 'timeFrame': '36 months'}, {'measure': 'Progression free survival', 'timeFrame': '36 months'}, {'measure': 'Time to treatment failure', 'timeFrame': '36 months'}, {'measure': 'Response duration', 'timeFrame': '36 months'}, {'measure': 'Duration of stable disease', 'timeFrame': '36 months'}, {'measure': 'Overall survival', 'timeFrame': '36 months'}, {'measure': 'Time to progression', 'timeFrame': '36 months'}, {'measure': 'Incidence and severity of adverse events (AE) (NCI CTC, version 3.0)', 'timeFrame': '36 months'}, {'measure': 'Changes in laboratory values', 'description': 'hemoglobin, hematocrit, platelets, creatinine, total bilirubin, alkaline phosphatase, ALT, AST, BUN or urea, glucose, sodium, potassium, calcium, phosphorus, LDH, GGT, magnesium, albumin, total protein, uric acid and lipase.', 'timeFrame': 'baseline and end of treatment, an expected average of 4 months'}, {'measure': 'Change in vital signs (weight loss and hypertension)', 'timeFrame': 'baseline and end of treatment, an expected average of 4 months'}, {'measure': 'Incidence of dose adjustments and compliance', 'timeFrame': '36 months'}, {'measure': 'Incidence of concomitant medication', 'timeFrame': '36 months'}, {'measure': 'Changes in ECOG performance status over time from baseline', 'timeFrame': 'baseline and end of treatment, an expected average of 4 months'}]
Title: Phase I, Open-Label, Multiple Dose, Dose-Finding and Expansion Clinical Study to Assess the Safety, Pharmacokinetics, and Efficacy of DBPR112 in Patients With Head and Neck Cancer and EGFR Mutated Lung Cancer \| Condition: Head and Neck Cancer, NSCLC \| Keywords: DBPR112, EGFR mutated NSCLC, squamous cell cancer of head and neck, maximum tolerated dose, recommended Phase 2 dose \| Summary: \| Description: This is a Phase I, multi-center, open-label, first-in-human study to determine the MTD and RP2D of DBPR112 and to assess the safety, tolerability and PK of DBPR112 in Asian patients. Patients with non-small cell cancer (NSCLC) who have progressed following prior therapy with an epidermal growth factor receptor (EGFR) tyrosine kinase (TK) inhibitor or in patients with squamous cell cancer of head and neck (SCCHN) who have progressed following prior standard therapy will be selected. Approximately 24 to 30 patients will be enrolled in this study as out patients/inpatients, in 2 study centers in Taiwan. \| ArmGroups: [{'label': 'DBPR112', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: DBPR112']}] \| Interventions:[{'type': 'DRUG', 'name': 'DBPR112', 'description': 'DBPR112 hard gelatin capsule solid dosage formulation; strength: 25 mg, 100 mg.', 'armGroupLabels': ['DBPR112']}] \| PrimaryOutcomes: [{'measure': 'Maximum Tolerated Dose (MTD)', 'timeFrame': 'up to 22 months'}, {'measure': 'Area Under the Plasma Concentration-Time Curve (AUC from 0 to infinity)', 'timeFrame': 'For Cycle 1 (each cycle is 28 days) and Cycle 2, Day 1, predose (0 hr), 0.5, 1, 2, 3, 4, 6, 8 and 24 hrs (i.e. predose on Day 2).Predose samples on Cycle 1 Days 8, 15, 22, and 28, Cycle 2 Day 15, and Cycle3-6 Days 1 and 15.'}, {'measure': 'Observed Maximum Plasma Concentration (Cmax)', 'timeFrame': 'For Cycle 1 (each cycle is 28 days) and Cycle 2, Day 1, predose (0 hr), 0.5, 1, 2, 3, 4, 6, 8 and 24 hrs (i.e. predose on Day 2).Predose samples on Cycle 1 Days 8, 15, 22, and 28, Cycle 2 Day 15, and Cycle3-6 Days 1 and 15.'}, {'measure': 'Time of Maximum Plasma Concentration (tmax)', 'timeFrame': 'For Cycle 1 (each cycle is 28 days) and Cycle 2, Day 1, predose (0 hr), 0.5, 1, 2, 3, 4, 6, 8 and 24 hrs (i.e. predose on Day 2).Predose samples on Cycle 1 Days 8, 15, 22, and 28, Cycle 2 Day 15, and Cycle3-6 Days 1 and 15.'}] \| SecondaryOutcomes: [{'measure': 'Incidence and intensity of Adverse Events and Serious Adverse Events as a measure of safety', 'timeFrame': 'Adverse events were collected from the time of the first dose of investigational product until 30 days after the last dose of investigational product administration.'}, {'measure': 'Preliminary antitumor activity of DBPR112 in patients with solid tumors', 'timeFrame': 'The tumor responses were collected from the time of the first dose of investigational product until 30 days after the last dose of investigational product administration.'}]
Title: Improving Uptake of Genetic Cancer Risk Assessment in African American Women- Video \| Condition: Breast Cancer \| Keywords: genetic counseling and testing \| Summary: \| Description: Breast cancer (BC) is the most frequently diagnosed cancer in African American women (hereafter referred to as "Black") and their cancer mortality is higher than other racial/ethnic groups in the United States (US). Compared to non-Hispanic Whites, Black women are diagnosed younger and with more advanced breast cancer. When diagnosed with BC, Black women present more often with triple-negative breast cancer (TNBC) an aggressive disease defined by the absence of estrogen and progesterone receptors, and human epidermal growth factor (HER)-2 expression. TNBC has been associated with pathogenic BRCA1 variants. Racial disparities also exist for women with ovarian cancer, the most lethal of the gynecologic cancers. Among women with advanced ovarian cancers up to 21% are associated with inherited pathogenic mutations the most common of which is BRCA1. Women who carry a pathogenic BRCA variant (PV) have a lifetime breast cancer risk of 55-70% and a lifetime ovarian cancer risk of up to 44%. The National Comprehensive Cancer Network (NCCN) recommends referral for Hereditary Breast and Ovarian Cancer (HBOC) genetic counseling and testing (GCT) for women at risk of carrying a BRCA PV. GCT provides women with information needed to make informed decisions to reduce their cancer risk, yet Black women are less likely to use GCT than whites. There is a dearth of interventions to address this issue and produced results are mixed and modest. Awareness of a positive result can inform treatment decisions for cancer patients and risk management in survivors or women unaffected with cancer. Reasons for the lower uptake of GCT in Black women are multi-factorial and include access, knowledge, psycho-social factors, and may vary by cancer status (affected versus unaffected). There are substantial scientific gaps regarding effective interventions to address the sub-optimal uptake of GCT in Black women. To be effective, GCT interventions should be anchored within the needs and cultural values of their audience. While improving knowledge about GCT and one's individual risks is important, interventions that only address knowledge may not enhance uptake, as risk information evokes emotional reactions that are often stronger predictors of behaviors than cognitive factors. Notably, this team has identified factors that contribute to Black women's uptake of GCT. In preliminary studies, researchers found that self-efficacy in making decisions about GCT and medical mistrust were associated with GCT uptake. Low knowledge among Black BC survivors at risk of HBOC has also been found. Anticipated negative emotions to GCT have been associated with lower uptake. Similar studies suggest that Black women report emotions related to fear of being singled out, and the fear of being hopeless. Because most interventions have focused solely on knowledge or access, the proposed study makes a considerable shift in the field by additionally targeting emotions, ambivalence, and developing a media-based risk communication tool. Guided by two evidenced-based theories and preliminary data, this will be a two-phased mixed methods study. In Phase I (months 1-7), formative research and preliminary data will be used to develop the script for the GCT video. The script will be reviewed by GCT experts (n=4) and piloted in two focus groups (n=16) followed by a staged reading to make final refinements. In Phase II (months 8-24), a two-arm randomized trial (RCT) to compare GCT uptake and psycho-social outcomes between 50 at-risk Black women receiving printed Susan G. Komen developed GCT literature (control group) (n=25) or a tailored YouTube video intervention (n=25) will be conducted . All women will be referred to an appointment scheduler who will assist them with making an appointment with a genetic counselor. Participants will complete a baseline survey and follow-up assessment. The primary outcome will be genetic counseling uptake and receipt testing at 3-months will be explored. Specific aims are to: Aim 1. Develop a YouTube video using a formative data for Black women at risk for HBOC. Aim 2. Evaluate the efficacy of the intervention by comparing outcomes between women in the YouTube intervention arm vs. control group arm. H.2.1. Women in the intervention group (vs control group) will have higher genetic counseling uptake. H.2.2. Women in the intervention group (vs control group) will report higher knowledge, higher self-efficacy, higher endorsement of positive attitudes, and positive anticipated emotions about GCT. H.2.3. Most women (≥75%) will be satisfied with the experimental intervention. Enhancing GCT in at-risk populations is a national priority. Given trends towards panel testing and other genomic advances, there is potential for existing disparities to widen. Findings will inform new strategies for behavioral interventions for Black women and a larger trial. If successful, the intervention could be easily disseminated broadening its reach to affected and unaffected women. This study meets the Healthy People 2020 goals to enhance GRCA in at-risk populations, and the national priorities to increase diversity in genetics research participation and incorporate emotions into cancer research. Findings will inform new strategies for behavioral interventions targeting African-Americans in a larger trial. \| ArmGroups: [{'label': 'Fact Sheet Arm', 'type': 'NO_INTERVENTION', 'description': 'Komen print materials about genetic counseling and testing will be given to women.'}, {'label': 'YouTube Video Arm', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants in this arm will receive the culturally tailored video either via a Youtube link or a DVD.', 'interventionNames': ['Behavioral: YouTube Video Arm']}] \| Interventions:[{'type': 'BEHAVIORAL', 'name': 'YouTube Video Arm', 'description': 'Participants (n=25) will watch a 20 minute YouTube video that will describe the genetic counseling and testing process and risk/benefit information in a culturally relevant format. Participants will complete pre and post assessments. After the session, participants interested in pursuing genetic counseling and testing services will be referred to a patient navigator who will navigate participants to identified no cost or low cost services.', 'armGroupLabels': ['YouTube Video Arm']}] \| PrimaryOutcomes: [{'measure': 'Rate of Genetic Counseling and Testing Uptake.', 'description': 'Our primary outcome will be for participants to receive genetic testing and counseling.Investigators will be able to see if participant has scheduled a genetic testing appointment within the VCU Health appointment system.', 'timeFrame': '3 months'}] \| SecondaryOutcomes: [{'measure': 'Knowledge Scale - Genetic Counseling and Testing Knowledge .', 'description': 'The investigators measured general knowledge about hereditary breast and ovarian cancer. GCT knowledge was ascertained using a 13 item scale developed by Erblich et al.\'s (2005). Example items included "have you ever heard about genetic counseling for BRCA 1 and 2?"" and have yes/no or true/false options. Scores across the 13 item Knowledge scale were summed with a range of ( 0-13) where higher values indicated higher knowledge.', 'timeFrame': 'Baseline was collected up to 48 hours from the start of the intervention and the follow-up was assessed within 48 hours post-intervention.'}, {'measure': 'Self-efficacy Scale', 'description': 'The investigators measured participants self-efficacy in genetic counseling services.Self-efficacy was measured with 3 items on a 5-point likert-scale, with questions that was developed for this study. Example items include "how confident are you that you can cope with your risk of developing cancer?". Response options are on a 5-point likert scale ranging from not at all confident (1) and very confident (5). Scores across the 3- item scale were summed with a range of (3-15) where higher scores indicated higher self efficacy.', 'timeFrame': 'Baseline was collected up to 48 hours from the start of the intervention and the follow-up was assessed within 48 hours post-intervention.'}]
Title: A Phase I Dose-finding Trial of Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin in Patients With Advanced-stage Ovarian Cancer \| Condition: Ovarian Cancer, Hyperthermic Intraperitoneal Chemotherapy, Paclitaxel \| Keywords: \| Summary: \| Description: N/A \| ArmGroups: [{'label': 'Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin', 'type': 'EXPERIMENTAL', 'description': 'Patients with ovarian cancer receive hyperthermic intraperitoneal paclitaxel combined with a fixed dose of cisplatin (75mg/m2)', 'interventionNames': ['Drug: Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin']}] \| Interventions:[{'type': 'DRUG', 'name': 'Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin', 'description': 'The starting dose for paclitaxel was 175 mg/m2, with escalation in 25 mg/m2 increments until the MTD was determined or the maximum dose level of 225 mg/m2 was reached. The target dose-limiting toxicity (DLT) rate was 25%, and the total sample size was 30 patients. HIPEC was delivered immediately following the debulking surgery using the closed technique with a target temperature of 43 ℃ for 90 minutes.', 'armGroupLabels': ['Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin']}] \| PrimaryOutcomes: [{'measure': 'Dose-Limiting Toxicity', 'description': 'Grade 3 AEs according to the National Cancer Institute Common Terminology Criteria for Adverse Event (CTC-AE) Version 4.0 classification are used to define DLT.', 'timeFrame': 'within 3 weeks following HIPEC'}] \| SecondaryOutcomes: N/A
Title: Eliminating Breast Surgery for Triple Negative or HR-/HER2+ Breast Cancer Patients With Clinical Complete Response to Combined Neoadjuvant Chemotherapy and Neoadjuvant Radiotherapy: A Multicenter, Phase 2 Trial (EBCS) \| Condition: Breast Cancer \| Keywords: \| Summary: \| Description: The main purpose: To explore the safety of eliminating surgery for triple negative or HER2 positive breast cancer patients with clinical response to neoadjuvant chemoradiotherapy. Secondary study objective: To explore predictive molecular biomarkers of response to neoadjuvant chemoradiotherapy and investigate whether ctDNA can predict pCR or survival outcome. Primary endpoint: 5-year event-free survival (5-year EFS). Secondary end points: Whether combined neoadjuvant chemoradiotherapy can improve breast pathological complete response rate (bpCR: ypT0), overall survival (OS), patient-reported outcomes (PROs) and safety \| ArmGroups: [{'label': 'Neoadjuvant Chemotherapy combined with Neoadjuvant Radiotherapy', 'type': 'EXPERIMENTAL', 'description': 'Patients who meet the criteria for enrollment initially receive four cycles of TCb (HP) \\* neoadjuvant chemotherapy, followed by neoadjuvant radiotherapy starting from the fifth cycle of TCb (HP) \\* neoadjuvant chemotherapy. After completion of six cycles of neoadjuvant chemotherapy, patients underwent breast magnetic resonance imaging. When a patient meets the MRI criteria suggestive of a complete clinical response (cCR), vacuum assisted core biopsy (VACB) targeting the primary lesion is performed under ultrasound or stereotactic guidance. A minimum of six cores, are obtained using a 7-10 G needle. Biopsy specimens are examined by a pathologist to assess the residual tumor and tumor bed. When no tumor or atypical cells are confirmed in the valid VACB specimen, breast and axillary surgery will be omitted.', 'interventionNames': ['Radiation: Neoadjuvant Chemotherapy combined with Neoadjuvant Radiotherapy']}] \| Interventions:[{'type': 'RADIATION', 'name': 'Neoadjuvant Chemotherapy combined with Neoadjuvant Radiotherapy', 'description': 'Neoadjuvant radiotherapy: whole-breast irradiation ( 50 Gy in 25 fractions) plus a mandatory boost (14 Gy in seven fractions, which began on the day following completion of whole-breast irradiation) TCb (HP) \\* : Triple negative patients will receive TCb regimens with or without immunotherapy and HER2 positive patients will receive TCb(HP) regimens.', 'armGroupLabels': ['Neoadjuvant Chemotherapy combined with Neoadjuvant Radiotherapy']}] \| PrimaryOutcomes: [{'measure': '5-year EFS', 'description': '5 years event-free survival after neoadjuvant chemoradiotherapy', 'timeFrame': '60 weeks'}] \| SecondaryOutcomes: [{'measure': 'b-pCR', 'description': 'Whether combined neoadjuvant chemoradiotherapy can improve breast pathological complete response rate (bpCR: ypT0)', 'timeFrame': '18 weeks'}, {'measure': 'OS', 'description': 'overall survival after completing of neoadjuvant chemoradiotherapy', 'timeFrame': '60 weeks'}]
Title: Phase 1 Trial of Single Agent MK-4166 and MK-4166 in Combination With Pembrolizumab in Subjects With Advanced Malignancies \| Condition: Solid Tumor \| Keywords: \| Summary: \| Description: In Part A, MK-4166 doses will be escalated quickly in successive cohorts and based on safety events may progress to Part B, in which the preliminary MTD will be identified. Based on safety events the study may progress to Part C in which the MTD will be confirmed. In Part D, participants will receive escalating doses of MK-4166 plus a fixed dose of pembrolizumab (MK-3475) 200 mg to determine the MTD for MK-4166 in combination with pembrolizumab. Based on safety events in Part D, the study may progress to Part E in which the MTD for MK-4166 in combination with pembrolizumab will be confirmed. With Amendments 05/06, the dose confirmation Part C will be removed and the dose confirmation Part E (combination of MK-4166 and pembrolizumab) will be limited to participants with advanced malignant melanoma. \| ArmGroups: [{'label': 'MK-4166 0.0015 mg', 'type': 'EXPERIMENTAL', 'description': 'Participant received 0.0015 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.', 'interventionNames': ['Biological: MK-4166']}, {'label': 'MK-4166 0.0045 mg', 'type': 'EXPERIMENTAL', 'description': 'Participant received 0.0045 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.', 'interventionNames': ['Biological: MK-4166']}, {'label': 'MK-4166 0.014 mg', 'type': 'EXPERIMENTAL', 'description': 'Participant received 0.014 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.', 'interventionNames': ['Biological: MK-4166']}, {'label': 'MK-4166 0.04 mg', 'type': 'EXPERIMENTAL', 'description': 'Participant received 0.04 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.', 'interventionNames': ['Biological: MK-4166']}, {'label': 'MK-4166 0.12 mg', 'type': 'EXPERIMENTAL', 'description': 'Participant received 0.12 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.', 'interventionNames': ['Biological: MK-4166']}, {'label': 'MK-4166 0.37 mg', 'type': 'EXPERIMENTAL', 'description': 'Participant received 0.37 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.', 'interventionNames': ['Biological: MK-4166']}, {'label': 'MK-4166 1.1 mg', 'type': 'EXPERIMENTAL', 'description': 'Participant received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.', 'interventionNames': ['Biological: MK-4166']}, {'label': 'MK-4166 3.3 mg', 'type': 'EXPERIMENTAL', 'description': 'Participant received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.', 'interventionNames': ['Biological: MK-4166']}, {'label': 'MK-4166 10 mg', 'type': 'EXPERIMENTAL', 'description': 'Participant received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.', 'interventionNames': ['Biological: MK-4166']}, {'label': 'MK-4166 30 mg', 'type': 'EXPERIMENTAL', 'description': 'Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.', 'interventionNames': ['Biological: MK-4166']}, {'label': 'MK-4166 42 mg', 'type': 'EXPERIMENTAL', 'description': 'Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.', 'interventionNames': ['Biological: MK-4166']}, {'label': 'MK-4166 59 mg', 'type': 'EXPERIMENTAL', 'description': 'Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.', 'interventionNames': ['Biological: MK-4166']}, {'label': 'MK-4166 82 mg', 'type': 'EXPERIMENTAL', 'description': 'Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.', 'interventionNames': ['Biological: MK-4166']}, {'label': 'MK-4166 120 mg', 'type': 'EXPERIMENTAL', 'description': 'Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.', 'interventionNames': ['Biological: MK-4166']}, {'label': 'MK-4166 170 mg', 'type': 'EXPERIMENTAL', 'description': 'Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.', 'interventionNames': ['Biological: MK-4166']}, {'label': 'MK-4166 240 mg', 'type': 'EXPERIMENTAL', 'description': 'Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.', 'interventionNames': ['Biological: MK-4166']}, {'label': 'MK-4166 340 mg', 'type': 'EXPERIMENTAL', 'description': 'Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.', 'interventionNames': ['Biological: MK-4166']}, {'label': 'MK-4166 480 mg', 'type': 'EXPERIMENTAL', 'description': 'Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.', 'interventionNames': ['Biological: MK-4166']}, {'label': 'MK-4166 670 mg', 'type': 'EXPERIMENTAL', 'description': 'Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.', 'interventionNames': ['Biological: MK-4166']}, {'label': 'MK-4166 900 mg', 'type': 'EXPERIMENTAL', 'description': 'Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.', 'interventionNames': ['Biological: MK-4166']}, {'label': 'MK-4166 1.1 mg + Pembro', 'type': 'EXPERIMENTAL', 'description': 'Participants received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.', 'interventionNames': ['Biological: MK-4166', 'Biological: Pembrolizumab']}, {'label': 'MK-4166 3.3 mg + Pembro', 'type': 'EXPERIMENTAL', 'description': 'Participants received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.', 'interventionNames': ['Biological: MK-4166', 'Biological: Pembrolizumab']}, {'label': 'MK-4166 10 mg + Pembro', 'type': 'EXPERIMENTAL', 'description': 'Participants received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.', 'interventionNames': ['Biological: MK-4166', 'Biological: Pembrolizumab']}, {'label': 'MK-4166 30 mg + Pembro', 'type': 'EXPERIMENTAL', 'description': 'Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.', 'interventionNames': ['Biological: MK-4166', 'Biological: Pembrolizumab']}, {'label': 'MK-4166 42 mg + Pembro', 'type': 'EXPERIMENTAL', 'description': 'Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.', 'interventionNames': ['Biological: MK-4166', 'Biological: Pembrolizumab']}, {'label': 'MK-4166 59 mg + Pembro', 'type': 'EXPERIMENTAL', 'description': 'Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.', 'interventionNames': ['Biological: MK-4166', 'Biological: Pembrolizumab']}, {'label': 'MK-4166 82 mg + Pembro', 'type': 'EXPERIMENTAL', 'description': 'Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.', 'interventionNames': ['Biological: MK-4166', 'Biological: Pembrolizumab']}, {'label': 'MK-4166 120 mg + Pembro', 'type': 'EXPERIMENTAL', 'description': 'Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.', 'interventionNames': ['Biological: MK-4166', 'Biological: Pembrolizumab']}, {'label': 'MK-4166 170 mg + Pembro', 'type': 'EXPERIMENTAL', 'description': 'Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.', 'interventionNames': ['Biological: MK-4166', 'Biological: Pembrolizumab']}, {'label': 'MK-4166 240 mg + Pembro', 'type': 'EXPERIMENTAL', 'description': 'Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.', 'interventionNames': ['Biological: MK-4166', 'Biological: Pembrolizumab']}, {'label': 'MK-4166 340 mg + Pembro', 'type': 'EXPERIMENTAL', 'description': 'Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.', 'interventionNames': ['Biological: MK-4166', 'Biological: Pembrolizumab']}, {'label': 'MK-4166 480 mg + Pembro', 'type': 'EXPERIMENTAL', 'description': 'Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.', 'interventionNames': ['Biological: MK-4166', 'Biological: Pembrolizumab']}, {'label': 'MK-4166 670 mg + Pembro', 'type': 'EXPERIMENTAL', 'description': 'Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.', 'interventionNames': ['Biological: MK-4166', 'Biological: Pembrolizumab']}, {'label': 'MK-4166 900 mg + Pembro', 'type': 'EXPERIMENTAL', 'description': 'Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.', 'interventionNames': ['Biological: MK-4166', 'Biological: Pembrolizumab']}] \| Interventions:[{'type': 'BIOLOGICAL', 'name': 'MK-4166', 'armGroupLabels': ['MK-4166 0.0015 mg', 'MK-4166 0.0045 mg', 'MK-4166 0.014 mg', 'MK-4166 0.04 mg', 'MK-4166 0.12 mg', 'MK-4166 0.37 mg', 'MK-4166 1.1 mg', 'MK-4166 1.1 mg + Pembro', 'MK-4166 10 mg', 'MK-4166 10 mg + Pembro', 'MK-4166 120 mg', 'MK-4166 120 mg + Pembro', 'MK-4166 170 mg', 'MK-4166 170 mg + Pembro', 'MK-4166 240 mg', 'MK-4166 240 mg + Pembro', 'MK-4166 3.3 mg', 'MK-4166 3.3 mg + Pembro', 'MK-4166 30 mg', 'MK-4166 30 mg + Pembro', 'MK-4166 340 mg', 'MK-4166 340 mg + Pembro', 'MK-4166 42 mg', 'MK-4166 42 mg + Pembro', 'MK-4166 480 mg', 'MK-4166 480 mg + Pembro', 'MK-4166 59 mg', 'MK-4166 59 mg + Pembro', 'MK-4166 670 mg', 'MK-4166 670 mg + Pembro', 'MK-4166 82 mg', 'MK-4166 82 mg + Pembro', 'MK-4166 900 mg', 'MK-4166 900 mg + Pembro']}, {'type': 'BIOLOGICAL', 'name': 'Pembrolizumab', 'armGroupLabels': ['MK-4166 1.1 mg + Pembro', 'MK-4166 10 mg + Pembro', 'MK-4166 120 mg + Pembro', 'MK-4166 170 mg + Pembro', 'MK-4166 240 mg + Pembro', 'MK-4166 3.3 mg + Pembro', 'MK-4166 30 mg + Pembro', 'MK-4166 340 mg + Pembro', 'MK-4166 42 mg + Pembro', 'MK-4166 480 mg + Pembro', 'MK-4166 59 mg + Pembro', 'MK-4166 670 mg + Pembro', 'MK-4166 82 mg + Pembro', 'MK-4166 900 mg + Pembro']}] \| PrimaryOutcomes: [{'measure': 'Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)', 'description': "DLT's were assessed during the first cycle (21 days) for each dose level and included the following if assessed by the Investigator to be possibly, probably or definitely related to MK-4166 or MK-4166 plus pembrolizumab combination: Grade 4 non-hematologic toxicity; Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia (Grade 4 thrombocytopenia of any duration or Grade 3 thrombocytopenia if associated with bleeding); Grade 3 non-hematologic toxicity lasting \\>3 days despite optimal supportive care; Grade 3 nausea, vomiting or diarrhea if \\>3 days despite optimal supportive care; any Grade 3 or Grade 4 non-hematologic laboratory abnormality if medical intervention is required or if leading to hospitalization or if persisting for \\>1 week; febrile neutropenia Grade 3 or Grade 4; any drug-related AE which caused participant to discontinue treatment during Cycle 1; Grade 5 toxicity; any treatment-related toxicity which caused a \\>2 week delay in initiation of Cycle 2.", 'timeFrame': 'Cycle 1 (up to 21 days)'}, {'measure': 'Number of Participants Experiencing Adverse Events (AEs)', 'description': "An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE.\n\nPer protocol, the number of participants experiencing an AE was assessed and reported by arm (MK-4166 monotherapy and MK-4166 plus pembrolizumab combination therapy) as well as by dose cohort.", 'timeFrame': 'From first dose up to 90 days post last dose (up to 27 months)'}, {'measure': 'Number of Participants Discontinuing Study Treatment Due to AEs', 'description': "An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE.\n\nPer protocol, the number of participants discontinuing study treatment due to AEs was assessed and reported by arm (MK-4166 monotherapy and MK-4166 plus pembrolizumab combination therapy) as well as by dose cohort.", 'timeFrame': 'Up to approximately 24 months'}] \| SecondaryOutcomes: [{'measure': 'Maximum Concentration (Cmax) of MK-4166 Over Time', 'description': 'Blood samples were collected at pre-specified time points during Cycles 1-4 and plasma isolated for analysis of MK-4166 Cmax. Cmax was defined as the maximum concentration of MK-4166 reached. MK-4166 Cmax was reported by dose cohort. Per protocol, percent geometric coefficient of variation (%GCV) values were not reported for cohorts with n\\<2 participants.', 'timeFrame': 'Cycles 1-4: Day 1 pre-dose, at end of MK-4166 infusion (up to 10 minutes), 2 hours; Days 2, 3, 5 (Cohorts 1-9 only), 8, 15. Each cycle was 21 days. (Up to ~3 months)'}, {'measure': 'Time to Maximum Concentration (Tmax) of MK-4166 Over Time', 'description': 'Blood samples were collected at pre-specified time points during Cycles 1-4 and plasma isolated for analysis of MK-4166 Tmax. Tmax was defined as time to the maximum concentration of MK-4166 reached. MK-4166 Tmax was reported by dose cohort.', 'timeFrame': 'Cycles 1-4: Day 1 pre-dose, at end of MK-4166 infusion (up to 10 minutes), 2 hours; Days 2, 3, 5 (Cohorts 1-9 only), 8, 15. Each cycle was 21 days. (Up to ~3 months)'}, {'measure': 'Terminal Half-Life (t ½) of MK-4166 Over Time', 'description': 'Blood samples were collected at pre-specified time points during Cycles 1-4 and plasma isolated for analysis of MK-4166 t½. t½ was defined as the time required to divide the MK-4166 plasma concentration by two after reaching pseudo-equilibrium, following a single dose of MK-4166. MK-4166 t½ was reported by dose cohort. Per protocol, % GCV values were not reported for cohorts with n\\<2 participants.', 'timeFrame': 'Cycles 1-4: Day 1 pre-dose, at end of MK-4166 infusion (up to 10 minutes), 2 hours; Days 2, 3, 5 (Cohorts 1-9 only), 8, 15. Each cycle was 21 days. (Up to ~3 months)'}, {'measure': 'Area Under the Concentration-Time Curve of MK-4166 From Time Zero to 21 Hours After Dosing (AUC 0-21) Over Time', 'description': 'Blood samples were collected at pre-specified time points during Cycles 1-4 and plasma isolated for analysis of MK-4166 AUC0-21. AUC0-21 was defined as the area under the concentration-time curve of MK-4166 from time zero to 21 hours after dosing. MK-4166 AUC0-21 was reported by dose cohort. Per protocol, % GCV values were not reported for cohorts with n\\<2 participants.', 'timeFrame': 'Cycles 1-4: Day 1 pre-dose, at end of MK-4166 infusion (up to 10 minutes), 2 hours; Day 2. Each cycle was 21 days. (Up to ~3 months)'}, {'measure': 'Area Under the Concentration-Time Curve of MK-4166 From Time Zero to The Last Quantifiable Sample (AUC 0-last) Over Time', 'description': 'Blood samples were collected at pre-specified time points during Cycles 1-4 and plasma isolated for analysis of MK-4166 AUC0-last. AUC0-last was defined as the area under the concentration-time curve of MK-4166 from time zero to the last quantifiable sample. MK-4166 AUC0-last was reported by dose cohort. Per protocol, % GCV values were not reported for cohorts with n\\<2 participants.', 'timeFrame': 'Cycles 1-4: Day 1 pre-dose, at end of MK-4166 infusion (up to 10 minutes), 2 hours; Days 2, 3, 5 (Cohorts 1-9 only), 8, 15. Each cycle was 21 days. (Up to ~3 months)'}, {'measure': 'Area Under the Concentration-Time Curve of MK-4166 From Time Zero to Infinity (AUC 0-inf) Over Time', 'description': 'Blood samples were collected at pre-specified time points during Cycles 1-4 and plasma isolated for analysis of MK-4166 AUC0-inf. AUC0-inf was defined as the area under the concentration-time curve of MK-4166 from time zero to infinity. MK-4166 AUC0-inf was reported by dose cohort. Per protocol, % GCV values were not reported for cohorts with n\\<2 participants.', 'timeFrame': 'Cycles 1-4: Day 1 pre-dose, at end of MK-4166 infusion (up to 10 minutes), 2 hours; Days 2, 3, 5 (Cohorts 1-9 only), 8, 15. Each cycle was 21 days. (Up to ~3 months)'}, {'measure': 'Apparent Clearance (CL) of MK-4166 Over Time', 'description': 'Blood samples were collected at pre-specified time points during Cycles 1-4 and plasma isolated for analysis of MK-4166 CL. CL was defined as the volume of plasma from which MK-4166 is eliminated per unit time following IV MK-4166 administration. MK-4166 CL was reported by dose cohort. Per protocol, % GCV values were not reported for cohorts with n\\<2 participants.', 'timeFrame': 'Cycles 1-4: Day 1 pre-dose, at end of MK-4166 infusion (up to 10 minutes), 2 hours; Days 2, 3, 5 (Cohorts 1-9 only), 8, 15. Each cycle was 21 days. (Up to ~3 months)'}, {'measure': 'Apparent Volume of Distribution (V) of MK-4166 Over Time', 'description': 'Blood samples were collected at pre-specified time points during Cycles 1-4 and plasma isolated for analysis of MK-4166 V. V was defined as the theoretical volume that would be necessary to contain the total amount of administered MK-4166 at the same concentration that it is observed in the blood plasma. MK-4166 V was reported by dose cohort. Per protocol, % GCV values were not reported for cohorts with n\\<2 participants.', 'timeFrame': 'Cycles 1-4: Day 1 pre-dose, at end of MK-4166 infusion (up to 10 minutes), 2 hours; Days 2, 3, 5 (Cohorts 1-9 only), 8, 15. Each cycle was 21 days. (Up to ~3 months)'}, {'measure': 'Maximum Concentration (Cmax) of Pembrolizumab Over Time', 'description': 'Blood samples were collected at pre-specified time points during Cycles 1-4 from MK-4166 plus pembrolizumab combination cohorts only and plasma isolated for analysis of pembrolizumab Cmax. Cmax was defined as the maximum concentration of pembrolizumab reached. Pembrolizumab Cmax was reported by dose cohort for all participants that received MK-4166 plus pembrolizumab combination therapy. Per protocol, participants receiving MK-4166 monotherapy were excluded from this analysis.', 'timeFrame': 'Cycles 1-4: Day 1 pre-dose, at end of pembro infusion (up to 10 minutes), at end of MK-4166 infusion (up to 10 minutes), ~2 hours after start of MK-4166 infusion, Days 2, 3, 8, 15. Each cycle was 21 days. (Up to ~3 months)'}, {'measure': 'Time to Maximum Concentration (Tmax) of Pembrolizumab Over Time', 'description': 'Blood samples were collected at pre-specified time points during Cycles 1-4 from MK-4166 plus pembrolizumab combination cohorts only and plasma isolated for analysis of pembrolizumab Tmax. Tmax was defined as time to the maximum concentration of pembrolizumab reached. Pembrolizumab Tmax was reported by dose cohort for all participants that received MK-4166 plus pembrolizumab combination therapy. Per protocol, participants receiving MK-4166 monotherapy were excluded from this analysis.', 'timeFrame': 'Cycles 1-4: Day 1 pre-dose, at end of pembro infusion (up to 10 minutes), at end of MK-4166 infusion (up to 10 minutes), ~2 hours after start of MK-4166 infusion, Days 2, 3, 8, 15. Each cycle was 21 days. (Up to ~3 months)'}, {'measure': 'Terminal Half-Life (t ½) of Pembrolizumab Over Time', 'description': 'Blood samples were collected at pre-specified time points during Cycles 1-4 from MK-4166 plus pembrolizumab combination cohorts only and plasma isolated for analysis of pembrolizumab t½. t½ was defined as the time required to divide the pembrolizumab plasma concentration by two after reaching pseudo-equilibrium, following a single dose of pembrolizumab. Pembrolizumab t½ was reported by dose cohort for all participants that received MK-4166 plus pembrolizumab combination therapy. Per protocol, participants receiving MK-4166 monotherapy were excluded from this analysis.', 'timeFrame': 'Cycles 1-4: Day 1 pre-dose, at end of pembro infusion (up to 10 minutes), at end of MK-4166 infusion (up to 10 minutes), ~2 hours after start of MK-4166 infusion, Days 2, 3, 8, 15. Each cycle was 21 days. (Up to ~3 months)'}, {'measure': 'Area Under the Concentration-Time Curve of Pembrolizumab From Time Zero to 21 Hours After Dosing (AUC 0-21) Over Time', 'description': 'Blood samples were collected at pre-specified time points during Cycles 1-4 from MK-4166 plus pembrolizumab combination cohorts only and plasma isolated for analysis of pembrolizumab AUC0-21. AUC0-21 was defined as the area under the concentration-time curve of pembrolizumab from time zero to 21 hours after dosing. Pembrolizumab AUC0-21 was reported by dose cohort for all participants that received MK-4166 plus pembrolizumab combination therapy. Per protocol, participants receiving MK-4166 monotherapy were excluded from this analysis.', 'timeFrame': 'Cycles 1-4: Day 1 pre-dose, at end of pembro infusion (up to 10 minutes), at end of MK-4166 infusion (up to 10 minutes), ~2 hours after start of MK-4166 infusion, Day 2. Each cycle was 21 days. (Up to ~3 months)'}, {'measure': 'Area Under the Concentration-Time Curve of Pembrolizumab From Time Zero to The Last Quantifiable Sample (AUC 0-last) Over Time', 'description': 'Blood samples were collected at pre-specified time points during Cycles 1-4 from MK-4166 plus pembrolizumab combination cohorts only and plasma isolated for analysis of pembrolizumab AUC0-last. AUC0-last was defined as the area under the concentration-time curve of pembrolizumab from time zero to the last quantifiable sample. Pembrolizumab AUC0-last was reported by dose cohort for all participants that received MK-4166 plus pembrolizumab combination therapy. Per protocol, participants receiving MK-4166 monotherapy were excluded from this analysis.', 'timeFrame': 'Cycles 1-4: Day 1 pre-dose, at end of pembro infusion (up to 10 minutes), at end of MK-4166 infusion (up to 10 minutes), ~2 hours after start of MK-4166 infusion, Days 2, 3, 8, 15. Each cycle was 21 days. (Up to ~3 months)'}, {'measure': 'Area Under the Concentration-Time Curve of Pembrolizumab From Time Zero to Infinity (AUC 0-inf) Over Time', 'description': 'Blood samples were collected at pre-specified time points during Cycles 1-4 from MK-4166 plus pembrolizumab combination cohorts only and plasma isolated for analysis of pembrolizumab AUC0-inf. AUC0-inf was defined as the area under the concentration-time curve of pembrolizumab from time zero to infinity. Pembrolizumab AUC0-inf was reported by dose cohort for all participants that received MK-4166 plus pembrolizumab combination therapy. Per protocol, participants receiving MK-4166 monotherapy were excluded from this analysis.', 'timeFrame': 'Cycles 1-4: Day 1 pre-dose, at end of pembro infusion (up to 10 minutes), at end of MK-4166 infusion (up to 10 minutes), ~2 hours after start of MK-4166 infusion, Days 2, 3, 8, 15. Each cycle was 21 days. (Up to ~3 months)'}, {'measure': 'Apparent Clearance (CL) of Pembrolizumab Over Time', 'description': 'Blood samples were collected at pre-specified time points during Cycles 1-4 from MK-4166 plus pembrolizumab combination cohorts only and plasma isolated for analysis of pembrolizumab CL. CL was defined as the volume of plasma from which pembrolizumab is eliminated per unit time following IV pembrolizumab administration. Pembrolizumab CL was reported by dose cohort for all participants that received MK-4166 plus pembrolizumab combination therapy. Per protocol, participants receiving MK-4166 monotherapy were excluded from this analysis.', 'timeFrame': 'Cycles 1-4: Day 1 pre-dose, at end of pembro infusion (up to 10 minutes), at end of MK-4166 infusion (up to 10 minutes), ~2 hours after start of MK-4166 infusion, Days 2, 3, 8, 15. Each cycle was 21 days. (Up to ~3 months)'}, {'measure': 'Apparent Volume of Distribution (V) of Pembrolizumab Over Time', 'description': 'Blood samples were collected at pre-specified time points during Cycles 1-4 from MK-4166 plus pembrolizumab combination cohorts only and plasma isolated for analysis of pembrolizumab V. V was defined as the theoretical volume that would be necessary to contain the total amount of administered pembrolizumab at the same concentration that it is observed in the blood plasma. Pembrolizumab V was reported by dose cohort for all participants that received MK-4166 plus pembrolizumab combination therapy. Per protocol, participants receiving MK-4166 monotherapy were excluded from this analysis.', 'timeFrame': 'Cycles 1-4: Day 1 pre-dose, at end of pembro infusion (up to 10 minutes), at end of MK-4166 infusion (up to 10 minutes), ~2 hours after start of MK-4166 infusion, Days 2, 3, 8, 15. Each cycle was 21 days. (Up to ~3 months)'}, {'measure': 'Glucocorticoid-Induced Tumor Necrosis Factor Receptor-Related Protein (GITR) Receptor Availability Following MK-4166 Administration', 'description': 'GITR protein receptor is internalized upon binding by MK-4166. To evaluate GITR target engagement, a GITR receptor availability assay was developed to assess the availability of cell surface GITR following administration of MK-4166. GITR was detected on CD4+CD25+ and CD4+CD95+ T-cell sub-populations in peripheral blood using flow cytometry. GITR receptor availability on representative CD4+ CD25+ T cell subsets following MK-4166 administration was reported over time for each dose cohort.', 'timeFrame': 'Cycle 1 Day 1: at end of infusion (up to 10 minutes), 2 hours post-infusion, Cycle 1 Days 2, 3, 5, 8, 15, Cycle 2 Day 1 pre-dose. Each cycle was 21 days.'}]
Title: A Phase 1, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-881 in Patients With Advanced Solid Tumors, Including Gliomas, With an IDH1 and/or IDH2 Mutation \| Condition: Glioma \| Keywords: Glioma, IDH1, IDH2, Dual Mutation, AG-881 \| Summary: \| Description: The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-881 in gliomas, that harbor an IDH1and/or IDH2 mutation. The first portion of the study is a dose escalation phase where cohorts of patients will receive ascending oral doses of AG-881 to determine the maximum tolerated dose (MTD) and/or the recommended Phase II dose. The second portion of the study is a dose expansion phase where patients will receive AG-881 to further evaluate the safety, tolerability, and clinical activity of the recommended Phase II dose. The anticipated time on study treatment is until disease progression, unacceptable toxicity occurs or the patient is removed at the discretion of the investigator \| ArmGroups: [{'label': 'AG881', 'type': 'EXPERIMENTAL', 'description': 'AG-881 administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle. Patients may continue treatment with AG-881 until disease progression, development of other unacceptable toxicity or Investigator discretion', 'interventionNames': ['Drug: AG881']}] \| Interventions:[{'type': 'DRUG', 'name': 'AG881', 'description': 'AG-881 administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle. Patients may continue treatment with AG-881 until disease progression or development of other unacceptable toxicity', 'armGroupLabels': ['AG881']}] \| PrimaryOutcomes: [{'measure': 'Safety/Tolerability; incidence of adverse events', 'timeFrame': 'Up to 26 weeks, on average'}, {'measure': 'Maximum Tolerated Dose and/or the recommended Phase II dose of AG881 in patients with advance solid tumors, including gliomas', 'timeFrame': 'Up to 26 weeks, on average'}] \| SecondaryOutcomes: [{'measure': 'Pharmacokinetic profiles including max concentration (Cmax), time to maximum concentration (Tmax), AUC, and elimination half-life', 'timeFrame': 'Up to 26 weeks, on average'}, {'measure': 'Pharmacodynamic levels of AG-881', 'timeFrame': 'Up to 26 weeks, on average'}, {'measure': 'Pharmacodynamic levels of 2-HG', 'timeFrame': 'Up to 26 weeks, on average'}, {'measure': 'Clinical Activity according to RECIST v 1.1 (2009) for patients with solid tumors, by RANO (2010) criteria for patients with glioma', 'timeFrame': 'Up to 26 weeks, on average'}]
Title: Oxaliplatin Phase II Trial in Association With 5FU and Folinic Acid in the Treatment of Advanced Unresectable or Metastatic Gastric Cancer. \| Condition: Stomach Neoplasms \| Keywords: \| Summary: \| Description: N/A \| ArmGroups: N/A \| Interventions:[{'type': 'DRUG', 'name': 'Oxaliplatin'}] \| PrimaryOutcomes: [{'measure': 'To evaluate response rate according to RECIST criteria'}, {'measure': 'To evaluate the progression-free survival in the ITT population'}] \| SecondaryOutcomes: [{'measure': 'To evaluate the overall survival in the ITT population'}, {'measure': 'To investigate safety using NCI-CTC criteria version 2'}]
Title: Phase I / II Study on Infusion of Alloreactive or Stimulated Natural Killer Cells With IL-15 ex Vivo After Haploidentical Transplantation of Hematopoietic Progenitors in Pediatric Patients With Hematological Neoplasms \| Condition: High-risk Leukemias \| Keywords: \| Summary: \| Description: Haploidentical hematopoietic stem cell transplantation (haploTPH) constitutes a highly complex but effective procedure for some hematologic malignancies high-risk pediatric patients in the absence of an identical HLA donor. Relapse Post-transplant leukemia is the main problem for survival. Just like reported different expert groups on haploTPH in adults and children, there is a determining role of Natural Killer (NK) cells in haploTPH as inducers powerful graft-versus-leukemia (EIcL) effect. The presence of NK cells allo-reactive is correlated with a lower relapse rate, in addition to favoring the graft, decrease graft versus recipient disease (GVHD) and decrease viral infections. This only occurs in half of the donor-recipient pairs, so that, in its absence, it is necessary to develop other strategies for activating the NK cells. In this sense, the investigational group has extensive experience in research translational with NK cells and is a pioneer in infusing ex vivo activated NK cells with IL-15. The investigators propose a phase I / II clinical trial with dose escalation, multicenter, framed in the Spanish Group of Hematopoietic Transplantation / Marrow Transplant Bone in Children (GETH / GETMON), to determine the safety and efficacy of a post-haploTPH IL-15 alloreactive / stimulated NK cell infusion in children with malignant blood diseases. The investigators will monitor immune reconstitution, chimerism, Post-transplantation NK cell expansion, phenotype, and function. Secondarily evaluate the effectiveness of therapy on the incidence of graft failure; EICR; viral reactivations; transplant-related mortality; and relapse of leukemia. \| ArmGroups: [{'label': 'KIR mismatch aloreactive NK donor cells', 'type': 'ACTIVE_COMPARATOR', 'description': 'Three patients from each cohort will receive NK aloreactive cells from a KIR mismatch donor', 'interventionNames': ['Biological: Alloreactive NK cells']}, {'label': 'NK cells stimulated ex vivo with IL-15 from KIR match donor', 'type': 'EXPERIMENTAL', 'description': 'Three patients in each cohort will receive ex vivo stimulated NK cells with IL-15 from a KIR match donor.', 'interventionNames': ['Biological: NK cells stimulated ex vivo with IL-15']}] \| Interventions:[{'type': 'BIOLOGICAL', 'name': 'NK cells stimulated ex vivo with IL-15', 'description': 'When patient and donor are KIR-HLA match, the patient submits all HLA class I molecules, or in the absence of any, your donor does not have this molecule, or having it lacks the corresponding KIR receiver. For more information detailed information on the product under investigation, reference is made to the Dossier of the Research Product (IMPD): PEI 09-008', 'armGroupLabels': ['NK cells stimulated ex vivo with IL-15 from KIR match donor']}, {'type': 'BIOLOGICAL', 'name': 'Alloreactive NK cells', 'description': 'When the patient lacks the HLA class I molecule and his donor has this molecule and also the donor NK cells have the KIR receptor that recognizes the absence of the corresponding HLA class I ligand', 'armGroupLabels': ['KIR mismatch aloreactive NK donor cells']}] \| PrimaryOutcomes: [{'measure': 'Dose-limiting toxicity (TLD)', 'description': 'To determine dose-limiting toxicity (TLD) of a single infusion of aloreactive NK cells or ex vivo IL-15-stimulated NK cells after haploTPH in pediatric patients with high-risk leukemias.', 'timeFrame': '52 weeks'}, {'measure': 'Maximum tolerated dose (MTD)', 'description': 'To determine maximum tolerated dose (MTD) of a single infusion of aloreactive NK cells or ex vivo IL-15-stimulated NK cells after haploTPH in pediatric patients with high-risk leukemias.', 'timeFrame': '52 weeks'}] \| SecondaryOutcomes: [{'measure': 'Efficacy of post haploTPH NK cell therapy', 'description': 'The efficacy of post haploTPH NK cell therapy will be determined, comparing it with the historical cohort recently reported by GETH/GETMON in the incidence of graft failure, acute/chronic GVHD, viral reactivations (CMV, EBV, HHV-6, adenovirus, BKV), transplant-related mortality (TRM), and leukemia relapse.', 'timeFrame': 'Week 52'}, {'measure': 'Clinical evolution of patients', 'description': 'The clinical course of patients will be compared based on the dose of infused NK cells, KIR match vs. KIR mismatch NK cells, expansion, chimerism, and phenotypic and functional characteristics of the infused NK cells, and the speed and characteristics of immune reconstitution post haploTPH.', 'timeFrame': 'Week 52'}, {'measure': 'Monitor immune reconstitution and characterize NK cells', 'description': 'Immune reconstitution will be monitored by quantifying immunoglobulins at different times, and characterizing NK cells in patients, at a phenotypic and functional level, for 1 year after haploTPH', 'timeFrame': 'Week 52'}]
Title: A Phase I Study of Single Agent OSI-774 (Tarceva) (NSC# 718781, IND# 63383) Followed by OSI-774 With Temozolomide for Patients With Selected Recurrent/Refractory Solid Tumors, Including Brain Tumors \| Condition: Previously Treated Childhood Rhabdomyosarcoma, Recurrent Childhood Brain Tumor, Recurrent Childhood Cerebellar Astrocytoma, Recurrent Childhood Cerebral Astrocytoma, Recurrent Childhood Ependymoma, Recurrent Childhood Malignant Germ Cell Tumor, Recurrent Childhood Medulloblastoma, Recurrent Childhood Rhabdomyosarcoma, Recurrent Childhood Soft Tissue Sarcoma, Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor, Recurrent Neuroblastoma, Recurrent Osteosarcoma \| Keywords: \| Summary: \| Description: PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose of erlotinib in children with recurrent or refractory solid tumors. II. Determine the dose-limiting toxic effects of this drug alone and with temozolomide in these patients. III. Determine the tolerability of this regimen in these patients. IV. Determine the pharmacokinetics of this regimen in these patients. SECONDARY OBJECTIVES: I. Determine, preliminarily, the antitumor activity of this regimen in these patients. OUTLINE: This is a 2-part, multicenter, dose-escalation study of erlotinib. Patients are stratified according to pretreatment (heavily pretreated \[received more than 2 prior multiagent myelosuppressive chemotherapy regimens OR received prior craniospinal or pelvic radiotherapy or bone marrow transplantation OR has bone marrow involvement\] vs less heavily pretreated).Part 1: Patients receive oral erlotinib once daily on days 1-28. Beginning with course 2, patients also receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 23 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of erlotinib during course 1 only until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Part 2: Patients receive erlotinib (at the MTD) and temozolomide as in part 1. PROJECTED ACCRUAL: A total of 9-45 patients (9-24 for part 1 and up to 21 for part 2) will be accrued for this study. \| ArmGroups: [{'label': 'Treatment (erlotinib hydrochloride, temozolomide)', 'type': 'EXPERIMENTAL', 'description': 'Patients receive oral erlotinib once daily on days 1-28. Beginning with course 2, patients also receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 23 courses in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: erlotinib hydrochloride', 'Drug: temozolomide', 'Other: pharmacological study', 'Other: laboratory biomarker analysis']}] \| Interventions:[{'type': 'DRUG', 'name': 'erlotinib hydrochloride', 'description': 'Given orally (PO)', 'armGroupLabels': ['Treatment (erlotinib hydrochloride, temozolomide)'], 'otherNames': ['CP-358,774', 'erlotinib', 'OSI-774']}, {'type': 'DRUG', 'name': 'temozolomide', 'description': 'Given PO', 'armGroupLabels': ['Treatment (erlotinib hydrochloride, temozolomide)'], 'otherNames': ['SCH 52365', 'Temodal', 'Temodar', 'TMZ']}, {'type': 'OTHER', 'name': 'pharmacological study', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (erlotinib hydrochloride, temozolomide)'], 'otherNames': ['pharmacological studies']}, {'type': 'OTHER', 'name': 'laboratory biomarker analysis', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (erlotinib hydrochloride, temozolomide)']}] \| PrimaryOutcomes: [{'measure': 'Dose-limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0', 'timeFrame': '56 days (2 courses)'}, {'measure': 'Maximum-tolerated dose (MTD) based on the incidence of DLT as assessed by NCI CTCAE version 3.0', 'timeFrame': '56 days (2 courses)'}, {'measure': 'Pharmacokinetics of erlotinib hydrochloride', 'timeFrame': 'At baseline and at 0.5, 1, 2, 4, 6, 8, and 24 hours of course 1'}] \| SecondaryOutcomes: N/A
Title: CLASSICA: Validating AI in Classifying Cancer in Real-Time Surgery Study 1 \| Condition: Rectum Neoplasm, Rectum Polyp, Rectal Cancer \| Keywords: Fluorescence, Indocyanine green, Tumour classification, Artificial Intelligence \| Summary: \| Description: Rectal polyps \>2cm in size (affecting c. 10,000 patients a year in Europe alone) represent a considerable clinical challenge. While smaller polyps can be addressed by routine endoscopic polypectomy and frank clinical cancer will advance through a traditional cancer surgery paradigm, polyps of this size have the option of being locally excised, intact by transanal endoscopic resection (also referred to as Transanal Minimally Invasive Surgery, TAMIS). This is the treatment of choice in this site due to its ability to provide a single complete unfragmented specimen versus other modalities (e.g. endoscopic submucosal resection). While the technology and training to enable transanal resection has become much more available over the past decade (especially TAMIS) meaning more patients can have large benign lesions and even some early rectal cancers excised in their local specialist centres, the major brake now on such care is patient selection: i.e. how to tell if a given patient has a benign polyp or a cancer in advance of its resection. Endoscopic biopsies are notoriously inaccurate in up to 20% of such lesions (rectal cancers commence most often as adenomatous lesions and so superficial biopsies may miss a malignant focus). Mistakenly identifying a cancer as a benign lesion and treating it by local excision significantly worsens prognosis and compromises subsequent cancer surgery - including potentially converting a reconstructable site of resection (i.e. a lesion suitable for anterior resection) to an unreconstructable one (i.e. needing an abdominoperineal resection with permanent colostomy) and by seeding cancer cells into a deep margin or different plane, particularly as in the case for anteriorly positioned lesions. Additionally, transanal excision techniques continue to have relatively high rates of positive margins; this risks regrowth in benign lesions and limits effective local therapy for earliest stage cancers due to the presence of inapparent disease close to the main tumour bulk. We have previously demonstrated, through the use of fluorescent indocyanine green (ICG), that perfusion is visibly different, between tumour and healthy tissue. This difference can be captured via infrared video and mathematical analysis can differentiate the perfusion pattern of malignant areas from any benign/normal tissue also visible in the same endoscopic view. In brief, the saturation of fluorescence in each region of interest (ie tumour or area of normal mucosa), can be measured from the recorded video using existing software developed by IBM. The change in fluorescence over time can be plotted on a curve, demonstrating the inflow, peak and outflow of ICG, which is depending on the perfusion patters within the region of interest. These curves differ depending on the tissue being examined and so can be used to classify benign from malignant tumours through calculating the slope of the uptake and area under the curve to measure outflow. Therefore, in a location (such as the rectum) where a cancer is suspected, analysis of the video can be used to differentiate between healthy and cancerous tissues. This discovery can be made exploited for clinical use by the application of AI methods including computer vision and machine learning. In essence, the fluorescence intensity of pixels displaying tissues of interest varies with blood flow (perfusion), when the blood is dyed with ICG and lit by near-infra-red (NIR) light. The intensity is captured over time, from multiple video frames, and this intensity is plotted as a curve. The intensity curves of tumour tissue are different from those of healthy tissue, and those of benign tumours are different from malignant tumours. Analysis of the curve features for each pixel in a region of interest can thus lead to a classification. Such an AI system has been prototyped and trained in the Mater Hospital previously with videos from a population of Irish cancer patients from two regional centres, so that it can automatically identify malignant tumours and benign lesions from healthy tissue by their perfusion patterns. This prototype has previously demonstrated accuracy of \>80%. In this study, we clinically validate the basic concept or method of classifying tissue by its fluorescence signal characteristics while also seeing if a device can be built on the basis of this that can extrapolate the data being generated from the videos by UCD staff. We also address the question of generalisability - can other surgeons use the system and get similar results from their specific patient cohorts? This will pave the way for future studies which are planned to determine the roles of biopsy (can the system enable optimal choice of biopsied tissue, and thus reduce biopsy error?); and tumour resection (can the system increase the completeness and accuracy of tumour resection?). \| ArmGroups: [{'label': 'Rectal tumour without prior evidence of cancer', 'description': '400 patients with a known rectal tumour that has not demonstrated evidence of cancer to date - may be benign or indeterminate on biopsy or without biopsy performed to date.\n\nPatients in this cohort will undergo examination under anaesthesia as is standard of care. During this examination the pattern of fluorescence seen in NIR camera within the tumour will be observed following administration of ICG (dose 0.25mg/kg) and recorded. Following this, patients will continue with standard of care at the discretion of their surgeon.\n\nThe operative video will be uploaded to a secure cloud based system and annotated by the surgeon where further mathematical analysis will be carried out for the purposes of tissue classification.'}, {'label': 'Rectal tumour previously confirmed as cancerous', 'description': '200 patients with a rectal tumour that has proven previously to contain cancer. Both patients who have and have not undergone neoadjuvant therapy are suitable for inclusion in this group.\n\nPatients in this group will undergo the same processes as the patients in cohort 1.'}] \| Interventions:N/A \| PrimaryOutcomes: [{'measure': 'Validation of tissue classification through fluorescence perfusion', 'description': 'The primary objective of CLASSICA Study 1 is to validate the concept of tissue characterisation by ICG signal perfusion patterns in a large series of data across multiple centres using mathematical models. Accuracy of this measurement will be determined through calculation of sensitivity and specificity rates of the classification system.', 'timeFrame': '48 months'}] \| SecondaryOutcomes: [{'measure': 'Usability of video sharing and annotation technology in multiple sites', 'description': 'CLASSICA-Web and CLASSICA-OR platforms will be deployed across all five clinical sites. Accessability and usablity of these systems will be assessed through user surveys and analysis of video quality measures.', 'timeFrame': '48 months'}]
Title: [68Ga]Ga-FAPI PET/CT: The Dagnostic Accuracy for Primary Staging and Re-staging After Chemotherapy in Patients With Gastric and Gastro-esophageal Junctional Cancer \| Condition: Gastric Cancer, Gastro Esophageal Junctional Cancer, Cancer \| Keywords: PET/CT, Cancer, Fibroblast activation protein inhibitor, FAPI, FAPI PET/CT \| Summary: \| Description: A new and promising PET-tracer in oncology has been developed; Gallium-68 labelled fibroblast activation protein inhibitor (FAPI). In general, FAPI PET/CT delivers increased sensitivity compared to 18F-Fluorodeoxyglucose (FDG) PET/CT in cancer types of mesenchymal origin (i.e., sarcomas), and in cancers characterized by a large proportion of stromal cells such as gastric and pancreatic cancers. It is currently debated whether FAPI PET/CT will take over FDG PET/CTs well-established role in oncological PET/CT, but more studies are needed to evaluate the diagnostic accuracy. The clinical interest in FAPI extends beyond the use as a diagnostic tool, as the 68Ga-isotope can be replaced by a β-emitting isotope, e.g., 177-Lu or 90-Y, enabling radionuclide therapy of FAPI-avid cancers. In recent comparative studies of FDG- and FAPI PET/CT, all primary tumors of the stomach were detected on FAPI PET, whereas the reported detection rate on FDG PET ranged from 40% to 86%. Regarding metastases, FAPI PET/CT showed comparable or better detection rate for regional lymph nodes, but outperformed FDG PET/CT in the detection of peritoneal and other distant metastases. Re-staging with FAPI PET after chemotherapy has been attempted in only a handful of patients and seems feasible. Even though the results of FAPI PET/CT compared to conventional imaging seem convincing, there are several limitations and therefore FAPI PET/CT is not yet implemented in cancer diagnostics. The investigators are conducting a prospective explorative study complying with the Standard for Reporting Diagnostic Accuracy (STARD) criteria where 20 patients with gastric cancer or gastro-eophageal junctional cancer are recruited. Study subject will undergo FAPI PET/CT at primary staging (before treatment, i.e., neoadjuvant chemotherapy or surgery) and at restaging (after neoadjuvant chemotherapy - before surgery) in addition to routing diagnostic workup (including FDG PET/CT). The FAPI PET/CT will be blinded and the choice of treatment will not be influence by the FAPI PET/CT results'. The additional scans will not interfere with or delay routine diagnostic workup or treatment. The FAPI PET/CTs (at primary staging and restaging) will be compared to the corresponding FDG PET/CTs, and histopathology of biopsied material and surgical specimens will serve as reference standard. FAPI PET/CTs before and after neoadjuvant chemotherapy will be assessed and compared to the FDG PET/CTs. FAP-immunohistochemistry will be conducted in surgical specimens. A tentative retrospective Multi-Disciplinary Team conference (MDT) will be arranged where treating clinicans are presented the FAPI PET/CT, and potential changes in patient management will be evaluated. This tentative MDT will not influence patient management. Follow up will be conducted for 10 years to evaluate the prognostic value of FAPI PET/CT. \| ArmGroups: [{'label': 'Gastric or gastro-esophageal junctioncancer', 'type': 'EXPERIMENTAL', 'description': 'Patients with biopsy verified gastric or gastro-esophageal junction cancer undergo FAPI PET/CT in addition to conventional imaging', 'interventionNames': ['Drug: 68Ga-FAPi-46']}] \| Interventions:[{'type': 'DRUG', 'name': '68Ga-FAPi-46', 'description': 'Gastric or gatro-esophageal junction cancer patients undergo 68Ga-FAPi-46 PET/CT at primary staging and at restaging', 'armGroupLabels': ['Gastric or gastro-esophageal junctioncancer']}] \| PrimaryOutcomes: [{'measure': 'Diagnostic accuracy', 'description': 'Compare the FAPI PET/CT and FDG PET/CT findings in primary tumor, regional lymph nodes and distant metastases to a histopathological reference standard where the sensitivity, specificity, positive predicative value, and negative predicative values of the PET/CTs are determined, both at primary staging and at restaging', 'timeFrame': '1.5 years'}, {'measure': 'Staging', 'description': 'Compare the cancer stage (according to AJCC 8th edition TNM-classification) as determined by FAPI PET/CT compared to conventional imaging (including FDG PET/CT) at primary staging and at restaging (after neoadjuvant chemotherapy). The proportion of patients downstaged, unchanged stage, and upstaged, due to the added FAPI PET/CT are determined.', 'timeFrame': '1.5 years'}, {'measure': 'Patient management', 'description': 'Investigate what proportion of patients will be (hypothetically) treated differently due to an added FAPI PET/CT at primary staging and at restaging (after neoadjuvant chemotherapy) by the treating clinicians', 'timeFrame': '1.5 - 2 years'}] \| SecondaryOutcomes: [{'measure': 'Uptake values', 'description': 'Standardized uptake value (SUV) and tumor to background ratio (TBR) values for primary, regional lymph nodes, and distant metastases for FAPI PET/CT and compare these values to FDG PET/CT, both at primary staging and at restaging (after neoadjuvant chemotherapy)', 'timeFrame': '1.5 years'}, {'measure': 'Chemotherapy effect on uptake values', 'description': 'Changes in SUV and TBR in primary, regional lymph nodes, and distant metastases for FAPI PET/CT - from before to after neoadjuvant chemotherapy and compare these values to the FDG PET/CT parameters.', 'timeFrame': '1.5 - 2 years'}, {'measure': 'Unexpected FAPI PET/CT findings', 'description': 'Seek supplementary information in medical records, biochemistry, pathology, or other imaging modalities for a final diagnosis/condition in cases of unexpected FAPI PET/CT findings not related to the known cancer', 'timeFrame': '1 -2 years'}, {'measure': 'Interobserver readability', 'description': 'Conduct an interobserver study of FAPI PET/CTs performed in the present and other future FAPI PET/CT in cancers studies.', 'timeFrame': '4 years'}, {'measure': 'Prognostic value', 'description': 'Investigate the prognostic value of FAPI PET/CT versus FDG PET/CT by conducting a 10 years follow up on included cancer patients. Overall survival (OS) and Recurrence free survival (RFS) will be estimated', 'timeFrame': '10 years'}]
Title: A Phase 1/1b Open-label, First-in-human, Single Agent, Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of SAR443216 in Participants With Relapsed/Refractory HER2 Expressing Solid Tumors. \| Condition: Neoplasm Malignant, Breast Cancer, Lung Neoplasm Malignant, Gastric Cancer, Neoplasm \| Keywords: \| Summary: \| Description: The expected duration of study intervention for participants may vary, based on progression date; median expected duration of study per participant is estimated to be: * 7.5 months (up to 1 month for screening, a median of 3.5 months for treatment, and a median of 3 months for long term follow-up) in escalation. * 9.5 months (up to 1 month for screening, a median of 5.5 months for treatment, and a median of 3 months for long term follow-up) in expansion. \| ArmGroups: [{'label': 'SAR443216-Dose Escalation', 'type': 'EXPERIMENTAL', 'description': 'Participants with metastatic solid tumors that express HER2 in tumor tissue and/or with HER2 aberration will receive SAR443216 as intravenous (IV) infusion or subcutaneous (SC) injection.', 'interventionNames': ['Drug: SAR443216 IV', 'Drug: SAR443216 SC']}, {'label': 'SAR443216-Dose Expansion - metastatic breast cancers with HER2 high expression: Cohort A', 'type': 'EXPERIMENTAL', 'description': 'Participants with metastatic breast cancers with HER2 high expression (with amplification) will receive SAR443216 as intravenous (IV) infusion.', 'interventionNames': ['Drug: SAR443216 IV']}, {'label': 'SAR443216-Dose Expansion- metastatic breast cancers with HER2 low expression: Cohort B', 'type': 'EXPERIMENTAL', 'description': 'Participants with metastatic breast cancers with HER2 low expression or HER2 mutation (without amplification) will receive SAR443216 as intravenous (IV) infusion.', 'interventionNames': ['Drug: SAR443216 IV']}, {'label': 'SAR443216-Dose Expansion- metastatic gastric cancers with HER2 low expression: Cohort C', 'type': 'EXPERIMENTAL', 'description': 'Participants with metastatic gastric cancers with HER2 low expression or HER2 mutation (without amplification) will receive SAR443216 as intravenous (IV) infusion.', 'interventionNames': ['Drug: SAR443216 IV']}, {'label': 'SAR443216-Dose Expansion - metastatic NSCLC with HER2 low or high expression: Cohort D', 'type': 'EXPERIMENTAL', 'description': 'Participants with metastatic NSCLC with HER2 low or high expression and/or HER2 mutation will receive SAR443216 as intravenous (IV) infusion.', 'interventionNames': ['Drug: SAR443216 IV']}] \| Interventions:[{'type': 'DRUG', 'name': 'SAR443216 IV', 'description': 'Pharmaceutical form: Powder for solution; Route of administration: IV infusion', 'armGroupLabels': ['SAR443216-Dose Escalation', 'SAR443216-Dose Expansion - metastatic NSCLC with HER2 low or high expression: Cohort D', 'SAR443216-Dose Expansion - metastatic breast cancers with HER2 high expression: Cohort A', 'SAR443216-Dose Expansion- metastatic breast cancers with HER2 low expression: Cohort B', 'SAR443216-Dose Expansion- metastatic gastric cancers with HER2 low expression: Cohort C']}, {'type': 'DRUG', 'name': 'SAR443216 SC', 'description': 'Pharmaceutical form: Powder for solution; Route of administration: SC injection', 'armGroupLabels': ['SAR443216-Dose Escalation']}] \| PrimaryOutcomes: [{'measure': 'Part 1: Dose Escalation Determine the MTD/maximum administered dose (MAD) and RD(s) of SAR443216', 'description': 'Incidence of study dose limiting toxicities (DLTs)', 'timeFrame': 'Cycle 1, cycle duration is 28 days for 2-week lead-in schedule and 35 days for 3-week lead-in schedule'}, {'measure': 'Part 1: Dose Escalation: Safety of SAR443216', 'description': 'Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and lab abnormalities according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.', 'timeFrame': 'Baseline until end of study, up to approximately 7.5 months'}, {'measure': 'Part 2: Dose Expansion Objective response rate (ORR) of SAR443216 in all participants', 'description': 'Objective response rate is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) per RECIST v1.1.', 'timeFrame': 'From date of enrollment until the end of treatment, up to approximately 5.5 months'}, {'measure': 'Part 2: Dose Expansion Duration of response (DoR) of SAR443216 in all participants.', 'description': 'Duration of response per RECIST v1.1 is defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of definitive disease progression or death due to any cause, whichever occurs first.', 'timeFrame': 'From date of enrollment until the end of treatment, up to approximately 5.5 months'}] \| SecondaryOutcomes: [{'measure': 'Part 1: Objective response rate (ORR) of SAR443216 in all participants', 'description': 'Objective response rate is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) per RECIST v1.1.', 'timeFrame': 'From date of enrollment until the end of treatment, up to approximately 3.5 months'}, {'measure': 'Part 1: Duration of response (DoR) of SAR443216 in all participants', 'description': 'Duration of response per RECIST v1.1 is defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of definitive disease progression or death due to any cause, whichever occurs first', 'timeFrame': 'From date of enrollment until the end of treatment, up to approximately 3.5 months'}, {'measure': 'Part 1 and Part 2: Progression Free Survival (PFS)', 'description': 'Progression free survival (PFS) will be assessed by the Investigator per RECIST v1.1 and will be summarized using the Kaplan-Meier method', 'timeFrame': 'From date of enrollment until the end of treatment, up to approximately 3.5 months for Part1 and 5.5 months for Part 2'}, {'measure': 'Part 2: Safety of SAR443216', 'description': 'Number of participants with treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and lab abnormalities according to NCI CTCAE Version 5.0', 'timeFrame': 'Baseline until the end of the study, up to approximately 9.5 months'}, {'measure': 'Part 1 and Part 2: Pharmacokinetic Parameter: Cmax of SAR443216', 'description': 'Maximum observed plasma concentration', 'timeFrame': 'From date of enrollment until the end of treatment, up to approximately 3.5 months for Part 1 and 5.5 months for Part 2'}, {'measure': 'Part 1 and Part 2: Pharmacokinetic Parameter: Ctrough of SAR443216', 'description': 'Plasma concentration observed just before treatment administration during repeated dosing', 'timeFrame': 'From date of enrollment until the end of treatment, up to approximately 3.5 months for Part 1 and 5.5 months for Part 2'}, {'measure': 'Part 1 and Part 2: Pharmacokinetic Parameter: t 1/2 of SAR443216', 'description': 'Terminal half-life associated with the terminal slope (λz)', 'timeFrame': 'From date of enrollment until the end of treatment, up to approximately 3.5 months for Part 1 and 5.5 months for Part 2'}, {'measure': 'Part 1 and Part 2: Pharmacokinetic Parameter: AUC0-τ of SAR443216', 'description': 'Area under the plasma concentration versus time curve', 'timeFrame': 'From date of enrollment until the end of treatment, up to approximately 3.5 months for Part 1 and 5.5 months for Part 2'}, {'measure': 'Part 1 and Part 2: Evaluation of SAR443216 immunogenicity', 'description': 'Incidence of ADA induction and ADA persistence', 'timeFrame': 'From date of enrollment until the end of treatment, up to approximately 3.5 months for Part 1 and 5.5 months for Part 2'}]
Title: Multi-Center Phase II Randomized Controlled Trial of Naïve T Cell Depletion for Prevention of Chronic Graft-Versus-Host Disease in Children and Young Adults \| Condition: Acute Biphenotypic Leukemia, Acute Leukemia, Acute Leukemia of Ambiguous Lineage, Acute Lymphoblastic Leukemia, Acute Undifferentiated Leukemia, Allogeneic Hematopoietic Stem Cell Transplantation Recipient, Blastic Plasmacytoid Dendritic Cell Neoplasm, Blasts Under 25 Percent of Bone Marrow Nucleated Cells, Blasts Under 5 Percent of Bone Marrow Nucleated Cells, Mixed Phenotype Acute Leukemia, Myelodysplastic Syndrome With Excess Blasts-1, Myelodysplastic Syndrome/Acute Myeloid Leukemia, Burkitt Leukemia, Chronic Monocytic Leukemia, Lymphoblastic Lymphoma, Mast Cell Leukemia, Myeloproliferative Neoplasm \| Keywords: \| Summary: \| Description: Patients are randomized to 1 of 2 arms. All patients receive 1 of 3 conditioning regimens. CONDITIONING REGIMEN A: Patients undergo total body irradiation (TBI) twice daily (BID) on days -10 to -7, then receive thiotepa intravenously (IV) over 3 hours once daily (QD) on days -6 and -5, and fludarabine IV over 30 minutes once daily on days -6 to -2. CONDITIONING REGIMEN B: Patients undergo TBI BID on days -8 to -5, then receive fludarabine IV over 30 minutes QD on days -4 to -2, and cyclophosphamide IV over 1 hour QD on days -3 and -2. CONDITIONING REGIMEN C: Patients receive fludarabine IV over 30 minutes QD on days -6 to -2, busulfan IV over 180 minutes QD on days -5 to -2, and undergo total body irradiation BID on day -1. ARM I: Patients receive naive T-cell depleted PBSCs on day 0. ARM II: Patients receive unmanipulated T cell-replete BM on day 0. GVHD PROPHYLAXIS: All patients receive tacrolimus IV on days -1 to +50 followed by a taper in the absence of grade II-IV aGVHD. Patients also receive methotrexate IV on days +1, +3, +6, and +11. Additionally, all patients undergo echocardiography (ECHO) and cerebrospinal fluid (CSF) collection at baseline as well as blood sample collection and bone marrow aspiration with or without biopsy throughout the trial. After completion of study treatment, patients are followed up at days 28, 56, 90, 180, 270, and 365 and then at months 15, 18, 21, and 24. \| ArmGroups: [{'label': 'Arm I (chemotherapy, naive T-cell depleted PBSC)', 'type': 'EXPERIMENTAL', 'description': 'CONDITIONING REGIMEN A: Patients undergo TBI BID on days -10 to -7, then receive thiotepa IV over 3 hours QD on days -6 and -5, and fludarabine IV over 30 minutes once daily on days -6 to -2.\n\nCONDITIONING REGIMEN B: Patients undergo TBI BID on days -8 to -5, then receive fludarabine IV over 30 minutes QD on days -4 to -2, and cyclophosphamide IV over 1 hour QD on days -3 and -2.\n\nCONDITIONING REGIMEN C: Patients receive fludarabine IV over 30 minutes QD on days -6 to -2, busulfan IV over 180 minutes QD on days -5 to -2, and undergo total body irradiation BID on day -1.\n\nTRANSPLANT: Patients receive naive T-cell depleted PBSCs on day 0.\n\nGVHD PROPHYLAXIS: All patients receive tacrolimus IV beginning on day -1 and methotrexate IV on days 1, 3, 6, and 11.\n\nAdditionally, patients undergo ECHO and CSF collection at baseline as well as blood sample collection and bone marrow aspiration with or without biopsy throughout the trial.', 'interventionNames': ['Radiation: Total-Body Irradiation', 'Drug: Thiotepa', 'Drug: Fludarabine', 'Drug: Cyclophosphamide', 'Drug: Busulfan', 'Drug: Tacrolimus', 'Drug: Methotrexate', 'Procedure: Naive T Cell-Depleted Hematopoietic Stem Cell Transplantation', 'Procedure: Echocardiography', 'Procedure: Biospecimen Collection', 'Procedure: Bone Marrow Aspiration', 'Procedure: Bone Marrow Biopsy']}, {'label': 'Arm II (chemotherapy, unmanipulated T cell replete BM)', 'type': 'ACTIVE_COMPARATOR', 'description': 'CONDITIONING REGIMEN A: Patients undergo TBI BID on days -10 to -7, then receive thiotepa IV over 3 hours QD on days -6 and -5, and fludarabine IV over 30 minutes once daily on days -6 to -2.\n\nCONDITIONING REGIMEN B: Patients undergo TBI BID on days -8 to -5, then receive fludarabine IV over 30 minutes QD on days -4 to -2, and cyclophosphamide IV over 1 hour QD on days -3 and -2.\n\nCONDITIONING REGIMEN C: Patients receive fludarabine IV over 30 minutes QD on days -6 to -2, busulfan IV over 180 minutes QD on days -5 to -2, and undergo total body irradiation BID on day -1.\n\nTRANSPLANT: Patients receive unmanipulated T cell-replete BM on day 0.\n\nGVHD PROPHYLAXIS: All patients receive tacrolimus IV beginning on day -1 and methotrexate IV on days 1, 3, 6, and 11.\n\nAdditionally, patients undergo ECHO and CSF collection at baseline as well as blood sample collection and bone marrow aspiration with or without biopsy throughout the trial.', 'interventionNames': ['Radiation: Total-Body Irradiation', 'Drug: Thiotepa', 'Drug: Fludarabine', 'Drug: Cyclophosphamide', 'Drug: Busulfan', 'Procedure: Allogeneic Bone Marrow Transplantation', 'Drug: Tacrolimus', 'Drug: Methotrexate', 'Procedure: Echocardiography', 'Procedure: Biospecimen Collection', 'Procedure: Bone Marrow Aspiration', 'Procedure: Bone Marrow Biopsy']}] \| Interventions:[{'type': 'RADIATION', 'name': 'Total-Body Irradiation', 'description': 'Undergo TBI', 'armGroupLabels': ['Arm I (chemotherapy, naive T-cell depleted PBSC)', 'Arm II (chemotherapy, unmanipulated T cell replete BM)'], 'otherNames': ['Total Body Irradiation', 'Whole-Body Irradiation', 'SCT_TBI', 'TBI', 'Whole Body Irradiation']}, {'type': 'DRUG', 'name': 'Thiotepa', 'description': 'Given IV', 'armGroupLabels': ['Arm I (chemotherapy, naive T-cell depleted PBSC)', 'Arm II (chemotherapy, unmanipulated T cell replete BM)'], 'otherNames': ['1,1\',1"-phosphinothioylidynetrisaziridine', 'Oncotiotepa', 'STEPA', 'Tepadina', 'Tespamin', 'Tespamine', 'Thio-Tepa', 'Thiofosfamide', 'Thiofozil', 'Thiophosphamide', 'Thiophosphoramide', 'triethylenethiophosphoramide']}, {'type': 'DRUG', 'name': 'Fludarabine', 'description': 'Given IV', 'armGroupLabels': ['Arm I (chemotherapy, naive T-cell depleted PBSC)', 'Arm II (chemotherapy, unmanipulated T cell replete BM)'], 'otherNames': ['2-Fluoro-9-beta-arabinofuranosyladenine', '2-Fluorovidarabine', 'Fluradosa']}, {'type': 'DRUG', 'name': 'Cyclophosphamide', 'description': 'Given IV', 'armGroupLabels': ['Arm I (chemotherapy, naive T-cell depleted PBSC)', 'Arm II (chemotherapy, unmanipulated T cell replete BM)'], 'otherNames': ['Carloxan', 'Ciclofosfamida', 'Ciclofosfamide', 'Cicloxal', 'Clafen', 'Claphene', 'Cycloblastin', 'Cytophosphane']}, {'type': 'DRUG', 'name': 'Busulfan', 'description': 'Given IV', 'armGroupLabels': ['Arm I (chemotherapy, naive T-cell depleted PBSC)', 'Arm II (chemotherapy, unmanipulated T cell replete BM)'], 'otherNames': ['Bussulfam', 'Busulfanum', 'Busulfex', 'Busulphan', 'Misulban', 'Misulfan', 'Mitosan', 'Myeleukon']}, {'type': 'PROCEDURE', 'name': 'Allogeneic Bone Marrow Transplantation', 'description': 'Receive unmanipulated T cell replete BM', 'armGroupLabels': ['Arm II (chemotherapy, unmanipulated T cell replete BM)'], 'otherNames': ['Allo BMT', 'Allogeneic Blood and Marrow Transplantation', 'Allogeneic BMT']}, {'type': 'DRUG', 'name': 'Tacrolimus', 'description': 'Given IV', 'armGroupLabels': ['Arm I (chemotherapy, naive T-cell depleted PBSC)', 'Arm II (chemotherapy, unmanipulated T cell replete BM)'], 'otherNames': ['Fujimycin', 'Hecoria', 'Prograf', 'Protopic']}, {'type': 'DRUG', 'name': 'Methotrexate', 'description': 'Given IV', 'armGroupLabels': ['Arm I (chemotherapy, naive T-cell depleted PBSC)', 'Arm II (chemotherapy, unmanipulated T cell replete BM)'], 'otherNames': ['Abitrexate', 'Alpha-Methopterin', 'Amethopterin', 'Brimexate', 'Emtexate', 'Emthexat', 'Emthexate', 'Farmitrexat', 'Medsatrexate', 'Methoblastin', 'Rheumatrex']}, {'type': 'PROCEDURE', 'name': 'Naive T Cell-Depleted Hematopoietic Stem Cell Transplantation', 'description': 'Receive naive T-cell depleted PBSCs', 'armGroupLabels': ['Arm I (chemotherapy, naive T-cell depleted PBSC)']}, {'type': 'PROCEDURE', 'name': 'Echocardiography', 'description': 'Undergo ECHO', 'armGroupLabels': ['Arm I (chemotherapy, naive T-cell depleted PBSC)', 'Arm II (chemotherapy, unmanipulated T cell replete BM)'], 'otherNames': ['EC', 'ECHO']}, {'type': 'PROCEDURE', 'name': 'Biospecimen Collection', 'description': 'Undergo CSF and blood sample collection', 'armGroupLabels': ['Arm I (chemotherapy, naive T-cell depleted PBSC)', 'Arm II (chemotherapy, unmanipulated T cell replete BM)']}, {'type': 'PROCEDURE', 'name': 'Bone Marrow Aspiration', 'description': 'Undergo bone marrow aspiration', 'armGroupLabels': ['Arm I (chemotherapy, naive T-cell depleted PBSC)', 'Arm II (chemotherapy, unmanipulated T cell replete BM)']}, {'type': 'PROCEDURE', 'name': 'Bone Marrow Biopsy', 'description': 'Undergo bone marrow biopsy', 'armGroupLabels': ['Arm I (chemotherapy, naive T-cell depleted PBSC)', 'Arm II (chemotherapy, unmanipulated T cell replete BM)']}] \| PrimaryOutcomes: [{'measure': 'Feasibility achievement', 'description': 'Success defined as achievement of cell selection goals for two consecutive Naive T cells (TN)-depleted peripheral blood stem cells (PBSC) hematopoietic cell transplantation (HCTs) at each study site (Feasibility)', 'timeFrame': 'Up to 2 years'}, {'measure': 'Engraftment of neutrophils by day 28 (Feasibility)', 'description': 'Success defined as achievement neutrophil engraftment (absolute neutrophil count \\[ANC\\] \\>= 500/mm\\^3) on first day of three consecutive laboratory values obtained on different days.', 'timeFrame': 'At day 28'}, {'measure': 'Current-graft versus host disease (GVHD)-free, relapse-free survival (Randomized Controlled Trial [RCT])', 'description': 'Defined as alive, no relapse after HCT, no current GVHD requiring prednisone, no graft rejection or graft failure. The proportion of subjects meeting the primary endpoint will be described in each arm with 90% confidence intervals (CI) and compared between arms using the chi-square test. A two-sided 10% significance level will be used for this comparison.', 'timeFrame': 'At 1 year'}] \| SecondaryOutcomes: [{'measure': 'Chronic GVHD (cGVHD) meeting National Institutes of Health (NIH) criteria and requiring prednisone (RCT)', 'description': "Cumulative incidence curve will be computed for each arm along with a 90% CI at 1 year and 2 years post-HCT. Death and/or relapse prior to occurrence of cGVHD will be considered as competing risks. The cumulative incidence curves will be compared between arms using Gray's test. The maximum severity of cGVHD will also be described in each arm and compared using the chi-squared test.", 'timeFrame': 'At 1 and 2 years'}, {'measure': 'Proportion of subjects alive and off prednisone (or equivalent systemic corticosteroid) for treatment of GVHD (RCT)', 'description': 'Proportions of subjects alive without requiring use of prednisone (or equivalent systemic corticosteroid) for GVHD will be estimated with 90% CI for both arms at time points over 24 months, and compared using the chi-squared test.', 'timeFrame': 'At 3, 6, 9, 12, 15, 18, 21 and 24 months post HCT'}]
Title: A Phase 1, First-in-human Study of Cabotamig (ARB202), Bispecific Antibody to CDH17 and CD3 in Advanced Gastrointestinal Malignancies \| Condition: Gastrointestinal Cancer, Cholangiocarcinoma, Liver Cancer, Colorectal Adenocarcinoma, Pancreatic Cancer, Gastric Cancer, Esophageal Adenocarcinoma, Gastroesophageal Junction \| Keywords: \| Summary: \| Description: N/A \| ArmGroups: [{'label': 'Phase 1a: Dose Escalation', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Cabotamig (ARB202)']}, {'label': 'Phase 1b: Low dose Cabotamig (ARB202)', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Cabotamig (ARB202)']}, {'label': 'Phase 1b: High dose Cabotamig (ARB202)', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Cabotamig (ARB202)']}, {'label': 'Phase 1b: Low dose Cabotamig (ARB202) + Immune Checkpoint Inhibitor', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Cabotamig (ARB202)']}, {'label': 'Phase 1b: High dose Cabotamig (ARB202) + Immune Checkpoint Inhibitor', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Cabotamig (ARB202)']}] \| Interventions:[{'type': 'DRUG', 'name': 'Cabotamig (ARB202)', 'description': 'Cabotamig (ARB202), Atezolizumab', 'armGroupLabels': ['Phase 1a: Dose Escalation', 'Phase 1b: High dose Cabotamig (ARB202)', 'Phase 1b: High dose Cabotamig (ARB202) + Immune Checkpoint Inhibitor', 'Phase 1b: Low dose Cabotamig (ARB202)', 'Phase 1b: Low dose Cabotamig (ARB202) + Immune Checkpoint Inhibitor']}] \| PrimaryOutcomes: [{'measure': 'Incidence and severity of adverse events', 'timeFrame': '8 weeks post initial dose'}] \| SecondaryOutcomes: [{'measure': 'Amount of Cabotamig (ARB202) in plasma after single and multiple doses of ARB202 (Cabotamig) in patients', 'timeFrame': '16 weeks'}, {'measure': 'Biochemical and physiological effects of Cabotamig (ARB202) on the amount of circulating ARB202 (Cabotamig) level in patients', 'timeFrame': '16 weeks'}, {'measure': 'Biochemical and physiological effects of Cabotamig (ARB202) on the amount of soluble CDH17 level in patients', 'timeFrame': '16 weeks'}, {'measure': 'Biochemical and physiological effects of Cabotamig (ARB202) on the amount IL-2 level in patients', 'timeFrame': '16 weeks'}, {'measure': 'Effect of Cabotamig (ARB202) on tumour as determined by changes in RECIST evaluation from baseline', 'timeFrame': '6 weeks'}]
Title: Quality of Life and Psychological Evaluation of Patients Affected by Head and Neck Cancer Treated With Curative Intent: Multicentric Prospective Study \| Condition: Quality of Life \| Keywords: \| Summary: \| Description: The multicentric prospective trial is to evaluate the quality of life and psychological effects in patients with head and neck tumor treated by curative intent radiation therapy. The treatment consists in a conventionally fractionated Intensity Modulated Radiotherapy (IMRT) or until 2.2 Gy per fraction with a total dose of 50-66 Gy in post-operative setting and 66-72 Gy in radical setting. \| ArmGroups: [{'label': 'Head and Neck patients', 'description': 'Patients affected by squamous cell carcinoma of head and neck (oral cavity, larynx, pharynx and hypopharynx) with no metastasis', 'interventionNames': ['Radiation: Head and Neck patients']}] \| Interventions:[{'type': 'RADIATION', 'name': 'Head and Neck patients', 'description': 'Treatment consists of Intensity Modulated Radiation Therapy (until 2.2 Gy) with a total dose of 50-66 Gy in post-operative setting and 66-72 Gy in radical setting.', 'armGroupLabels': ['Head and Neck patients']}] \| PrimaryOutcomes: [{'measure': 'Quality of life and psychological effetcs evaluated by patient reported outcome (PRO)', 'timeFrame': '18 months'}] \| SecondaryOutcomes: N/A
Title: Social Determinants of Health in Hepatobiliary Cancer Patients \| Condition: Malignant Hepatobiliary Neoplasm \| Keywords: \| Summary: \| Description: PRIMARY OBJECTIVE: I. To characterize the social determinants of health - and specifically travel-limiting access to cancer care but also other issues, such as trouble in finding childcare, joblessness, and limited education - among Southeast Asian Americans with hepatobiliary cancers, exposure risk including aflatoxin and viral hepatitis among other exposures. OUTLINE: This is an observational study. Patients complete a questionnaire, undergo blood sample collection and have their medical records reviewed on study. \| ArmGroups: [{'label': 'Observational', 'description': 'Patients complete a questionaire, undergo blood sample collection and have their medical records reviewed on study.', 'interventionNames': ['Other: Non-Interventional Study']}] \| Interventions:[{'type': 'OTHER', 'name': 'Non-Interventional Study', 'description': 'Non-interventional study', 'armGroupLabels': ['Observational']}] \| PrimaryOutcomes: [{'measure': 'Percentage of patients reporting transportation barriers that affect medical care', 'description': 'Estimated using Social Determinants of Health Screening Tool designed by the American Academy of Family Medicine, by the proportion of patients who respond "yes" to the question, "Do you put off or neglect going to the doctor because of distance or transportation?".', 'timeFrame': 'Baseline; up to 2 years'}] \| SecondaryOutcomes: N/A
Title: A Phase 2, Open-label Study of Amivantamab in Subjects With Previously Treated Advanced or Metastatic Gastric or Esophageal Cancer \| Condition: Stomach Neoplasms, Esophageal Neoplasms \| Keywords: \| Summary: \| Description: N/A \| ArmGroups: [{'label': 'Amivantamab: Gastric Cancer (GC) Cohorts', 'type': 'EXPERIMENTAL', 'description': 'Participants in Phase 2a GC cohorts will receive intravenous (IV) infusion of weight-based dose of amivantamab in 28-day cycles. Participants with body weight less than (\\<) 80 kilograms (kg) will receive IV infusion of amivantamab 1,050 milligrams (mg) and participants with body weight greater than or equal to (\\>=) 80 kg will receive IV infusion of amivantamab 1,400 mg once weekly in Cycle 1 and then every 2 weeks in subsequent cycles (on Days 1 and 15 of each cycle), followed by additional dosing based on body weight if recommended by clinical trial management team (CTMT) (amivantamab 1750 mg for body weight \\<80 kg and 2100 mg for body weight \\>=80 kg as IV infusion) every 2 weeks on Days 1 and 15 of 28 day cycle. Phase 2b GC expansion cohorts will be initiated if activity is observed within Phase 2a cohorts.', 'interventionNames': ['Drug: Amivantamab']}, {'label': 'Amivantamab: Esophageal Cancer (EC) Cohorts', 'type': 'EXPERIMENTAL', 'description': 'Participants in Phase 2a EC cohorts will receive IV infusion of weight-based dose of amivantamab in 28-day cycles. Participants with body weight \\<80 kg will receive IV infusion of amivantamab 1,050 mg and participants with body weight \\>=80 kg will receive IV infusion of amivantamab 1,400 mg once weekly in Cycle 1 and then every 2 weeks in subsequent cycles (on Days 1 and 15 of each cycle) followed by additional dosing based on body weight if recommended by CTMT (amivantamab 1750 mg for body weight \\<80 kg and 2100 mg for body weight \\>=80 kg as IV infusion) every 2 weeks on Days 1 and 15 of 28 day cycle. Phase 2b EC expansion cohorts will be initiated if activity is observed within Phase 2a cohorts.', 'interventionNames': ['Drug: Amivantamab']}] \| Interventions:[{'type': 'DRUG', 'name': 'Amivantamab', 'description': 'Amivantamab will be administered intravenously.', 'armGroupLabels': ['Amivantamab: Esophageal Cancer (EC) Cohorts', 'Amivantamab: Gastric Cancer (GC) Cohorts'], 'otherNames': ['JNJ-61186372']}] \| PrimaryOutcomes: [{'measure': 'Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1', 'description': 'ORR was defined as the percentage of participants who achieved a confirmed complete response (CR) or partial response (PR) as determined by investigator per RECIST version 1.1. As per RECIST version 1.1, CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (\\<)10 millimeter (mm). PR was defined as at least a 30 percent (%) decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-progressive disease (PD). For non-target lesions, PD: unequivocal progression of existing non-target lesions. The appearance of one or more new lesions was also considered progression.', 'timeFrame': 'From start of the treatment (Day 1) up to 30 days after the last dose of study drug (up to 9 months)'}] \| SecondaryOutcomes: [{'measure': 'Disease Control Rate (DCR) Per RECIST Version 1.1', 'description': 'DCR was defined as the percentage of participants achieving CR or PR or stable disease (SD) for at least 6 weeks as defined by RECIST version 1.1. As per RECIST version 1.1 CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures \\<10 mm. PR was defined as \\>=30% decrease in sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. For non-target lesions, PD: unequivocal progression of existing non-target lesions. The appearance of one or more new lesions was also considered progression. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, and no appearance of new lesion(s).', 'timeFrame': 'From start of the treatment (Day 1) up to 30 days after the last dose of study drug (up to 9 months)'}, {'measure': 'Duration of Response (DOR) as Per RECIST Version 1.1', 'description': 'DOR was defined as time between date of first documented response (CR/PR) and date of first documented progression or death, whichever occurred first. CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes short axis measures \\<10 mm. PR was defined as \\>=30% decrease in sum of measures (tumor lesions-longest diameter and nodes-short axis) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. For non-target lesions, PD: unequivocal progression of existing non-target lesions. The appearance of one or more new lesions was also considered progression. There was no participant who had event (CR/PR) in Phase 2a EC higher dose cohort, hence data could not be collected and analyzed for this cohort.', 'timeFrame': 'From the date of first documented response up to date of first documented PD or death (up to 9 months)'}, {'measure': 'Time to Response (TTR) as Per RECIST Version 1.1', 'description': 'TTR was defined as time from date of first amivantamab administration to date of achieving objective response (CR/PR) as assessed by investigator per RECIST v1.1 among participants who achieved objective response. Per RECIST v1.1, CR: disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures \\<10 mm. PR: \\>=30% decrease in sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. For non-target lesions, PD: unequivocal progression of existing non-target lesions. The appearance of one or more new lesions was also considered progression. There was no participant who had event (CR/PR) in Phase 2a EC higher dose cohort, hence data could not be collected and analyzed for this cohort.', 'timeFrame': 'From first dose of study treatment until first documentation of CR or PR (up to 9 months)'}, {'measure': 'Progression Free Survival (PFS) as Per RECIST Version 1.1', 'description': 'PFS was defined as the time from the date of first dose of study drug until the date of objective disease progression or death (by any cause in the absence of progression), whichever comes first, based on investigator assessment using RECIST Version 1.1.', 'timeFrame': 'From day of first dose (Day 1) until PD or death (up to 9 months)'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0', 'description': 'An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs was defined as AEs occurring at or after first dose of study drug up to 30 days after last dose or until the start of new anticancer therapy, whichever occurred first. TEAEs were graded according to NCI-CTCAE v5.0. Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe or medically significant but not immediately life-threatening; Grade 4- Life-threatening consequences; Grade 5- Death related to AE. All TEAEs including serious and non-serious events are reported in this outcome measure.', 'timeFrame': 'From start of the treatment (Day 1) up to 30 days after last dose or start of new anticancer therapy, whichever occurred first (up to 9 months)'}, {'measure': 'Maximum Observed Serum Concentration (Cmax) for Amivantamab', 'description': 'Cmax was defined as the maximum observed serum concentration of amivantamab. The concentrations of amivantamab were measured using a validated, specific, and sensitive enzyme-linked immunosorbent assay (ELISA) method. Data for this outcome measure was planned to be collected and analyzed for each cancer type (GC and EC) and overall participants (GC and EC combined cohorts: Amivantamab \\[1050/1400 mg\\]). As planned, data for Cmax was not collected and analyzed for Phase 2a EC higher dose cohort.', 'timeFrame': 'Pre-dose, 0, 24, 26, 48, 72, 96 and 168 hours post-dose on Day 1 of Cycle 1; pre-dose, 0, 2, 24, 48, 72, 168 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days)'}, {'measure': 'Time to Reach Maximum Observed Serum Concentration (Tmax) for Amivantamab', 'description': 'Tmax was defined as the time to reach maximum observed serum concentration of amivantamab. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method. Data for this outcome measure was planned to be collected and analyzed for each cancer type (GC and EC) and overall participants (GC and EC combined cohorts: Amivantamab \\[1050/1400 mg\\]). As planned, data for Tmax was not collected and analyzed for Phase 2a EC higher dose cohort.', 'timeFrame': 'Pre-dose, 0, 24, 26, 48, 72, 96 and 168 hours post-dose on Day 1 of Cycle 1; pre-dose, 0, 2, 24, 48, 72, 168 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days)'}, {'measure': 'Area Under the Curve From Time (0) to Time (168h) (AUC [0-168h]) for Amivantamab', 'description': 'AUC (0-168h) was defined as area under the serum concentration time-curve from time zero to the time point 168 hours. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method. Data for this outcome measure was planned to be collected and analyzed for each cancer type (GC and EC) and overall participants (GC and EC combined cohorts: Amivantamab \\[1050/1400 mg\\]). As planned, data for AUC (0-168h) was not collected and analyzed for Phase 2a EC higher dose cohort.', 'timeFrame': 'Pre-dose, 0, 24, 26, 48, 72, 96 and 168 hours post-dose on Day 1 of Cycle 1 (each cycle was of 28 days)'}, {'measure': 'Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Amivantamab', 'description': 'Area under the serum concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 336 hours was reported. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method. Data for this outcome measure was planned to be collected and analyzed for each cancer type (GC and EC) and overall participants (GC and EC combined cohorts: Amivantamab \\[1050/1400 mg\\]). As planned, data for AUCtau was not collected and analyzed for Phase 2a EC higher dose cohort.', 'timeFrame': 'Pre-dose, 0, 2, 24, 48, 72, 168 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days)'}, {'measure': 'Phase 2a Gastric Cancer and Esophageal Cancer Cohorts: Serum Trough Concentrations (Ctrough) of Amivantamab', 'description': 'Ctrough of amivantamab in GC and EC cohorts were reported. Ctrough was defined as pre-dose serum drug concentration. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method. Data for this outcome measure was planned to be collected and analyzed for each cancer type (GC and EC) and overall participants (GC and EC combined cohorts: Amivantamab \\[1050/1400 mg\\]).', 'timeFrame': 'Pre-dose at 0 hour: Days 8 and 15 of Cycle 1; Days 1 and 15 of Cycles 2, 3 and 4; Day 1 of Cycles 6 and 8 (each cycle was of 28 days)'}, {'measure': 'Phase 2a Esophageal Cancer Higher Dose Cohort: Serum Trough Concentrations (Ctrough) of Amivantamab', 'description': 'Ctrough of amivantamab in phase 2a EC higher dose cohort was reported. Ctrough was defined as pre-dose serum drug concentration. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method.', 'timeFrame': 'Pre-dose at 0 hour: Day 15 of Cycle 1; Days 1 and 15 of Cycles 2 and 3; Day 1 of Cycles 6 and 8 (each cycle was of 28 days)'}, {'measure': 'Phase 2a Gastric Cancer Cohort: Terminal Elimination Half-Life (t1/2) for Amivantamab', 'description': 'Terminal elimination half-life (t1/2) was the time measured for the serum concentration of a drug to decrease by half of its initial concentration. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method.', 'timeFrame': 'Pre-dose, 0, 2, 24, 48, 72, 168 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days)'}, {'measure': 'Phase 2a Esophageal Cancer and Overall Combined Cohorts: Terminal Elimination Half-Life (t1/2) for Amivantamab', 'description': 'Terminal elimination half-life (t1/2) was the time measured for the serum concentration of a drug to decrease by half of its initial concentration. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method. Data for this outcome measure was planned to be collected and analyzed for EC cohort and overall participants (GC and EC combined cohorts: Amivantamab \\[1050/1400 mg\\]). As planned, data for t1/2 was not collected and analyzed for Phase 2a EC higher dose cohort.', 'timeFrame': 'Pre-dose, 0, 2, 24, 48, 72, 168 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days)'}, {'measure': 'Apparent Clearance at Steady State (CLss) of Amivantamab', 'description': 'Clearance was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method. Data for this outcome measure was planned to be collected and analyzed for each cancer type (GC and EC) and overall participants (GC and EC combined cohorts: Amivantamab \\[1050/1400 mg\\]). As planned, data for CLss was not collected and analyzed for Phase 2a EC higher dose cohort.', 'timeFrame': 'Pre-dose, 0, 2, 24, 48, 72, 168 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days)'}, {'measure': 'Apparent Volume of Distribution at Steady State (Vss) of Amivantamab', 'description': 'Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method. Data for this outcome measure was planned to be collected and analyzed for each cancer type (GC and EC) and overall participants (GC and EC combined cohorts: Amivantamab \\[1050/1400 mg\\]). As planned, data for Vss was not collected and analyzed for Phase 2a EC higher dose cohort.', 'timeFrame': 'Pre-dose, 0, 2, 24, 48, 72, 168 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days)'}, {'measure': 'Accumulation Ratio (AR) of AUCtau for Amivantamab', 'description': 'Accumulation ratio for AUC was calculated as AUC (0-336h) for Cycle 2 Day 1 divided by AUC (0-168h) for Cycle 1 Day 1. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method. Data for this outcome measure was planned to be collected and analyzed for each cancer type (GC and EC) and overall participants (GC and EC combined cohorts: Amivantamab \\[1050/1400 mg\\]). As planned, data for AR of AUCtau was not collected and analyzed for Phase 2a EC higher dose cohort.', 'timeFrame': 'Pre-dose, 0, 24, 26, 48, 72, 96 and 168 hours post-dose on Day 1 of Cycle 1; pre-dose, 0, 2, 24, 48, 72, 168 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days)'}, {'measure': 'Number of Participants With Anti-Amivantamab Antibodies', 'description': 'Number of participants with anti-amivantamab antibodies were reported. Serum samples were assessed for anti-drug antibodies.', 'timeFrame': 'From start of the treatment (Day 1) up to 30 days after the last dose of study drug (up to 9 months)'}]
Title: A Randomized Phase II Trial of Tamoxifen Versus Z-Endoxifen HCL in Postmenopausal Women With Metastatic Estrogen Receptor Positive, HER2 Negative Breast Cancer \| Condition: Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v7, Stage IIIA Breast Cancer AJCC v7, Stage IIIB Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7, Stage IV Breast Cancer AJCC v6 and v7 \| Keywords: \| Summary: \| Description: PRIMARY OBJECTIVES: I. To assess whether progression-free survival with z-endoxifen hydrochloride (HCl) relative to that with tamoxifen (tamoxifen citrate) is prolonged in postmenopausal women with local advanced or metastatic estrogen receptor (ER) positive/Her2 negative breast cancer. SECONDARY OBJECTIVES: I. To assess the safety profile of each of these agents in this patient population. II. To assess whether the tumor response rate (as determined using the Response Evaluation Criteria in Solid Tumors \[RECIST\] criteria) among those randomized to z-endoxifen HCl differs from that among those randomized to tamoxifen. III. To estimate the median progression-free survival time for those who receive z-endoxifen HCl after disease progression with tamoxifen. CORRELATIVE SCIENCE OBJECTIVES: I. To examine whether ER alpha alterations (defined as either ER activating mutations or ER amplification) are associated with longer progression-free survival (PFS) or higher response rates in the z-endoxifen HCl arm compared to the tamoxifen arm. II. To determine changes in lipid profiles comparing tamoxifen and z-endoxifen HCl. III. For each treatment, to evaluate changes in markers of bone formation and absorption after 12 weeks (4 cycles) of treatment. IV. For all patients and by treatment arm, to determine whether progression-free survival differs with respect to the sensitive to endocrine therapy (SET) index. V. To examine whether deoxyribonucleic acid (DNA) alterations as measured by Foundation medicine in all coding exons of 287 cancer-related genes as well as 78 polymorphisms in 34 absorption, distribution, metabolism, and excretion (ADME)-related genes are associated with longer PFS or higher response rates in the z-endoxifen HCl arm compared to the tamoxifen arm. VI. To assess whether the molecular characteristics identified in the tumor biopsies are detectable in the circulating tumor cells (CTCs) and/or cell-free DNA (cfDNA). VII. For each treatment arm: to examine changes in ER expression on CTCs, changes in estrogen receptor (ESR) mutations or amplification in CTCs or CfDNA and explore the impact of these changes on PFS and response rates. PHARMACOKINETICS AND PHARMACOGENOMICS OBJECTIVES: I. To further characterize pharmacokinetics, pharmacogenetics and metabolism of z-endoxifen HCl and tamoxifen. II. To determine the impact of the concentrations of tamoxifen and its metabolites on PFS in the tamoxifen arm. III. To determine the impact of the concentrations of z-endoxifen HCl and its metabolites on PFS in the endoxifen arm. V. To determine the impact of genetic variation in the enzymes responsible for tamoxifen and z-endoxifen HCl metabolism. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive z-endoxifen hydrochloride orally (PO) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive tamoxifen citrate PO once daily (QD) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression and bone metastases may cross over to Arm I and receive z-endoxifen hydrochloride starting no later than 28 days after documentation of disease progression. After completion of study treatment, patients are followed up yearly for up to 5 years. \| ArmGroups: [{'label': 'Arm I (z-endoxifen hydrochloride)', 'type': 'EXPERIMENTAL', 'description': 'Patients receive z-endoxifen hydrochloride PO on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Endoxifen Hydrochloride', 'Other: Laboratory Biomarker Analysis', 'Other: Pharmacological Study']}, {'label': 'Arm II (tamoxifen citrate)', 'type': 'EXPERIMENTAL', 'description': 'Patients receive tamoxifen citrate PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression and bone metastases may cross over to Arm I and receive z-endoxifen hydrochloride starting no later than 28 days after documentation of disease progression.', 'interventionNames': ['Other: Laboratory Biomarker Analysis', 'Other: Pharmacological Study', 'Drug: Tamoxifen Citrate']}] \| Interventions:[{'type': 'DRUG', 'name': 'Endoxifen Hydrochloride', 'description': 'Given PO', 'armGroupLabels': ['Arm I (z-endoxifen hydrochloride)'], 'otherNames': ['Z-Endoxifen HCl', 'Z-Endoxifen Hydrochloride']}, {'type': 'OTHER', 'name': 'Laboratory Biomarker Analysis', 'description': 'Correlative studies', 'armGroupLabels': ['Arm I (z-endoxifen hydrochloride)', 'Arm II (tamoxifen citrate)']}, {'type': 'OTHER', 'name': 'Pharmacological Study', 'description': 'Correlative studies', 'armGroupLabels': ['Arm I (z-endoxifen hydrochloride)', 'Arm II (tamoxifen citrate)']}, {'type': 'DRUG', 'name': 'Tamoxifen Citrate', 'description': 'Given PO', 'armGroupLabels': ['Arm II (tamoxifen citrate)'], 'otherNames': ['Apo-Tamox', 'Clonoxifen', 'Dignotamoxi', 'Ebefen', 'Emblon', 'Estroxyn', 'Fentamox', 'Gen-Tamoxifen', 'Genox', 'ICI 46,474', 'ICI 46474', 'ICI-46474', 'ICI46474', 'Jenoxifen', 'Kessar', 'Ledertam', 'Lesporene', 'Nolgen', 'Noltam', 'Nolvadex', 'Nolvadex-D', 'Nourytam', 'Novo-Tamoxifen', 'Novofen', 'Noxitem', 'Oestrifen', 'Oncotam', 'PMS-Tamoxifen', 'Soltamox', 'TAM', 'Tamax', 'Tamaxin', 'Tamifen', 'Tamizam', 'Tamofen', 'Tamoxasta', 'Tamoxifeni Citras', 'Zemide']}] \| PrimaryOutcomes: [{'measure': 'Progression Free Survival (PFS)', 'description': 'The primary endpoint is progression-free survival (PFS) defined as the time from randomization to documentation of local, regional or distant disease progression or death without progression of disease.', 'timeFrame': 'Assessed up to 5 years'}] \| SecondaryOutcomes: [{'measure': 'Incidence of Adverse Events, Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0', 'description': 'For a given adverse event (AE), the proportion of patients on each treatment arm who report developing a grade 2-5 of this AE will be determined.', 'timeFrame': 'Up to 5 years'}, {'measure': 'Tumor Response Rate by Study Arm, Defined as the Number of Patients With a Complete or Partial Response', 'description': 'Defined by Response Evaluation Criteria in Solid Tumors on 2 consecutive evaluations at least 6 weeks apart, divided by the total number of eligible patients who began study treatment. A 90% binomial confidence interval will be constructed for the true response rate.', 'timeFrame': 'Up to 5 years'}, {'measure': 'Overall Survival Distribution by Study Arm', 'description': 'The distribution of survival times will be estimated using the method of Kaplan-Meier.', 'timeFrame': 'The time from registration to death due to any cause, assessed up to 5 years'}]
Title: A Pilot Study Evaluating the Effect of 'R' (Electro-Kinetically Altered Beverage) on Insomnia, Fatigue and Depression in Breast Cancer Patients Receiving Adjuvant Chemotherapy \| Condition: Breast Cancer \| Keywords: Breast Cancer, Stage I breast cancer, Stage II breast cancer, Water study, 'R', Electro-kinetically altered beverage, altered beverage, Insomnia, Fatigue, Depression, Adjuvant chemotherapy \| Summary: \| Description: Female breast cancer patients eligible for adjuvant therapy with four cycles of Taxotere and Cytoxan chemotherapy after surgery will be enrolled for the study. Eligible subjects will begin to consume either "R" or purified water (placebo) just prior to the 1st cycle of chemotherapy. Subjects will continue to consume either "R" or placebo through Cycle 1, Cycle 2, Cycle 3, Cycle 4, and for an additional 12 weeks after completing chemotherapy. Study procedures will include clinical lab assessments, analysis of inflammatory markers, RNA biomarkers, adverse events, subject diary, and quality of life measurements for insomnia, fatigue and depression. \| ArmGroups: [{'label': 'Purified Water', 'type': 'PLACEBO_COMPARATOR', 'description': 'In this arm, eligible subjects will begin to consume purified water (placebo) just prior to the 1st cycle of chemotherapy. Subjects will continue to consume the placebo through their chemotherapy and then for an additional 12 weeks after completing chemotherapy.\n\nSubjects will consume a specific volume based on the following weight categories: \\<150 lb = 2 bottles/day; ≥150 lb and \\<225 lb = 3 bottles/day; ≥225 lb = 4 bottles/day. Subjects will consume placebo for a minimum of 168 days.', 'interventionNames': ['Other: Placebo (water)']}, {'label': "'R' (Electro-kinetically altered beverage)", 'type': 'EXPERIMENTAL', 'description': 'Patients randomized to this arm will begin to consume "R" (Electro-kinetically altered beverage) just prior to the 1st cycle of chemotherapy and continue it through their chemotherapy cycles and then for an additional 12 weeks after completing chemotherapy.\n\nSubjects will consume a specific volume based on the following weight categories: \\<150 lb = 2 bottles/day; ≥150 lb and \\<225 lb = 3 bottles/day; ≥225 lb = 4 bottles/day. Subjects will consume R for a minimum of 168 days.', 'interventionNames': ["Other: 'R' (Electro-kinetically altered beverage)"]}] \| Interventions:[{'type': 'OTHER', 'name': "'R' (Electro-kinetically altered beverage)", 'armGroupLabels': ["'R' (Electro-kinetically altered beverage)"]}, {'type': 'OTHER', 'name': 'Placebo (water)', 'armGroupLabels': ['Purified Water']}] \| PrimaryOutcomes: [{'measure': 'The effects of consuming "R" on quality of life in the areas of insomnia in breast cancer patients receiving multi-cycle adjuvant chemotherapy', 'description': 'SleepMed Insomnia Questionnaire: This is a test to assess, in general, how a subject is feeling about their sleep using a "0-4" point scale - with the "0" representing no problem with sleep and "4" representing a big problem with how a subject feels about the quality of their sleep.', 'timeFrame': 'Patients will be followed for up to 25 weeks'}, {'measure': 'The effects of consuming "R" on quality of life in the areas of fatigue in breast cancer patients receiving multi-cycle adjuvant chemotherapy', 'description': 'FACIT Fatigue Scale: A list of questions that asks a patient how fatigued they have felt in the last 7 days.', 'timeFrame': 'Patients will be followed for up to 25 weeks'}] \| SecondaryOutcomes: [{'measure': 'The effects of consuming "R" on quality of life in the areas of depression in breast cancer patients receiving multi-cycle adjuvant chemotherapy', 'description': 'Beck Depression Inventory-II: A list of statements that ask a subject about the way they have been feeling for the last two weeks.', 'timeFrame': 'Patients will be followed for up to 25 weeks'}]
Title: A Phase Ⅰ Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of WJ01075 Tablets in Oral Dose Escalation and Expansion in Patients With Advanced Solid Tumors \| Condition: Advanced Solid Tumors \| Keywords: \| Summary: \| Description: N/A \| ArmGroups: [{'label': 'WJ01075 tablets', 'type': 'EXPERIMENTAL', 'description': 'Once a week (QW).', 'interventionNames': ['Drug: WJ01075']}] \| Interventions:[{'type': 'DRUG', 'name': 'WJ01075', 'description': 'Phase Ia: Dose Escalation Accelerated titration (the first two dose groups) and "3 + 3" combination (the subsequent dose group) were used for dose escalation.\n\nPhase Ib: Dose Expansion and Cohort Expansion The actual dose, dosing schedule (including combination) and indication selection will be evaluated based on the results of existing trials.', 'armGroupLabels': ['WJ01075 tablets']}] \| PrimaryOutcomes: [{'measure': 'Dose limited toxicity (DLT)', 'description': 'incidence and severity of Dose limited toxicity(DLT);', 'timeFrame': '3 years'}, {'measure': 'Adverse event (AE)', 'description': 'incidence and severity of adverse event (AE), Abnormal changes in laboratory and other tests of clinical significance;', 'timeFrame': '3 years'}, {'measure': 'Serious adverse event (SAE)', 'description': 'incidence and severity of Serious adverse event (SAE);', 'timeFrame': '3 years'}, {'measure': 'Maximum tolerated dose (MTD)', 'description': 'Maximum tolerated dose (MTD)', 'timeFrame': '2 years'}, {'measure': 'Recommended phase II dose (RP2D)', 'description': 'Recommended phase II dose (RP2D)', 'timeFrame': '2 years'}] \| SecondaryOutcomes: [{'measure': 'Objective response rate(ORR)', 'description': 'Efficacy endpoints: Objective response rate(ORR) per RECIST v1.1', 'timeFrame': '2 years'}, {'measure': 'Duration of response (DOR)', 'description': 'Efficacy endpoints: Duration of response (DOR) per RECIST v1.1', 'timeFrame': '2 years'}, {'measure': 'Disease control rate (DCR)', 'description': 'Efficacy endpoints: Disease control rate (DCR) per RECIST v1.1', 'timeFrame': '2 years'}, {'measure': 'Time to response(TTR)', 'description': 'Efficacy endpoints: Time to response(TTR) per RECIST v1.1', 'timeFrame': '2 years'}, {'measure': 'Progression-free survival (PFS)', 'description': 'Efficacy endpoints: Progression-free survival (PFS) per RECIST v1.1', 'timeFrame': '2 years'}, {'measure': 'Overall survival (OS)', 'description': 'Efficacy endpoints: Overall survival (OS) per RECIST v1.1', 'timeFrame': '2 years'}, {'measure': 'Peak time(Tmax)', 'description': 'Pharmacokinetic (PK) parameter : Peak time(Tmax) after a single dose;', 'timeFrame': '2 years'}, {'measure': 'Maximum plasma concentration (Cmax)', 'description': 'Pharmacokinetic (PK) parameter : Maximum plasma concentration (Cmax) after a single dose;', 'timeFrame': '2 years'}, {'measure': 'Clearance rate (CL/F)', 'description': 'Pharmacokinetic (PK) parameter : Clearance rate (CL/F) after a single dose;', 'timeFrame': '2 years'}, {'measure': 'Apparent volume of distribution (Vd/F)', 'description': 'Pharmacokinetic (PK) parameter : Apparent volume of distribution (Vd/F) after a single dose;', 'timeFrame': '2 years'}, {'measure': 'Area under blood concentration - time curve (AUC)', 'description': 'Pharmacokinetic (PK) parameter : Area under blood concentration - time curve (AUC) after a single dose;', 'timeFrame': '2 years'}, {'measure': 'Elimination rate constant (λz)', 'description': 'Pharmacokinetic (PK) parameter : Elimination rate constant (λz) after a single dose;', 'timeFrame': '2 years'}, {'measure': 'Elimination half-life time ( t1/2) and other parameters', 'description': 'Pharmacokinetic (PK) parameter : Elimination half-life time ( t1/2) and other parameters after a single dose;', 'timeFrame': '2 years'}, {'measure': 'Steady state valley concentration(Cssmin)', 'description': 'Pharmacokinetic (PK) parameter : Steady state valley concentration(Cssmin) after repeated administration;', 'timeFrame': '2 years'}, {'measure': 'Steady state peak concentration(Cssmax)', 'description': 'Pharmacokinetic (PK) parameter : Steady state peak concentration(Cssmax) after repeated administration;', 'timeFrame': '2 years'}, {'measure': 'Average steady-state plasma concentration(Css-av)', 'description': 'Pharmacokinetic (PK) parameter : Average steady-state plasma concentration(Css-av) after repeated administration;', 'timeFrame': '2 years'}, {'measure': 'Elimination half-life time ( t1/2)', 'description': 'Pharmacokinetic (PK) parameter : Elimination half-life time ( t1/2) after repeated administration;', 'timeFrame': '2 years'}, {'measure': 'Steady state Area under blood concentration - time curve(AUCss)', 'description': 'Pharmacokinetic (PK) parameter : Steady state Area under blood concentration - time curve(AUCss) after repeated administration;', 'timeFrame': '2 years'}, {'measure': 'Fluctuation coefficient (DF)', 'description': 'Pharmacokinetic (PK) parameter : Fluctuation coefficient (DF) after repeated administration;', 'timeFrame': '2 years'}, {'measure': 'Steady-state distribution volume(Vss )', 'description': 'Pharmacokinetic (PK) parameter : Steady-state distribution volume(Vss ) after repeated administration;', 'timeFrame': '2 years'}, {'measure': 'Accumulation coefficient (AR) and other parameters', 'description': 'Pharmacokinetic (PK) parameter : Accumulation coefficient (AR) and other parameters after repeated administration;', 'timeFrame': '2 years'}]
Title: Phase III Trial Evaluating Memory Preservation of Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance in Small Cell LUNG Cancer (PREMER-TRIAL) \| Condition: Small Cell Lung Carcinoma \| Keywords: \| Summary: \| Description: Prophylactic cranial irradiation (PCI) has become a standard of care for selected patients with limited and extensive stage small cell lung cancer (SCLC) who have shown benefit after chemotherapy with or without thoracic radiotherapy. Because hippocampal involvement by metastatic disease is rare, and because preclinical and clinical evidence suggests that radiation dose received by the hippocampus during whole brain radiotherapy may play a role in radiation-induced neurocognitive decline, sparing of the hippocampus during the administration of PCI should result in lower rates of memory loss. Previous studies have demonstrated the dosimetric capabilities of intensity modulated radiation therapy (IMRT) to conformably avoid the hippocampus without detriment to the radiation dose the remaining brain receives. The main objective of this trial is compare neurocognitive functioning following hippocampal avoidance PCI to standard PCI treatment measured by Free and Cued Selective Reminding Test (FCSRT). The FCSRT measures verbal learning and memory. The FCSRT emphasizes encoding specificity during learning and recall. One of the secondary objectives of this trial is to test the hypothesis that the lowered neurocognitive function of the patients is due to a substantial reduction in hippocampal volume in magnetic resonance imaging (MRI). Others objectives are to evaluate quality of life (QoL) and the rate of metastases in the hippocampus. \| ArmGroups: [{'label': 'Prophylactic cranial irradiation (PCI)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Radiation. Prophylactic cranial irradiation : 25 Gy in 10 daily fractions, five times a week', 'interventionNames': ['Radiation: Prophylactic cranial irradiation (PCI)']}, {'label': 'Hippocampal avoidance PCI', 'type': 'EXPERIMENTAL', 'description': 'Hippocampal avoidance prophylactic cranial irradiation. 25 Gy in 10 daily fractions, five times a week', 'interventionNames': ['Radiation: Hippocampal avoidance PCI']}] \| Interventions:[{'type': 'RADIATION', 'name': 'Prophylactic cranial irradiation (PCI)', 'description': 'Prophylactic cranial irradiation (PCI): 25 Gy in 10 daily fractions, five times a week', 'armGroupLabels': ['Prophylactic cranial irradiation (PCI)']}, {'type': 'RADIATION', 'name': 'Hippocampal avoidance PCI', 'description': 'Hippocampal avoidance prophylactic cranial irradiation 25 Gy in 10 daily fractions, five times a week', 'armGroupLabels': ['Hippocampal avoidance PCI']}] \| PrimaryOutcomes: [{'measure': 'Neurocognitive functioning (NCF) (Free and Cued Selective Reminding Test)', 'description': 'Free and Cued Selective Reminding Test (FCSRT) evaluated at baseline and 3 months after radiation', 'timeFrame': 'Change from baseline to 3 months'}] \| SecondaryOutcomes: [{'measure': 'Neurocognitive functioning (NCF) (Free and Cued Selective Reminding Test)', 'description': 'Free and Cued Selective Reminding Test (FCSRT) evaluated at baseline and 6,12 and 24 months after radiation', 'timeFrame': 'Change from baseline to 6,12 and 24 months'}, {'measure': 'Hippocampus brain metastases (brain magnetic resonance imaging) (MRI)', 'description': 'Evaluation of hippocampus brain metastases at 3, 6, 12 and 24 months after radiation', 'timeFrame': 'Change from baseline to 3, 6,12 and 24 months'}, {'measure': 'Hippocampus volume (brain magnetic resonance imaging) (MRI)', 'description': 'Evaluation of hippocampus volume at 3, 6, 12 and 24 months after radiation', 'timeFrame': 'Change from baseline to 3, 6,12 and 24 months'}, {'measure': 'Adverse effects (according to Common Toxicity Criteria for Adverse Effects)', 'description': 'Evaluation of adverse effects according to Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) version 4.0 at 3, 6, 12 and 24 months after radiation', 'timeFrame': 'Change from baseline to 3, 6,12 and 24 months'}, {'measure': 'Quality of life (measured by European Organization for Research and Treatment of Cancer (EORTC) questionnaire (QLQ C-30 and QLQ BN-20)', 'description': 'Evaluation of Quality of Life (QoL) measured by European Organization for Research and Treatment of Cancer (EORTC) questionnaire (QLQ C-30 and QLQ BN-20)', 'timeFrame': 'Change from baseline to 3, 6,12 and 24 months'}, {'measure': 'Overall survival', 'description': 'From the start date of PCI until the date of death from any cause, or the last follow-up date whichever came first, assessed up to 60months"', 'timeFrame': 'Up to 5 years'}]
Title: Pilot Phase II Study of Safety and Immunogenicity of an ALVAC-CEA/B7.1 Vaccine Administered With Chemotherapy, Alone or in Combination With Tetanus Toxoid, as Compared to Chemotherapy Alone, in Patients With Metastatic Colorectal Adenocarcinoma \| Condition: Colorectal Cancer \| Keywords: stage IV colon cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum \| Summary: \| Description: OBJECTIVES: * Determine the safety of ALVAC-CEA-B7.1 vaccine and chemotherapy, with or without tetanus toxoid, vs chemotherapy alone in patients with metastatic colorectal adenocarcinoma. * Determine whether tetanus toxoid enhances the immune response in patients treated with the vaccine and chemotherapy. OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 3 treatment arms. * Arm I: Patients receive a priming dose of tetanus toxoid. Beginning 2 weeks later, patients receive tetanus toxoid and ALVAC-CEA-B7.1 vaccine subcutaneously (SC) once weekly for 3 weeks. Two weeks after the third vaccine administration, patients receive tetanus toxoid and ALVAC-CEA-B7.1 vaccine SC on day 1 and irinotecan IV over 90 minutes, leucovorin calcium IV, and fluorouracil IV on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. * Arm II: Patients receive ALVAC-CEA-B7.1 vaccine and chemotherapy as in arm I. * Arm III: Patients receive chemotherapy as in arm I. After completion of chemotherapy, patients with partial or complete response may receive ALVAC-CEA-B7.1 vaccine SC once weekly on weeks 1-3 and 6. PROJECTED ACCRUAL: A total of 90 patients (30 per treatment arm) will be accrued for this study. \| ArmGroups: N/A \| Interventions:[{'type': 'BIOLOGICAL', 'name': 'ALVAC-CEA-B7.1 vaccine'}, {'type': 'BIOLOGICAL', 'name': 'tetanus toxoid'}, {'type': 'DRUG', 'name': 'FOLFIRI regimen'}, {'type': 'DRUG', 'name': 'fluorouracil'}, {'type': 'DRUG', 'name': 'irinotecan hydrochloride'}, {'type': 'DRUG', 'name': 'leucovorin calcium'}] \| PrimaryOutcomes: N/A \| SecondaryOutcomes: N/A
Title: Breast Cancer Risk Reduction: A Patient Doctor Intervention \| Condition: Breast Cancer \| Keywords: Breast cancer concern, breast cancer risk perception, breast cancer risk \| Summary: \| Description: N/A \| ArmGroups: [{'label': 'BreastCARE Intervention', 'type': 'EXPERIMENTAL', 'description': 'Intervention Clinic Patients: The RA will welcome the patient upon arrival at the clinic and again explain study procedures and field any questions. The RA will have the patient sign the HIPAA authorization form and then demonstrate how to enter information and answer questions on the tablet-PC and the patient will indicate their consent electronically before beginning the assessment.\n\nIntervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patietns before she meets with her doctor.', 'interventionNames': ['Other: BreastCARE']}, {'label': 'BreastCARE Comparison', 'type': 'NO_INTERVENTION', 'description': 'Patients will be randomized into the intervention or comparison groups at the time of recruitment. Block-randomization will be used to assign patients to intervention or comparison groups.\n\nComparison Clinic Patients. Contact and baseline interview procedures will be the same for patients from the comparison clinics, however there will be no computer assessment at the time of their clinic visit. An RA will meet the patient 10 minutes prior to her appointment time to obtain written HIPAA authorization.'}] \| Interventions:[{'type': 'OTHER', 'name': 'BreastCARE', 'description': "Physician Report. At the time of an individual participant's visit to her primary care physician and her completion of the assessment tool, her physician will receive a physician report. The physician report is designed to facilitate communication about breast cancer risk during the primary care visit and to provide tailored risk reduction recommendations.", 'armGroupLabels': ['BreastCARE Intervention']}] \| PrimaryOutcomes: [{'measure': 'Knowledge of Breast Cancer Risk Factors', 'description': 'Risk knowledge was assessed using a post-survey. Participants could have scored 0-100 (with 0 meaning no correct answers, and 100 is all correct answers). This outcome was measured through a survey. Breast cancer risk knowledge was based on a series of eight questions in the survey. O', 'timeFrame': 'one week post-initial visit (approximately one week)'}, {'measure': 'Percentage of Participants With Correct Perception of Risk', 'description': 'This outcome was measured through a survey. Women were asked what they thought about their risk of getting breast cancer was compared to other women of the same age.', 'timeFrame': 'baseline, one week post-initial visit (approximately one week)'}, {'measure': 'Percentage of Participants Who Had a Discussion of Breast Cancer Risk', 'description': 'Self-reported discussion of breast cancer risk with physicians.', 'timeFrame': 'one week post-initial visit (approximately one week)'}, {'measure': 'Percentage of Participants Who Reported Discussion of Mammography Screening', 'description': 'Self reported discussion of mammography with physician.', 'timeFrame': 'up to 14 months'}] \| SecondaryOutcomes: N/A
Title: Representation of the Body and Treatment of Peritoneal Cancer by Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) - A Collaborative Approach Between Professionals of Health / Patients / Researchers \| Condition: Peritoneal Carcinomatosis \| Keywords: \| Summary: \| Description: N/A \| ArmGroups: [{'label': 'Treated by HIPEC', 'type': 'OTHER', 'description': 'Patients treated by HIPEC for peritoneal cancer', 'interventionNames': ['Behavioral: Interviews']}, {'label': 'Standard chemiotherapy', 'type': 'OTHER', 'description': 'Patients treated by standard chemiotherapy for peritoneal cancer', 'interventionNames': ['Behavioral: Interviews']}] \| Interventions:[{'type': 'BEHAVIORAL', 'name': 'Interviews', 'description': 'Interviews will be done with patients', 'armGroupLabels': ['Standard chemiotherapy', 'Treated by HIPEC']}] \| PrimaryOutcomes: [{'measure': 'Body representations', 'description': 'Comprehensive knowledge concerning the way the patients are living cancer event, treatment, changes in their body representations and conceptions of their lives.\n\nThis qualitative study do not include outcome measures. Its purpose is restricted to the meanings', 'timeFrame': '3 months'}] \| SecondaryOutcomes: N/A
Title: Phase I Study of Veliparib (ABT-888) in Combination With Cisplatin Plus Gemcitabine in Advanced Biliary, Pancreatic, Urothelial, and Non-small Cell Lung Cancer \| Condition: Advanced Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer, Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter, Regional Transitional Cell Cancer of the Renal Pelvis and Ureter, Stage III Bladder Cancer, Stage III Pancreatic Cancer, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Bladder Cancer, Stage IV Non-small Cell Lung Cancer, Stage IV Pancreatic Cancer, Transitional Cell Carcinoma of the Bladder, Unresectable Extrahepatic Bile Duct Cancer, Unresectable Gallbladder Cancer \| Keywords: \| Summary: \| Description: PRIMARY OBJECTIVES: I. Determine the maximum-tolerated dose of veliparib (ABT-888) (days 1-12 of a 21-day schedule) in combination with cisplatin (day 3) and gemcitabine (days 3, 10) in patients with advanced, previously untreated carcinoma of the bile ducts, gallbladder or pancreas, non-small cell lung cancer, or transitional cell carcinoma of the bladder/urothelial tract. SECONDARY OBJECTIVES: I. Describe the dose-limiting toxicity (DLT) and other toxicities associated with veliparib in combination with cisplatin plus gemcitabine as assessed by CTCAE v4.0. II. Determine the recommended phase 2 dose of veliparib (ABT-888) (RP2D) in combination with cisplatin plus gemcitabine. III. Document anti-tumor activity of veliparib (ABT-888), cisplatin, and gemcitabine as assessed by RECIST 1.1. IV. Determine the plasma pharmacokinetics of veliparib (ABT-888), cisplatin, and gemcitabine. V. Determine the abundance of gemcitabine triphosphate in PBMCs following gemcitabine administration. VI. Measure the abundance of DNA-platinum adducts in tumor tissue following cisplatin administration. VII. Measure PARP enzymatic activity in PBMC and tumor tissue following study treatment. VIII. Perform an exploratory correlation between abundance of BRCA and other proteins assessed by tumor immunohistochemistry and clinical response. OUTLINE: This is a multicenter, dose-escalation study of veliparib and gemcitabine hydrochloride. Patients are stratified according to presence of suspected or known BRCA mutations (no vs yes). Patients receive veliparib orally every 12 hours on days 1-12, gemcitabine hydrochloride IV over 30 minutes on days 3 and 10, and cisplatin IV over 60-120 minutes on day 3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with suspected or known germline BRCA mutations may continue to receive single-agent veliparib continuously in the absence of disease progression or unacceptable toxicity. Patients may undergo blood, tumor tissue, and hair follicle sample collection periodically for pharmacokinetic and correlative studies. After completion of study treatment, patients are followed up for 4 weeks. \| ArmGroups: [{'label': 'Treatment (veliparib, gemcitabine hydrochloride, cisplatin)', 'type': 'EXPERIMENTAL', 'description': 'Patients receive veliparib orally every 12 hours on days 1-12, gemcitabine hydrochloride IV over 30 minutes on days 3 and 10, and cisplatin IV over 60-120 minutes on day 3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with suspected or known germline BRCA mutations may continue to receive single-agent veliparib continuously in the absence of disease progression or unacceptable toxicity. Patients may undergo blood, tumor tissue, and hair follicle sample collection periodically for pharmacokinetic and correlative studies.', 'interventionNames': ['Drug: gemcitabine hydrochloride', 'Drug: veliparib', 'Other: diagnostic laboratory biomarker analysis', 'Other: pharmacological study', 'Drug: cisplatin']}] \| Interventions:[{'type': 'DRUG', 'name': 'gemcitabine hydrochloride', 'description': 'Given IV', 'armGroupLabels': ['Treatment (veliparib, gemcitabine hydrochloride, cisplatin)'], 'otherNames': ['dFdC', 'difluorodeoxycytidine hydrochloride', 'gemcitabine', 'Gemzar']}, {'type': 'DRUG', 'name': 'veliparib', 'description': 'Given orally', 'armGroupLabels': ['Treatment (veliparib, gemcitabine hydrochloride, cisplatin)'], 'otherNames': ['ABT-888']}, {'type': 'OTHER', 'name': 'diagnostic laboratory biomarker analysis', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (veliparib, gemcitabine hydrochloride, cisplatin)']}, {'type': 'OTHER', 'name': 'pharmacological study', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (veliparib, gemcitabine hydrochloride, cisplatin)'], 'otherNames': ['pharmacological studies']}, {'type': 'DRUG', 'name': 'cisplatin', 'description': 'Given IV', 'armGroupLabels': ['Treatment (veliparib, gemcitabine hydrochloride, cisplatin)'], 'otherNames': ['CACP', 'CDDP', 'CPDD', 'DDP']}] \| PrimaryOutcomes: [{'measure': 'Maximum-tolerated dose of veliparib in combination with cisplatin and gemcitabine', 'description': 'The maximum toxicity for each category of interest that are determined to be possibly, probably or definitely related to study treatment will be recorded for each patient and the summary results will be tabulated (according to CTCAE v4.0).', 'timeFrame': '21 days'}] \| SecondaryOutcomes: [{'measure': 'Dose-limiting and other toxicities according to CTCAE v4.0', 'timeFrame': 'Up to 4 weeks post-treatment'}, {'measure': 'Recommended phase II dose', 'timeFrame': 'Up to 4 weeks post-treatment'}]
Title: Effects of Pulmonary Rehabilitation and Airway Management on Short-term and Long-term Perioperative Results of Lobectomy in Smoker Patients With Lung Cancer \| Condition: Pulmonary Neoplasm \| Keywords: pulmonary rehabilitation, lobectomy, smoker \| Summary: \| Description: In China, the smoker population is about 300 hundred million. Tobacco has become one of the world's public health problem. 30 percent of global surgery patients have smoking history. It is reported that smoker patients (\>400 cigarette/year) will suffer more postoperative complications than non-smoker patients after lobectomy (38.2% vs 12.5%). Smoking is an independent risk factor of postoperative complications of cardiothoracic surgery. Evidences showed that smoking had a negative effect on airway management which plays an important role in postoperative recovery for thoracic surgery. Therefore, we hypothesise that intervention-related study to find a way to reduce postoperative complications for smoker patients is significantly meaningful in improving the overall outcome after pulmonary surgery as 80 percent of patients with lung cancer are smoker in China. Recently, a series of strategies on airway management have been proposed by clinical doctors. As one of the important parts of airway management, pulmonary rehabilitation has been demonstrated by evidence-base medicine to reduce the pulmonary complications after thoracic surgery and increase the breathing capacity. According to the reported literatures, the effect and long-term results of pulmonary rehabilitation on smoker patients have not been studied, so we designed this randomized controlled trial to determine whether pulmonary rehabilitation would be effective to smoker patients who underwent lobectomy which was associated with significant loss of lung function. According to the reported papers in China, main observation index in experimental group was about 25.7, and in control group was about 10%. At the level of α=0.05 (Bilateral), power of test (1-β)=0.80, ratio=1:1. The estimated minimum required sample size of each group was 93 cases, the statistical loss rate was set as 10%. The overall sample size of this study was about 200 cases. \| ArmGroups: [{'label': 'regular care', 'type': 'NO_INTERVENTION', 'description': '\\[Control group\\] preoperative treatment: smoking cession, aerosol inhalation for expectorant and antiasthmatic, anti-infection therapy if necessary and regular rehabilitation-propaganda; postoperative treatment: regular postoperative treatment (anti-infection, pain control, oxygen Inhalation aerosol inhalation for expectorant and antiasthmatic), patting back (3 times/day, 15min/time) and early ambulation unless serious patients.'}, {'label': 'pulmonary rehabilitation', 'type': 'EXPERIMENTAL', 'description': '\\[Study group\\] preoperative treatment: smoking cession, aerosol inhalation for expectorant and antiasthmatic, anti-infection therapy if necessary, regular rehabilitation-propaganda and interventional pulmonary rehabilitation (preoperative part); postoperative treatment: regular postoperative treatment (anti-infection, pain control, oxygen Inhalation aerosol inhalation for expectorant and antiasthmatic), patting back (3 times/day, 15min/time), early ambulation unless serious patients and interventional pulmonary rehabilitation (postoperative part).', 'interventionNames': ['Other: pulmonary rehabilitation']}] \| Interventions:[{'type': 'OTHER', 'name': 'pulmonary rehabilitation', 'description': 'pulmonary rehabilitation (preoperative part): lower extremity endurance training (using bike ergometer for 3 days, 2 times/day, 15-20min/time) or stair climbing training (3 days, 2 times/day, 30min/time), keep dyspnea index (Borg) score between 5 to 7 points. And inspiratory muscle training (using threshold inspiratory muscle trainer for 3 days, 5 times/day, 2 sessions/time, every session includes 10-20 cycle respirations).\n\npulmonary rehabilitation (postoperative part): inspiratory muscle training (using threshold inspiratory muscle trainer until hospital discharge, 3-5 times/day, 1 session/time, every session includes 10-20 cycle respirations).', 'armGroupLabels': ['pulmonary rehabilitation']}] \| PrimaryOutcomes: [{'measure': 'postoperative pulmonary complications', 'timeFrame': 'postoperative in-hospital stay up to 30 days'}] \| SecondaryOutcomes: [{'measure': 'length of stay (LOS)', 'timeFrame': 'postoperative in-hospital stay up to 90 days'}, {'measure': 'therapeutic time of antibiotics', 'timeFrame': 'Postoperative in-hospital stay up to 30 days'}, {'measure': 'arterial blood gas analysis', 'timeFrame': 'before treatment, 3 days after treatment, 1 day after surgery, 3 days after surgery'}, {'measure': 'vital signs', 'timeFrame': 'before treatment, 3 days after treatment, 1 day after surgery, 3 days after surgery'}, {'measure': 'pain score of expectoration', 'description': 'Visual Analogue Scale (VAS) Pain Score', 'timeFrame': '1 day and 3 days after surgery'}, {'measure': 'amount of expectoration drainage', 'timeFrame': 'postoperative in-hospital stay up to 30 days'}, {'measure': 'peak expiratory flow', 'timeFrame': 'before treatment, 3 days after treatment, 1 day after surgery, 3 days after surgery'}, {'measure': 'lung function test', 'timeFrame': 'before treatment, 3 days after surgery, 3 months after surgery, 6 months after surgery'}, {'measure': 'total hospitalization expenditures', 'timeFrame': 'postoperative in-hospital stay up to 30 days'}]
Title: Supporting Older Adults With Cancer and Their Support Person Through Geriatric Assessment and Remote Exercise and Education: the SOAR Study \| Condition: Lung Cancer, Gastro-intestinal Cancer, Genito-Urinary Cancer, Breast Cancer, Gynecologic Cancer, Lymphoma \| Keywords: comprehensive geriatric assessment, chair-based exercise, health education \| Summary: \| Description: The purpose of this randomized clinical trial is to compare the standard of care alone to using a detailed health assessment for older adults followed by a 12 week program of online physical activity and health education (also called the intervention) plus the standard of care. The addition of the detailed health assessment for older adults followed by a 12 week program of online physical activity and health education to the standard of care could benefit older adults with cancer in terms of improving their physical activity, muscle strength, quality of life, and fatigue. The intervention group will receive a detailed health assessment for older adults followed by a 12- week program of physical activity and health education. During the assessment they will be asked to provide information on current health, mood, weight loss, vision and hearing, memory, fatigue, pain, and a review of medications. Additionally, they will be asked to undergo a few tests that assess walking, grip strength, and balance and complete questionnaires that evaluate quality of life, fatigue, anxiety, depression, and physical function. Two weekly sessions of group-based exercise (20-40) minutes are conducted via Zoom by a qualified exercise professional. These sessions include aerobic exercise for 20 minutes; resistance training, for 10 minutes; balance training 8 minutes, and flexibility training for 7 minutes. They will receive a weekly check-in to discuss the exercises and progress with the QEP who will adjust the exercises based on tolerance. During the first session of each of the 12- weeks, a video about a health topic by an expert will be shown on Zoom so that they can think about it after the class and prepare questions for the discussion with the expert. Their support person are invited to participate in this study. We assume that involving support persons in this study, including exercising together, can improve the health and quality of life of the patient and and their support person. If they or their support person do not have a tablet/laptop to join the class, this will be provided along with training on how to use them. The control group will receive usual care and the option to receive the intervention after 12 weeks. May 2024. We have added a single pre-post test group for patients who receive the geriatric assessment already in the older adults with cancer clinic. These participants will receive the 12 week virtual intervention and will not be randomized. They will be in the study for 12 weeks (no waitlist control period). \| ArmGroups: [{'label': 'Intervention group', 'type': 'ACTIVE_COMPARATOR', 'description': 'geriatric assessment (GAM) and remote exercise and education prior to and during curative/adjuvant or first/second line palliative chemotherapy /immunotherapy or targeted therapy', 'interventionNames': ['Behavioral: GAM, exercise, health education']}, {'label': 'Waitlist control group', 'type': 'NO_INTERVENTION', 'description': 'Wait list, receiving standard of care and option to receive intervention after treatment.'}, {'label': 'single arm pre-post test study for participants recruited from geriatric oncology clinic', 'type': 'EXPERIMENTAL', 'description': 'They will receive the 12 week virtual chair-based exercise and health education intervention except no geriatric assessment', 'interventionNames': ['Behavioral: online chair-based exercise combined with health education']}] \| Interventions:[{'type': 'BEHAVIORAL', 'name': 'GAM, exercise, health education', 'description': 'geriatric assessment, exercise and health education', 'armGroupLabels': ['Intervention group'], 'otherNames': ['Comprehensive Geriatric Assessment and Management (GAM) combined with online chair-based exercise (CBE) and health education for 12 weeks.']}, {'type': 'BEHAVIORAL', 'name': 'online chair-based exercise combined with health education', 'description': 'online chair-based exercise and health education for 12 weeks', 'armGroupLabels': ['single arm pre-post test study for participants recruited from geriatric oncology clinic']}] \| PrimaryOutcomes: [{'measure': 'Feasability of the study', 'description': 'What is the feasibility of implementation of the study? Feasibility will be measured by recruitment rate which will be the proportion of eligible patients and support persons who agree to enroll in the study, collected from our recruitment log) and measured in percentage with range 0-100. Feasibility of retention will be measured proportion of participants who complete the study data collection, collected from our study log), range 0-100.\n\nFeasibility of data outcome collection will be the percentage of patients who have complete data collection (collected from our study log), range 0-100.\n\nFeasibility of the study will be defined as recruitment of \\>60% of all eligible older adults; retention of \\>80% of the dyads; and 3) capture of outcome data of 80% or more.', 'timeFrame': '12 weeks'}, {'measure': 'Acceptability of the intervention and the study', 'description': 'What is the acceptability of the intervention and study? Acceptability will be measured by 1) adherence to the intervention and 2) satisfaction. Adherence to the intervention= 1) adherence to the geriatric assessment recommendations (collected through chart review) and expressed as percentage of recommendations received and implemented by the patient, range 0-100. 2) Adherence to online classes will be measured through the number of sessions missed as documented in the intervention log.\n\nA 5-item Likert scale satisfaction with the study scale ranging from very satisfied to very unsatisfied and satisfied and very Satisfied= satisified.\n\nAcceptability will be defined as 1) adherence to the intervention of \\>85% of participants adhering to at least 80% of the classes and recommendations; 2) satisfaction by 80% of participants.', 'timeFrame': '12 weeks'}] \| SecondaryOutcomes: [{'measure': 'Effect intervention on Physical function', 'description': 'What are the preliminary estimate of the intervention on physical function? This will be measured with the Short Physical Performance Battery (SPPB). The Short Physical Performance Battery is a test battery comprising of a four-meter gait speed test, a balance test, and 5 timed chair stand tests. The total score ranges between 0-12, and a change of one point is considered the minimal clinically important difference (MCID).', 'timeFrame': '12 weeks'}, {'measure': 'Effect intervention on Grip strength', 'description': 'What are the preliminary estimates of the intervention on grip strength? Grip strength in kilos will be measured with a handheld dynamometer three times in the dominant hand (range 0-80 kg). The maximum score will be used, and the minimal clinically important difference (MCID) is 5 kg.', 'timeFrame': '12 weeks'}, {'measure': 'Effect intervention on Life space Mobility', 'description': 'What are the preliminary estimates of the intervention on Life Space Mobility? Life Space Mobility (LSM) will be measured with the University of Alabama Birmingham Study of Aging Life Space Assessment. The Life Space Mobility total score ranges from 0 (bed-bound) to 120 (daily independent out-of-town mobility). The minimal clinically important difference (MCID)is five points.', 'timeFrame': '12 weeks'}, {'measure': 'Effect intervention on Physical Activity', 'description': 'What are the preliminary estimates of the intervention on Physical Activity? Physical activity will be measured with the Godin Leisure time Exercise questionnaire. It asks how many times in the past seven days the participant has done vigorous, moderate, and light exercise for at least 15 min each time, and how much time the participant spent on the exercise, to calculate the total score. A score of 24+ indicates Active, 14 - 23 indicates Moderately Active, and \\<14 indicates inactive/sedentary', 'timeFrame': '12 weeks'}, {'measure': 'Effect intervention on number of self-reported Falls', 'description': 'What are the preliminary estimates of the intervention on the number of self-reported falls? Self-reported falls will be assessed weekly by a phone call by the RA as well as circumstances of the fall and will be scored as the total number of falls (ranging from 0- 200).', 'timeFrame': '12 weeks'}, {'measure': 'Effect of the intervention on Fatigue', 'description': 'What are the preliminary estimates of the intervention on fatigue? This will be measured with the Pittsburgh Fatigability questionnaire (PFS). The Pittsburgh Fatigability questionnaire measures both physical and mental fatigability. Participants rate their tiredness/exhaustion from 0 ("no fatigue") to 5 ("extreme fatigue") for how they expected or imagined they would feel after completing activities ranging in type and intensity (10 items). Continuous scores for each dimension can range from 0 to 50, with higher scores indicating higher fatigability and scores \\>25 will be used to indicate severe fatigability.', 'timeFrame': '12 weeks'}, {'measure': 'Effect of the intervention on Quality of life', 'description': 'What are the preliminary estimates of intervention on quality of life? This will be measured with the 12-item Short Form Survey (SF-12) . The 12 items are summarized in a physical subscale ranging from 0-100 and a mental health subscale ranging from 0-100.', 'timeFrame': '12 weeks'}, {'measure': 'Effect of the intervention on treatment toxicity', 'description': 'What are the effect of the intervention on Treatment toxicity ? This will be abstracted from the medical charts and treatment toxicity will be graded using the Common Terminology Criteria for Adverse Events version 5.0. Each toxicity is graded from 0-5. The number of toxicities grade 3-5 will be summed.', 'timeFrame': '12 weeks'}, {'measure': 'Effect of the intervention on unplanned healthcare utilization', 'description': 'What are the effect of the intervention on unplanned Emergency Department (ED) visits and/or hospitalization? This will be abstracted from the medical charts and summarized as the number of unplanned emergency department visits and number of unplanned hospitalizations. Both could range from 0-100.', 'timeFrame': '12 weeks'}]
Title: Symptom Management, Quality of Life and Satisfaction With Care for Advanced Stage Cancers - Control Arm \| Condition: Cancer, Advanced Cancer \| Keywords: Palliative Care, Hospice, End of Life, Health Service Utilization, Quality of Life \| Summary: \| Description: Symptom Management, Quality of Life and Satisfaction with Care for Advanced Stage Cancers is the first part of a two part study (The Lancaster Cancer Care Model (LCCM) - Non-Concurrent Control Study) that was submitted to the National Cancer Institute (NCI) for funding. A decision on funding the full study should be forthcoming in the early part of 2015. The primary aim of the study is to compare the proportion of advanced cancer patients who have a hospitalization or emergency department visit in the last 6 months of life before and after implementation of a new care model that provides more comprehensive symptom management and supportive care, including earlier referral to palliative care. The secondary comparative aim is to assess measures of quality of life and satisfaction in both groups. To accomplish the aims of the study by the end of the funding period, we propose to begin data collection in advance of a funding decision. Should the study not receive funding, the data collected will be used to inform decisions regarding other funding applications and/or implementation of program changes at the Ann B. Barshinger Cancer Institute. Data collection does not represent more than minimal risk for the patients enrolled. This protocol is for the first phase of the study, which is the enrollment and collection of data on the control group, to serve as the baseline for comparison regarding hospitalizations, ED visits, quality of life, and patient and family satisfaction. To achieve sufficient number of subjects and observed deaths in the control group, we are targeting the start of enrollment and data collection in this group during the third quarter of 2014. If the project is funded, the intervention and enrollment in the intervention group are targeted to start in the second quarter of 2016. Background and study aims are presented for the entire project to provide context, but the intent of this application is only for approval of the enrollment and data collection on the control subjects (which contributes to aims 2 and 3 of the larger project). A second protocol would be presented for review and approval at the start of the intervention if the project funding is granted. In phase one of the project, subjects would be approached and consented at the point of a determination/diagnosis of advanced cancer and followed until the end of life or the start of the intervention period in the 2nd quarter of 2016 (whichever comes first) per protocol. This current study is to collect data on the control group only. After system redesign, we will open an intervention arm study to collect data after implementation of the new care model (about 18-24 months from start of control phase). \| ArmGroups: [{'label': 'Non-concurrent control group', 'description': 'A group of advanced cancer patients who received care at our Center before implementation of the LCCM model. They will receive current standard of care.\n\nThis current study is to collect data on the control group only. After system redesign, we will open an intervention arm study to collect data after implementation of the new care model (about 18-24 months from start of control phase).', 'interventionNames': ['Other: Standard of care']}] \| Interventions:[{'type': 'OTHER', 'name': 'Standard of care', 'description': 'Patients will be cared for using current standard of care preceding the design and implementation of the LCCM model of care.', 'armGroupLabels': ['Non-concurrent control group']}] \| PrimaryOutcomes: [{'measure': "Frequency of patients' ED visits and hospitalizations", 'description': 'All cause: ED admission treat and release, ED admission to inpatient visit and direct inpatient admission', 'timeFrame': 'Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months'}] \| SecondaryOutcomes: [{'measure': 'Patient quality of life', 'description': 'Assessed with FACT-G (Functional Assessment of Cancer-General measure)', 'timeFrame': 'Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months'}, {'measure': 'Patient satisfaction', 'description': 'Assessed with FAMCARE-2 (patient and family satisfaction with care)', 'timeFrame': 'Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months'}, {'measure': 'Caregiver burden', 'description': 'Assessed with BASC (Brief Assessment Scale for Caregivers) Caregiver Burden', 'timeFrame': 'Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months'}, {'measure': 'Caregiver satisfaction', 'description': 'Assessed with FAMCARE-2 (patient and family satisfaction with care)', 'timeFrame': 'Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months'}, {'measure': 'Patient symptoms', 'description': 'Assessed with the ESAS-R (Edmonton Symptom Assessment System Revised) and ECOG (Eastern Cooperative Oncology Group) performance status', 'timeFrame': 'Collected at baseline and every outpatient oncology clinic visit from enrollment until death from any cause or assessed up to 18 months'}]
Title: Nivolumab Plus Ipilimumab Plus Two Cycles of Platinum-based Chemotherapy as First Line Treatment for Stage IV/Recurrent Non-small Cell Lung Cancer (NSCLC) Patients With Synchronous Brain Metastases \| Condition: Non Small Cell Lung Cancer, Brain Metastases, Adult, Lung Cancer \| Keywords: Lung Diseases, Chemotherapy, Immunotherapy, Induction chemotherapy, Maintenance treatment, Nivolumab, Ipilimumab \| Summary: \| Description: This is an open-label, non-randomised, phase II, multicenter clinical trial. The total sample size is 71 patients. The population to be included are stage IV or recurrent, non-small cell lung cancer patients with synchronous brain metastases. Patients randomised will receive induction treatment with two cycles of platinum-based chemotherapy plus Nivolumab and Ipilimumab. At the end of induction treatment the patient with start maintenance with Nivolumab and Ipilimumab until disease progression, unacceptable toxicity, loss of clinical benefit as judged by the investigator or up to a maximum of 2 years of treatment The primary objective of this trial is to determine the rate of intracranial clinical benefit, defined as the percentage of patients who had lack of radiological or clinical progression for at least 6 months according to RANO-BM assessment criteria. Patient accrual is expected to be completed within 1.5 years, treatment is planned to extend for 1 year and the patients will be followed up for 2 years. The study will end once survival follow-up has concluded. \| ArmGroups: [{'label': 'Induction treatment + Maintenance', 'type': 'EXPERIMENTAL', 'description': 'Induction: 2 cycles of platinum-based chemotherapy plus (Nivolumab + Ipilimumab):\n\n- Non-squamous NSCLC patients: Pemetrexed: 500 mg/m2 IV, Q3W Carboplatin: AUC 5 o 6 or Cisplatin: 75 mg/m2 IV, Q3W Nivolumab: 360 mg IV Q3W Ipilimumab: 1mg/kg IV Q6W\n\n2 cycles will be administered at 21-day intervals (Q3W) for Pemetrexed, Carboplatin/Cisplatin and Nivolumab. Ipilimumab will be administered at 42 days interval (Q6W).\n\n- Squamous NSCLC patients: Paclitaxel: 200 mg/m2 IV, Q3W Carboplatin: AUC 5 o 6, Q3W Nivolumab: 360 mg IV, Q3W Ipilimumab: 1mg/kg IV, Q6W\n\nMaintenance: following two cycles of chemo-immunotherapy the patients will receive:\n\nNivolumab: 360 mg IV, Q3W Ipilimumab: 1mg/kg IV, Q6W\n\nImmunotherapy will be administered until disease progression, unacceptable toxicity, loss of clinical benefit or up to a maximum of 2 years of treatment.', 'interventionNames': ['Drug: Ipilimumab', 'Drug: Nivolumab', 'Drug: Carboplatin', 'Drug: Cisplatin', 'Drug: Paclitaxel', 'Drug: Pemetrexed']}] \| Interventions:[{'type': 'DRUG', 'name': 'Ipilimumab', 'description': 'Patients will receive Ipilimumab 1mg/Kg administered by IV infusion every 42 days (Q6W) until disease progression, unacceptable toxicity, loss of clinical benefit as judged by the investigator or up to a maximum of 2 years of treatment.\n\nStructure: is a fully human monoclonal antibody with two heavy chains and two kappa light chains linked together by way of disulfide bonds. The molecular weight is approximately 148 kDa and it exists in solution at a physiologic pH of 7.0.\n\nRoute of administration: Intravenous infusion.', 'armGroupLabels': ['Induction treatment + Maintenance'], 'otherNames': ['Yervoy']}, {'type': 'DRUG', 'name': 'Nivolumab', 'description': 'Patients will receive Nivolumab 360 mg administered by IV infusion every 21 days (Q3W) until disease progression, unacceptable toxicity, loss of clinical benefit as judged by the investigator or up to a maximum of 2 years of treatment.\n\nStructure: Nivolumab is a soluble protein consisting of 4 polypeptide chains, which include 2 identical heavy chains and 2 identical light chains.\n\nRoute of administration: Intravenous infusion.', 'armGroupLabels': ['Induction treatment + Maintenance'], 'otherNames': ['Opdivo']}, {'type': 'DRUG', 'name': 'Carboplatin', 'description': 'Patients will receive Carboplatin AUC 5 or 6 administered by IV infusion every 21 days (Q3W), for 2 cycles.\n\nStructure: The cis-diamino (cyclobutane-1, 1 dicarboxylate) platin. Stability: 24 hours at ambient temperature in 5% glucose, glucosa or physiologic saline. It is recommended not to dilute with chlorinated solutions since this could affect the carboplatin.\n\nRoute of administration: Intravenous infusion. Guidelines of Carboplatin administration: According to the standard of each center.', 'armGroupLabels': ['Induction treatment + Maintenance'], 'otherNames': ['Paraplatin']}, {'type': 'DRUG', 'name': 'Cisplatin', 'description': 'Patients will receive Cisplatin 75mg/m2 administered by IV infusion every 21 days (Q3W), for 2 cycles.\n\nStructure: (CAS No. 15663-27-1, MF-Cl2H6N2Pt; NCF-119875), cisplatinum, also called cis-diamminedichloroplatinum(II), is a metallic (platinum) coordination compound with a square planar geometry. It is a white or deep yellow to yellow-orange crystalline powder at room temperature.\n\nStability: Do not store above 25°C. Do not refrigerate or freeze. Keep container in the outer carton to protect from light. Following dilution in 0.9% sodium chloride injection, chemical and physical in-use stability has been demonstrated for up to 14 days at 20°C.\n\nRoute of administration: Intravenous infusion. Guidelines of Cisplatin administration: According to the standard of each center.', 'armGroupLabels': ['Induction treatment + Maintenance'], 'otherNames': ['Cis-diamminedichloroplatinum', 'Platinol']}, {'type': 'DRUG', 'name': 'Paclitaxel', 'description': 'Patients will receive Paclitaxel 200mg/m2 administered by IV infusion every 21 days (Q3W), for 2 cycles.\n\nStructure: A diterpene whose composition is: 5b, 20-epoxy-1, 2a, 4,7b, 10b, 13a-hexahidroxytax-11-en 9 one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)- N-benzoyl-3-phenylisoserine.\n\nStability: Concentrations of 0.3-1.2 mg/ml in 5% dextrose or normal saline have demonstrated chemical and physical stability for more that 27 hours at ambient temperature (25ºC approximately). The intact vial must be stored between 15º and 25ºC.\n\nGuidelines of Paclitaxel administration: Paclitaxel must be administered by infusion over 3 hours in dextrose (D5W) or normal saline (NS). The concentration must not exceed 1.2 mg/ml.', 'armGroupLabels': ['Induction treatment + Maintenance'], 'otherNames': ['Taxol']}, {'type': 'DRUG', 'name': 'Pemetrexed', 'description': 'Patients will receive Pemetrexed 500mg/m2 administered by IV infusion every 21 days (Q3W), for 2 cycles.\n\nStructure: Pemetrexed disodium (ALIMTA®, pemetrexed) is a novel pyrrol \\[2,3 d\\]-pyrimidine based folic acid analogue.\n\nRoute of administration: Intravenous infusion. Guidelines of Pemetrexed administration: According to the standard of each center', 'armGroupLabels': ['Induction treatment + Maintenance'], 'otherNames': ['Pemetrexed disodium; ALIMTA']}] \| PrimaryOutcomes: [{'measure': 'Rate of intracranial clinical benefit', 'description': 'Defined as the percentage of patients who had lack of radiological or clinical progression for at least 6 months according to RANO-BM assessment criteria', 'timeFrame': 'From the date of the end of treatment until the date of last follow up, assessed up to 24 months'}] \| SecondaryOutcomes: [{'measure': 'To assess the efficacy of the treatment in terms of the Progression Free Survival (PFS)', 'description': 'PFS defined as systemic PFS (excluding CNS) as per RECIST version 1.1 and PFS in the CNS as per RANO-BM criteria', 'timeFrame': 'From the date of the end of treatment until the date of last follow up, assessed up to 24 months'}, {'measure': 'To evaluate the Overall Response Rate (ORR) of the treatment', 'description': 'Intracranial ORR, defined as a complete response or partial response as determined by the investigator according to RANO for brain disease. Systemic ORR, defined as a complete response or partial response as determined by the investigator according to RECIST v1.1. criteria for systemic disease.', 'timeFrame': 'From the date of the end of treatment until the date of last follow up, assessed up to 24 months'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)', 'description': 'Occurrence and severity of adverse events, with severity determined by NCI CTCAE v5.0 criteria.', 'timeFrame': "From the subject's written consent to participate in the study through 100 days after the final administration of the drug"}]
Title: An Open-Label, Multi-Center Phase II Trial of Neoadjuvant Irinotecan in Combination With Infusional 5-FU, Leucovorin (Folfiri) Plus Bevacizumab in Patients With Unresectable Hepatic-Only Metastases of Colorectal Carcinoma \| Condition: Colorectal Neoplasms, Liver Neoplasms \| Keywords: \| Summary: \| Description: N/A \| ArmGroups: N/A \| Interventions:[{'type': 'DRUG', 'name': 'Combination therapy of irinotecan with 5-FU, leucovorin plus bevacizumab in the neoadjuvant setting.'}] \| PrimaryOutcomes: [{'measure': 'To determine the rate of R0 resection or pathologically confirmed CR in patients with hepatic only metastases'}] \| SecondaryOutcomes: [{'measure': 'oTo determine the resectable rate, defined as the number of subjects with R0 resection, pathologically staged CR, or undergoing non-surgical ablative procedures with curative intent divided by the total number of evaluable subjects following treatment'}]
Title: Effectiveness of Accelerated Intervention With Custom-made Compression Sleeve in Women With Mild and Moderate Arm Lymphedema Secondary to Breast Cancer Treatment \| Condition: Breast Cancer, Lymphedema \| Keywords: \| Summary: \| Description: Use of a custom-made compression sleeve is an initial treatment of mild and moderate arm lymphedema secondary to primary breast cancer treatment. The compression sleeve improves the flow of lymph fluid out of the arm, reduces the swelling, and prevents progression of the lymphedema in the future. Early intervention is recommended though early is not well-defined in literature. The purpose of this study is to evaluate reduction of excess limb volume and changes in arm disability and clinical symptoms in accelerated treatment with compression sleeve compared to standard treatment. \| ArmGroups: [{'label': 'Accelerated treatment', 'type': 'EXPERIMENTAL', 'interventionNames': ['Device: Custom-made compression sleeve and -gauntlet', 'Other: Educational information, recommendation and instruction']}, {'label': 'Standard treatment', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Device: Custom-made compression sleeve and -gauntlet', 'Other: Educational information, recommendation and instruction']}] \| Interventions:[{'type': 'DEVICE', 'name': 'Custom-made compression sleeve and -gauntlet', 'description': 'Device: Compression garments worn for a minimum of six hours per day', 'armGroupLabels': ['Accelerated treatment', 'Standard treatment'], 'otherNames': ['Jobst Elvarex']}, {'type': 'OTHER', 'name': 'Educational information, recommendation and instruction', 'description': 'Educational information and recommendations about lymphedema and skin care. Instruction in physical exercises to enhance the lymph flow', 'armGroupLabels': ['Accelerated treatment', 'Standard treatment']}] \| PrimaryOutcomes: [{'measure': 'Change of excess limb volume (ELV)', 'description': 'ELV in the affected arm compared to the non-affected arm. ELV described as both absolute volume in ml and relative volume in percent', 'timeFrame': '8 weeks follow-up'}] \| SecondaryOutcomes: [{'measure': 'Changes in arm disability', 'description': 'Measured with Disabilities of Arm, Shoulder, and Hand (DASH)', 'timeFrame': '8 weeks follow-up'}, {'measure': 'Changes in subjective symptoms (pain, tension, and heaviness)', 'timeFrame': '8 weeks follow-up'}]
Title: A Randomised, Placebo-controlled, Crossover Trial of Acetaminophen in Cancer Patients on Strong Opioids \| Condition: Cancer, Pain \| Keywords: cancer pain, acetaminophen, opioids \| Summary: \| Description: Aim: To assess whether regular oral acetaminophen can reduce pain in cancer patients already on a strong opioid regimen. Rationale: It is estimated that 75% of people with advanced cancer suffer significant pain. Many of these people continue to have pain despite being on strong opioids. The rationale behind adding an additional analgesic with a different mechanism of action is to attempt to improve analgesia without increasing side effects. Overview: This is a double blind, randomised placebo-controlled, crossover trial to evaluate whether the addition of regular acetaminophen can reduce pain in cancer patients already on a strong opioid regimen. The study will be performed in ambulatory cancer patients who have pain that is believed to be caused by their cancer, and who have already been stabilised on an opioid regimen of \> 60mg/day of morphine equivalents. Each patient will be randomly allocated to receive either acetaminophen 1g qid or an identical appearing placebo qid for a seven-day period, and then crossed over to the other arm for a further seven-day period. Patients will complete daily pain diaries and weekly questionnaires (Brief Pain Inventory) and comparison will be made between the pain scores for the two treatment periods. Patient preference for the two treatment periods will also be evaluated. Research Question: A randomised, double-blind, placebo controlled crossover trial to determine if the addition of regular acetaminophen (1g PO qid) leads to improved analgesic control in adult cancer patients at Princess Margaret Hospital, who are already on strong opioids (\> 60mg morphine equivalents/day) as evaluated by daily pain scores measured by Numerical Rating Scales (NRS) and the Brief Pain Inventory (BPI). Hypothesis: Regular acetaminophen improves pain control in cancer patients who are already on strong opioid regimens. \| ArmGroups: [{'label': 'A, 1, acetaminophen', 'type': 'ACTIVE_COMPARATOR', 'description': 'acetaminophen', 'interventionNames': ['Drug: Acetaminophen']}, {'label': 'B placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'placebo PO qid', 'interventionNames': ['Drug: placebo, sugar pill']}] \| Interventions:[{'type': 'DRUG', 'name': 'Acetaminophen', 'description': 'acetaminophen 1g po qid', 'armGroupLabels': ['A, 1, acetaminophen']}, {'type': 'DRUG', 'name': 'acetaminophen', 'description': 'acetaminophen 1g po qid for 7 days', 'armGroupLabels': ['A, 1, acetaminophen']}, {'type': 'DRUG', 'name': 'placebo, sugar pill', 'armGroupLabels': ['B placebo']}] \| PrimaryOutcomes: [{'measure': 'Patient preference for the acetaminophen or the placebo arm as assessed by asking the patient whether he/she preferred treatment period 1 or treatment period 2', 'timeFrame': 'Post completion of period 2'}, {'measure': 'Differences in the mean pain intensity score as assessed by the daily average Numeric Rating Scale (NRS) pain score during the week given acetaminophen compared with the daily average NRS pain score during the week given placebo', 'timeFrame': 'post period 2'}] \| SecondaryOutcomes: [{'measure': 'Symptoms possibly associated with acetaminophen use for each period using an NRS: feeling sick (nausea and vomiting)', 'timeFrame': 'post period 2'}, {'measure': 'drowsiness', 'timeFrame': 'post period 2'}, {'measure': 'constipation', 'timeFrame': 'post period 2'}, {'measure': 'cold sweats', 'timeFrame': 'post period 2'}, {'measure': 'overall sense of well being', 'timeFrame': 'post period 2'}, {'measure': 'Total analgesic consumption in each treatment period', 'timeFrame': 'post period 2'}, {'measure': 'Best and worst pain scores for each treatment period', 'timeFrame': 'post period 2'}, {'measure': 'Pain relief obtained in each treatment period', 'timeFrame': 'post period 2'}, {'measure': 'Effect of pain on functional ability', 'timeFrame': 'post period 2'}, {'measure': 'Strength of preference for acetaminophen versus placebo on a 5-point scale', 'timeFrame': 'post period 2'}, {'measure': 'Proportion of patients who had a preference for acetaminophen who perceived the improvement warranted taking the additional tablets', 'timeFrame': 'post period 2'}, {'measure': 'Proportion of patients having a clinically significant improvement in pain (defined as an improvement in mean NRS of at least 33% during the week taking acetaminophen)', 'timeFrame': 'post period 2'}]
Title: A Phase I/II Trial of Herceptin and ZD1839 (Iressa, NSC #715055, IND#61187) in Patients With Metastatic Breast Cancer That Overexpresses HER2/Neu (erbB-2) \| Condition: Male Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer \| Keywords: \| Summary: \| Description: PRIMARY OBJECTIVES: I. Determine the response rate, duration of response, and time to progression in patients with metastatic breast cancer that overexpresses HER2-neu treated with trastuzumab (Herceptin) and gefitinib. II. Determine the phase II dose of gefitinib when given in combination with trastuzumab in these patients. III. Determine the toxicity of this regimen in these patients. IV. Determine the 3- and 6-month progression-free survival of patients treated with this regimen. V. Correlate response rates with plasma levels of circulating HER2 and tumor levels of epidermal growth factor receptor, activated HER2, and HER2 receptors, as measured by immunohistochemistry and/or fluorescent in situ hybridization (FISH), in patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of gefitinib. The phase I portion of this study was open in only 5 ECOG institutions. The phase I portion has been completed, and the study is being opened in all ECOG-affiliated institutions. Phase I (completed): Patients receive trastuzumab (Herceptin) IV over 30-90 minutes once weekly and oral gefitinib once daily beginning on day 1. Cohorts of 3-6 patients receive escalating doses of gefitinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is established, additional patients are accrued to the phase II portion of the study and are treated at that dose. Phase II: Patients receive oral gefitinib once daily (at the MTD established in phase I) and trastuzumab IV weekly until week 24, at which time trastuzumab is given every 3 weeks (with daily gefitinib) until disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until 2 years from study entry. \| ArmGroups: [{'label': 'Treatment (trastuzumab, gefitinib)', 'type': 'EXPERIMENTAL', 'description': 'Phase I (completed): Patients receive trastuzumab (Herceptin) IV over 30-90 minutes once weekly and oral gefitinib once daily beginning on day 1.\n\nCohorts of 3-6 patients receive escalating doses of gefitinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is established, additional patients are accrued to the phase II portion of the study and are treated at that dose.\n\nPhase II: Patients receive oral gefitinib once daily (at the MTD established in phase I) and trastuzumab IV weekly until week 24, at which time trastuzumab is given every 3 weeks (with daily gefitinib) until disease progression or unacceptable toxicity.', 'interventionNames': ['Biological: trastuzumab', 'Drug: gefitinib', 'Other: laboratory biomarker analysis']}] \| Interventions:[{'type': 'BIOLOGICAL', 'name': 'trastuzumab', 'description': 'Given IV', 'armGroupLabels': ['Treatment (trastuzumab, gefitinib)'], 'otherNames': ['anti-c-erB-2', 'Herceptin', 'MOAB HER2']}, {'type': 'DRUG', 'name': 'gefitinib', 'description': 'Given orally', 'armGroupLabels': ['Treatment (trastuzumab, gefitinib)'], 'otherNames': ['Iressa', 'ZD 1839']}, {'type': 'OTHER', 'name': 'laboratory biomarker analysis', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (trastuzumab, gefitinib)']}] \| PrimaryOutcomes: [{'measure': 'MTD and DLT in patients treated with Herceptin and ZD1839 graded using the NCI CTC (Phase I)', 'timeFrame': '4 weeks'}] \| SecondaryOutcomes: [{'measure': 'Median time to progression (Phase II)', 'timeFrame': '6 months'}, {'measure': 'Progression-free survival (Phase II)', 'timeFrame': '3 months'}]
Title: Clinical Study of Single Ultra-high Dose Stereotactic Body Radiation Therapy for Early Lung Cancer \| Condition: Early Lung Cancer, Stereotactic Body Radiotherapy \| Keywords: lung cancer, Stereotactic body radiotherapy (SBRT), High dose, Fraction \| Summary: \| Description: The goal of this prospective single-arm phase II study is to study the efficacy and safety of stereotactic body radiotherapy (SBRT) for early lung cancer. This study intends to enroll 100 participants in 2 years. The participants enrolled will receive single fraction of ultra-high dose stereotactic body radiotherapy (SBRT) (30Gy/1F). \| ArmGroups: [{'label': 'Participants receiving SBRT', 'type': 'EXPERIMENTAL', 'description': 'The participants enrolled will receive single fraction of ultra-high dose SBRT(30Gy/1F).', 'interventionNames': ['Radiation: SBRT']}] \| Interventions:[{'type': 'RADIATION', 'name': 'SBRT', 'description': 'The participants enrolled will receive single fraction of ultra-high dose SBRT(30Gy/1F).', 'armGroupLabels': ['Participants receiving SBRT']}] \| PrimaryOutcomes: [{'measure': 'PFS', 'description': 'The time from the date of treatment to the date of disease progression or death or last follow-up.', 'timeFrame': '3 years'}] \| SecondaryOutcomes: [{'measure': 'OS', 'description': 'The time from the date of treatment to the date of death or last follow-up.', 'timeFrame': '3 years'}, {'measure': 'AE', 'description': 'The incidence of All adverse event (AE), treatment emergent AE (TEAE), treatment-related AE (TRAE), immune-related AE (irAE), serious AE (SAE) and radiation-related AE(rAE), the relevance and severity related with the study protocol.', 'timeFrame': '3 years'}]
Title: Second Line Erlitinib Combination With Gemcitabine Cisplatinum in Non-small Cell Lung Cancer Patients Who Harbored EGFR Sensitive Mutation Developed Resistance After First Line TKI Treatment \| Condition: Carcinoma, Non-Small Cell Lung, EGFR Gene Mutation \| Keywords: TKI, resistance, erlotinib, combined chemotherapy \| Summary: \| Description: The investigators will enroll patients diagnosed with advanced non-squamous,non-small cell lung cancer, patients with EGFR TKI sensitive mutations and developed TKI resistance in first line treatment. After enrollment, the investigators will do biopsy again before second line treatment to find out the potential mechanism of TKI resistance, do EGFR mutation test for both sensitive and resistant mutation in exon 18, 19, 20 and 21; do KRAS, BRAF and PI3K mutation test, do FISH for MET and HER-2, the investigators do all these test to evaluated both primary and secondary resistance, the investigators do all these tests to get an overview for EGFR mutation status of each patient who develop TKI resistance. For second line treatment, patients will received a 28 days gemcitabine platinum combined with erlotinib scheme, after 4 cycle of combined chemotherapy, patients will receive erlotinib for further treatment until progression disease. For the patients who have stable brain metastases, combined chemotherapy should begin after local treatment, such as whole brain radiotherapy or sterotactic radiosurgery. the main endpoint of this study is mean PFS, second endpoints of this study consist of mean OS, 8 week ORR. \| ArmGroups: [{'label': 'experimental', 'type': 'EXPERIMENTAL', 'description': 'patients will received a 28 days gemcitabine platinum combined with erlotinib scheme(gemcitabine for day 1 and day 8, 1250mg/m2. Platinum for day 1, 75mg/m2. Erlotinib for 150mg/day, day 9-21 every cycle, after 4 cycles, erlotinib should be used daily), after 4 cycle of combined chemotherapy, patients will receive erlotinib for further treatment until progression disease.', 'interventionNames': ['Drug: Gemcitabine platinum combined with erlotinib']}] \| Interventions:[{'type': 'DRUG', 'name': 'Gemcitabine platinum combined with erlotinib', 'description': 'patients will received a 28 days gemcitabine platinum combined with erlotinib scheme, after 4 cycles combined chemotherapy, patients will receive erlotinib for maintain treatment until progression disease.Gemcitabine for day 1 and day 8, 1250mg/m2. Platinum for day 1, 75mg/m2. Erlotinib for day 9-21 during combined chemotherapy, 150mg/day, then erlotinib should be used daily until patients develop progression disease.', 'armGroupLabels': ['experimental'], 'otherNames': ['Gemzar', 'Tarceva']}] \| PrimaryOutcomes: [{'measure': 'mean progression free survival(mPFS)', 'description': 'mean progression free survival(mPFS) will be recorded in enroll patients who received second line gemcitabine platinum combined with erlotinib. mPFS should be measured before second line treatment, before the third combined chemotherapy, after the fourth combined chemotherapy, every 3 months during erlotinib treatment, mPFS should be measured up to two years or every time progression disease occurs within two years.', 'timeFrame': 'after patients receive treatment, mPFS should be measured before the third cycle of chemotherapy, after the fourth cycle, mPFS should be measured every 3 months up to two years'}] \| SecondaryOutcomes: [{'measure': 'mean overall survival(mOS)', 'description': 'mOS should be measured since enrollment, every 3 months we will contact patients to find out detail survival data of each patient until 3 years, or within 3 years if all survival data is obtained.', 'timeFrame': 'every 3 months up to 3 years, or until all the survival data is obtained'}, {'measure': '8 week overall response rate(8 week ORR)', 'description': '8 week ORR should be measured after enrollment, after combined chemotherapy for 8 weeks, the exact time point should be the ninth week during combined chemotherapy. CR, PR, SD shoud be measured according to RESICT 1.1', 'timeFrame': '8 week ORR should be measured after enrollment, the exact time point should be the ninth week after combined chemotherapy'}]
Title: Evaluation of External Lymphedema Treatment on Pharyngeal Pressure in Head and Neck Cancer Patients \| Condition: Head and Neck Cancer \| Keywords: Head and Neck Cancer, Lymphedema, Treatment \| Summary: \| Description: Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. The lymphedema seen in patients treated for head and neck cancer can be seen externally on the neck and face, as well as internally in the lining of the throat. In this study, the investigators plan to treat the external lymphedema with a device called the Flexitouch Plus, which is already approved by the Food and Drug Administration (FDA) for lymphedema treatment, and to measure the degree of internal lymphedema using a pressure sensor to detect throat muscle pressure before and after the treatment with the Flexitouch Plus device. \| ArmGroups: [{'label': 'Single arm', 'type': 'EXPERIMENTAL', 'interventionNames': ['Device: Flexitouch Plus system']}] \| Interventions:[{'type': 'DEVICE', 'name': 'Flexitouch Plus system', 'description': 'A single treatment for external lymphedema using the FDA-approved Flexitouch Plus device.', 'armGroupLabels': ['Single arm']}] \| PrimaryOutcomes: [{'measure': 'Internal lymphedema measurement', 'description': 'The pressure in the throat will be measured using a device called high-resolution manometry before and after wearing a treatment jacket (Flexitouch plus device).', 'timeFrame': '2 hours'}] \| SecondaryOutcomes: [{'measure': 'External lymphedema measurement', 'description': 'Neck circumference measurement will be done using standard tape measure before and after wearing a treatment jacket (Flexitouch plus device).', 'timeFrame': '2 hours'}]
Title: LDR Brachytherapy Versus Hypofractionated SBRT for Low and Intermediate Risk Prostate Cancer Patients \| Condition: Prostate Cancer \| Keywords: Low risk prostate cancer, Intermediate risk prostate cancer, Low dose-rate brachytherapy, Hypofractionated, Robotic external beam radiation, Quality of life \| Summary: \| Description: Prostate cancer (PC) is the most common solid malignancy among the men in the Western world. The classification to low, intermediate and high risk groups is determined by the PSA, Gleason score and clinical TNM status at the moment of diagnosis. There are several treatment options available for patients with low and intermediate risk PC and generally their prognosis is good. The men live long after their radical treatments and they have to live with the possible adverse effects caused by the treatment. In this prospective, randomised clinical trial we are comparing two radiotherapy modalities to find out if there are differences in the acute and late adverse effects among men treated either by low dose-rate (LDR) brachytherapy or hypofractionated external radiotherapy. Also the PSA-responses and cost utilities will be analysed. The number of patients recruited for the study is 60 and the patients will be randomised 1:1 to each treatment arm. \| ArmGroups: [{'label': 'LDR-brachytherapy with I125 seeds', 'type': 'ACTIVE_COMPARATOR', 'description': 'Low-dose rate-brachytherapy with I125 permanent seeds in prostate cancer.', 'interventionNames': ['Radiation: LDR-brachytherapy with I125 seeds']}, {'label': 'Hypofractionated RT 5 x 7,25 Gy', 'type': 'ACTIVE_COMPARATOR', 'description': 'Hypofractionated stereotactic radiotherapy 5 x 7,25 Gy delivered every second day in prostate cancer.', 'interventionNames': ['Radiation: Hypofractionated RT 5 x 7,25 Gy']}] \| Interventions:[{'type': 'RADIATION', 'name': 'Hypofractionated RT 5 x 7,25 Gy', 'armGroupLabels': ['Hypofractionated RT 5 x 7,25 Gy']}, {'type': 'RADIATION', 'name': 'LDR-brachytherapy with I125 seeds', 'armGroupLabels': ['LDR-brachytherapy with I125 seeds']}] \| PrimaryOutcomes: [{'measure': 'Differences in acute adverse effects', 'description': 'questionnaires', 'timeFrame': '6 months'}] \| SecondaryOutcomes: [{'measure': 'Time to PSA response', 'timeFrame': '6 months'}, {'measure': 'Time to PSA nadir', 'timeFrame': '2 years'}, {'measure': 'Biological progression free survival (bPFS)', 'timeFrame': '3 years'}]
Title: Recombinant Human Endostatin Combined With Evafolimab Injection and Synchronal Radiochemotherapy for First-line Treatment of Locally Advanced Stage III Squamous Non-small Cell Lung Cancer \| Condition: Locally Advanced Squamous Non-small Cell Lung Cancer \| Keywords: recombinant human endostatin, envafolimab, synchronal radiochemotherapy \| Summary: \| Description: This study is a prospective, single arm, single center open clinical study aimed at evaluating the efficacy and safety of recombinant human endostatin and envafolimab combined with synchronal radiochemotherapy in patients with locally advanced squamous non-small cell lung cancer who cannot undergo surgery in stage III. Patients with locally advanced stage III squamous non-small cell lung cancer who have not received systematic treatment in the past and cannot be treated surgically, after signing informed consent, qualified subjects who meet the inclusion criteria will be screened. They will receive 2 cycles of recombinant human endostatin combined with envafolimab and platinum containing chemotherapy. Radiotherapy will be carried out simultaneously in cycles 1-2, and after 2 cycles, they will receive maintenance treatment with envafolimab until the disease progresses and intolerable toxicity is detected, The treatment period does not exceed 12 months \| ArmGroups: [{'label': 'recombinant human endostatin Group', 'type': 'EXPERIMENTAL', 'description': 'Recombinant human endostatin and enrolizumab injection combined with Synchronal Radiochemotherapy', 'interventionNames': ['Drug: Recombinant Human Endostatin Injection']}] \| Interventions:[{'type': 'DRUG', 'name': 'Recombinant Human Endostatin Injection', 'description': 'Recombinant Human Endostatin Injection：210 mg, intravenous infusion for 72 hours, once every three weeks cycle Evafolimab Injection：Subcutaneous injection on day 1, 8, and 15, once every three weeks cycle', 'armGroupLabels': ['recombinant human endostatin Group'], 'otherNames': ['Evafolimab Injection']}] \| PrimaryOutcomes: [{'measure': 'objective response rate', 'description': 'After treatment, the ratio of patients assessed as CR and PR according to RECIST 1.1', 'timeFrame': 'After 6 weeks'}] \| SecondaryOutcomes: [{'measure': 'Overall survival', 'description': 'The time from the start of treatment to death or last follow-up', 'timeFrame': 'The time from the start of treatment to death or last follow-up'}, {'measure': 'Progression-free survival', 'description': 'The time from the start of treatment to the first recording of disease progression.', 'timeFrame': 'The time from the start of treatment to the first recording of disease progression'}]
Title: A Phase II Study Evaluating the Efficacy and Safety of Combination of CPGJ602 and Chemotherapy as First Line Treatment in KRAS/NRAS/BRAF Wild-type, Metastatic Colorectal Cancer Patients \| Condition: Metastatic Colorectal Cancer \| Keywords: \| Summary: \| Description: This is an open label, randomized, positive control, phase II study to treat subjects with KRAS/NRAS/BRAF wild-type, unresectable metastatic colorectal cancer. The patients will be randomized into three arms consist of CPGJ602 (2 weeks/cycle) + mFOLFOX6, CPGJ602 (1 week/cycle) + mFOLFOX6, and cetuximab (1 week/cycle) + mFOLFOX6 at a ratio of 2:2:1. This study is conduct to assess the efficacy and safety of three treatments for patients. \| ArmGroups: [{'label': 'Arm A', 'type': 'EXPERIMENTAL', 'description': 'CPGJ602 325mg/m2 IV Q2W； mFOLFOX6 therapy starts on day 1 and ends on day 2, then repeats every 2 weeks.', 'interventionNames': ['Drug: CPGJ602']}, {'label': 'Arm B', 'type': 'EXPERIMENTAL', 'description': 'CPGJ602 400 mg/m2 IV in the first infusion， then 250mg/m2 followed per every week； mFOLFOX6 therapy starts on day 1 and ends on day 2, then repeats every 2 weeks', 'interventionNames': ['Drug: CPGJ602']}, {'label': 'Arm C', 'type': 'ACTIVE_COMPARATOR', 'description': 'cetuximab 400 mg/m2 IV in the first infusion， then 250mg/m2 followed per every week； mFOLFOX6 therapy starts on day 1 and ends on day 2, then repeats every 2 weeks', 'interventionNames': ['Drug: cetuximab']}] \| Interventions:[{'type': 'DRUG', 'name': 'CPGJ602', 'description': 'Q2W/QW iv', 'armGroupLabels': ['Arm A', 'Arm B']}, {'type': 'DRUG', 'name': 'cetuximab', 'description': 'QW iv', 'armGroupLabels': ['Arm C']}] \| PrimaryOutcomes: [{'measure': 'Best of Response (BOR)', 'description': 'Defined as the percentage of patients whose overall response is CR or PR from day 1 to 16th week of study and maintain at least until efficacy confirmation assessment (4 weeks ± 2 days), per RECIST v1.1 for target lesions assessed by BIRC.', 'timeFrame': 'for 16 weeks'}] \| SecondaryOutcomes: [{'measure': 'Progression Free Survival (PFS)', 'description': 'Defined as the interval from the date of randomization until first documented disease progression or death from any cause, whichever occurs first, assessed based on tumor assessments according to RECIST v1.1 per BICR and Investigator.', 'timeFrame': 'for 16 weeks'}, {'measure': 'BOR Assessed by investigator', 'timeFrame': 'for 16 weeks'}, {'measure': 'Disease Control Rate (DCR)', 'description': 'Defined as the percentage of patients whose overall response is CR, PR and SD from day 1 to 16th week and maintain at least until efficacy confirmation assessment (4 weeks ± 2 days), per RECIST v1.1 for target lesions assessed by BIRC and Investigator.', 'timeFrame': 'for 16 weeks'}, {'measure': 'unConfirmed BOR at the end of 16th week by BICR and Investigator.', 'description': 'Defined as the percentage of patients whose overall response is CR or PR from day 1 to 16th week per RECIST v1.1 for target lesions assessed by BIRC and Investigator.', 'timeFrame': 'for 16 weeks'}, {'measure': 'Time to Tumor Response (TTR)', 'description': 'Defined as the time from the first dose study treatment until the date of the first assessment of confirmed CR or PR, assessed by BICR and Investigator', 'timeFrame': 'for 16 weeks'}, {'measure': 'Deepness of Response (DpR)', 'description': 'The relative change in the sum of longest diameters of RECIST target lesions at the nadir, in the absence of new lesions or progression of non-target lesions, when compared with baseline assessed by BIRC and Investigator', 'timeFrame': 'for 16 weeks'}]
Title: PROCLAIM: A Phase 3 Randomized Placebo-controlled Double-blind Study of Romiplostim for the Treatment of Chemotherapy-induced Thrombocytopenia in Patients Receiving Chemotherapy for Treatment of Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer \| Condition: Chemotherapy-induced Thrombocytopenia \| Keywords: Chemotherapy-induced thrombocytopenia, Non-small Cell Lung Cancer, Ovarian Cancer, Breast Cancer \| Summary: \| Description: This is a phase 3, randomized, placebo-controlled, multicenter, international study for the treatment of CIT in adult subjects receiving chemotherapy for the treatment of NSCLC, ovarian cancer, or breast cancer. Subjects must have a platelet count ≤ 85 x 10\^9/L on day 1 of the study. The study will consist of a screening period of up to 4 weeks, a treatment period long enough to allow for assessment of 3 planned cycles of chemotherapy, a follow-up visit, and long-term follow-up (LTFU). Given that subjects are required to have 3 remaining planned cycles of chemotherapy, the chemotherapy cycles may be 3 or 4 weeks in duration, and the investigational product dose adjustment guidelines allow for up to 12 weeks of dosing before a subject is declared a non-responder, the majority of study subjects will receive investigational product for a range of 10-24 weeks. \| ArmGroups: [{'label': 'Romiplostim', 'type': 'EXPERIMENTAL', 'description': 'The study in a 2:1 randomization ratio(108 subjects to romiplostim). Amgen investigational product (romiplostim or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection.', 'interventionNames': ['Drug: Romiplostim']}, {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'The study in a 2:1 randomization ratio (54 subjects to placebo) Amgen investigational product (romiplostim or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection.', 'interventionNames': ['Drug: Placebo']}] \| Interventions:[{'type': 'DRUG', 'name': 'Romiplostim', 'description': 'This study is designed to study Romiplostim for the treatment of chemotherapy-induced thrombocytopenia (CIT) in patients receiving chemotherapy for the treatment of non-small cell lung cancer (NSCLC), ovarian cancer, or breast cancer', 'armGroupLabels': ['Romiplostim'], 'otherNames': ['Nplate']}, {'type': 'DRUG', 'name': 'Placebo', 'description': 'Placebo comparator', 'armGroupLabels': ['Placebo']}] \| PrimaryOutcomes: [{'measure': 'Incidence of either a chemotherapy dose delay or reduction', 'description': 'No thrombocytopenia-induced modification of any myelosuppressive agent in the second and third cycles of the planned on-study chemotherapy regimen. Thrombocytopenia-induced modifications include chemotherapy dose reduction, delay, omission, or chemotherapy treatment discontinuation due to platelet counts below 100 x 109/L', 'timeFrame': '48 days'}] \| SecondaryOutcomes: [{'measure': 'Depth of Platelet Count', 'description': 'the depth of the platelet count nadir from the start of the first on-study chemotherapy cycle through the end of the treatment period', 'timeFrame': '48 days'}, {'measure': 'Time to First platelet response', 'description': 'The time to first platelet response, defined by platelet count ≥ 100 x 109/L in the absence of platelet transfusions during the preceding 7 days', 'timeFrame': '7 days'}, {'measure': 'the duration-adjusted event rate of ≥ grade 2 bleeding events', 'description': 'the duration-adjusted event rate of ≥ grade 2 bleeding events, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grading scale', 'timeFrame': '48 days'}, {'measure': 'Overall survival', 'description': '1-year overall survival', 'timeFrame': '1 Year'}, {'measure': 'Proportion of subjects with at leat 1 incidence of platelet transfusion', 'description': 'platelet transfusion(s) during the treatment period', 'timeFrame': '48 days'}, {'measure': 'proportion of patients achieving platelet count >= 100 x 10 9/L', 'description': '7 days after 3rd dose of IP with no transfusions in preceding 7 days', 'timeFrame': '7 days'}, {'measure': 'The subject incidence of adverse events', 'description': 'Through end of study, up to 36 months. It will be counted in as an adverse event: any treatment - emergent adverse events, fatal adverse events, serious adverse events, or clinically significant changes in laboratory values.', 'timeFrame': '36 months'}, {'measure': 'Number of subjects who develop anti-romiplostim antibodies', 'description': 'Through end of study up to 36 months', 'timeFrame': '36 Months'}, {'measure': 'Number of subjects who develop anti-TPO antibodies', 'description': 'Through end of study, up to 36 months', 'timeFrame': '36 months'}, {'measure': 'Number of subjects who experience myelodysplastic syndromes', 'description': 'Through end of study, up to 36 months', 'timeFrame': '36 months'}, {'measure': 'Number of subjects who experience secondary malignancies', 'description': 'Through end of study, up to 36 months', 'timeFrame': '36 months'}]
Title: Impact of a Group Intervention on Breast Cancer Patient's Adjustment and Emotion Regulation at the End of Treatment \| Condition: Breast Cancer \| Keywords: patients at the end of treatment \| Summary: \| Description: N/A \| ArmGroups: [{'label': 'Cognitive-behavioral therapy and hypnosis group', 'type': 'EXPERIMENTAL', 'description': 'Patients will receive (in groups of 6) fifteen 120-min sessions of group therapy including cognitive-behavioral techniques and hypnosis.', 'interventionNames': ['Behavioral: Cognitive-behavioral therapy and hypnosis group']}, {'label': 'Support group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients will receive (in groups of 6) fifteen 120-min support group session.', 'interventionNames': ['Behavioral: Support group']}] \| Interventions:[{'type': 'BEHAVIORAL', 'name': 'Cognitive-behavioral therapy and hypnosis group', 'armGroupLabels': ['Cognitive-behavioral therapy and hypnosis group']}, {'type': 'BEHAVIORAL', 'name': 'Support group', 'armGroupLabels': ['Support group']}] \| PrimaryOutcomes: [{'measure': 'Physical wellbeing: emotion regulation ability (heart rate, relaxation, quality of life,...)', 'description': 'Questionnaires:\n\n* Quality of life questionnaires: "EORTC QLQ-C30" and "EORTC-BR23"\n* Edmonton symptom evaluation scale\n* Way of life questionnaire', 'timeFrame': 'Change from baseline in heart rate and relaxation ability at 6 (T2) and 12 months (T3)'}, {'measure': 'Psychological wellbeing: emotional state, emotional adjustment, social adjustment, quality of life,...', 'description': "Questionnaires:\n\n* the Hospital Anxiety and Depression Scale\n* the Rosenberg's Self-Esteem\n* the Mental Adjustment to Cancer Scale\n* the Fear of Cancer Recurrence Inventory\n* the Perceived Social Support Questionnaire\n* the Courtauld Emotional Control scale\n* the Ways of Coping Checklist\n* the Toronto Alexithymia Scale\n* a questionnaire about usual emotional state\n* a questionnaire about the use of relaxation techniques and self-hypnosis", 'timeFrame': 'Change from baseline in emotional state, emotional adjustment, social adjustment and quality of life at 6 (T1) and 12 (T2) months.'}] \| SecondaryOutcomes: N/A
Title: Two-Arm, Randomized (2:1), Open-Label Phase II/III Study in EpCAM Positive Cancer Patients With Symptomatic Malignant Ascites Using the Trifuncitonal Bispecific Antibody Removab (Anti-EpCAM x Anti-CD3) Versus an Untreated Control Group \| Condition: EpCam Positive Tumor (e.g.Ovarian, Gastric, Colon, Breast), Malignant Ascites \| Keywords: EpCAM positive tumor, malignant ascites, intraperitoneal \| Summary: \| Description: N/A \| ArmGroups: [{'label': '1 Catumaxomab', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patient received Catumaxomab and paracentesis', 'interventionNames': ['Biological: Catumaxomab (Removab)', 'Procedure: paracentesis']}, {'label': '2:', 'type': 'NO_INTERVENTION', 'description': 'Patient treated by paracentesis alone, but after the second paracentesis the patient is able to cross-over in the Catumaxomab-arm'}] \| Interventions:[{'type': 'BIOLOGICAL', 'name': 'Catumaxomab (Removab)', 'description': 'Puncture free survival', 'armGroupLabels': ['1 Catumaxomab'], 'otherNames': ['Removab']}, {'type': 'PROCEDURE', 'name': 'paracentesis', 'armGroupLabels': ['1 Catumaxomab']}] \| PrimaryOutcomes: N/A \| SecondaryOutcomes: N/A
Title: Phase II Trial of VEGF Trap in Patients With Previously Treated Metastatic Colorectal Cancer \| Condition: Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IV Colon Cancer, Stage IV Rectal Cancer \| Keywords: \| Summary: \| Description: PRIMARY OBJECTIVES: I. Determine the response rate (complete and partial) in patients with previously treated metastatic colorectal cancer treated with VEGF Trap. II. Determine the incidence of disease stabilization, in terms of 4-month progression-free survival, in patients treated with this drug. SECONDARY OBJECTIVES: I. Determine the median survival time of patients treated with this drug. II. Determine the 1-year survival rate and stable disease rate in patients treated with this drug. III. Determine the response or stable disease duration in patients treated with this drug. IV. Determine the toxicity of this drug in these patients. V. Determine the time to disease progression in patients treated with this drug. VI. Determine if changes in free VEGF Trap levels correlate with response or toxicity. OUTLINE: This is a multicenter, open-label study. Patients are stratified according to prior bevacizumab treatment (yes vs no). Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood collection at the beginning of each course and at 60 days after completion of study treatment. Samples are analyzed by immunoenzyme techniques to determine the pharmacokinetics of VEGF Trap. After completion of study treatment, patients are followed at 30 and 60 days and then every 3 months thereafter. \| ArmGroups: [{'label': 'Arm I', 'type': 'EXPERIMENTAL', 'description': 'Patients receive VEGF Trap (aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: aflibercept']}] \| Interventions:[{'type': 'DRUG', 'name': 'aflibercept', 'description': 'Given intravenously', 'armGroupLabels': ['Arm I'], 'otherNames': ['vascular endothelial growth factor trap', 'VEGF Trap', 'Zaltrap', 'ziv-aflibercept']}] \| PrimaryOutcomes: [{'measure': 'Objective Tumor Response (Defined as Partial or Complete Response as Defined by the RECIST Criteria)', 'description': 'Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions:Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions', 'timeFrame': 'Up to 6 years'}, {'measure': 'Progression-free Survival (Bevacizumab- naïve Group)', 'description': 'Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions\n\nKaplan-Meier method will be used.Progression-free survival (Bevacizumab- naïve group)', 'timeFrame': '4 months'}, {'measure': 'Progression-free Survival (Bevacizumab-treated Group)', 'description': 'Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions\n\nKaplan-Meier method will be used. Progression-free survival (Bevacizumab-treated group)', 'timeFrame': '4 months'}] \| SecondaryOutcomes: [{'measure': 'Overall Survival (Bevacizumab-naïve Group)', 'description': 'Kaplan-Meier method will be used. (Bevacizumab- naïve Group)', 'timeFrame': '12 months'}, {'measure': 'Overall Survival (Prior Bevacizumab Treated Group)', 'description': 'Kaplan-Meier method will be used (Bevacizumab-naïve Group)', 'timeFrame': '12 months'}, {'measure': 'Time to Progression', 'description': 'Kaplan-Meier method will be used.', 'timeFrame': '12 months'}, {'measure': 'Objective Stable Disease Rate', 'timeFrame': 'Up to 6 years'}, {'measure': 'Number of Participants With Response (Bevacizumab-naïve Group)', 'description': 'Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions; Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD;\n\nStable disease for atleast 16 weeks', 'timeFrame': 'Up to 6 years'}, {'measure': 'Overall Survival (Bevacizumab-treated Group)', 'description': 'Kaplan-Meier method will be used. (Bevacizumab-treated Group)', 'timeFrame': '6 months'}, {'measure': 'Overall Survival (Bevacizumab-treated Group)', 'description': 'Kaplan-Meier method will be used (Bevacizumab-treated Group)', 'timeFrame': '12 months'}, {'measure': 'Number of Participants With Response (Bevacizumab-treated Group)', 'description': 'Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions; Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD;\n\nStable disease for atleast 16 weeks', 'timeFrame': 'Up to 6 years'}]
Title: A Randomized, Open-Label Phase II Clinical Trial of Combination Erlotinib (Tarceva®) and Fulvestrant (Faslodex®) Versus Erlotinib (Tarceva®) Alone in Advanced Non-Small Cell Lung Cancer Patients \| Condition: Lung Cancer \| Keywords: stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer \| Summary: \| Description: OBJECTIVES: Primary * Compare objective tumor response in patients stage IIIB or IV non-small cell lung cancer treated with erlotinib hydrochloride with vs without fulvestrant. Secondary * Correlate response rate with ER and EGF receptor expression in patients treated with these regimens. * Correlate measurement of ER-α, ER-β, EGF/HER-1 receptor and HER-2/neu receptor with clinical response in patients treated with these regimens. * Correlate erlotinib hydrochloride resistance with ER and HER receptor expression in patients treated with these regimens. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to performance status, gender, and participating center. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral erlotinib hydrochloride once daily on days 1-28. Courses repeat every 28 days. * Arm II: Patients receive erlotinib hydrochloride as in arm I and fulvestrant intramuscularly on days 1, 15, and 29, and then every 28 days thereafter. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for 30 days and then every 2 months until disease progression. PROJECTED ACCRUAL: A total of 102 patients (34 in arm I and 68 in arm II) will be accrued for this study. \| ArmGroups: [{'label': 'Arm I', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients receive oral erlotinib hydrochloride once daily on days 1-28. Courses repeat every 28 days.', 'interventionNames': ['Drug: erlotinib hydrochloride']}, {'label': 'Arm II', 'type': 'EXPERIMENTAL', 'description': 'Patients receive erlotinib hydrochloride as in arm I and fulvestrant intramuscularly on days 1, 15, and 29, and then every 28 days thereafter.', 'interventionNames': ['Drug: erlotinib hydrochloride', 'Drug: fulvestrant']}] \| Interventions:[{'type': 'DRUG', 'name': 'erlotinib hydrochloride', 'description': 'Given orally', 'armGroupLabels': ['Arm I', 'Arm II']}, {'type': 'DRUG', 'name': 'fulvestrant', 'description': 'Given intramuscularly', 'armGroupLabels': ['Arm II']}] \| PrimaryOutcomes: [{'measure': 'Objective tumor response', 'timeFrame': '30 days'}] \| SecondaryOutcomes: [{'measure': 'Correlation of response rate with receptor expression', 'timeFrame': '30 days'}]
Title: Role of Piwi-protein Interacting RNA, miRNA-194 and Amino Acids in Patients With Prostate Cancer \| Condition: Finding New Biomarkers That Could be Evaluated in Patients With Prostate Cancer and Clarify Their Role in Early Detection of Prostate Cancer \| Keywords: \| Summary: \| Description: Currently, early detection of prostate cancer involves mainly digital rectal examination (DRE) and testing of prostate-specific antigen (PSA) level in blood . However, over the years it became clear that PSA is not a specific biomarker of prostate cancer . Finding out new biomarkers is pivotal for early detection of prostate cancer, increasing the accuracy of diagnosis, and reducing the false positives in PSA testing These biomarkers include many biological compounds such as, microRNAs, small nuclear RNAs (sncRNA), proteins and metabolites . PIWI-interacting RNAs (piRNAs), a class of sncRNA molecules, are associated with the PIWI proteins. Moreover, MicroRNAs (miRNAs) are conserved small non-coding RNAs (19-22 nucleotide-long) that mediate post-transcriptional regulation of gene expression, affecting mRNA stability and translation by binding complementary sites on target mRNAs\[15\]. Studies have shown that the miRNAs have critical roles in a variety of biological processes such as: cell proliferation, differentiation, apoptosis and carcinogenesis. Regucalcin (RGN) is an inhibitory protein of calcium signaling with calcium-binding properties. It plays a multifunctional role in the regulation of cell functions. Free amino acids, in biological fluids can be a reduced invasive method associated to a high diagnostic potential. It was found that free amino acid profiles vary depending on type of cancer and its stage. \| ArmGroups: [{'label': 'control group', 'description': 'The control group consisted of healthy men with no cancer and no chronic diseases. They will be age-matched with patient group and recruited among men subjected to the routine periodic medical examination.', 'interventionNames': ['Diagnostic Test: piRNAs, miRNA-194, regucalcin and plasma aminoacids levels']}, {'label': 'Prostate cancer group', 'description': 'Patients who are confirmed to have prostate cancer based on digital rectal examination (DRE), trasrectal ultrasonography and histopathological examination of biopsy tissue with no other coexisting cancers or prostate cancer treatment', 'interventionNames': ['Diagnostic Test: piRNAs, miRNA-194, regucalcin and plasma aminoacids levels']}, {'label': 'benign prostatic hyperplasia group', 'description': 'Patients who are confirmed to have benign prostatic hyperplasia based on digital rectal examination (DRE), trasrectal ultrasonography and histopathological examination of biopsy tissue', 'interventionNames': ['Diagnostic Test: piRNAs, miRNA-194, regucalcin and plasma aminoacids levels']}] \| Interventions:[{'type': 'DIAGNOSTIC_TEST', 'name': 'piRNAs, miRNA-194, regucalcin and plasma aminoacids levels', 'description': 'PIWI-interacting RNAs (piRNAs), a class of small nuclear RNA molecules, are associated with the PIWI proteins. MicroRNAs (miRNAs) are conserved small non-coding RNAs (19-22 nucleotide-long) that mediate post-transcriptional regulation of gene expression, affecting mRNA stability and translation by binding complementary sites on target mRNAs. Regucalcin (RGN) is an inhibitory protein of calcium signaling with calcium-binding properties. It plays a multifunctional role in the regulation of cell functions, including maintenance of intracellular calcium homeostasis, inhibitions of protein kinases and protein phosphatases linked to cell signaling process, suppressions of protein production and nuclear DNA and RNA synthesis.Free amino acids, in biological fluids can be a reduced invasive method associated to a high diagnostic potential. It was found that free amino acid profiles vary depending on type of cancer and its stage.', 'armGroupLabels': ['Prostate cancer group', 'benign prostatic hyperplasia group', 'control group']}] \| PrimaryOutcomes: [{'measure': '• To investigate the role of piRNAs, miRNA-194, regucalcin and aminoacids in prostate cancer development. and highlight their potential clinical utilities as biomarkers as well as potential targets for cancer treatment', 'timeFrame': '1 year'}] \| SecondaryOutcomes: N/A
Title: BOS3: Randomized Phase II/III Trial Evaluating the Efficacy of FOLFOX Alone Versus FOLFOX Plus Aflibercept in K-ras Mutant as Perioperative Treatment in Patients With Resectable Liver Metastases From Colorectal Cancer. \| Condition: Colorectal Cancer Metastatic, Liver Metastases, KRAS Mutated Colorectal Cancer \| Keywords: Liver metastases, Colorectal Cancer, KRAS mutated, FOLFOX, Aflibercept, Randomized, Phase II-III, Perioperative treatment, Adjuvant, Neo-adjuvant, Surgery, Progression Free Survival \| Summary: \| Description: N/A \| ArmGroups: [{'label': 'Arm A: modified FOLFOX6 and Surgery', 'type': 'ACTIVE_COMPARATOR', 'description': '6 cycles before and 6 cycles after surgery consisting in:\n\nHour 0: Oxaliplatin 85 mg/m² IV 2-h infusion\n\nHour 0: Folinic Acid 400 mg/m² (DL form) or 200 mg/m2 (L form) IV 2-h infusion\n\nHour 2: 5-FU 400 mg/m² IV bolus over 2-4 minutes\n\nHour 2: 5-FU 2400 mg/m² given as a continuous infusion over 46h.\n\nOn day 1 of a 14 day cycle', 'interventionNames': ['Drug: Modified FOLFOX6', 'Procedure: Surgery']}, {'label': 'Arm B: modified FOLFOX6 + Aflibercept and Surgery', 'type': 'EXPERIMENTAL', 'description': '6 cycles before and 6 cycles after surgery consisting in:\n\nHour 0: Aflibercept 4 mg/kg intravenous infusion 1-h\n\nHour 1: Oxaliplatin 85 mg/m2 2-h infusion\n\nHour 1: Folinic Acid 400 mg/m2 (DL form) or 200 mg/m2 (L form) 2-h infusion\n\nHour 3: 5-FU bolus 400 mg/m2 IV bolus over 2-4 minutes\n\nHour 3: 5-FU 2400 mg/m² given as a continuous infusion over 46h.\n\nDay 1 of a 14 day cycle\n\nAflibercept should be given in all cycles, except cycle 6 of pre-operative treatment.', 'interventionNames': ['Drug: Modified FOLFOX6', 'Biological: Aflibercept', 'Procedure: Surgery']}] \| Interventions:[{'type': 'DRUG', 'name': 'Modified FOLFOX6', 'armGroupLabels': ['Arm A: modified FOLFOX6 and Surgery', 'Arm B: modified FOLFOX6 + Aflibercept and Surgery'], 'otherNames': ['5-FU, folinic acid, oxaliplatin']}, {'type': 'BIOLOGICAL', 'name': 'Aflibercept', 'description': 'Targeted therapy', 'armGroupLabels': ['Arm B: modified FOLFOX6 + Aflibercept and Surgery']}, {'type': 'PROCEDURE', 'name': 'Surgery', 'armGroupLabels': ['Arm A: modified FOLFOX6 and Surgery', 'Arm B: modified FOLFOX6 + Aflibercept and Surgery']}] \| PrimaryOutcomes: [{'measure': 'Progression free survival', 'description': 'Increase in progression free survival rate at 1 year in the experimental arm (mFOLFOX6 + aflibercept) compared to mFOLFOX6 alone arm.', 'timeFrame': '1 year'}] \| SecondaryOutcomes: [{'measure': 'Pathological response rate', 'description': 'Increase in major pathological response rate between mFOLFOX6 alone arm and each experimental arm.', 'timeFrame': '4 years'}, {'measure': 'Resection rate', 'description': 'Compare the percentage of patients with total resection with these three treatments.', 'timeFrame': '4 years'}, {'measure': 'Overall survival', 'description': 'Overall survival is defined as the time interval between the date of randomization and the date of death. Patients who are still alive when last traced will be censored at the date of last follow-up.', 'timeFrame': '8 years'}, {'measure': 'Safety', 'description': 'All adverse events will be recorded; the investigator will assess whether those events are drug related (reasonable possibility, no reasonable possibility) and this assessment will be recorded in the database for all adverse events.', 'timeFrame': '4 years'}]
Title: A Phase 1, Multi-Center, Dose Escalation, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-3068 in Adult Patients With Advanced Solid Tumors \| Condition: Non-small Cell Lung Cancer, Head and Neck Cancer, Esophageal Cancer, Other Metastatic Solid Tumors \| Keywords: JAB-3068, SHP2, advanced solid tumor, NSCLC, ESCC, HNSCC, PTPN11, EGFR, Colorectal cancer \| Summary: \| Description: N/A \| ArmGroups: [{'label': 'JAB-3068 (SHP2 inhibitor)', 'type': 'EXPERIMENTAL', 'description': 'Daily oral administration of JAB-3068', 'interventionNames': ['Drug: JAB-3068']}] \| Interventions:[{'type': 'DRUG', 'name': 'JAB-3068', 'description': 'JAB-3068 will be orally administered on a daily basis. Patients need to fast 2 hours before （6 hours for PK days) and 2 hours after each dosing.', 'armGroupLabels': ['JAB-3068 (SHP2 inhibitor)']}] \| PrimaryOutcomes: [{'measure': 'Number of participants with dose limiting toxicities', 'description': 'Incidence of dose limiting toxicities (DLTs) in the dose escalation phase. A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first treatment cycle with JAB-3068.', 'timeFrame': 'up to 28-day per cycle'}] \| SecondaryOutcomes: [{'measure': 'Number of participants with adverse events', 'description': 'All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms, cardiac imaging and ophthalmological assessments', 'timeFrame': 'Approximately 2 years'}, {'measure': 'Area under the curve', 'description': 'Area under the plasma concentration time curve of JAB-3068', 'timeFrame': 'Approximately 2 years'}, {'measure': 'Cmax', 'description': 'Highest observed plasma concentration of JAB-3068', 'timeFrame': 'Approximately 2 years'}, {'measure': 'Tmax', 'description': 'Time of highest observed plasma concentration of JAB-3068', 'timeFrame': 'Approximately 2 years'}, {'measure': 'T1/2', 'description': 'Half life of JAB-3068', 'timeFrame': 'Approximately 2 years'}, {'measure': 'Objective response rate', 'description': 'ORR is defined as the proportion of participants with complete response or partial response (CR+PR)', 'timeFrame': 'Approximately 2 years'}, {'measure': 'Duration of response', 'description': "DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first.", 'timeFrame': 'Approximately 2 years'}]
Title: A Randomized, Placebo-Controlled Phase 2b Study of Tamibarotene Plus Paclitaxel and Carboplatin Versus Placebo Plus Paclitaxel and Carboplatin as First Line Treatment for Subjects With Advanced Non-Small Cell Lung Cancer \| Condition: Stage IIIB Non-small Cell Lung Cancer With Pleural Effusion, Stage IV Non-small Cell Lung Cancer \| Keywords: NSCLC, non-small cell lung cancer, tamibarotene \| Summary: \| Description: N/A \| ArmGroups: [{'label': 'Tamibarotene', 'type': 'EXPERIMENTAL', 'description': 'Subjects will receive tamibarotene, 6 mg/m2, divided as twice daily orally starting 1 week before chemotherapy and continuing through all 6 cycles and through the duration of the study. Chemotherapy will include paclitaxel (IV; 200 mg/m2) and carboplatin (IV; AUC=6)administered once every 3 weeks for up to 6 cycles.', 'interventionNames': ['Drug: Tamibarotene']}, {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Subjects will take an equal number of placebo tablets as the group receiving tamibarotene divided as twice daily orally, starting 1 week before chemotherapy and continuing through all 6 cycles and through the duration of the study. Paclitaxel (IV; 200 mg/m2) and carboplatin (IV; AUC=6) will be administered once every 3 weeks for up to 6 cycles.', 'interventionNames': ['Drug: Placebo']}] \| Interventions:[{'type': 'DRUG', 'name': 'Tamibarotene', 'description': 'Tablet, 6 mg/m2, oral, divided into twice a day dosing.', 'armGroupLabels': ['Tamibarotene']}, {'type': 'DRUG', 'name': 'Placebo', 'description': 'Tablets, orally, daily', 'armGroupLabels': ['Placebo']}] \| PrimaryOutcomes: [{'measure': 'Progression-free survival', 'description': 'Progression-free survival (PFS) is defined as the time from enrollment (i.e., assignment of subject ID number) to first documentation of objective tumor progression or to death due to any cause in the absence of previous documentation of objective tumor progression.', 'timeFrame': 'Within 18 months of study start.'}] \| SecondaryOutcomes: [{'measure': 'Objective response rate', 'description': 'Objective tumor response will be evaluated using the RECIST 1.1 criteria.', 'timeFrame': 'Within 18 months of study start.'}, {'measure': 'Overall survival', 'timeFrame': 'Within 24 months of study start.'}, {'measure': 'Assessment of quality of life', 'description': 'EORTC QLQ-C30 version 3.', 'timeFrame': 'Within 24 months of study start.'}]
Title: Phase II Trial of Abraxane® in the Treatment of Patients With Pancreatic Cancer Who Have Failed First-Line Treatment With Gemcitabine-Based Therapy \| Condition: Pancreatic Cancer \| Keywords: recurrent pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer \| Summary: \| Description: OBJECTIVES: Primary * To establish preliminary evidence of efficacy of paclitaxel albumin-stabilized nanoparticle formulation in patients with locally advanced (unresectable) or metastatic pancreatic cancer that failed first-line therapy with a gemcitabine hydrochloride-containing regimen. Secondary * To determine the safety and characterize the toxicity profile of this drug. * To determine the complete, partial, and overall response rates and duration of response in patients with measurable disease. * To determine CA 19-9 response. * To determine progression-free survival. OUTLINE: This is a multicenter study. Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 1 year and then annually thereafter. \| ArmGroups: [{'label': 'Abraxane', 'type': 'EXPERIMENTAL', 'description': 'One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4.', 'interventionNames': ['Drug: Abraxane']}] \| Interventions:[{'type': 'DRUG', 'name': 'Abraxane', 'description': 'One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment', 'armGroupLabels': ['Abraxane'], 'otherNames': ['Paclitaxel Albumin-Stabilized Nanoparticle Formulation']}] \| PrimaryOutcomes: [{'measure': 'Overall Survival Rate at 6 Months', 'description': 'Overall survival was measured from the start of treatment (date of first dose of Abraxane® therapy) to date of death due to any cause. For patients who are alive, follow-up time will be censored at date of last contact.', 'timeFrame': '6 months'}] \| SecondaryOutcomes: [{'measure': 'Number of Participants Showing Complete or Partial Response', 'description': 'Number of participants showing complete or partial response to protocol therapy according to Response Evaluation Criteria In Solid Tumors(RECIST) v1.0 criteria for target lesions and assessed by CT/MRI. Per RECIST, Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR), \\>= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.', 'timeFrame': '6 months'}, {'measure': 'Number of Participants Showing Stable Disease', 'description': 'Number of participants showing stable disease according to RECIST 1.0 criteria', 'timeFrame': '12 months'}, {'measure': 'Progression-free Survival', 'description': 'Median number of months participants experienced progression-free survival, according to Response Evaluation Criteria In Solid Tumors(RECIST) v1.0 criteria for target lesions and assessed by CT/MRI. Per RECIST, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.', 'timeFrame': '6 months'}, {'measure': 'Number of Participants Experiencing Adverse Events', 'timeFrame': '6 months'}, {'measure': 'Median Overall Survival of Participants', 'description': 'Median overall survival rate of participants measured in months', 'timeFrame': '12 months'}]
Title: Randomised Phase II Trial of Olaparib, Chemotherapy or Olaparib and Cediranib in Patients With Platinum-resistant Ovarian Cancer \| Condition: Ovarian Cancer \| Keywords: BRCA1/2 mutation, Platinum resistance \| Summary: \| Description: Olaparib is a PARP inhibitor which targets BRCA1/2 mutated tumour cells and cediranib is an anti-angiogenic drug which reduces blood supply to the tumour, suppressing tumour viability. Phase I/II trials of both drugs have shown these are well tolerated alone or in combination in ovarian cancer. The trial aims to compare the efficacy of the combination and of olaparib alone with paclitaxel chemotherapy and whether the olaparib/cediranib combination is better tolerated thus improving quality of life. Secondly standard paclitaxel chemotherapy must be administered weekly at hospital whereas the olaparib/cediranib combination can be administered at home potentially also improving patient quality of life. Participants' tumours will be resistant to platinum based therapies. Participants will be randomised into one of the 3 treatment arms after stratification for prior PARP/anti-angiogenic treatments/BRCA status. Participants will be on trial up to 18 months. \| ArmGroups: [{'label': 'A: Paclitaxel', 'type': 'ACTIVE_COMPARATOR', 'description': 'Paclitaxel, IV weekly, 80mg/m2; until progression', 'interventionNames': ['Drug: Paclitaxel']}, {'label': 'B: Olaparib', 'type': 'EXPERIMENTAL', 'description': 'Olaparib, oral, 300mg twice daily; until progression', 'interventionNames': ['Drug: Olaparib']}, {'label': 'C: Olaparib and Cediranib', 'type': 'EXPERIMENTAL', 'description': 'Olaparib, oral, 300mg twice daily and Cediranib, tablet, 20mg once daily; until progression', 'interventionNames': ['Drug: Olaparib', 'Drug: Cediranib']}] \| Interventions:[{'type': 'DRUG', 'name': 'Olaparib', 'description': 'Tablet, 100mg and 150mg', 'armGroupLabels': ['B: Olaparib', 'C: Olaparib and Cediranib']}, {'type': 'DRUG', 'name': 'Cediranib', 'description': 'Tablet 15mg and 20mg', 'armGroupLabels': ['C: Olaparib and Cediranib']}, {'type': 'DRUG', 'name': 'Paclitaxel', 'description': 'Intravenous (IV)', 'armGroupLabels': ['A: Paclitaxel']}] \| PrimaryOutcomes: [{'measure': 'Progression free survival', 'description': 'Progression free survival (PFS), measured as time from date of randomisation to RECIST-defined progression or death from any cause (whichever is first)', 'timeFrame': 'up to 18 months'}] \| SecondaryOutcomes: [{'measure': 'Adverse events', 'description': 'Adverse events using CTCAE v4.03', 'timeFrame': 'up to 18 months'}, {'measure': 'Overall Survival', 'description': 'Overall Survival', 'timeFrame': '12 & 18 months'}, {'measure': 'Objective Response Rate', 'description': 'Objective Response Rate based on RECIST v1.1', 'timeFrame': 'up to 18 months'}, {'measure': 'Objective Response Rate', 'description': 'Objective Response Rate based GCIG CA125', 'timeFrame': 'up to 18 months'}, {'measure': 'Quality of Life Outcomes', 'description': 'Quality of Life Outcomes based on EORTC-QLQ C30', 'timeFrame': 'up to 18 months'}, {'measure': 'Quality of Life Outcomes', 'description': 'Quality of Life Outcomes based on EQ5D', 'timeFrame': 'up to 18 months'}, {'measure': 'Quality of Life Outcomes', 'description': 'Quality of Life Outcomes based on OV28.', 'timeFrame': 'up to 18 months'}]
Title: A Comparison for Laparoscopically Assisted and Open Surgery for Advanced Rectal Cancer After Preoperative Chemoradiation- Randomized Prospective Trial \| Condition: Rectal Cancer \| Keywords: rectal cancer, laparoscopic assisted resection, open resection, preoperative chemoradiation, randomized trial \| Summary: \| Description: 1. Title: A comparison for laparoscopically assisted and open surgery for advanced rectal cancer after preoperative chemoradiation - randomized prospective trial 2. Principal investigator: Jae Hwan Oh Co-investigator: Seung Yong Jeong, Sung Bum Kang, Hyo Seong Choi, Seok-Byung Lim 3. Purpose of the study: To compare efficacy of laparoscopic and open resection for locally advanced rectal cancer after preoperative chemoradiation 4. Specific aims 1. comparison of oncologic outcomes 2. comparison of quality of life 3. comparison of anorectal function 5. Materials Rectal cancer \<9cm from anal verge, measured by rigid sigmoidoscopy histologically proven adenocarcinoma locally advanced (T3), determined by CT, transrectal ultrasonography, MRI without any contraindication for general anesthesia,operation and chemoradiation Completion of preoperative chemoradiation 6. Statistics 1. Sample size calculation for non-inferiority trial: 340 2. Disease free survival: Log-rank test,Cox regression analysis 3. QOL and anorectal function: Repeated measured ANCOVA 7. Methods 1. operation time of operation : 6-8 weeks after end of preoperative chemoradiation surgical technique standard total mesorectal excision and high ligation of inferior mesenteric vessels 2. preoperative chemoradiation chemotherapy: 2 cycles of 5-FU (400 mg/m2/day) + LV (20 mg/m2/day) IV bolus, for 3 days in 1st \& 5th wks of RT or Capecitabine 825 mg/m2 p.o. bid during RT RT:45 Gy/ 25 fractions to the pelvis, 5.4 Gy/ 3 fractions boost to the primary tumor over 5.5 wks 3. postoperative chemotherapy 4 cycles of 5-FU (400 mg/m2/day) + LV (20 mg/m2/day) IV bolus, for 5 days, 4 wks interval 4. oncologic outcomes 1. Short-term outcomes Surgical length of incision op time blood loss intraoperative complications conversion rate Pathological resection margins (proximal, distal, circumferential) number of harvested lymph nodes length of resected bowel tumor regression grade (Dworak's grading) TNM staging Perioperative recovery duration of use of parenteral narcotics initiation of peristalsis initiation of oral intake duration of hospital stay 30-day postoperative mortality morbidity 2. Long-term outcomes Primary end point Disease free survival (3 years after surgery) Secondary end points Overall survival Local recurrence Distant metastasis Port-site and wound site recurrence 5. Quality of life Urinary function Duration of urinary catheterization Residual urine volume at discharge International Prostate Symptom Score (IPSS) Male sexual function International Index of Erectile Function (IIEF) Female sexual function Female Sexual Function Index (FSFI) QOL assessment EORTC QLQ C30 EORTC QLQ CR38 6. Anorectal function Anorectal manometry Maximum Resting Pressure Maximum Squeezing Pressure High Pressure Zone Sphincter Length Sensory Threshold Rectal Capacity Rectal Compliance Rectoanal Inhibitory Reflex Fecal Incontinence Severity Index (FISI) \| ArmGroups: [{'label': 'open rectal resection', 'type': 'ACTIVE_COMPARATOR', 'description': 'conventional open resection', 'interventionNames': ['Procedure: open rectal resection']}, {'label': 'laparoscopic rectal resection', 'type': 'ACTIVE_COMPARATOR', 'description': 'laparoscopic rectal resection', 'interventionNames': ['Procedure: laparoscopic rectal resection']}] \| Interventions:[{'type': 'PROCEDURE', 'name': 'open rectal resection', 'description': 'open rectal resection', 'armGroupLabels': ['open rectal resection']}, {'type': 'PROCEDURE', 'name': 'laparoscopic rectal resection', 'description': 'laparoscopic assisted rectal resection', 'armGroupLabels': ['laparoscopic rectal resection']}] \| PrimaryOutcomes: [{'measure': 'Disease free survival', 'timeFrame': '3 years'}] \| SecondaryOutcomes: [{'measure': 'Anorectal function', 'timeFrame': '1 year'}, {'measure': 'Overall survival', 'timeFrame': '3 year, 5 year'}, {'measure': 'Quality of life', 'timeFrame': 'preop, postop 3mo, posop 1 yr, 3yr, 5yr'}]
Title: Study Evaluating the Efficacy and Safety of Chimeric Antigen Receptor-Modified pNK Cells in MUC1 Positive Advanced Refractory or Relapsed Solid Tumor \| Condition: Hepatocellular Carcinoma, Non-small Cell Lung Cancer, Pancreatic Carcinoma, Triple-Negative Invasive Breast Carcinoma, Malignant Glioma of Brain, Colorectal Carcinoma, Gastric Carcinoma \| Keywords: \| Summary: \| Description: N/A \| ArmGroups: [{'label': 'CAR-pNK Cell immunotherapy', 'type': 'EXPERIMENTAL', 'description': 'Enrolled patients will receive CAR-pNK cell immunotherapy with a novel specific chimeric antigen receptor targeting MUC1 antigen by infusion.', 'interventionNames': ['Biological: anti-MUC1 CAR-pNK cells']}] \| Interventions:[{'type': 'BIOLOGICAL', 'name': 'anti-MUC1 CAR-pNK cells', 'armGroupLabels': ['CAR-pNK Cell immunotherapy'], 'otherNames': ['Chimeric antigen receptor NK cells with specificity for MUC1']}] \| PrimaryOutcomes: [{'measure': 'Phase I: Adverse events attributed to the administration of the anti-MUC1 CAR-pNK cells', 'description': 'Determine the toxicity profile of the MUC1 targeted CAR-pNK cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.', 'timeFrame': '2 years'}] \| SecondaryOutcomes: [{'measure': 'Phase II: Objective Response Rate', 'description': 'The objective response rate (ORR) is defined as the proportion of patients who achieve radiographic partial or complete response (PR or CR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guideline.', 'timeFrame': '2 years'}]
Title: A Motion Exergaming Approach to Promote Self-Managing Fatigue and Pain After Head and Neck Cancer Treatment \| Condition: Head and Neck Cancer \| Keywords: \| Summary: \| Description: Among head and neck cancer (HNC) patients, 92% report fatigue and 73% have pain. A 10% increase in fatigue or pain is associated with a 10-25% reduction in HNC survival. During the critical transition period from the end of active treatment to 6 months post-treatment, untreated physical symptoms negatively impact functional status (ADL) and quality of life (QOL). Fatigue and musculoskeletal pain are known to improve in response to physical activity (PA). However, 51% of HNC survivors rarely engage in any type of PA because of complicated PA barriers. Our overall objective is to test an intervention to overcome these PA barriers for HNC patients during the critical transition period to self-management. PAfitME, a personalized Physical Activity intervention with fitness graded Motion Exergames, is a telehealth program built on Social Cognitive Theory and the exercise principle of adaptation. PAfitME, delivered via a tested mix of FaceTime calls and home visits, uses commercially available exergaming platforms (Wii Fit and Xbox Kinect). We propose the following specific aims: (1) When compared to an attention control group, determine the effect of PAfitME on fatigue and musculoskeletal pain at week 6, when controlling for age and sex; (2) when compared to an attention control group, determine the effect of PAfitME on functional status and QOL at week 6, when controlling for age and sex; and (3) explore if PA self-efficacy, PA enjoyment, and exergame minutes mediate the effect of PAfitME on fatigue and musculoskeletal pain. This study will evaluate 150 post-treatment (radiation, chemotherapy, or chemoradiation) HNC patients in an RCT with an attention control. For 6 weeks, the experimental (PAfitME) group will receive the PAfitME intervention, and the attention control group will receive NCI-based survivorship education and exergame equipment. For Aims 1 and 2, using an intention-to-treat framework, we will fit a series of linear mixed-effects models with each of the outcome variables. For Aim 3, we will conduct our exploratory analyses in ml_mediation (STATA 15), which will compute direct and indirect effects for multi-level data. This study aligns with the NCI Cancer Moonshot goal to minimize cancer treatment-associated side effects and the key recommendation in the National Comprehensive Cancer Network Clinical Guidelines of the need for evidence-based non- pharmacological fatigue/pain treatments (National Priority). \| ArmGroups: [{'label': 'PAfitME', 'type': 'EXPERIMENTAL', 'description': 'For 6 weeks, the experimental (PAfitME) group will receive the PAfitME intervention.', 'interventionNames': ['Behavioral: A personalized Physical Activity intervention with fitness graded Motion Exergames (PAfitME)']}, {'label': 'Attention Control', 'type': 'NO_INTERVENTION', 'description': 'For 6 weeks, the attention control group will receive National Cancer Institute-based survivorship education and exergame equipment (Nintendo Switch).'}] \| Interventions:[{'type': 'BEHAVIORAL', 'name': 'A personalized Physical Activity intervention with fitness graded Motion Exergames (PAfitME)', 'description': "A total of 7 weekly intervention sessions will occur in a period of 6 weeks. Week 0 is a setup session conducted at the participant's home, including equipment set up, safety instruction, personalized exergame prescription development, exergame physical activity practice, discussion of barriers and strategies, and Q\\&A session. Weeks 1 and 2 are coaching sessions delivered by the interventionist using the FaceTime application in iPad, including exergame minutes and prescription review, exergame physical activity practice, discussion of barriers and strategies, and Q\\&A session. Week 3 is a progress session conducted at the participant's home. The personalized exergame prescription will be adjusted. This session also will include exergame minutes review, exergame physical activity practice, discussion of barriers and strategies, and Q\\&A session. Weeks 4 and 5 are the same as weeks 1 and 2. Week 6 is the final session. Exergame platform will be picked up at the participant's home.", 'armGroupLabels': ['PAfitME']}] \| PrimaryOutcomes: [{'measure': 'Fatigue will be measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0-Fatigue (NIH Common Data Elements [CDE]).', 'description': 'In the PROMIS Short Form v1.0-Fatigue, the 6 items ask about fatigue status, including fatigue severity and fatigue distress in the past 7 days. The scale ranges from 1 to 5. The higher the score, the worse the symptom. The mean score of 6 items will be calculated in the analysis to test the changes from baseline to week 6.', 'timeFrame': 'Baseline and Week 6'}, {'measure': 'Musculoskeletal Pain will be measured by the PROMIS Short Form v.1.0-Pain Intensity (CDE).', 'description': 'In the PROMIS Short Form v1.0-Pain, the 3 items ask about pain intensity in the past 7 days. The scale ranges from 1 to 5. The higher the score, the worse the symptom. The mean score of 3 items will be calculated in the analysis to test the changes from baseline to week 6.', 'timeFrame': 'Baseline and Week 6'}] \| SecondaryOutcomes: [{'measure': 'Subjective Functional Status will be measured by the self-report Lawton Instrumental Activities of Daily Living Scale (IADL).', 'description': 'In the IADL, the 8-item IADL measures dependence/independence of 8 daily activities. Participants will respond based on their highest level of independence for that activity. The total score ranges from 8 to 31. The higher the score, the better the function. The toal score of 8 items will be calculated in the analysis to test the changes from baseline to week 6.', 'timeFrame': 'Baseline and Week 6'}, {'measure': 'Objective Functional Status will be measured by 2-minute walk test.', 'description': 'The 2-minute walk measures distance (in meters) walked in 2 minutes. The distance in meters will will be calculated in the analysis to test the changes from baseline to week 6.', 'timeFrame': 'Baseline and Week 6'}, {'measure': 'Objective Functional Status will be measured by combined grip sum.', 'description': 'Combined grip sum is calculated by "\\[left hand grip strength maximum + right hand grip strength maximum\\] ÷ body weight". It levels out the dominant hand effect (by using the sum of left hand and right hand strength) and represents the ratio of hand muscle strength and body weight. Hand grip strength will be measured by Jamar hydraulic hand dynamometer (Jamar Technologies, Inc., Hatfield, PA).The combined grip sum will be calculated in the analysis to test the changes from baseline to week 6.', 'timeFrame': 'Week 0 and Week 6'}, {'measure': 'Objective Functional Status will be measured by upper extremity range of motion (ROM).', 'description': 'Upper extremity ROM is upper extremity flexibility and includes shoulder abduction, shoulder forward flexion, neck forward flexion, neck extension, neck lateral flexion, and neck lateral rotation. The ROM will be measured by a plastic 12" goniometer 360 degree (Szy Holdings LLC, Brooklyn, NY). The degrees of range of motion will be calculated in the analysis to test the changes from baseline to week 6.', 'timeFrame': 'Week 0 and Week 6'}, {'measure': 'Objective Functional Status will be measured by chair sit and reach.', 'description': 'Chair sit and reach is to measure lower extremity flexibility. The participant sits on a chair with one foot flat on the floor to support the balance and the other leg extended forward with knee straight, heel on the floor, and ankle bent at 90º. With one hand on top of the other, the participant reaches forward toward the toes by bending at the hip. The distance between the tip of the fingertips and the toes is measured. If the fingertips touch the toes, the score is zero. If they do not touch, the distance between the fingers and the toes (a negative score) is measured; if they overlap, the overlap distance is measured (a positive score). The distance in positive or negative centImeters (cm) will be calculated in the analysis to test the changes from baseline to week 6.', 'timeFrame': 'Week 0 and Week 6'}, {'measure': 'Objective Functional Status will be measured by Timed up and go.', 'description': 'Timed up and go requires participants to stand up from a chair, walk 3 meters, turn around, walk back to the chair and sit down. The result of the test is the time from standing up from the chair to sitting back on the same chair. The time in seconds will be calculated in the analysis to test the changes from baseline to week 6.', 'timeFrame': 'Week 0 and Week 6'}, {'measure': 'Quality of Life will be measured using the Functional Assessment of Chronic Illness Therapy-Head and Neck Scale, version 4 (FACIT-H&N).', 'description': 'FACIT-H\\&N includes a 28-item general scale and a 12-item HNC scale. The scale ranges from 0 to 4. The greater the score, the better the quality of life. The mean scores of the 28-item general scale and 12-item HNC scale will be calculated in the analysis to test the changes from baseline to week 6.', 'timeFrame': 'Week 0 and Week 6'}]
Title: Randomized Trial of Mobile Application to Improve Health-Related Outcomes in Patients With Advanced Lung Cancer \| Condition: Lung Cancer \| Keywords: Quality of life \| Summary: \| Description: Multi-site randomized controlled trial of the THRIVE digital health application versus usual care in 250 patients diagnosed with advanced lung cancer within the previous 12 weeks to examine the effect of the intervention on patient-reported QOL, physical symptoms, anxiety and depression symptoms, coping, and self-efficacy. Participants will be randomized in a 1:1 fashion and stratified by study site and lung cancer type to ensure a balanced representation of these factors between the two study groups. The study team will provide iPads to patients assigned to THRIVE and provide instructions on how to use the iPad and digital app. The study team will administer patient-reported outcome measures at enrollment and again at six, 12, and 24 weeks post-enrollment to evaluate the short and long-term impact of THRIVE. \| ArmGroups: [{'label': 'THRIVE Digital Health App', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients assigned to the intervention will be provided a study-issued tablet computer from which they will access the THRIVE digital health app. Study staff will give intervention patients a comprehensive tutorial and detailed instructions regarding how to use the app. Tutorial sessions may be conducted in person during a clinic appointment, via telephone, and/or via Zoom videoconferencing. Participants will complete the intervention modules at their desired pace over approximately 10 weeks.', 'interventionNames': ['Behavioral: Digital Health App']}, {'label': 'Usual Care', 'type': 'NO_INTERVENTION', 'description': 'Patients assigned to the usual care group will not receive the digital app but rather standard oncology care.'}] \| Interventions:[{'type': 'BEHAVIORAL', 'name': 'Digital Health App', 'description': 'access to a digital health app', 'armGroupLabels': ['THRIVE Digital Health App']}] \| PrimaryOutcomes: [{'measure': 'Functional Assessment of Cancer Therapy - Lung (FACT-L)', 'description': 'Quality of Life (higher scores indicate better quality of life)', 'timeFrame': '12 weeks'}] \| SecondaryOutcomes: [{'measure': 'MD Anderson Symptom Inventory (MDASI)', 'description': 'Physical Symptoms (higher scores indicate worse symptoms)', 'timeFrame': '12 weeks'}, {'measure': 'Hospital Anxiety and Depression Scale (HADS)', 'description': 'Anxiety and Depression Symptoms (higher scores indicate worse symptoms)', 'timeFrame': '12 weeks'}]
Title: Randomized, Phase III-b, Multi-centre, Open-label, Parallel Study of Enoxaparin (Low Molecular Weight Heparin) Given Concomitantly With Chemotherapy vs Chemotherapy Alone in Patients With Inoperable Gastric and Gastro-oesophageal Cancer \| Condition: Gastric Cancer, Gastroesophageal Cancer \| Keywords: Bleeding events \| Summary: \| Description: In the GASTRANOX study, patients will have inoperable (locally advanced) or metastatic newly diagnosed gastric or gastro oesophageal cancer. These patients carry a definite thrombosis risk. Patients will be scheduled to have at least 6 months of palliative chemotherapy. During this period symptomatic thromboembolism will be common but currently no routine prophylaxis is provided. The dose of Enoxaparin to be evaluated in this study is 1mg/kg. This represents half of the full treatment dose. For an average weight individual this will represent between 60 and 70 mg a day of Enoxaparin. The prophylactic dose for high-risk surgical patients in the United States is 60mg total daily dosing of Enoxaparin per day. This high-risk dose has been shown to be safe and effective in preventing thromboembolic disease in high-risk populations such as those undergoing major elective orthopaedic surgery. An alternative for high-risk dose is 40mg given once a day. This dose is also effective and safe. Thus the dose to be provided in the GASTRANOX study is not markedly different from the high-risk doses already in routine clinical practice either in North America (30mg twice a day - 60mg total daily dosing) or 40mg once a day in Europe. It is also half of the full treatment dose which has been shown to be effective and safe in the treatment of venous thromboembolism. Since cancer patients are recognised to have bleeding risk it was felt inappropriate to provide the full treatment dose of Enoxaparin. Thus half the full treatment doses provided. On the other hand the biological effect of low molecular weight heparins in cancer suggests that higher doses be given to enhance the potential survival benefit. The study is intended to evaluate the safety and efficacy of the study drug compared to best normal practice. The standard methodology for such a comparison is to conduct a randomized, comparative study. Multi-centre: It is anticipated that a single centre will be unable to recruit sufficient subjects, in 1 year, to conduct the assessment and therefore multiple centres will be recruited to conduct the study. Open Label: All patients will receive standard care at their site. It would not be feasible to expect placebo parenteral administration for six months. All VTE events will be adjudicated. Mortality is an objective end-point. Standard treatment control: subjects will be treated according to best practice with half also receiving the study treatment. Parallel-group: due to the nature of the condition this is the only practical design. \| ArmGroups: [{'label': 'B', 'type': 'ACTIVE_COMPARATOR', 'description': 'Standard Chemotherapy (upto 6 cycles)', 'interventionNames': ['Drug: Standard Chemotherapy']}, {'label': 'A', 'type': 'EXPERIMENTAL', 'description': 'Enoxaparin: 1 mg/kg once daily in addition to standard chemotherapy up to 6 months', 'interventionNames': ['Drug: Enoxaparin']}] \| Interventions:[{'type': 'DRUG', 'name': 'Enoxaparin', 'description': 'Once daily dose of 1mg/Kg of body weight for 6 months', 'armGroupLabels': ['A']}, {'type': 'DRUG', 'name': 'Standard Chemotherapy', 'description': "Investigator's discretion", 'armGroupLabels': ['B'], 'otherNames': ['Some commonly prescribed Chemotherapy regimens in India are:', '- Epirubicin + Cisplatin + Capecitabine', '- Capecitabine + Oxaliplatin', '- Docetaxil + Carboplatin', '- Epirubicin + Cisplatin + Fluorouracil', '- Docetaxil + Cisplatin with G/C/S/F support', '- Epirubicin + Cisplatin + Flourouracil', '- Docetaxil + Cisplatin + Flourouracil']}] \| PrimaryOutcomes: [{'measure': 'Event Free Survival (EFS) - Composite endpoint of overall survival plus free of symptomatic VTE .', 'timeFrame': 'up to 1 year from start of treatment'}] \| SecondaryOutcomes: [{'measure': 'Incidence of SVTE Overall survival Major and minor haemorrhages during chemotherapy and / or up to 30 days after last dose is provided. Serious adverse events, All reported adverse events HIT', 'timeFrame': 'upto 1 year from the start of treatment'}]
Title: Phase III Clinical Study of PD-1 Monoclonal Antibody-activated Autologous Peripheral Blood T-lymphocyte (PD1-T) Combined With XELOX and Bevacizumab in the First-line Treatment of Recurrent and Metastatic Colorectal Cancer \| Condition: Colorectal Cancer \| Keywords: effcet, safety \| Summary: \| Description: N/A \| ArmGroups: [{'label': 'Arm 1', 'type': 'EXPERIMENTAL', 'description': 'Bevacizumab \\& Oxaliplatin \\& Capecitabine \\& PD1-T cells\n\nBevacizumab, 7.5mg/kg, intravenous infusion, d1; Oxaliplatin, 130mg/m2, intravenous infusion, d1; Capecitabine, 1g/m2, oral administration, d1-14; PD1-T cells, 1x10\\^10 (10 billion), intravenous infusion, d17; Q3W, 6 cycles. After 6 cycles, Bevacizumab, 7.5mg/kg, intravenous infusion, d1; Capecitabine, 1g/m2, oral administration, d1-14; Q3W, maintenance treatment.', 'interventionNames': ['Drug: Bevacizumab Injection [Avastin]', 'Drug: Oxaliplatin', 'Drug: Capecitabine', 'Biological: PD1-T cells']}, {'label': 'Arm 2: Control', 'type': 'ACTIVE_COMPARATOR', 'description': 'Bevacizumab \\& Oxaliplatin \\& Capecitabine\n\nBevacizumab, 7.5mg/kg, intravenous infusion, d1; Oxaliplatin, 130mg/m2, intravenous infusion, d1; Capecitabine, 1g/m2, oral administration, d1-14; Q3W, 6 cycles. After 6 cycles, Bevacizumab, 7.5mg/kg, intravenous infusion, d1; Capecitabine, 1g/m2, oral administration, d1-14; Q3W, maintenance treatment.', 'interventionNames': ['Drug: Bevacizumab Injection [Avastin]', 'Drug: Oxaliplatin', 'Drug: Capecitabine']}] \| Interventions:[{'type': 'DRUG', 'name': 'Bevacizumab Injection [Avastin]', 'description': 'Bevacizumab injection', 'armGroupLabels': ['Arm 1', 'Arm 2: Control'], 'otherNames': ['Avastin']}, {'type': 'DRUG', 'name': 'Oxaliplatin', 'description': 'Oxaliplatin injection', 'armGroupLabels': ['Arm 1', 'Arm 2: Control']}, {'type': 'DRUG', 'name': 'Capecitabine', 'description': 'Capecitabine oral agent', 'armGroupLabels': ['Arm 1', 'Arm 2: Control']}, {'type': 'BIOLOGICAL', 'name': 'PD1-T cells', 'description': 'PD1-T cells injection', 'armGroupLabels': ['Arm 1'], 'otherNames': ['PD-1 monoclonal antibody-activated peripheral blood T-lymphocyte']}] \| PrimaryOutcomes: [{'measure': 'Progression-free survival', 'description': 'PFS will be calculated from initiation of treat- ment until first progression, and patients alive in stable state will be censored at the time of last contact.', 'timeFrame': '3 years'}] \| SecondaryOutcomes: N/A
Title: A Phase II Study of Gemcitabine and Cisplatin for Advanced or Recurrent Endometrial Cancer \| Condition: Endometrial Cancer \| Keywords: Endometrial Cancer, Gemcitabine, Gemzar, Gemcitabine Hydrochloride, Cisplatin, Platinol-AQ, Platinol, CDDP \| Summary: \| Description: Gemcitabine and cisplatin are drugs that are used in the treatment of many types of cancer. Each acts to kill cancer cells throughout the body. Before treatment starts, you will have a complete physical exam, pelvic exam, blood tests (about 2-3 teaspoons), a chest x-ray, and a CT scan or MRI. Women able to have children must have a negative blood pregnancy test. On Day 1 and Day 8, you will receive gemcitabine chemotherapy through a small tube placed in a vein over 1 hour. This will be followed by cisplatin chemotherapy given by vein over 1 hour. Before chemotherapy is given, you will receive medications to prevent nausea. You will not receive any therapy on Day 15. One course of therapy is 3 weeks long. Routine blood tests (about 1 teaspoon) will be done weekly during treatment and before each course of therapy (every 3 weeks). A complete checkup, including a history and physical exam, pelvic exam, and routine blood tests (about 2-3 teaspoons) will also be done before each course of therapy and a month after treatment ends. CT or MRI scans will be repeated every 2 to 3 cycles and at the end of treatment. Participants who have a partial or complete response (the tumor shrinks by more than 50% or disappears completely) will have the CT or MRI repeated at least 4 weeks later to confirm the response. You may continue to receive treatment as long as your disease remains stable or improves. Participants who experience significant side effects may be allowed to drop to a lower dose if their disease is not worse. If the disease gets worse or if intolerable side effects occur, you will be taken off study. When you are taken off the study, a complete medical history and physical exam will be performed. Routine blood tests (about 2-3 teaspoons) will be performed. Any side effects will be monitored until they go away. This is an investigational study. Both of the study drugs are FDA approved and commercially available, though their use together in this study is investigational. Up to 35 patients will take part in this study. Patients will be enrolled at M.D. Anderson, St. Lukes Episcopal Hospital and The Woman's Hospital of Texas. \| ArmGroups: [{'label': 'Gemcitabine + Cisplatin', 'type': 'EXPERIMENTAL', 'description': 'Gemcitabine 900 mg/m\\^2 by vein (IV) over 1 hour on Day 1 and Day 8. Cisplatin 30 mg/m\\^2 by vein over 1 hour on Day 1 and Day 8.', 'interventionNames': ['Drug: Gemcitabine', 'Drug: Cisplatin']}] \| Interventions:[{'type': 'DRUG', 'name': 'Gemcitabine', 'description': '900 mg/m\\^2 by vein over 1 hour on Day 1 and Day 8.', 'armGroupLabels': ['Gemcitabine + Cisplatin'], 'otherNames': ['Gemzar', 'Gemcitabine Hydrochloride']}, {'type': 'DRUG', 'name': 'Cisplatin', 'description': '30 mg/m\\^2 by vein over 1 hour on Day 1 and Day 8.', 'armGroupLabels': ['Gemcitabine + Cisplatin'], 'otherNames': ['Platinol-AQ', 'Platinol', 'CDDP']}] \| PrimaryOutcomes: [{'measure': 'Participant Responses', 'description': 'Response Evaluation Criteria In Solid Tumors (RECIST): Complete Response (CR): disappearance all target \\& nontarget lesions, absence new lesions, documented by 2 disease assessments 4 weeks apart; Partial response (PR): 30% decrease in sum longest diameter (LD) all measurable target lesions (baseline sum LDs as reference) \\& absence of progression of nontarget lesions or development of new, documented by 2 disease assessments 4 weeks apart. When only target lesion solitary pelvic mass measurable by physical examination but not radiography, a 50% decrease in LD required to be PR; Progressive disease (PD): 20% increase in sum LDs of target lesions (reference smallest sum of LDs at any assessment) or appearance of new lesions within 9 weeks of study entry, and unequivocal progression of existing nontarget lesions, other than pleural effusions without cytological proof of neoplastic origin within 9 weeks of enrollment; Stable disease (SD): any condition not meeting above CR, PR, or PD.', 'timeFrame': 'Responses required confirmation by imaging after 4-week+ interval following 3 week (21 day) therapy course.'}, {'measure': 'Overall Objective Response Rate (CR + PR)', 'description': 'Objective response (OR) defined as percentage of participants with RECIST Complete Response (CR) and Partial Response (PR), defined as CR: Disappearance all target and non-target lesions, no evidence of new lesions documented by 2 disease assessments at least 4 weeks apart. Normalization of CA-125, if elevated at baseline, is required; PR: 30% decrease in sum of longest dimensions (LD) of all target measurable lesions reference baseline sum of LD, no unequivocal progression of non-target lesions; no new lesions documented by 2 disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical examination, which is not radiographically measurable, a 50% decrease in the LD is required. 21-day cycle assessments or until either disease progression or adverse effects prohibit further treatment.', 'timeFrame': 'Responses required confirmation by imaging after 4-week+ interval following 3 week (21 day) therapy course.'}] \| SecondaryOutcomes: N/A
Title: Independent Predictors Analysis and Model Construction of Cavitary Central Lung Cancer: a Retrospective, Multicenter Trial \| Condition: Central Lung Cancer \| Keywords: Central Lung Cancer, Cavity, Predictor \| Summary: \| Description: N/A \| ArmGroups: N/A \| Interventions:N/A \| PrimaryOutcomes: [{'measure': 'Formation of cavities in the central lung cancer, assessed up to 18 months.', 'description': 'Time from enrollment to the time of cavities formation, assessed up to 18 months.', 'timeFrame': 'Time from enrollment to the time of cavities formation, assessed up to 18 months.'}] \| SecondaryOutcomes: [{'measure': 'Hemoptysis in patients with central lung cancer, assessed up to 18 months.', 'description': 'Time from enrollment to hemoptysis, assessed up to 18 months.', 'timeFrame': 'Time from enrollment to hemoptysis, assessed up to 18 months.'}]
Title: Phase II Study of Bay 43-9006 (Sorafenib) With Evaluation of RAS Signal Pathway in Patients With Relapsed Non-Small Cell Lung Cancer \| Condition: Non-Small-Cell Lung Carcinoma \| Keywords: Non-Small Cell, Molecular, Targeted, Therapies, Cancer, Non-Small Cell Lung Cancer, NSCLC \| Summary: \| Description: Despite advances in systemic chemotherapy, patients with stage IV NSCLC will die from their disease. The median survival of all patients is 8-16 months, with a one year-survival rate of 33%. Chemotherapy is the mainstay of treatment of advanced disease. Based on available data from randomized trials, current treatment recommendations are to treat with one of several effective cisplatin-doublets which have resulted in median survival of 16 to 18 months. Second line chemotherapy is able to improve outcome in patients who have had prior cisplatin therapy. Although these important milestones represent improvements in the care of patients with metastatic NSCLC, outcome has not been able to be further improved by substituting one active drug for another in a platinum-based doublet, treating patients with more than four cycles of chemotherapy or by using cisplatin-based triplets. It is clear that if we are to improve outcome of NSCLC patients, we will need to develop drugs with novel mechanisms of action that perhaps will inhibit major cellular signaling pathways affecting survival, proliferation and angiogenesis. One new compound, BAY 43-9006, was designed to inhibit Raf and is also known to inhibit other kinases including VEGFR2, VEGFR3, PDGFR-beta, Flt3, c-KIT, and p38(1). BAY 43-9006 has shown in vitro activity against NSCLC cell lines NCI-H460 and A549 with tumor growth inhibition of 27% to 68%. In addition, BAY 43-9006 has shown activity in the H460 NSCLC xenograft model. In NSCLC, the proliferation signaling of the Ras/Raf/MEK/ERK pathway is increased due to the frequent (30%) presence of K-ras mutations in the tumor. Mutations in K-ras have been associated with malignant transformation of normal epithelium and constitutive activation of p21 and its downstream effects on cellular proliferation and inhibition of apoptosis. Clinical observations have shown that tumors with K-ras mutations tended to be smaller but more poorly differentiated, and associated with a significantly worse three-year mortality rate. As mentioned above, other pathways significant to the malignant potential of NSCLC, particularly those involved in angiogenesis, may also be affected by BAY 43-9006. The in vitro and in vivo data support the clinical investigation of BAY 43-9006 as an inhibitor of the Ras/Raf/MEK/ERK downstream proliferation effects. The goal of this phase II trial is to determinate if BAY 43-9006 is active in NSCLC, and to measure the BAY 43-9006 biological effects on the Ras/Raf/MEK/ERK pathway. To achieve these goals, patients with relapsed or recurrent NSCLC will be given BAY 43-9006 (four weeks cycle of 400mg PO BID). A series of correlative studies will be done during treatment to measure biological and clinical effects of BAY 43-9006. These studies will include analyses of tissue and blood samples as well as correlative imaging studies. \| ArmGroups: [{'label': 'BAY 43-9006 (Sorafenib)', 'type': 'EXPERIMENTAL', 'description': 'Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.', 'interventionNames': ['Drug: BAY 43-9006 (Sorafenib)']}] \| Interventions:[{'type': 'DRUG', 'name': 'BAY 43-9006 (Sorafenib)', 'description': 'Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.', 'armGroupLabels': ['BAY 43-9006 (Sorafenib)'], 'otherNames': ['Sorafenib tosylate']}] \| PrimaryOutcomes: [{'measure': 'Response Rate', 'description': 'Percentage of participants with response rate = CR + PR. Response will be evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR (complete response) is the disappearance of all target lesions; PR (partial response) is a 30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease) is a 20% increase in the sum of the longest diameter of target lesions; and SD (stable disease) are small changes that do not meet the above criteria. Please see the Protocol Link module for additional information about RECIST if desired.', 'timeFrame': '17 months'}, {'measure': 'Progression Free Survival', 'description': 'Time between the first day of treatment to the day of disease progression. Progressive disease is at least a 20% increase in the sum of the longest diameter of target lesions.\n\nAppearance of one or more new lesions and/or unequivocal progressions of existing non-target lesions.', 'timeFrame': '17 months'}, {'measure': 'The Number of Participants With Adverse Events', 'description': 'Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.', 'timeFrame': '5 1/2 years'}] \| SecondaryOutcomes: [{'measure': 'Overall Survival', 'description': 'Time between the first day of treatment to the days of death.', 'timeFrame': '17 months'}, {'measure': 'Percent of Participants With Genotyping of CYP3A4/5 and 5 Polymorphisms', 'description': 'All patients will be genotyped for CYP3A4/5 and 5 polymorphisms.', 'timeFrame': '58 months'}, {'measure': 'Overall Survival Reported Separately for Participants With a Change in PLGF Below 11 pg/ml and Above 12 pg/ml', 'description': 'Difference in placental derived growth factor (PLGF) between day 28 and day 0 of \\< 11 pg/ml vs. \\> 12 pg/ml.', 'timeFrame': '17 months'}, {'measure': 'Cytokine Levels', 'description': 'Serial plasma samples were collected from all patients and cytokine levels were measured. The concentrations of the cytokines were determined with recombinant standards and expressed as picograms per milliliter (pg/ml).', 'timeFrame': '54 days'}, {'measure': 'Correlation of Response to Treatment With KRAS Mutational Status', 'description': 'Mutational analysis of these genes was performed on paraffin-imbedded tissue blocks from prior pathologic specimens. Disease control rate was correlated with KRAS mutational status. Disease control rate was defined as complete remission (CR) + partial remission (PR)+ stable disease (SD).', 'timeFrame': '42 months'}, {'measure': 'Overall Survival Associated With Basic Fibroblast Growth Factor (bFGF)', 'description': 'Serum plasma is collected at the beginning of each cycle during the course of the study and analyzed by the enzyme-linked immunosorbent assay (ELISA).', 'timeFrame': '42 months'}, {'measure': 'Progression Free Survival Associated With Basic Fibroblast Growth Factor (bFGF)', 'description': 'Serum plasma is collected at the beginning of each cycle during the course of the study and analyzed by the enzyme-linked immunosorbent assay (ELISA).', 'timeFrame': '17 months'}, {'measure': 'Percentage of Participants With an Increase or Decrease in the Reverse Contrast Transfer Rate (Kep), Forward Contrast Transfer Rate (Ktrans), and Extravascular Fraction (Ve) With the Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI)', 'description': 'DCE-MRI was used to evaluate changes (e.g. decrease/increase in Ve, Ktrans, Kep value) in vascularity and quality of index lesions to provide early indication of treatment effect before changes in size can be perceived on CT. Changes were reflected in a decrease/increase of Ve, Ktrans, or Kep (Kep, Ve, Ktrans measurements at day 0, day 14 and the difference between the day 14 and the day 0 measurements (day 14-day 0).', 'timeFrame': '59 months'}, {'measure': 'Percent of Participants Who Had Immunohistochemical Analysis Performed for Raf, MEK, ERK, ERK-1 and p90RSK,ERK, E Twenty-six (ETS)-Like Transcription Factor 1 (ELK-1) and p90Ribosomal S6 Kinase (p90RSK).', 'description': 'Immunohistochemical analysis performed by using state specific antibodies against Raf, methyl ethyl ketone (MEK), extracellular-signal regulated kinase (ERK), and two downstream substrates of ERK, E twenty-six (ETS)-like transcription factor 1 (ELK-1) and p90Ribosomal S6 kinase (p90RSK).', 'timeFrame': '59 months'}, {'measure': 'Percent of Participants Who Had Cytokine Profiling for IL-6 and IL-8', 'description': 'Serial plasma samples were collected from all patients at pretreatment (baseline - day 0), and on days 14, 28, and 54. The concentrations of the cytokines were determined with recombinant standards and expressed as picograms per milliliter (pg/ml).', 'timeFrame': '60 months'}, {'measure': 'Percentage of Participants With BRAF Mutations', 'description': 'Extracted DNA was subjected to an initial PCR using a single primer set encompassing codom V600. Pyrosequencing was carried out on a Qiagen PyroMaark Q24 system.', 'timeFrame': '60 months'}, {'measure': 'Percent of Pts With Primary Pharmacoproteomic Modulation Targets', 'description': 'Pharmacoproteomic modulation targets (AKT, p-AKT, ERK 1/2, MEK, Cyclin D, p-ERK 1/2, p-MEK, pMEK, eNOA, p-eNOA, Cleaved PARP, PDGFRbeta, p-PDGFRbeta,Cyclin D, CD31, PARP. Caspase 9, Caspase 3, Cleaved Caspase-9 Cleaved Caspase 3)', 'timeFrame': '60 months'}, {'measure': 'Secondary Pharmacoproteomic Modulation Targets', 'description': 'Secondary pharmacoproteomic modulation targets (mTOR, EGFR, Src, NFkB, STAT1, TGFa, p38, Jak 1, lkB, IGFR, p-mTOR, p-EGFR, p-Src, p-NFkB, p-STAT1, Phospho-p38, p-Jak1, p-lkB,Pyk2, p-Pyk2, VEGFR-2, GSK3beta, p-GSK3beta, p-bad, p-Bcl-2, PCNA, Fos, Raf, CREB, Rho, avbeta3complex, Bad, CD34, VEGFR-1, bfGF, vWF, Factor VIII, Annexin V, Bcl-2).', 'timeFrame': '60 months'}]
Title: A Phase 2 Multicenter Study of the Effect of the Addition of SNDX-275 to Continued Aromatase Inhibitor (AI) Therapy in Postmenopausal Women With ER+ Breast Cancer Whose Disease is Progressing \| Condition: ER+ Breast Cancer \| Keywords: breast cancer, estrogen receptor positive \| Summary: \| Description: N/A \| ArmGroups: [{'label': 'Entinostat 5 mg + AI', 'type': 'EXPERIMENTAL', 'description': 'Entinostat 5 mg tablet orally every week on Days 1, 8. 15 and 22 of each 28-day treatment cycle in combination with continued treatment with AI therapy at labeled dose and schedule until disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Entinostat', 'Drug: Aromatase Inhibitor (AI) Therapy']}] \| Interventions:[{'type': 'DRUG', 'name': 'Entinostat', 'description': 'Entinostat 5 mg PO every week', 'armGroupLabels': ['Entinostat 5 mg + AI'], 'otherNames': ['SNDX-275']}, {'type': 'DRUG', 'name': 'Aromatase Inhibitor (AI) Therapy', 'description': 'AI therapy at labeled dose and schedule as prescribed in clinical practice. AI therapies include: Arimidex® (anastrozole) 1 mg/day by mouth (PO), Fermara® (letrozole) 2.5 mg/day PO , Aromasin® (exemestane) 25 mg/day PO.', 'armGroupLabels': ['Entinostat 5 mg + AI']}] \| PrimaryOutcomes: [{'measure': 'Clinical Benefit Rate (CBR)', 'description': 'CBR is defined as the percentage of participants who achieved complete response (CR) or partial response (PR) or stable disease (SD) for 6 months as assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started.', 'timeFrame': '6 months'}] \| SecondaryOutcomes: [{'measure': 'Progression-Free Survival (PFS)', 'description': 'PFS is defined as the number of months from the date of randomization to the earlier of progressive disease (PD) or death due to any cause.', 'timeFrame': 'Up to 6, 28-day cycles'}, {'measure': 'Objective Response Rate (ORR) During the First 6 Cycles of Study Treatment', 'description': 'ORR is defined as the percentage of participants with response during treatment classified as CR or PR, as assessed by the investigator based on RECIST, version 1.0. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.', 'timeFrame': 'Up to 6, 28-day cycles'}, {'measure': 'Number of Participants With Adverse Events (AEs)', 'description': 'An AE is defined as any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Worsening of a pre-existing medical condition was considered an AE if there was either an increase in severity, frequency, or duration of the condition or an association with significantly worse outcomes. Abnormal clinical laboratory findings determined by the investigator to be clinically significant were recorded as AEs.', 'timeFrame': 'Up to 6, 28-day cycles + 30 days'}]
Title: Effect of Pentoxifylline and Vitamin E in Preventing Radiation-induced Toxicity in the Treatment of Recurrent or New Primary NSCLC Using Stereotactic Ablative Radiotherapy in Patients Previously Treated With Thoracic Radiation \| Condition: Non-small Cell Lung Cancers \| Keywords: \| Summary: \| Description: N/A \| ArmGroups: [{'label': 'radiotherapy (SABR) plus pentoxifylline', 'type': 'EXPERIMENTAL', 'description': 'standard of care radiotherapy (SABR) plus pentoxifylline and Vitamin E', 'interventionNames': ['Radiation: stereotactic ablative radiotherapy (SABR)', 'Drug: Pentoxifylline']}] \| Interventions:[{'type': 'RADIATION', 'name': 'stereotactic ablative radiotherapy (SABR)', 'description': 'standard of care radiation therapy', 'armGroupLabels': ['radiotherapy (SABR) plus pentoxifylline']}, {'type': 'DRUG', 'name': 'Pentoxifylline', 'description': 'pentoxifylline', 'armGroupLabels': ['radiotherapy (SABR) plus pentoxifylline']}] \| PrimaryOutcomes: [{'measure': 'primary endpoint is to estimate overall treatment-related toxicity', 'timeFrame': '36 months-end of trial'}] \| SecondaryOutcomes: [{'measure': 'Estimate progression free survival', 'timeFrame': '12 months'}, {'measure': 'Estimate tumor failure', 'timeFrame': '12 months'}, {'measure': 'estimate overall survival', 'timeFrame': '12 months'}]
Title: Effectiveness of a Childcare Intervention on Retention in the Cervical Cancer Screening and Diagnostic Continuum \| Condition: Cervical Dysplasia \| Keywords: Childcare, Social determinant of health, Patient navigation \| Summary: \| Description: N/A \| ArmGroups: [{'label': 'Intervention', 'type': 'ACTIVE_COMPARATOR', 'description': 'The intervention is comprised of two components to link randomized patients to our health system childcare facility: 1) navigation by the research assistant to the childcare facility and 2) placement of the facility EMR referral. Navigation will occur an eligible patient is randomized to the intervention group. Navigation will consist of the research assistant educating the patient about the childcare facility and providing information about how to access the childcare facility during the telephone contact and via mailed written materials.', 'interventionNames': ['Behavioral: Navigation and EMR referral to childcare facility']}, {'label': 'Standard Care', 'type': 'NO_INTERVENTION', 'description': 'Patients randomized to the control group will undergo current standard of care with regards to childcare, which currently consists of passive sources of information about our childcare facility (Parkland website, signage in the hospital, or via word of mouth). Currently, there is no formalized mechanism for patients referred to gynecology from primary care to receive information about childcare aside from the above passive sources of information.'}] \| Interventions:[{'type': 'BEHAVIORAL', 'name': 'Navigation and EMR referral to childcare facility', 'description': 'See arm description', 'armGroupLabels': ['Intervention']}] \| PrimaryOutcomes: [{'measure': 'Show-rate for initial visit to gynecology dysplasia clinic', 'description': 'Show-rate assessed via EMR', 'timeFrame': 'Up to 2 years'}] \| SecondaryOutcomes: [{'measure': 'Rate of completion of indicated diagnostic and therapeutic procedures', 'description': 'May include colposcopy, biopsies, and cervical excisional procedures, including hysterectomy, in the clinic and operating room (OR). Will vary based on clinical indication and assessment during initial appointment.', 'timeFrame': 'Up to 2 years'}, {'measure': 'Show-rate for follow-up visits in gynecology', 'description': 'Show-rate assessed via EMR', 'timeFrame': 'Up to 2 years'}, {'measure': 'Rate of utilization of childcare facility during scheduled gynecology visits', 'description': "Rate of utilization assessed by health system's dashboard for childcare facility", 'timeFrame': 'Up to 2 years'}]
Title: A Phase II Study of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) for the Treatment of Patients With Evidence of Serologic (PSA) Progression After Definitive Therapy for Localized Prostate Cancer \| Condition: Prostate Cancer \| Keywords: \| Summary: \| Description: N/A \| ArmGroups: [{'label': 'Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: GM-CSF']}] \| Interventions:[{'type': 'DRUG', 'name': 'GM-CSF', 'description': 'Each cycle will consist of 28 days. Patients will receive 250 ug/m2/day of GM-CSF administered subcutaneously on days 1-14.', 'armGroupLabels': ['Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)']}] \| PrimaryOutcomes: [{'measure': 'PSA Response', 'timeFrame': 'Monthly'}] \| SecondaryOutcomes: N/A
Title: A Dose-Escalation and Dose-Expansion Study Evaluating the Safety and Efficacy of Personalized Neoantigen Vaccine in Advanced Solid Tumors \| Condition: Solid Tumor \| Keywords: Vaccine, Neoantigen, Solid Tumor \| Summary: \| Description: N/A \| ArmGroups: [{'label': 'Personalized neoantigen vaccine or neoantigen tumor vaccine + PD-1', 'type': 'EXPERIMENTAL', 'description': 'In dose escalation phase, subject will only receive personalized neoantigen tumor vaccine. In dose expansion phase, subject will receive personalized neoantigen tumor vaccine combination with PD-1.', 'interventionNames': ['Biological: Personalized neoantigen tumor vaccine']}] \| Interventions:[{'type': 'BIOLOGICAL', 'name': 'Personalized neoantigen tumor vaccine', 'description': 'Biological: neoantigen tumor vaccine with or without PD-1 In dose escalation phase, subjects will receive neoantigen tumor vaccine only. In dose expansion phase, subjects will receive neoantigen tumor vaccine combination with PD-1', 'armGroupLabels': ['Personalized neoantigen vaccine or neoantigen tumor vaccine + PD-1'], 'otherNames': ['PGV002 mRNA Vaccine']}] \| PrimaryOutcomes: [{'measure': 'Maximum tolerated dose (MTD) or recommended clinical dose', 'timeFrame': 'Up to 16 weeks'}, {'measure': 'Dose-limiting toxicity(DLT)', 'timeFrame': 'Up to 16 weeks'}, {'measure': 'Incidence and degree of Adverse Events and Serious Adverse Events [Safety]', 'timeFrame': 'Up to 100 weeks'}] \| SecondaryOutcomes: [{'measure': 'Reaction of antigen-specific T cells in peripheral blood', 'timeFrame': 'Up to 16 weeks'}, {'measure': 'Efficacy indicators: Objective response rate (ORR)', 'description': 'Objective response rate (ORR: complete response \\[CR\\] + partial response \\[PR\\]), duration of response (DoR), best response rate (BOR), disease control rate (DCR: CR + PR + stable disease \\[SD\\]), progression-free survival (PFS), and overall survival (OS) based on RECIST 1.1.', 'timeFrame': 'Up to 100 weeks'}]
Title: Addressing Mental Health Disparities in Spanish Speaking Latina Breast Cancer Patients \| Condition: Breast Cancer, Depression, Anxiety, Mindfulness, Sleep Disturbance \| Keywords: behavioral intervention, Spanish speaking, Latina, Breast Cancer, Mindfulness \| Summary: \| Description: Primary aims of this study are to: 1) translate a behavioral health intervention into Spanish, 2) deliver it to a population of Spanish speaking Latina breast cancer patients, and 3) determine acceptability and feasibility. Secondary aims are to gather preliminary data on anxiety, depression and sleep quality pre and post intervention. \| ArmGroups: [{'label': 'Mindfulness group visit', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants will attend 6 weekly educational and mindfulness sessions', 'interventionNames': ['Behavioral: Mindfulness']}, {'label': 'Wait list control', 'type': 'PLACEBO_COMPARATOR', 'description': 'Participants will be placed on a wait list', 'interventionNames': ['Behavioral: Control group']}] \| Interventions:[{'type': 'BEHAVIORAL', 'name': 'Mindfulness', 'description': '6 weekly 2.0 hour video-conferenced group sessions with the following components: 1) short grounding meditation, 2) check in/review of prior weeks practice and symptoms, 3) educational topic, 3) main meditation, 4) reflection on meditation, and 5) action plan formation', 'armGroupLabels': ['Mindfulness group visit'], 'otherNames': ['Educational video']}, {'type': 'BEHAVIORAL', 'name': 'Control group', 'description': 'Wait list control', 'armGroupLabels': ['Wait list control']}] \| PrimaryOutcomes: [{'measure': 'Acceptability change across session', 'description': 'The Acceptability scale was developed for this study and is a 5 point Likert scored scale that will be administered after end of each weeks for 6 weeks. There are two questions with scores ranging from "strongly disagree" (score 0), "disagree" (score 1), "neutral" (score 2), "agree" (score 3), and "strongly agree" (score 4). Scores range from 0 to 8 with the higher scores representing greater levels of acceptability. It has 2 additional open ended questions: "What changes did you make in your daily routine as a result of this intervention, if none, why" and "Were there any barriers to making changes you listed on your action plan, if so what were they? The scale takes approximately 5 minutes to complete. Acceptability change will be measured after each session (week 1-6). The mean score with standard deviation for each 6 sessions and acceptability will be reported.', 'timeFrame': 'End of each week for 6 weeks'}, {'measure': 'Difference in Feasibility', 'description': 'The Feasibility and Satisfaction scale was developed for this study and is a 5 point Likert scored scale that will be administered at at time of completion of intervention or at time of withdraw (if participant withdraws prior to completion of intervention.) Five questions are scored from "strongly disagree" (score 0), "disagree" (score 1), "neutral" (score 2), "agree" (score 3), and "strongly agree" (score 4). Scores range from 0 to 20 with higher scores representing greater levels of feasibility. Differences in Feasibility will be evaluated and reported. There is also 1 open-ended question "What is the optimal number of visits" with continuous numeric score (participants able to write in number of preferred visits) with higher score representing desire for greater number of visits. The scale takes approximately 5-10 minutes to complete', 'timeFrame': 'Through study completion, an average of 1 year'}] \| SecondaryOutcomes: [{'measure': 'Differences in Generalized Anxiety Disorder-7 (GAD7) between time points.', 'description': 'The GAD7 is a well validated seven-item self-administered questionnaire used to measure anxiety. It has 7 questions with Likert scores ranging from "not at all" (score 0), "several days" (score 1), "more than half the days" (score 2), and "nearly every day (score 3).Scores range from 0 to 21 with higher scores indicating higher levels of anxiety, and a cutoff of or above 10 representing high likelihood of generalized anxiety disorder. Difference in GAD-7 measured at three time points (week 1 and 6 of the intervention and 3 months post intervention) will be compared and reported. The scale takes approximately 5-10 minutes to complete', 'timeFrame': 'Three time points (week 1 and 6 of intervention, and 3 months post intervention.)'}, {'measure': 'Differences in Center for Epidemiological Studies-Depression (CES-D) between time points.', 'description': 'The CES-D scale is a well validated self-administered questionnaire used to measure depression. The 20 item scale has Likert scores ranging from "rarely or none of the time" (score 0), "some or little of the time" (score 1), "moderate or much of the time" (score 2), and "most or almost all the time" (score 3).Scores range from 0 to 60 with higher scores indicated greater depressive symptoms. A cut off at or above 20 has sensitivity 79% and specificity of 80% for major depression. Difference in CES-D measured at three time points (week 1 and 6 of the intervention and 3 months post intervention) will be reported and compared. The scale takes approximately 5-10 minutes to complete.', 'timeFrame': 'Three time points (week 1 and 6 of intervention, and 3 months post intervention.)'}, {'measure': 'Differences in PROMIS-SD between time points', 'description': 'The Participant Reported Outcomes Measurement Information System (PROMIS) Adult Short Form: Sleep Disturbance (PROMIS-SD), is an 8 item scale measuring overall sleep quality, disturbances, and satisfaction over the past 7 days on 5 point Likert scale with scores ranging from 1 to 5. Raw scores are converted into t scores ranging from 28.9 to 76.5, with higher scores indicating greater sleep disturbance. Exploratory analysis will compare scores at three time points (week 1 and 6 of the intervention and 3 months post intervention). The scale takes approximately 2 minutes to complete 26 and is available in Spanish.', 'timeFrame': 'Three time points (week 1 and 6 of intervention, and 3 months post intervention.)'}]
Title: A Phase II Trial of Intravenous Gemcitabine (NSC #613327) and Intraperitoneal Carboplatin (NSC # 241240) in the Treatment of Patients With Platinum-Sensitive Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Carcinoma With Non-Measurable Disease \| Condition: Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer \| Keywords: recurrent ovarian epithelial cancer, fallopian tube cancer, peritoneal cavity cancer \| Summary: \| Description: OBJECTIVES: Primary * Determine the progression-free survival of patients with persistent or recurrent platinum-sensitive ovarian epithelial, fallopian tube, or primary peritoneal cancer treated with gemcitabine hydrochloride and intraperitoneal carboplatin. * Evaluate the systemic and regional toxicity of this regimen in these patients. Secondary * Determine the overall survival of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive gemcitabine hydrochloride IV over 30 minutes followed by intraperitoneal carboplatin on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 3 years. PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study. \| ArmGroups: N/A \| Interventions:[{'type': 'DRUG', 'name': 'carboplatin'}, {'type': 'DRUG', 'name': 'gemcitabine hydrochloride'}] \| PrimaryOutcomes: [{'measure': 'Relative risk of progression-free survival'}, {'measure': 'Frequency and severity of observed adverse effects by CTCAE version 3.0'}] \| SecondaryOutcomes: [{'measure': 'Relative risk of survival'}]
Title: A Randomized Phase 2 Trial of Flat Dose Vs. Weight-based Dose of Intra-peritoneal (IP) Chemotherapy for Patients Undergoing Cytoreductive Surgery and Heated Intra-peritoneal Chemotherapy (CRS/HIPEC) for Advanced Gastrointestinal Malignancy \| Condition: Peritoneal Carcinomatosis \| Keywords: cytoreductive surgery, colorectal cancer, pseudomyxoma peritonei, appendiceal mucinous neoplasm, mitomycin C, pharmacokinetics, CRS/HIPEC, HIPEC, Appendix cancer, LAMN \| Summary: \| Description: N/A \| ArmGroups: [{'label': 'Flat Dose Mitomycin C', 'type': 'EXPERIMENTAL', 'description': 'Participants in this group will receive flat doses of mitomycin C intra-operatively: 1) 30mg at minute 0 and 2) 10mg at minute 60. Mitomycin C will be delivered via HIPEC (hyperthermic intraperitoneal chemotherapy).', 'interventionNames': ['Drug: Mitomycin C, flat dose 40 mg']}, {'label': 'Weight-Based Mitomycin C', 'type': 'EXPERIMENTAL', 'description': 'Participants in this group will receive weight-based dosing of mitomycin C intra-operatively: 1) 9 mg/m2 at minute 0 and 2) 3.5 mg/m2 at minute 60 for total dose of 12.5 mg/m2. Mitomycin C will be delivered via HIPEC (hyperthermic intraperitoneal chemotherapy).', 'interventionNames': ['Drug: Mitomycin C, weight-based dose 12.5 mg/m2']}] \| Interventions:[{'type': 'DRUG', 'name': 'Mitomycin C, flat dose 40 mg', 'description': 'Mitomycin C will be delivered as heated intraperitoneal chemotherapy (HIPEC) in two flat doses. Dose 1 will be 30mg at minute 0 and dose 2 will be 10 mg at minute 60.', 'armGroupLabels': ['Flat Dose Mitomycin C']}, {'type': 'DRUG', 'name': 'Mitomycin C, weight-based dose 12.5 mg/m2', 'description': 'Mitomycin C will be delivered as heated intraperitoneal chemotherapy (HIPEC) in two weight-based doses of 9 mg/m2 at minute 0 and 3 mg/m2 at minute 60.', 'armGroupLabels': ['Weight-Based Mitomycin C']}] \| PrimaryOutcomes: [{'measure': 'Area Under the Curve (AUC) - Pharmacokinetics', 'description': 'Drug exposure will be measured by calculating the area under the curve (AUC) or integral of a plasma concentration-time curve. Samples will be collected at 0,15, 30, 60 and 90 minutes intra-operatively, and 2, 4, and 12 hours postoperatively.', 'timeFrame': 'Approximately 20 hours'}, {'measure': 'Drug Clearance (CL) - Pharmacokinetics', 'description': 'Drug clearance will be calculated as the volume of plasma cleared per unit time. Samples will be collected at 0,15, 30, 60 and 90 minutes intra-operatively, and 2, 4, and 12 hours postoperatively.', 'timeFrame': 'Approximately 20 hours'}, {'measure': 'Drug Half-Life (T1/2) - Pharmacokinetics', 'description': 'Drug half-life will be calculated as the time required for the plasma Mitomycin C concentration to be half of its maximum concentration. Samples will be collected at 0,15, 30, 60 and 90 minutes intra-operatively, and 2, 4, and 12 hours postoperatively.', 'timeFrame': 'Approximately 20 hours'}] \| SecondaryOutcomes: N/A
Title: Prospective Phase II Trial of Single Fraction Real-time High-Dose-Rate (19-HDR) Brachytherapy in Patients With Low and Intermediate Risk Prostate Cancer \| Condition: Prostate Cancer \| Keywords: Cancer, Prostate Cancer, Brachytherapy, Dose escalation, High Dose Rate, MRI-TRUS fusion, Detection of DILs by MRI, SINGLE FRACTION \| Summary: \| Description: Treatment: The patient´s treatment will consist of MRI-TRUS fusion single HDR brachytherapy fraction (1 fraction of 1900 cGray). Brachytherapy performed under general anesthesia as an outpatient procedure TRUS-MRI fusion: T2 axial volumetric sequence (VISTA) is imported directly from the picture archiving and communication systems (PACS). Then MR images are reconstructed and segmented. Target volumes (prostate gland, dominant intraprostatic lesions (DILs) Organs at risk (OARs) urethra and rectum are delineated. A transrectal sagittal volumetric ultrasound image is immediately acquired every 2 degrees, a rapid reconstruction algorithm converts the series of 2D images into a 3D volume, which is then displayed in axial, sagittal and coronal views and transferred to the module of fusion with the MRI. The MRI images and the real-time sonography examination are displayed on a split-screen with the possibility of overlaying the images live in one image. A graphical user interface is used for rigid manual registration of the ultrasound and MRI volumes. This interface allows for displacements in the three dimensions and rotations, until both images are correctly superimposed. Then the contoured structures are transferred to the US dataset, and these contours are slightly modified until a perfect matching with the US images is achieved. Dose prescription: Ultrasound images with the catheters in place will be exported to Oncentra Prostate. The prostate, Foley catheter and anterior rectal wall will be contoured. Catheters will be reconstructed on the planning system. Anatomy based inverse planning will be used for dwell time optimization. The homogeneity parameters used for optimization aim are: -For prostate V100 \> 95%, V150 \<35%, V200 \< 6%, where Vn is the fractional volume of the organ that receives n% of the prescribed dose. The dose constraints for the organ at risk will be: * Urethral dmax \< 110% and * Rectal 1cc \< 60% of prescribed dose. Endpoints Feasibility of higher doses administration, toxicity and efficacy will be measured \| ArmGroups: [{'label': 'MRI-TRUS fusion guided Single Frac HDR', 'type': 'EXPERIMENTAL', 'description': 'Patients treated with a Single Fraction Real-Time High-Dose-Rate (HDR 19Gy)', 'interventionNames': ['Radiation: MRI-TRUS fusion guided Single Frac HDR']}] \| Interventions:[{'type': 'RADIATION', 'name': 'MRI-TRUS fusion guided Single Frac HDR', 'armGroupLabels': ['MRI-TRUS fusion guided Single Frac HDR'], 'otherNames': ['Single Fraction real time HDR (19Gy)', 'Planning software Oncentra Prostate for Nucletron']}] \| PrimaryOutcomes: [{'measure': 'Safety measured by i) urinary retention rate and duration ii) maximum International Prostate Symptom Score and time to normalize', 'description': 'Data to be collected are:\n\ni) urinary retention rate and duration ii) maximum International Prostate Symptom Score and time to normalize', 'timeFrame': '12 months'}, {'measure': 'Quality of Life measured by alidated instruments including International Prostate Symptom Score and the urinary, bowel and sexual domains of EPIC', 'description': 'Quality of life will be measured through validated instruments including International Prostate Symptom Score and the urinary, bowel and sexual domains of EPIC', 'timeFrame': '12 months'}] \| SecondaryOutcomes: [{'measure': 'Acute toxicity measured by urinary retention rate, International Prostate Symptom Score over time, rectal toxicity and genitourinary toxicity', 'description': 'Data to be collected: urinary retention rate, International Prostate Symptom Score over time, rectal toxicity and genitourinary toxicity', 'timeFrame': '24 months'}, {'measure': 'Efficacy, measured by PSA', 'description': 'Patients will be followed with PSA at every follow-up;', 'timeFrame': '24 months'}, {'measure': 'Patient satisfaction measured with Likert scale question', 'description': 'Patient Satisfaction will be measured with Likert scale question', 'timeFrame': '24 months'}]
Title: Assessment of a Tailored Home-Based Exercise Program on Symptoms, Well-Being, and Resilience Among Cancer Survivors With Multiple Chronic Conditions \| Condition: Cancer, Hypertension, Diabetes \| Keywords: Multiple chronic conditions \| Summary: \| Description: The benefits of physical activity on managing chronic illnesses and multiple symptoms are well established. However, increasing the physical activity of persons living with Multiple Chronic Conditions (MCC), especially low -income cancer survivors with MCC, is challenging. Home-based exercise improves physical activity and symptoms among persons with the single chronic disease. One major challenge of the home-based exercise is the motivation and adherence. The mobile technologies (e.g., wearable device and smartphone application) have been used to improve motivation and monitor a person physical activity. Guided by the society to cells framework and previous preliminary findings, the investigators developed a technology-enhanced home-based exercise program using a combination of the integrated mobile technologies (wearable device and phone application) and tailored home-based exercise. Participants will choose one of the four home-based exercise options \[National Institute of Aging (NIA) Go4Life, Iyengar-style yoga, walking, and modified Otago exercise\] based on participants' preference and goals. The integrated mobile technologies system will allow the investigators to extract heart rate data directly from the wearable device to the research server. This data will be used to provide appropriate and personalized feedback on physical performance and trigger algorithms to send the survey and notification to the participants in real time. This pilot project will examine the feasibility of this technology-enhanced home exercise tailored to participants' goals and preferences. The intervention will leverage the cancer survivorship phase (post-treatment) to motivate self-care by combining tailored existing evidence-based physical activity programs and mobile technology for participants to engage in the resilience-enhancing physical activity. Identification of BDNF's role as one of the exercise outcomes provide a novel target for an intervention and increase the investigators' understanding of the underlying mechanism of symptoms and resilience. This study aims to examine the feasibility and acceptability of the iHBE program among low-income cancer survivors living with co-morbid conditions. Eight participants who have completed treatment for a solid tumor cancer with at least one comorbidity (e.g., diabetes and/or hypertension) will be assigned to an open-label trial of the idea. The investigators will gather feedback on goal setting, problem-solving strategies, exercise choices, and tracking mechanisms, program feasibility, and acceptability and modify the intervention as needed. \| ArmGroups: [{'label': 'The iHBE program group', 'type': 'EXPERIMENTAL', 'description': 'Tailored Technology-Enhance Home-based exercise program (iHBE)', 'interventionNames': ['Other: Tailored Technology-Enhance Home-based exercise program (iHBE)']}, {'label': 'Usual Care (Control group)', 'type': 'NO_INTERVENTION', 'description': 'Participants were required to wear physical activity tracker (Fitbit) and respond to the daily symptoms survey (mEMA) while receiving usual care'}] \| Interventions:[{'type': 'OTHER', 'name': 'Tailored Technology-Enhance Home-based exercise program (iHBE)', 'description': 'The tailored technology enhanced home-based exercise (iHBE) program is a 12-week program with 1 assessment home visit session, 5 home visits and 7 phone follow ups during exercise. The technologies, a wearable device, and a smartphone application, will be used as a tool to monitor physical performance (heart rate \\[HR\\], step count), provide immediate feedback, send daily reminding message through Mobile Ecological Momentary Assessment (mEMA). The coded raw data without personal identification information from the wearable device will be sent to the servers where the investigators can store it in the database alongside the mEMA data and create custom reports showing Heart Rate (HR) 30 minute before each Ecological Momentary Assessment (EMA) survey, showing HR and previous self-report responses before/ after each automatically triggered EMA.', 'armGroupLabels': ['The iHBE program group'], 'otherNames': ['iHBE']}] \| PrimaryOutcomes: [{'measure': 'Change in Fatigue as Assessed by Self-reported Fatigue Questionnaire', 'description': 'Patient-Reported Outcomes Measures Information System (PROMIS) Short Form V1.0-Fatigue 6a. A 6-items; self-reported fatigue (frequency, duration, intensity) and the impact on physical, mental, and social activities, has five response options (1 or never to 5 or always). The overall score range from 6 (no fatigue) to 30 (extreme fatigue). Higher score means a greater fatigue', 'timeFrame': 'Pre- and post-intervention, up to 12 weeks'}, {'measure': 'Change in Resilience as Assessed by Connor-Davidson Resilience Scale', 'description': 'Connor-Davidson Resilience scale: 10 item self-report rating scale 0 (not true at all) to 4 (true nearly all the time). The overall score range from 0 (no resilience) to 40 (High Resilience). The higher score means a better resilience', 'timeFrame': 'Pre- and post-intervention, up to 12 weeks'}, {'measure': 'Change in Physical Well Being', 'description': 'Physical well being as assessed by 36 item self-report instrument. The overall score derived from the physical functioning, role limitation-physical, and bodily pain domains. The overall score range from 0-400, with a score 400 reflecting the highest rating of physical health.', 'timeFrame': 'Pre- and post-intervention, up to 12 weeks'}, {'measure': 'Change in Mental Well Being', 'description': 'Mental component of the Short Form Survey (SF-36), the 36 item self-report instrument. The overall score was derived from the mental health, and role limitation-emotional domains. The total score range from 0 to 200, with a score of 200 indicating high mental well being', 'timeFrame': 'Pre- and post-intervention, up to 12 weeks'}] \| SecondaryOutcomes: [{'measure': 'Physical Activity', 'description': 'The physical activity will be measured in a form of average step count/day measured by a wrist-worn wearable device.', 'timeFrame': '12 weeks'}, {'measure': 'Change in Brain-Derived Neurotrophic Factor Level (in Serum)', 'description': 'The level of Brain-Derived Neurotrophic Factor in serum was measured by ELISA. The level will be measured in nanograms/milliliter.', 'timeFrame': 'Pre-and post-intervention, up to 12 weeks'}, {'measure': 'Change in Brain-Derived Neurotrophic Factor Level (in Sweat)', 'description': 'Brain-Derived Neurotrophic Factor level in sweat collected through the sweat pad. The level will be measured in nanograms/milliliter.', 'timeFrame': 'Pre- and post-intervention, up to 12 weeks'}]
Title: Reduced-dose Radiotherapy Following High-dose Chemotherapy and Autologous Stem Cell Transplantation in Patients With Central Nervous System Non-germinomatous Germ Cell Tumors \| Condition: Intracranial Non-germinomatous Germ Cell Tumor \| Keywords: \| Summary: \| Description: Treatment outcome of intracranial NGGCT is around 50% with conventional chemo- and radiotherapy. Also, late sequelae such as endocrinopathy or cognitive problem are unavoidable especially with craniospinal irradiation. In this study, high dose chemotherapy and reduced dose of radiotherapy will be used to improve survival and minimize the late sequelae in the patients with intracranial NGGCT. \| ArmGroups: [{'label': 'Intracranial NGGCT', 'type': 'EXPERIMENTAL', 'description': '1. Six cycles of chemotherapy with carboplatin, etoposide, bleomycin (CEB) and cyclophosphamide, etoposide, bleomycin (CyEB) regimen.\n2. Peripheral blood stem cell collection during the first cycle of chemotherapy.\n3. Surgery, if there is residual tumor after chemotherapy.\n4. Tandem high dose chemotherapy (HDCT) and autologous stem cell transplantation (auto-SCT)\n\n * 1st HDCT: Carboplatin, thiotepa, etoposide\n * 2nd HDCT: Cyclophosphamide, melphalan\n5. Reduced dose of radiotherapy', 'interventionNames': ['Drug: Carboplatin', 'Drug: Etoposide', 'Drug: Cyclophosphamide', 'Drug: Bleomycin', 'Drug: Thiotepa', 'Drug: Melphalan', 'Radiation: Reduced dose radiotherapy']}] \| Interventions:[{'type': 'DRUG', 'name': 'Carboplatin', 'armGroupLabels': ['Intracranial NGGCT']}, {'type': 'DRUG', 'name': 'Etoposide', 'armGroupLabels': ['Intracranial NGGCT']}, {'type': 'DRUG', 'name': 'Cyclophosphamide', 'armGroupLabels': ['Intracranial NGGCT']}, {'type': 'DRUG', 'name': 'Bleomycin', 'armGroupLabels': ['Intracranial NGGCT']}, {'type': 'DRUG', 'name': 'Thiotepa', 'armGroupLabels': ['Intracranial NGGCT']}, {'type': 'DRUG', 'name': 'Melphalan', 'armGroupLabels': ['Intracranial NGGCT']}, {'type': 'RADIATION', 'name': 'Reduced dose radiotherapy', 'armGroupLabels': ['Intracranial NGGCT']}] \| PrimaryOutcomes: [{'measure': 'Rate of event free survival', 'timeFrame': 'Up to 3 years'}] \| SecondaryOutcomes: [{'measure': 'Rate of late adverse events', 'timeFrame': 'Up to 5 years'}]
Title: Phase I Trial of R115777 (NSA 702818) in Advanced Malignant Solid Tumors \| Condition: Unspecified Adult Solid Tumor, Protocol Specific \| Keywords: unspecified adult solid tumor, protocol specific \| Summary: \| Description: OBJECTIVES: * Determine the maximum tolerated dose of R115777 in patients with advanced malignant solid tumors. * Assess the toxicity of this drug in these patients. * Determine, preliminarily, the efficacy of this drug in these patients. * Determine the potential predictors of response in patients treated with drug. OUTLINE: This is a multicenter, dose-escalation study. Patients receive oral R115777 twice daily on weeks 1 and 3. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of R115777 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A minimum of 20 patients will be accrued for this study within 12 months. \| ArmGroups: N/A \| Interventions:[{'type': 'DRUG', 'name': 'tipifarnib'}] \| PrimaryOutcomes: N/A \| SecondaryOutcomes: N/A
Title: A Phase I/IIa Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD7789, an Anti-PD-1 and Anti-TIM-3 Bispecific Antibody, in Participants With Advanced or Metastatic Solid Tumors. \| Condition: Carcinoma, Non-Small-Cell Lung, Gastric Cancer, Gastroesophageal Junction Cancer \| Keywords: Solid tumor, Non-small cell lung cancer, NSCLC, Gastric Cancer, Gastroesophageal Junction Cancer, anti-PD-1/PD-L1, anti-TIM-3 \| Summary: \| Description: This first time in patients, open-label, multi-centre study will have AZD7789 administered intravenously (IV) to participants with advanced solid tumors. This study will have 2 parts: Part A which will have dose escalation cohorts and Part B which will have the dose expansion cohorts. \| ArmGroups: [{'label': 'Dose Escalation Part A: NSCLC Immuno-oncology (IO) acquired or primary resistance', 'type': 'EXPERIMENTAL', 'description': 'AZD7789 monotherapy', 'interventionNames': ['Drug: AZD7789']}, {'label': 'Dose Expansion Part B1: NSCLC IO acquired resistance - RP2D level 1', 'type': 'EXPERIMENTAL', 'description': 'AZD7789 Monotherapy', 'interventionNames': ['Drug: AZD7789']}, {'label': 'Dose Expansion Part B2: NSCLC IO naive, PD-L1 50% or greater - RP2D level 1', 'type': 'EXPERIMENTAL', 'description': 'AZD7789 Monotherapy', 'interventionNames': ['Drug: AZD7789']}, {'label': 'Dose Expansion Part B3: NSCLC IO acquired resistance - RP2D level 2', 'type': 'EXPERIMENTAL', 'description': 'AZD7789 Monotherapy', 'interventionNames': ['Drug: AZD7789']}, {'label': 'Dose Expansion Part B4: advanced or metastatic gastric and GEJC IO acquired resistance- RP2D level 1', 'type': 'EXPERIMENTAL', 'description': 'AZD7789 monotherapy', 'interventionNames': ['Drug: AZD7789']}, {'label': 'Dose Expansion Part B5: NSCLC IO naive, PD-L1 1-49% - RP2D Level 1', 'type': 'EXPERIMENTAL', 'description': 'AZD7789 monotherapy', 'interventionNames': ['Drug: AZD7789']}] \| Interventions:[{'type': 'DRUG', 'name': 'AZD7789', 'description': 'anti-PD-1 and anti-TIM-3 bispecific antibody', 'armGroupLabels': ['Dose Escalation Part A: NSCLC Immuno-oncology (IO) acquired or primary resistance', 'Dose Expansion Part B1: NSCLC IO acquired resistance - RP2D level 1', 'Dose Expansion Part B2: NSCLC IO naive, PD-L1 50% or greater - RP2D level 1', 'Dose Expansion Part B3: NSCLC IO acquired resistance - RP2D level 2', 'Dose Expansion Part B4: advanced or metastatic gastric and GEJC IO acquired resistance- RP2D level 1', 'Dose Expansion Part B5: NSCLC IO naive, PD-L1 1-49% - RP2D Level 1']}] \| PrimaryOutcomes: [{'measure': 'Number of participants with adverse events (AE), serious adverse events (SAE) and immune-mediated AEs (imAE)', 'description': 'Number of participants with AEs, SAEs, imAEs including AEs leading to discontinuation of study intervention and clinically significant alterations in vital signs, laboratory parameters and ECG results', 'timeFrame': 'From time of Informed Consent to 90 days post last dose of study intervention'}, {'measure': 'Number of participants with dose-limiting toxicity (DLT), as defined in the protoocol', 'description': 'A DLT is a toxicity defined by the study protocol that occurs from the first dose of study intervention up to the end of the DLT evaluation period that is assessed as clearly unrelated to the primary disease or intercurrent illness.', 'timeFrame': 'From the first patient until the end of the dose escalation period; approximately 18 months.'}, {'measure': 'Preliminary anti-tumour activity of AZD7789', 'description': 'Objective response rate as defined by RECIST v1.1', 'timeFrame': 'From first participant until last participant assessment; a duration of approximately 4 years. Disease assessments will be performed until progression or initiation of another anticancer therapy.'}] \| SecondaryOutcomes: [{'measure': 'Objective response rate', 'description': 'Objective response rate as defined by RECIST v1.1', 'timeFrame': 'From first participant until last participant assessment; a duration of approximately 4 years. Disease assessments will be performed until progression or initiation of another anticancer therapy.'}, {'measure': 'Disease control rate', 'description': 'The percentage of participants according to RECIST v1.1 with a response or stable disease', 'timeFrame': 'From first documented response to confirmed progressive disease or death; approximate duration of 4 years.'}, {'measure': 'Duration of response', 'description': 'The time from first response according to RECIST v1.1 until progression or death', 'timeFrame': 'From first documented response to confirmed progressive disease or death; approximate duration of 4 years.'}, {'measure': 'Progression-free survival', 'description': 'The time from first dose of study intervention until the date of objective disease progression or death', 'timeFrame': 'From first dose of study intervention to confirmed progressive disease or death; approximate duration of 4 years.'}, {'measure': 'Overall survival', 'description': 'The time from first dose of study intervention until death due to any cause', 'timeFrame': 'From first dose of study intervention to death. Overall survival will be monitored for the duration of the study, which will last approximately 4 years.'}, {'measure': 'Pharmacokinetics of AZD7789: Maximum plasma concentration of the study drug (Cmax)', 'description': 'Maximum observed plasma concentration of the study drug.', 'timeFrame': 'From first dose of study intervention, at predefined intervals throughout the administration of study intervention; approximately 4 years.'}, {'measure': 'Immunogenicity of AZD7789', 'description': 'The number and percentage of participants who develop detectable anti-drug antibodies (ADA).', 'timeFrame': 'From first dose of study intervention, at predefined intervals throughout the administration of study intervention. A duration of approximately 4 years.'}, {'measure': 'Pharmacokinetics of AZD7789: Area Under the concentration-time curve (AUC)', 'description': 'Area under the plasma concentration-time curve.', 'timeFrame': 'From first dose of study intervention, at predefined intervals throughout the administration of study intervention; approximately 4 years.'}, {'measure': 'Pharmacokinetics of AZD7789: Clearance', 'description': 'A pharmacokinetic measurement of the volume of plasma from which the study drug is completely removed per unit time.', 'timeFrame': 'From first dose of study intervention, at predefined intervals throughout the administration of study intervention; approximately 4 years.'}, {'measure': 'Pharmacokinetics of AZD7789: Terminal elimination half-life (t 1/2)', 'description': 'Terminal elimination half life.', 'timeFrame': 'From first dose of study intervention, at predefined intervals throughout the administration of study intervention; approximately 4 years.'}, {'measure': 'Preliminary anti-tumour activity of AZD7789: Changes in circulating tumor DNA (ctDNA)', 'description': 'Changes in ctDNA between baseline and on treatment.', 'timeFrame': 'From first dose of study intervention, at predefined intervals throughout the administration of study intervention; approximately 4 years.'}]
Title: An Open-label, Multi-center, Non-interventional Study to Investigate Clinical Usefulness of Hydromorphone OROS in Korean Cancer Patients \| Condition: Pain \| Keywords: Open-label, Non-interventional, OROS hydromorphone, Korean cancer patients \| Summary: \| Description: The primary purpose of this observational study is to collect clinical data on cancer pain control using OROS (ORal Osmotic Active System) hydromorphone and to investigate the clinical usefulness of OROS hydromorphone for Korean cancer patients. Information on the effectiveness of cancer pain control and any adverse events reported by those patients using OROS Hydromorphone will be reported. In addition, clinical usefulness of OROS hydromorphone will be evaluated through assessing sleep disturbance due to pain, breakthrough pain, and end-of-dose failure before and after the study drug administration and examining the patient's satisfaction with study drug and the investigator's global assessment. This is a multi-center, open-label, prospective, exploratory, and observational study with approximately 770 patients. Efficacy endpoints will be analyzed to examine the difference between before and after the treatment. Since this is an observational study under the condition of routine practice, OROS Hydromorphone dosage should be adjusted at the discretion of the investigator, based on patient response. It is recommended that the dosage be conservative at first and adjusted appropriately considering the adverse events and analgesic effect for all the patients. \| ArmGroups: [{'label': '001', 'description': 'OROS Hydromorphone 8 16 32 mg once a day for 4 weeks', 'interventionNames': ['Drug: OROS Hydromorphone']}] \| Interventions:[{'type': 'DRUG', 'name': 'OROS Hydromorphone', 'description': '8,16, 32 mg once a day for 4 weeks', 'armGroupLabels': ['001']}] \| PrimaryOutcomes: [{'measure': 'Change in pain intensity score (where 0 is worst and 10 is best) as measured on the Numeric Rating Scale (NRS) from baseline to Day 36', 'timeFrame': 'Between Visit 1 (day 1) and the last visit (day 29 ± 7: from day 22 to day 36)'}] \| SecondaryOutcomes: [{'measure': 'Change in sleep disturbance', 'timeFrame': 'between Visit 1 (DAY 1) and the last visit (DAY29 ± 7: from 22 day to 36 day))'}, {'measure': 'Breakthrough pain experience', 'timeFrame': 'between Visit 1 (DAY 1) and the last visit (DAY29 ± 7: from 22 day to 36 day))'}, {'measure': 'End-of-dose failure experience', 'timeFrame': 'between Visit 1 (DAY 1) and the last visit (DAY29 ± 7: from 22 day to 36 day))'}, {'measure': 'Patient satisfaction with study drug and detailed reason', 'timeFrame': 'at the last visit (DAY29 ± 7: from 22 day to 36 day))'}, {'measure': "Investigator's global assessment", 'timeFrame': 'the last visit (DAY29 ± 7: from 22 day to 36 day)'}]
Title: Comparison of Sublobar Resection and Lobectomy to Treat Lung Cancer \| Condition: Lung Cancer, Surgery \| Keywords: lung cancer, surgery, lobectomy, sublobar resection \| Summary: \| Description: Background: Lung cancer has become an important disease threatening the public health world-wide. Surgical resection is the standard of care for treating non-small cell lung cancer in early stage. For decades, pulmonary lobectomy with lymph node dissection remains the gold standard of surgical approach. Pulmonary sublobar resection with pulmonary wedge resection or segmentectomy was reserved for the patients with high surgical risk, who were unsuitable for radical surgical resection. Pulmonary sublobar resection for tumor less than three centimeter was demonstrated to associated with higher risk of tumor recurrence or worsening survival outcome as compared to that done by lobectomy. 1 However, these data was which was not necessarily applicable to patients with early lung cancer with tumor of smaller size which was more frequently detected with the health screening test by CT scan in general population now. Although several retrospective studies has demonstrated that sublobar resection can offer a similar survival outcome after surgery as compared to that done by standard lobectomy once the tumor was smaller than two centimeter 2, there is still no consensus about the role of sublobar resection for these small early lung cancer. In general, there are several factors associating with higher risk of local recurrence which should be avoided for sublobar resection, including resection margin less than 2 cm or less than the diameter of the tumor itself 3, more obvious speculation in CT image or central location which makes it difficult to obtain adequate resection margin 4,5. Therefore, sublobar resection should be applied to the patients of early lung cancer when two cm of resection margin is achievable. The central location , obvious tumor infiltration in image study or presence of lymph node metastasis should be also avoided. Patients and methods: The study will include surgical patients from six medical centers in Taiwan. All of the patients will receive complete study about the surgical risk and tumor staging before surgery. The patients will receive general anesthesia and pulmonary resection as the standard procedures including division of pulmonary vessels and bronchus. Either VATS (Video-assisted thoracoscopic surgery) or open surgery is acceptable for the surgical approaches. The patients will be randomly assigned to lobectomy and sublobar resection groups. Two cm of resection margin will be obtained in each patient in the sublobar resection group by wedge resection or segmentectomy. Standard lymph node dissection including the pulmonary hilum and mediastinum will be done in both groups of patients. For suspicious of pulmonary hilum or mediastinal lymph node metastasis, frozen pathological examination will be requested. Post operative care and follow-up: The patients will be transferred to intensive care unit or surgical recovery room after surgery. Medication for pain control and postoperative rehabilitation education will be given to each patient after surgery. The chest tube will be removed after daily discharge less than 100 to 200 ml without air-leakage, adequate lung expansion noted in chest X ray imaging. The patient will be discharged from the hospital one or two days after removal of the chest tube. Whole body bone scan and CT scan will be given in every 6 months at least after surgery for postoperative follow-up. \| ArmGroups: [{'label': 'early phase lung cancer', 'type': 'EXPERIMENTAL', 'description': 'sublobar resection and lobectomy', 'interventionNames': ['Procedure: Sublobar resection', 'Procedure: lobectomy']}] \| Interventions:[{'type': 'PROCEDURE', 'name': 'Sublobar resection', 'description': 'Sublobar resection', 'armGroupLabels': ['early phase lung cancer']}, {'type': 'PROCEDURE', 'name': 'lobectomy', 'description': 'lobectomy', 'armGroupLabels': ['early phase lung cancer']}] \| PrimaryOutcomes: [{'measure': 'Disease-free survival (DFS)', 'description': 'The time interval from randomization to the earliest onset of any of the following events: tumor local recurrence, distant metastasis, and mortality', 'timeFrame': '5 years'}] \| SecondaryOutcomes: [{'measure': 'post-operative complication', 'description': 'defined as any deviation from the normal postoperative course', 'timeFrame': '3 months'}, {'measure': 'Hospitalization time', 'description': 'the time interval from the day of surgery to discharge', 'timeFrame': '3 months'}, {'measure': 'Chest tube duration', 'description': 'the time interval from the day of surgery to the day of chest tube removal', 'timeFrame': '3 months'}, {'measure': 'post-operative pulmonary function', 'description': 'the pulmonary function at 6, 12, and 24 months post-operation', 'timeFrame': '6, 12 and 24 months'}]
Title: Effect of 5α Reductase Inhibitor Dutasteride on the Prevention of the Prostate Cancer in Men With High Grade Intraepithelial Neoplasia of the Prostate \| Condition: Prostate Cancer \| Keywords: prostate cancer, chemoprevention, dutasteride \| Summary: \| Description: N/A \| ArmGroups: [{'label': 'dutasteride', 'type': 'EXPERIMENTAL', 'description': 'treatment group', 'interventionNames': ['Drug: dutasteride', 'Procedure: prostate biopsy']}, {'label': 'watchful waiting strategy', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Procedure: prostate biopsy']}] \| Interventions:[{'type': 'DRUG', 'name': 'dutasteride', 'description': '0.5mg', 'armGroupLabels': ['dutasteride']}, {'type': 'PROCEDURE', 'name': 'prostate biopsy', 'description': 'prostate biopsy', 'armGroupLabels': ['dutasteride', 'watchful waiting strategy']}] \| PrimaryOutcomes: [{'measure': 'rate of prostate cancer at repeated transrectal ultrasound guided biopsies in case of HPIN', 'timeFrame': '6, 12, 24, and 36 months'}] \| SecondaryOutcomes: [{'measure': 'effect of 5 alfa reductase inhibitor (dutasteride) on prevention of prostate cancer development for patients with high grade intraepithelial neoplasia (HPIN).', 'timeFrame': '6, 12, 24, and 36 months'}]
Title: Phase Ib Trial of the KRAS G12C Inhibitor Adagrasib (MRTX849) in Combination with the PARP Inhibitor Olaparib in Patients with KRAS G12C Mutated Advanced Solid Tumors, with a Focus on Gynecological, Breast, Pancreatic and KEAP1 Mutated Non-small Cell Lung Cancers \| Condition: Advanced Solid Tumor, Non-small Cell Lung Cancers \| Keywords: \| Summary: \| Description: Primary Objectives * To evaluate the safety and tolerability of adagrasib in combination with olaparib in participants with KRAS G12C mutant advanced solid tumors. * To establish the maximum tolerated dose and/or recommended phase 2 dose (MTD/RP2D) of the combination in participants with KRAS G12C mutant advanced solid tumors. Secondary Objectives * To assess the preliminary antitumor activity of the combination of adagrasib in combination with olaparib using objective response rate (ORR) = RECISTv1.1 complete response plus partial response (CR+PR). Exploratory Objectives * To assess predictive biomarkers of response and resistance to the combination of adagrasib with olaparib. * To evaluate the pharmacodynamic profile of the combination of adagrasib and olaparib in participants with KRAS G12C mutant advanced solid tumors. * To assess potential mechanisms of response and resistance by comparing serially collected circulating tumor DNA (ctDNA) samples and biopsies in responders and non-responders. \| ArmGroups: [{'label': 'Adagrasib+Olaparib', 'type': 'EXPERIMENTAL', 'description': 'Participants will take adagrasib and olaparib by mouth 2 times each day. Each dose should be taken at about 12 hours apart (1 dose in the morning, 1 dose in the evening). The study drugs should be swallowed whole with water. Do not chew, crush, dissolve, or divide the study drugs.\n\nIf forget a dose and less than 2 hours have passed since the usual time participants take the study drug, take the dose as soon as participants remember. If more than 2 hours have passed, do not take the dose. Wait and take the next dose as scheduled', 'interventionNames': ['Drug: Adagrasib', 'Drug: Olaparib']}] \| Interventions:[{'type': 'DRUG', 'name': 'Adagrasib', 'description': 'Given by PO BID', 'armGroupLabels': ['Adagrasib+Olaparib'], 'otherNames': ['MRTX849']}, {'type': 'DRUG', 'name': 'Olaparib', 'description': 'Given by PO BID', 'armGroupLabels': ['Adagrasib+Olaparib'], 'otherNames': ['Lynparza™']}] \| PrimaryOutcomes: [{'measure': 'Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0', 'timeFrame': 'through study completion; an average of 1 year.'}] \| SecondaryOutcomes: N/A
Title: Effectiveness of Home-based Exercise in Quality of Life and Physical Fitness in Older Woman in Breast Cancer Treatment: Randomized Clinical Trial \| Condition: Breast Cancer \| Keywords: Breast Cancer, elderly, quality of life, exercise \| Summary: \| Description: Cancer has excelled as a leading cause of mortality. It is particularly serious in the elderly due to increased risk of functional impairment and present comorbidities. The physical exercise appears as a promising intervention in the various stages of the treatment, mitigating the adverse effects in short- and long-term the oncologic treatment. Its regular practice after a diagnosis of breast cancer is associated with 40 % to 50 % lower rates of mortality. Produces metabolic and morphological changes that may make it an important option in the treatment, prevention, and recovery process of these patients. In this context the present study aims to verify the effectiveness of home exercise on quality of life and physical fitness of elderly undergoing treatment for breast cancer. This study it's a Randomized Clinical Trial. Data will be collected at the Department of Oncology at the Professor Fernando Figueira Integral Medicine Institute (IMIP), which serves patients in the public health system (SUS) from the metropolitan area of Recife, State of Pernambuco. will be held from March to December 2015. Will be studied elderly diagnosed with breast cancer undergoing treatment in the Adult Oncology Service of IMIP. For the analysis of means and frequencies, the investigators intend to use descriptive statistics and the results will be displayed in graphs and tables. For inferential statistical analysis, the investigators intend to use the Student's t test, or the Mann - Whitney test, according to the normality of the sample. For categorical variables, contingency tables are constructed of type 2x2. Chi-square tests of association with Yates correction and Fisher's exact test will be used. The risk ratio (RR) will be calculated as a measure of the relative risk of different outcomes according to the realization of one or another approach to exercise and control group. The Software Stata 12.0 will be used for data processing and will be accepted at p \< 0,05. The project meets the requirements of the National Board of Health and was approved by the IMIP Research Ethics Committee. Patients who agree to sign the Instrument of Consent will be included in the study. \| ArmGroups: [{'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'The control group will be accompanied according to the service routine.'}, {'label': 'Exercise', 'type': 'EXPERIMENTAL', 'description': 'The group will be instructed to perform home exercises autonomously for range of motion and muscular fitness', 'interventionNames': ['Other: Home exercise']}] \| Interventions:[{'type': 'OTHER', 'name': 'Home exercise', 'description': 'Will be offered to the group, instructional material (manual exercises) and point you to an exercise routine to be performed independently for range of motion and muscular fitness, using the environmental resources of the same household. A daily frequency in performing this exercise routine is suggested. Also, be given incentives and guidelines for the practice of active commuting (walking) to be accumulated at least 10 to 20 minutes of this activity daily. All control guidelines and training for the use of the exercise manual will be offered through an introductory lecture and subsequent weekly telephone contacts (2 times a week). The participants in this group should fulfill their respective program for a total period of 12 weeks.', 'armGroupLabels': ['Exercise'], 'otherNames': ['Exercise']}] \| PrimaryOutcomes: [{'measure': 'Variation in the performance of Lift and Sitting Test', 'description': 'Test which comprises the Battery Senior Fitness Test (SFT). Evaluates the Lower body strength according to the number of times the individual stood up and sat down in 30 seconds. Characterized as continuous numeric variable.', 'timeFrame': 'Change from Baseline in Lift and Sitting Test and after 12 weeks'}, {'measure': 'Variation in the performance of Flexion forearm Test', 'description': 'Test which comprises the Battery Senior Fitness Test (SFT). Evaluates the upper body strength according to the number of push-ups of forearm in 30 seconds. Characterized as continuous numeric variable.', 'timeFrame': 'Change from Baseline in Flexion forearm Test and after 12 weeks'}, {'measure': 'Variation in the performance of Six Minute Walk Test (6MWT)', 'description': 'Test which comprises the Battery Senior Fitness Test (SFT). Evaluates aerobic endurance. Total meters walked for 6 minutes walk. Characterized as continuous numeric variable.', 'timeFrame': 'Change from Baseline in Six Minute Walk Test (6MWT) and after 12 weeks'}, {'measure': 'Variation in the performance of March Stationary two minutes Test', 'description': 'Test which comprises the Battery Senior Fitness Test (SFT). Evaluates aerobic endurance (alternative test). Total double past stationary in 2 minutes. Characterized as continuous numeric variable.', 'timeFrame': 'Change from Baseline in March Stationary two minutes Test and after 12 weeks'}, {'measure': 'Variation in the performance of Skip and Vir 2.44 meters test', 'description': 'Test which comprises the Battery Senior Fitness Test (SFT). Assesses motor agility and dynamic balance. Evaluates the time in seconds and hundredths in an established path of 2.44 meters on the route to go and return to starting position. Characterized as continuous numerical variable.', 'timeFrame': 'Change from Baseline in Skip and Vir 2.44 meters test and after 12 weeks'}, {'measure': 'Variation in the performance of Sit and Reach Modified test (In the Chair)', 'description': 'Test which comprises the Battery Senior Fitness Test (SFT). Evaluates the lower hemisphere flexibility. distance in centimeters reached the tip of the middle fingers and the floor in the sitting position. Characterized as continuous numerical variable.', 'timeFrame': 'Change from Baseline in Sit and Reach Modified test (In the Chair) and after 12 weeks'}, {'measure': 'Variation in the performance of Flexibility test of the upper limbs', 'description': 'Test which comprises the Battery Senior Fitness Test (SFT). Evaluates the flexibility of the upper limbs. It measures the distance in centimeters between the tips of the fingers in the back area. Characterized as continuous numeric variable.', 'timeFrame': 'Change from Baseline in Flexibility test of the upper limbs and after 12 weeks'}, {'measure': 'Body Mass Index', 'description': 'the calculation will be determined by the ratio between the weight (in kilograms) and the square of height (in meters). Characterized as continuous numeric variable', 'timeFrame': 'Change from Baseline in Body Mass Index and after 12 weeks'}, {'measure': 'Variation in the performance of Muscle strength Test', 'description': 'Hand Grip Strength Test. Continuous numeric variable: average kilogram-force (KgF)', 'timeFrame': 'Change from Baseline in Muscle strength Test after 12 weeks'}] \| SecondaryOutcomes: [{'measure': 'Quality of life', 'description': 'Numeric variable: average score from 0 to 100 for 30 issues of questionnaire developed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)', 'timeFrame': 'Change from Baseline in Quality of life after 12 weeks'}]
Title: Randomized Controlled Trial of Integrated Early Palliative Care for Advanced Cancer Patients \| Condition: Advanced Cancer, Solid Tumor \| Keywords: Integrated Early Palliative Care \| Summary: \| Description: Previous reports suggest that starting palliative care early in cancer patients appears to improve patient's quality of life, symptom management, depression, and anxiety. This study aims to evaluate the effect of the introduction of early palliative care services to advanced cancer patients. Eligible patients are 20 years or older, and has an advanced cancer diagnosis (histologically or cytologically confirmed) due to a solid tumor, a European Cooperative Oncology Group performance status of 0-2, an estimated life expectancy of 12 months or less. The primary goal of an integrated early palliative care program is to improve the overall quality of life of patients and their families. Secondarily, it is to help understand the disease, resolving conflicts in the decision-making process, improving the crisis coping capacity, and further determining the patient's and family's advanced care planning. At last, it is desired to evaluate the effect of the program on overall medical cost savings and 1 year survival. Participants of the study will be allocated in the intervention group and the control group equally. Within three weeks from the time of randomization, the first meeting with a palliative care team will be held. In the time of baseline questionnaire, patients will be provided with self-study education materials and videos on the early palliative care and advance care planning. Once in every three weeks for six months, which is the duration for one treatment course, palliative care for advance care planning, symptom control, and other mental, social and spiritual problems will be provided. After the first meeting with the palliative care team, telephone coaching will be performed once a week for the first 12 weeks and then every two weeks until the end of the study. \| ArmGroups: [{'label': 'Intervention group', 'type': 'EXPERIMENTAL', 'description': 'Consultation with PCT doctor every 3 weeks. Telephone coaching once a week for 3 months and once in 2 weeks for another 3 months.', 'interventionNames': ['Behavioral: Telephone coaching', 'Behavioral: Consultation with PCT doctor']}, {'label': 'Control Group', 'type': 'NO_INTERVENTION', 'description': 'Usual palliative care can be provided if desired.'}] \| Interventions:[{'type': 'BEHAVIORAL', 'name': 'Telephone coaching', 'description': 'Telephone coaching about overcoming the crisis is provided once a week for 3 months and once in 2 weeks for another 3 months.', 'armGroupLabels': ['Intervention group']}, {'type': 'BEHAVIORAL', 'name': 'Consultation with PCT doctor', 'description': 'Consultation with PCT physician every 3 weeks.', 'armGroupLabels': ['Intervention group']}] \| PrimaryOutcomes: [{'measure': 'Change in level of EORTC QLQ-C15-PAL', 'description': 'A questionnaire developed to assess the quality of life of palliative cancer care patients.', 'timeFrame': 'baseline, 12 weeks, 18 weeks, 24 weeks'}] \| SecondaryOutcomes: [{'measure': 'Change in level of MQOL', 'description': 'A questionnaire that measures psychological, existential well-being, and support.', 'timeFrame': 'Baseline, 12 weeks, 18 weeks, 24 weeks'}, {'measure': 'Change in level of EQ-5D of EuroQoL', 'description': 'A questionnaire that measures mobility, self-care, daily activity, pain/discomfort, and anxiety/depression.', 'timeFrame': 'Baseline, 12 weeks, 18 weeks, 24 weeks'}, {'measure': 'Change in level of PHQ-9', 'description': '9-question instrument given to patients in a primary care setting to screen for the presence and severity of depression.', 'timeFrame': 'Baseline, 12 weeks, 18 weeks, 24 weeks'}, {'measure': 'Change in level of Understanding the illness', 'description': '2 questions to assess how patients understand the prognosis of their illness', 'timeFrame': 'Baseline, 12 weeks, 18 weeks, 24 weeks'}, {'measure': 'Change in level of Crisis Overcoming Capability(SAT-SF)', 'description': 'A questionnaire about goal of life, current crisis/goal, positivity, preparation and practice.', 'timeFrame': 'Baseline, 12 weeks, 18 weeks, 24 weeks'}, {'measure': 'Change in Advance Care Preference', 'description': 'Questions about advance directive and treatment preference in case of terminal condition', 'timeFrame': 'Baseline, 12 weeks, 18 weeks, 24 weeks'}, {'measure': 'Medical cost and utilization of CAM', 'description': 'Overall medical cost savings (cost effectiveness) and use of complementary and alternative medicine', 'timeFrame': '12 weeks, 24 weeks'}, {'measure': '1 year survival', 'description': '1 year survival', 'timeFrame': '1 year'}, {'measure': 'Changes of CQOL', 'description': 'A questionnaire that measures quality of life and burden for family caregivers', 'timeFrame': 'Baseline, 12 weeks, 18 weeks, 24 weeks'}, {'measure': 'Change in level of PHQ-9 of family caregivers', 'description': '9-question instrument given to caregivers in a primary care setting to screen for the presence and severity of depression.', 'timeFrame': 'Baseline, 12 weeks, 18 weeks, 24 weeks'}, {'measure': 'Change in level of Understanding the illness of family caregivers', 'description': "2 questions to assess how family caregivers understand the prognosis of patients' illness", 'timeFrame': 'Baseline, 12 weeks, 18 weeks, 24 weeks'}, {'measure': 'Change in level of Crisis Overcoming Capability(SAT-SF) of family caregivers', 'description': 'A questionnaire about goal of life, current crisis/goal, positivity, preparation and practice of family caregivers.', 'timeFrame': 'Baseline, 12 weeks, 18 weeks, 24 weeks'}, {'measure': 'Change in Advance Care Preference of family caregivers', 'description': "Questions about family caregivers' preference on advance directive and treatment in case of terminal condition", 'timeFrame': 'Baseline, 12 weeks, 18 weeks, 24 weeks'}, {'measure': 'Change in Quality Care Questionnaire', 'description': 'The 4-factor, 32-item Quality Care Questionnaire-Palliative Care (QCQ-PC), which covers appropriate communication with health care professionals (ten items), discussing value of life and goals of care (nine items), support and counseling for needs of holistic care (seven items), and accessibility and sustainability of care (six items).', 'timeFrame': 'Baseline, 12 weeks, 3 months after death'}]
Title: Reasons for Changing HOrmonal Therapy of Advanced Breast Cancer \| Condition: Breast Cancer \| Keywords: Advanced Breast Cancer, Hormonal Treatment \| Summary: \| Description: N/A \| ArmGroups: [{'label': 'All patients', 'description': 'Patients with ABC and two lines of hormonal treatment'}] \| Interventions:N/A \| PrimaryOutcomes: [{'measure': 'Reasons for change of hormonal therapy (biochemical progression, objective progression, symptomatic progression, safety reasons, other)', 'timeFrame': 'Every 3 months'}] \| SecondaryOutcomes: [{'measure': 'Changes in values of tumor markers (CEA, CA 15.3)', 'timeFrame': 'Every 3 months.'}, {'measure': 'Time to progression', 'timeFrame': 'Every 3 months'}, {'measure': 'Type of hormonal treatment', 'timeFrame': 'Every 3 months.'}]
Title: A Multicenter, Randomized, Open-label, Phase II Trial Aiming to Evaluate the Impact of Pegfilgrastim on Trastuzumab Anti-tumor Effect and ADCC in Operable HER2 Positive Breast Cancer Patients \| Condition: HER2-positive Breast Cancer, Operable Breast Cancer \| Keywords: Pegfilgrastim, Trastuzumab/Paclitaxel, Antibody-dependent cell-mediated cytotoxicity \| Summary: \| Description: The duration of the neoadjuvant treatment period is planned to be 12 weeks (4 cycles of 3 weeks), except in case of Inacceptable toxicity, or Patient decision, or Withdrawal of consent, or Clinical/radiological signs of disease progression.This neoadjuvant treatment period will be ended with a short term safety visit (STSVNeo) to be scheduled 28 days after the last dose of study treatments (considering the latest study treatments administered). Following the STSVNeo, patients will undergo surgery as per usual practice and pathological response will be centrally assessed by a referent pathologist blinded for the treatment arms.Following surgery, all patients will be treated in the adjuvant setting with trastuzumab administered every 3 weeks for up to 12 months in both arms with clinical assessments every 3 months (cf. Réseau régional de Cancérologie, http://espacecancer.sante-ra.fr/Pages/Accueil.aspx). In case of RH+ disease, endocrine therapy may be initiated as per standard treatment guidelines.This adjuvant treatment period is planned for a maximum of 12 months; except in case of Inacceptable toxicity, or Patient decision, or Withdrawal of consent, or Clinical/radiological signs of disease progression. All randomized and treated patients will be followed-up for relapse and survival for at least 15 months post-randomization (i.e. 1 year post-surgery). A total of 90 patients will be randomized in the study. (45 per arm). All the data concerning the patients will be recorded in the electronic case report form (eCRF) throughout the study serious adverse event (SAE) reporting will be also paper-based by e-mail and/or Fax. The sponsor will perform the study monitoring and will help the investigators to conduct the study in compliance with the clinical trial protocol, Good Clinical Practices (GCP) and local law requirements \| ArmGroups: [{'label': 'Paclitaxel+Trastuzumab+Pegfilgrastim', 'type': 'EXPERIMENTAL', 'description': 'NEOADJUVANT TREATMENT PERIOD (up to 12 weeks) :Paclitaxel (80 mg/m2, weekly (D1, D8, D15), IV) + Trastuzumab (a loading dose 8 mg/kg at C1D1 followed by 6 mg/kg Q3W, IV OR 600mg, Q3W SC) + Pegfilgrastim (6 mg, Q3W, subcutaneously, the day after the trastuzumab + paclitaxel infusion (i.e. Day 2 of each cycle)).\n\nADJUVANT TREATMENT PERIOD (up to 12 months) : Trastuzumab (a loading dose 8 mg/kg at C1D1 followed by 6 mg/kg Q3W, (IV) OR 600mg, Q3W SC)', 'interventionNames': ['Drug: Trastuzumab + Paclitaxel', 'Drug: Pegfilgrastim']}, {'label': 'Paclitaxel+Trastuzumab', 'type': 'ACTIVE_COMPARATOR', 'description': 'NEOADJUVANT TREATMENT PERIOD (up to 12 weeks) :Paclitaxel (80 mg/m2, weekly (D1, D8, D15), IV) + Trastuzumab (a loading dose 8 mg/kg at C1D1 followed by 6 mg/kg Q3W, IV OR 600mg, Q3W SC).\n\nADJUVANT TREATMENT PERIOD (up to 12 months) : Trastuzumab (a loading dose 8 mg/kg at C1D1 followed by 6 mg/kg Q3W, (IV) OR 600mg, Q3W SC)', 'interventionNames': ['Drug: Trastuzumab + Paclitaxel']}] \| Interventions:[{'type': 'DRUG', 'name': 'Trastuzumab + Paclitaxel', 'description': 'During neoadjuvant period, weekly paclitaxel + trastuzumab (every 3 weeks, Q3W) During adjuvant period, weekly trastuzumab (every 3 weeks, Q3W)', 'armGroupLabels': ['Paclitaxel+Trastuzumab', 'Paclitaxel+Trastuzumab+Pegfilgrastim']}, {'type': 'DRUG', 'name': 'Pegfilgrastim', 'description': 'During neoadjuvant period, weekly pegfilgrastim (every 3 weeks, Q3W)', 'armGroupLabels': ['Paclitaxel+Trastuzumab+Pegfilgrastim'], 'otherNames': ['Neulasta']}] \| PrimaryOutcomes: [{'measure': 'Pathological complete response rate (pCR)', 'description': 'Defined as ypT0 ypN0 or ypT0/is ypN0 after 12 weeks of treatment by trastuzumab + paclitaxel ± pegfilgrastim with ypT0/Tis ypN0 defined as absence of invasive cancer in the breast and axillary nodes in all surgically excised specimens.', 'timeFrame': '16 weeks after start of treatment'}] \| SecondaryOutcomes: [{'measure': 'Disease Free survival', 'description': 'From the date of randomisation until the date of event defined as the first documented relapse after surgery or death from any cause.', 'timeFrame': 'At least 15 months following randomisation'}, {'measure': 'Time to relapse', 'description': 'From the time of treatment start until the first documented relapse', 'timeFrame': 'At least 15 months following randomisation'}, {'measure': 'Overall survival', 'description': 'From the date of randomisation to the date of death from any cause', 'timeFrame': 'At least 15 months following randomisation'}, {'measure': 'Adverse events reporting', 'description': 'Based mainly on the frequency of AE graded according to the common toxicity criteria grading system (CTCAE-V4.03).', 'timeFrame': 'At least 15 months following randomisation'}]
Title: Randomized Phase II Trial of Carboplatin/Gemcitabine Followed By Paclitaxel or Cisplatin/Vinorelbine Followed by Docetaxel in Advanced Non-Small Cell Lung Cancer \| Condition: Lung Cancer \| Keywords: recurrent non-small cell lung cancer, squamous cell lung cancer, large cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung \| Summary: \| Description: OBJECTIVES: I. Assess the survival and failure free survival of patients with advanced primary non-small cell lung cancer treated with carboplatin and gemcitabine followed by paclitaxel OR cisplatin and vinorelbine followed by docetaxel. II. Evaluate the response (confirmed plus unconfirmed) and toxicities associated with these two regimens in these patients. OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. Arm I: Patients receive carboplatin IV over 30 minutes on day 1 followed by gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 3 courses. Following the 3 courses of carboplatin and gemcitabine, patients receive paclitaxel IV over 3 hours on day 1 every 21 days for 3 courses. Arm II: Patients receive cisplatin IV over 30-60 minutes on day 1 followed by vinorelbine IV over 6-10 minutes on days 1 and 8. Treatment repeats every 21 days for 3 courses. Following the 3 courses of cisplatin and vinorelbine, patients receive docetaxel IV over 1 hour on day 1 every 21 days for 3 courses. Patients receive no further treatment until evidence of disease progression. Patients are followed every 2 months for the first year, every 6 months for years 2 and 3, and annually thereafter. PROJECTED ACCRUAL: A total of 160 patients will be accrued for this study. \| ArmGroups: [{'label': 'carboplatin/gemcitabine/paclitaxel', 'type': 'EXPERIMENTAL', 'description': 'IV carboplatin AUC=5.5 day 1 every 21 days X 3 IV gemcitabine 1,000 mg/m\\^2/day, days 1 and 8 every 21 days X3 IV paclitaxel 225 mg/m\\^2/day, day 1 every 21 days X 3', 'interventionNames': ['Drug: carboplatin', 'Drug: gemcitabine', 'Drug: paclitaxel']}, {'label': 'cisplatin/vinorelbine/docetaxel', 'type': 'EXPERIMENTAL', 'description': 'IV cisplatin 100 mg/m\\^2 day 1 every 21 days X 3 IV vinorelbine 25 mg/m\\^2/day, days 1 and 8 every 21 days X 3 IV docetaxel 75 mg/m\\^2 day 1 every 21 days X 3', 'interventionNames': ['Drug: cisplatin', 'Drug: docetaxel', 'Drug: vinorelbine']}] \| Interventions:[{'type': 'DRUG', 'name': 'carboplatin', 'description': 'AUC=5.5 day 1 every 21 days X 3', 'armGroupLabels': ['carboplatin/gemcitabine/paclitaxel'], 'otherNames': ['carbo']}, {'type': 'DRUG', 'name': 'cisplatin', 'description': 'IV cisplatin 100 mg/m\\^2 day 1 every 21 days X 3', 'armGroupLabels': ['cisplatin/vinorelbine/docetaxel'], 'otherNames': ['platinol']}, {'type': 'DRUG', 'name': 'docetaxel', 'description': 'IV docetaxel 75 mg/m\\^2 day 1 every 21 days X 3', 'armGroupLabels': ['cisplatin/vinorelbine/docetaxel'], 'otherNames': ['taxotere']}, {'type': 'DRUG', 'name': 'gemcitabine', 'description': 'IV gemcitabine 1,000 mg/m\\^2/day, days 1 and 8 every 21 days X3', 'armGroupLabels': ['carboplatin/gemcitabine/paclitaxel'], 'otherNames': ['gemzar']}, {'type': 'DRUG', 'name': 'paclitaxel', 'description': 'IV paclitaxel 225 mg/m\\^2/day, day 1 every 21 days X 3', 'armGroupLabels': ['carboplatin/gemcitabine/paclitaxel'], 'otherNames': ['taxol']}, {'type': 'DRUG', 'name': 'vinorelbine', 'description': 'IV vinorelbine 25 mg/m\\^2/day, days 1 and 8 every 21 days X 3', 'armGroupLabels': ['cisplatin/vinorelbine/docetaxel'], 'otherNames': ['navelbine']}] \| PrimaryOutcomes: N/A \| SecondaryOutcomes: N/A
Title: Patient Navigation for Colorectal Cancer Screening for Patients With Mental Illness and/or Substance Use Disorder \| Condition: ColoRectal Cancer Screening \| Keywords: \| Summary: \| Description: N/A \| ArmGroups: [{'label': 'patient navigation', 'type': 'EXPERIMENTAL', 'description': 'PN will contact patients during their visits to health cancer or over the phone. During this initial contact, the PN will educate patients about CRC, screening and explore their barriers to screening. The PN will coordinate scheduling of CRC screening and remind patients about the tests. PN will explain preparation for colonoscopy and whenever feasible, accompany patient to obtain the test. Further interventions may include: reminding the patient about the test, helping with translation, insurance issues, transportation, and overcoming any other system barriers as needed.', 'interventionNames': ['Behavioral: patient navigation']}, {'label': 'usual care', 'type': 'NO_INTERVENTION', 'description': 'patients randomly assigned to the control will receive usual care and be eligible for navigation after the study period.'}] \| Interventions:[{'type': 'BEHAVIORAL', 'name': 'patient navigation', 'description': 'Current standard of care is for PNs to work with patients from health centers who are referred by providers. Intervention patients will appear on a PN list without any referral by providers. Control high risk patients will proceed normally and will be eligible to transfer to a PN list after the 6-month study period.', 'armGroupLabels': ['patient navigation']}] \| PrimaryOutcomes: [{'measure': 'Percentage of patients in intervention and control groups who completed any colorectal cancer screening during the six-month study period', 'description': 'To obtain the data about colorectal cancer screening we will use billing data from our institution repository. Additionally, and when/if the data is not available (percentage of colonoscopy results) we will perform EMR reviewed of trial participants.', 'timeFrame': '6 months'}, {'measure': 'Percentage of patients in intervention and control groups who completed any colorectal cancer screening during the six-month study period', 'description': 'To obtain the data about colorectal cancer screening we will use billing data from our institution repository. Additionally, and when/if the data is not available (percentage of fecal occult blood test results) we will perform EMR reviewed of trial participants.', 'timeFrame': '6 months'}] \| SecondaryOutcomes: [{'measure': 'As-treated primary outcomes among intervention patients contacted by patient navigator.', 'description': 'Percentage of patients in intervention and control groups who completed colorectal cancer cancer screening stratified by Mental health vs Substance use disorder, language spoken, race and age (\\<\\> 65 years) during the study period', 'timeFrame': '1 year'}, {'measure': 'Number of cancers (stage) found in the intervention and control group during the study period', 'timeFrame': '1 year'}, {'measure': 'Number of polys found in intervention polyps (histology)', 'timeFrame': '1 year'}]
Title: Feasibility of a Supportive Education Program for Latina Breast Cancer Survivors \| Condition: Cancer Survivor, Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer \| Keywords: Breast Cancer \| Summary: \| Description: PRIMARY OBJECTIVES: I. Describe the feasibility of implementing the BBCEI. II. Describe the cultural and linguistic appropriateness of the BBCEI. III. Determine topics requiring further emphasis in the BBCEI. IV. Identify ways to enhance program content, format, and materials. OUTLINE: Participants undergo 2 tailored BBCEI sessions within 1 month. At the beginning of the first session the research nurse will present the participants with a list of common physical and social concerns. The participant will then be asked to identify 3 topics that she wants to discuss. The research nurse will discuss with the participant any relevant supportive care resources and make the appropriate referrals. At the second session the focus of the BBCEI will be on psychological and spiritual well-being. \| ArmGroups: [{'label': 'Supportive Care (BBCEI)', 'type': 'EXPERIMENTAL', 'description': 'Participants undergo 2 tailored BBCEI sessions within 1 month. At the beginning of the first session the research nurse will present the participants with a list of common physical and social concerns. The participant will then be asked to identify 3 topics that she wants to discuss. The research nurse will discuss with the participant any relevant supportive care resources and make the appropriate referrals. At the second session the focus of the BBCEI will be on psychological and spiritual well-being.', 'interventionNames': ['Other: Educational Intervention']}] \| Interventions:[{'type': 'OTHER', 'name': 'Educational Intervention', 'description': 'Undergo Bilingual Breast Cancer Educational Intervention', 'armGroupLabels': ['Supportive Care (BBCEI)']}] \| PrimaryOutcomes: [{'measure': 'Determine the feasibility of implementation of a Bilingual Breast Cancer Education Intervention (BBCEI)', 'description': 'A semi-structured interview guide will be used to describe participant satisfaction with the BBCEI. It allows the patient to describe in their own words whether the BBCEI was effective for their QOL concerns, helpfulness of intervention content, describe the cultural and linguistic appropriateness and identify ways to enhance program content, format and materials.', 'timeFrame': '2 months after completion of the educational session'}, {'measure': 'Determine the cultural and linguistic appropriateness of the BBCEI', 'description': 'A semi-structured interview guide will be used to describe participant satisfaction with the BBCEI. It allows the patient to describe in their own words whether the BBCEI was effective for their QOL concerns, helpfulness of intervention content, describe the cultural and linguistic appropriateness and identify ways to enhance program content, format and materials', 'timeFrame': '2 months after completion of the educational session'}, {'measure': 'Determine topics requiring further emphasis in the BBCEI', 'description': 'A semi-structured interview guide will be used to describe participant satisfaction with the BBCEI. It allows the patient to describe in their own words whether the BBCEI was effective for their QOL concerns, helpfulness of intervention content, describe the cultural and linguistic appropriateness and identify ways to enhance program content, format and materials', 'timeFrame': '2 months after completion of the educational session'}, {'measure': 'Determine ways to enhance program content, format and materials', 'description': 'A semi-structured interview guide will be used to describe participant satisfaction with the BBCEI. It allows the patient to describe in their own words whether the BBCEI was effective for their QOL concerns, helpfulness of intervention content, describe the cultural and linguistic appropriateness and identify ways to enhance program content, format and materials', 'timeFrame': '2 months after completion of the educational session'}] \| SecondaryOutcomes: N/A
Title: Association Between Tumor Size and Prognosis in Patients With Small Bowel adenocarcinoma-a SEER-based Study \| Condition: Prognosis \| Keywords: \| Summary: \| Description: N/A \| ArmGroups: [{'label': 'tumor size 0-1cm', 'description': 'No intervention. Select small bowel adenocarcinoma patients with tumor size of 0-1 cm.', 'interventionNames': ['Other: no interventions']}, {'label': 'tumor size 1-2 cm', 'description': 'No intervention. Select small bowel adenocarcinoma patients with tumor size of 1-2 cm.'}, {'label': 'tumor size 2-3 cm', 'description': 'No intervention. Select small bowel adenocarcinoma patients with tumor size of 2-3 cm.'}, {'label': 'tumor size 3-4 cm', 'description': 'No intervention. Select small bowel adenocarcinoma patients with tumor size of 3-4 cm.'}, {'label': 'tumor size 4-5 cm', 'description': 'No intervention. Select small bowel adenocarcinoma patients with tumor size of 4-5 cm.'}, {'label': 'tumor size 5-6 cm', 'description': 'No intervention. Select small bowel adenocarcinoma patients with tumor size of 5-6 cm.'}, {'label': 'tumor size 6-7 cm', 'description': 'No intervention. Select small bowel adenocarcinoma patients with tumor size of 6-7 cm.'}, {'label': 'tumor size 7-8 cm', 'description': 'No intervention. Select small bowel adenocarcinoma patients with tumor size of 7-8 cm.'}, {'label': 'tumor size 8-9 cm', 'description': 'No intervention. Select small bowel adenocarcinoma patients with tumor size of 8-9 cm.'}, {'label': 'tumor size 9-10 cm', 'description': 'No intervention. Select small bowel adenocarcinoma patients with tumor size of 9-10 cm.'}, {'label': 'tumor size >10 cm', 'description': 'No intervention. Select small bowel adenocarcinoma patients with tumor size of \\>10 cm.'}] \| Interventions:[{'type': 'OTHER', 'name': 'no interventions', 'description': 'no interventions', 'armGroupLabels': ['tumor size 0-1cm']}] \| PrimaryOutcomes: [{'measure': 'Association Between Tumor Size and Prognosis in Patients With Small Bowel adenocarcinoma-a SEER-based Study', 'description': 'We will study the relationship between tumor size and prognosis in small bowel adenocarcinoma patients in the SEER database', 'timeFrame': '2024.9.1'}] \| SecondaryOutcomes: N/A
Title: Donor Lymphocyte Infusion (DLI) as Adoptive Immunotherapy for Relapse Malignancies After Allogeneic Hematopoietic Transplantation \| Condition: Breast Cancer, Chronic Myeloproliferative Disorders, Gestational Trophoblastic Tumor, Kidney Cancer, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Neuroblastoma, Ovarian Cancer, Sarcoma, Testicular Germ Cell Tumor \| Keywords: stage IV breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, recurrent childhood acute lymphoblastic leukemia, recurrent adult Hodgkin lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, refractory multiple myeloma, recurrent childhood rhabdomyosarcoma, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer, disseminated neuroblastoma, recurrent neuroblastoma, recurrent Wilms tumor and other childhood kidney tumors, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, recurrent childhood lymphoblastic lymphoma, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia, recurrent childhood acute myeloid leukemia, recurrent adult acute myeloid leukemia, recurrent adult acute lymphoblastic leukemia, relapsing chronic myelogenous leukemia, refractory chronic lymphocytic leukemia, stage III malignant testicular germ cell tumor, recurrent malignant testicular germ cell tumor, chronic phase chronic myelogenous leukemia, accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, meningeal chronic myelogenous leukemia, chronic idiopathic myelofibrosis, childhood acute promyelocytic leukemia (M3), testicular embryonal carcinoma, testicular choriocarcinoma, testicular teratoma, testicular yolk sac tumor, testicular embryonal carcinoma and teratoma, testicular embryonal carcinoma and teratoma with seminoma, testicular embryonal carcinoma and yolk sac tumor, testicular embryonal carcinoma and yolk sac tumor with seminoma, testicular embryonal carcinoma and seminoma, testicular yolk sac tumor and teratoma, testicular yolk sac tumor and teratoma with seminoma, testicular choriocarcinoma and yolk sac tumor, testicular choriocarcinoma and embryonal carcinoma, testicular choriocarcinoma and teratoma, testicular choriocarcinoma and seminoma, refractory hairy cell leukemia, recurrent/refractory childhood Hodgkin lymphoma, recurrent ovarian germ cell tumor, ovarian yolk sac tumor, ovarian embryonal carcinoma, ovarian polyembryoma, ovarian choriocarcinoma, ovarian immature teratoma, ovarian mature teratoma, ovarian monodermal and highly specialized teratoma, ovarian mixed germ cell tumor, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse large cell lymphoma, stage III adult immunoblastic large cell lymphoma, stage III adult lymphoblastic lymphoma, stage III adult Burkitt lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, stage IV adult diffuse small cleaved cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult immunoblastic large cell lymphoma, stage IV adult lymphoblastic lymphoma, stage IV adult Burkitt lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult Burkitt lymphoma, stage II adult T-cell leukemia/lymphoma, secondary acute myeloid leukemia, de novo myelodysplastic syndromes, poor prognosis metastatic gestational trophoblastic tumor, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, recurrent childhood small noncleaved cell lymphoma, recurrent childhood large cell lymphoma, noncontiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 3 follicular lymphoma, noncontiguous stage II adult diffuse small cleaved cell lymphoma, noncontiguous stage II mantle cell lymphoma, noncontiguous stage II adult diffuse mixed cell lymphoma, noncontiguous stage II adult immunoblastic large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult Burkitt lymphoma, noncontiguous stage II adult lymphoblastic lymphoma, stage III mantle cell lymphoma, stage IV mantle cell lymphoma, recurrent mantle cell lymphoma, previously treated childhood rhabdomyosarcoma, recurrent mycosis fungoides/Sezary syndrome, noncontiguous stage II small lymphocytic lymphoma, noncontiguous stage II marginal zone lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, stage III small lymphocytic lymphoma, stage III marginal zone lymphoma, stage IV small lymphocytic lymphoma, stage IV marginal zone lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma, childhood myelodysplastic syndromes \| Summary: \| Description: OBJECTIVES: I. Offer donor lymphocyte infusion as adoptive immunotherapy in patients with relapsed malignancies after allogeneic bone marrow or peripheral blood stem cell transplantation and who are not eligible for other FHCRC protocols. OUTLINE: Patients with rapidly progressive disease receive reinduction chemotherapy and radiotherapy prior to study therapy. Donor lymphocyte infusions (DLI) begin after recovery from chemotherapy or sooner, if clinically indicated. Patients receive 1 or more DLI from the original donor. Patients are followed monthly for 3 months, then every 3-6 months for 9 months. PROJECTED ACCRUAL: An unlimited number of patients will be accrued for this study. \| ArmGroups: N/A \| Interventions:[{'type': 'BIOLOGICAL', 'name': 'peripheral blood lymphocyte therapy'}] \| PrimaryOutcomes: N/A \| SecondaryOutcomes: N/A
Title: A Phase I/II Study of Immunotherapy With TIL (Tumor Infiltrating Lymphocytes) in Combination With Intra-tumoral Injections of Interferon Gamma-adenovirus (Ad-IFNg) in Patients With Stage IIIc or Stage IV Metastatic Melanoma (AJCC) \| Condition: Metastatic Melanoma \| Keywords: Immunotherapy TIL (Tumor Infiltrating Lymphocytes), Intra-tumoral injection, Interferon gamma-adenovirus(Ad-IFNg), Metastatic melanoma, A stage IIIc/IV metastatic melanoma with nodal relapse, in transit metastasis, cutaneous unresectable metastases, visceral metastases \| Summary: \| Description: N/A \| ArmGroups: [{'label': 'TIL-Ad-INFg', 'type': 'EXPERIMENTAL', 'interventionNames': ['Other: TIL-Ad-INFg']}] \| Interventions:[{'type': 'OTHER', 'name': 'TIL-Ad-INFg', 'description': 'After verification of inclusion and non-inclusion criteria and after obtaining informed consent from the patients, a tumor sample will be taken for sterile production of TIL. Patients will receive intra-tumoral injections of Ad-INFg every 15 days from J-15 to M2, then every month from M3 to M11 or until disease progression. The Ad-INFg will be administered by intra-tumoral injection at a dose of 5x1010 vp (viral particles) per lesion. A maximum of 6 lesions will be treated simultaneously. They will also receive two infusion of TIL at M0 (Cycle 1) and M1 (Cycle 2) by intravenous infusion lasting 30 to 65 minutes followed by subcutaneous injections of IL2 from J1 to J5 and from J8 to J12 of each cycle.An evaluation of injected and not injected tumoral lesions including photographs will be realised at the pre-inclusion visit, J-15, M0 and every month until M12.', 'armGroupLabels': ['TIL-Ad-INFg']}] \| PrimaryOutcomes: [{'measure': 'Clinical and biological toxicity of combined treatment TIL, IL2 et Ad-INFg', 'description': 'The evaluation of clinical and biological toxicity of combined treatment including infusion of TIL associated with subcutaneous injections of low-doses of IL-2 and intra-tumoral injections of Ad-IFNg will be performed according to clinical and biological criteria defined by NCI (Common Toxicity Criteria - version 3.0, August 2006).', 'timeFrame': '12 months'}] \| SecondaryOutcomes: [{'measure': 'Objective response rate', 'description': 'The evaluation of the objective response rate', 'timeFrame': '12 months'}, {'measure': 'Tumoral response', 'description': 'The evaluation of the tumoral response of injected lesions every month', 'timeFrame': '12 months'}, {'measure': 'Progression-free survival', 'description': 'The evaluation of the progression-free survival,', 'timeFrame': '12 months'}, {'measure': 'Overall survival', 'description': 'The evaluation of the overall survival', 'timeFrame': '12 months'}, {'measure': 'Immunological response', 'description': 'The evaluation of the immunological response', 'timeFrame': '12 months'}]
Title: A Study to Evaluate 68Ga-P3 PET/CT Imaging of PSMA Expression in Malignant Tumors \| Condition: Neoplasms \| Keywords: [68Ga]P3, PSMA, PET/CT, Neoplasms \| Summary: \| Description: Prostate-specific membrane antigen (PSMA) is a type II transmembrane glycoprotein that consists of 750 amino acids. It is highly expressed on most prostate cancer cells and neovascular endothelial cells of tumors, making PSMA a highly specific and significant imaging target for malignancies.\[68Ga\]P3, a novel molecular probe of PET imaging agent that targets PSMA, can be used in the diagnosis and research of a wide variety of PSMA high-expression malignanciesr. \| ArmGroups: [{'label': '[68Ga]P3', 'type': 'EXPERIMENTAL', 'description': 'Subjects with suspected or confirmed malignancy will receive an intravenous injection of 68Ga-P3 followed by PET imaging. The subjects will also receive a whole-body 18F-FDG PET/CT scan within a one-week period.', 'interventionNames': ['Drug: [68Ga]P3']}] \| Interventions:[{'type': 'DRUG', 'name': '[68Ga]P3', 'description': '68Ga-P3 is injected intravenously with a dose of 0.06-0.08 mCi/kg.', 'armGroupLabels': ['[68Ga]P3'], 'otherNames': ['[68Ga]-P3', 'PSMA specific PET imaging']}] \| PrimaryOutcomes: [{'measure': 'The diagnostic efficacy of 68Ga-P3 PET/CT in the evaluation of malignant tumors', 'description': 'Compare the standardized Uptake Value (SUV) of lesions on 68Ga-P3 and 18F-FDG PET/CT', 'timeFrame': '1 year'}, {'measure': 'The detection efficacy of 68Ga-P3 PET/CT in the evaluation of malignant tumors', 'description': 'Compare the number of lesions detected by 68Ga-P3 and 18F-FDG PET/CT, based on the pathology or clinical follow-up as gold standard.', 'timeFrame': '1 year'}] \| SecondaryOutcomes: [{'measure': 'The dosimetry of 68Ga-P3', 'description': 'Research on the dose distribution of 68Ga-P3 in healthy volunteers and cancer patients by 1-hour dynamic PET/CT acquisition and analyze by the dosimetry software', 'timeFrame': '1 year'}, {'measure': 'Quantitative evaluation of 68Ga-P3', 'description': 'Evaluation of quantitative parameters of 68Ga-P3, such as time-activity curve.', 'timeFrame': '1 year'}, {'measure': 'Correlation with pathological expression', 'description': 'Analyze PSMA expression at the imaging level in combination with PSMA expression in pathological specimens', 'timeFrame': '1 year'}]
Title: A Phase I Dose-Escalation Study of Erlotinib in Combination With Bortezomib in Subjects With Advanced Cancer. Companion Study to Umbrella Protocol 2007-0638. \| Condition: Advanced Cancer \| Keywords: Metastatic Cancer, Bortezomib, Velcade, Erlotinib, Erlotinib Hydrochloride, Tarceva, EGFR, EGFR mutations \| Summary: \| Description: The Study Drugs: Erlotinib hydrochloride and bortezomib are both designed to block proteins that are thought to cause cancer cells to grow. These drugs may help slow the growth of tumors. Study Drug Dose Level: If you are found to be eligible to take part in this study, you will be assigned to a dose level of erlotinib hydrochloride and bortezomib based on when you join the study. Up to 4 dose levels of this study drug combination will be tested. There will be 3-6 participants enrolled at each dose level of the study drug combination. The first group of participants will receive the lowest dose level of erlotinib hydrochloride (Group 1). If all of Group 1 tolerate that dose level, the next group (Group 2) will receive a higher dose. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen (Groups 2-4). This will continue until the highest tolerable dose of the study drug combination is found. However, if Group 1 did not tolerate the first dose level, the next group will receive a lower dose (called Dose Level -1). If that dose level is still intolerable, the third group will receive an even lower dose (called Dose Level -2). The dose of bortezomib will be based in which group you in. Groups 1 and 2 will receive the same dose, Group 3 will receive a higher dose, and Group 4 will receive an even higher dose. After the highest tolerable dose is found, up to an additional 10 participants, called the "expansion group," will receive the study drug combination at that dose. Study Drug Administration: Erlotinib hydrochloride will be taken by mouth 1 time every day for 21-days, called a study "cycle." You should take erlotinib hydrochloride on an empty stomach either 1 hour before eating or 2 hours after eating. Depending on which dose level you are assigned to, you will receive bortezomib by vein over about 1-5 minutes on Days 1 and 8, or on Days 1, 4, 8, and 11 of each 21-day cycle. Study Visits: You will have a single study visit just before each cycle. At these visits, the following tests and procedures will be performed: * Your performance status will be recorded. * You will be asked to list any drugs you may be taking, including over-the-counter drugs. * You will be asked about any symptoms you may have. * You will have a physical exam, including measurement of your vital signs. * Blood (about 2 teaspoons) will be collected for routine tests. * Blood (about 2 teaspoons) will be collected for pharmacodynamic (PD) testing. PD testing is used to look at how the level of study drug in your body may affect the disease. After every 2 cycles (Cycles 2, 4, 6, and so on), you will have a CT or MRI scan to check the status of the disease. Length of Study: You may continue taking the study drugs for as long as you are benefitting. You will be taken off study if the disease gets worse or intolerable side effects occur. Follow-up Visit: About 30 days after the last dose of study drugs, you will have a follow-up visit. You will be asked to return any unused study drug. At this visit, the following tests and procedures will be performed: * Your performance status will be recorded. * You will be asked to list any drugs you may be taking, including over-the-counter drugs. * You will be asked about any symptoms you may have. * You will have a physical exam, including measurement of your vital signs. * Blood (about 2 teaspoons) and urine will be collected for routine tests. This is an investigational study. Bortezomib and erlotinib hydrochloride are both FDA approved and commercially available. Bortezomib is FDA approved for the treatment of multiple myeloma. Erlotinib hydrochloride is FDA approved for the treatment of lung cancer and pancreatic cancer. The use of these drugs together is investigational and authorized for use in research only. Up to 48 participants will take part in this study. All will be enrolled at M. D. Anderson. \| ArmGroups: [{'label': 'Erlotinib + Bortezomib', 'type': 'EXPERIMENTAL', 'description': 'Up to 4 dose levels of study drug combination tested with 3-6 participants enrolled at each dose level. Erlotinib beginning dose of 150 mg taken by mouth daily for 21-day cycle. Bortezomib beginning dose of 1. mg/m\\^2 by vein over about 1-5 minutes on Days 1, 4, 8, and 11 of each 21-day cycle.', 'interventionNames': ['Drug: Erlotinib Hydrochloride', 'Drug: Bortezomib']}] \| Interventions:[{'type': 'DRUG', 'name': 'Erlotinib Hydrochloride', 'description': 'Beginning dose of 150 mg taken by mouth daily for 21-day cycle.', 'armGroupLabels': ['Erlotinib + Bortezomib'], 'otherNames': ['Erlotinib', 'Tarceva']}, {'type': 'DRUG', 'name': 'Bortezomib', 'description': 'Beginning dose of 1. mg/m\\^2 by vein over about 1-5 minutes on Days 1, 4, 8, and 11 of each 21-day cycle.', 'armGroupLabels': ['Erlotinib + Bortezomib'], 'otherNames': ['Velcade', 'LDP-341', 'MLN341', 'PS-341']}] \| PrimaryOutcomes: [{'measure': 'Tumor Response', 'description': 'Tumor response defined as one or more of the following: (1) stable disease for more than or equal to 4 months, (2) decrease in measurable tumor (sentinel lesions) by more than or equal to 20% by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, (3) decrease in tumor markers by more than or equal to 25% (for example, a \\>/= 25% decrease in cancer antigen 125 (CA125) for patients with ovarian cancer), or (4) a partial response according to the Choi criteria, i.e. decrease in size by 10% or more, or a decrease in the tumor density, as measured in Hounsfield units (HU), by more than or equal to 15%.', 'timeFrame': 'Evaluation of response after two 21-day cycles of treatment'}, {'measure': 'Maximum Tolerated Dose (MTD)', 'description': 'MTD defined as highest dose studied in which incidence of dose limiting toxicity (DLT) was less than 33%. DLT defined as any Grade 3 or 4 non-hematologic toxicity defined in the NCI CTC v3.0, even if expected and believed related to study medications (except nausea and vomiting responsive to appropriate regimens or alopecia), any Grade 4 hematologic toxicity lasting 2 weeks or longer (as defined by the NCI-CTCAE), despite supportive care; any Grade 4 nausea or vomiting \\> 5 days despite maximum anti-nausea regimens, and any other Grade 3 non-hematologic toxicity, including symptoms/signs of vascular leak or cytokine release syndrome; or any severe or life-threatening complication or abnormality not defined in the NCI-CTCAE that is attributable to the therapy.', 'timeFrame': '21 days'}] \| SecondaryOutcomes: N/A
Title: Phase II Study of Panitumumab, Nab-paclitaxel, and Carboplatin for Patients With Primary Inflammatory Breast Cancer (IBC) Without HER2 Overexpression \| Condition: Breast Cancer \| Keywords: Inflammatory Breast Cancer, IBC, Primary breast carcinoma, HER2 negative overexpression, Panitumumab, Vectibix, Nab-paclitaxel, Paclitaxel, Abraxane, Carboplatin, Paraplatin, PNC, 5-fluorouracil, 5-FU, Adrucil, Efudex, Epirubicin, Ellence, Cyclophosphamide, Cytoxan, Neosar, FEC \| Summary: \| Description: Study Drugs: Panitumumab is designed to prevent or slow down the growth of tumor cells by blocking the proteins on the surface the cancer cell, called the epidermal growth factor receptor (EGFR). Nab-paclitaxel is designed to kill tumor cells by binding a chemotherapy drug paclitaxel to albumin, a protein made by the liver. The albumin gets into the cancer cell and releases the paclitaxel directly to the tumor. Carboplatin is designed to stop or slow cancer cells from growing by damaging the RNA or DNA (the genetic material of cells) that tells the tumor cells to grow. 5-fluorouracil, epirubicin, and cyclophosphamide each work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Study Drug Administration: On Day 1 of Week 1, you will receive panitumumab through a needle in your vein over 60 minutes. After Week 1, you will receive a total of 4 cycles of PNC. Each cycle is 4 weeks. During Cycles 1-3 (Weeks 2-13), you will receive PNC by vein once a week for 3 weeks, followed by a week of rest. You will receive PNC through a needle in your vein. The infusion will take 90 minutes. During Cycle 4 (Week 14 to 17), you will receive PNC on Day 1 of Weeks 14 and 15. On Day 1 of Week 16, you will receive only carboplatin and nab-paclitaxel. Starting on Day 1 of Week 18, you will receive FEC through a needle in your vein. The infusion will take 90 minutes. You will receive a total of 4 cycles, each 3 weeks long, over 12 weeks. Surgery: After you have completed both PNC and FEC treatments, you will have the standard of care surgery performed. You will be given a separate consent form to read and sign. During surgery, breast tissue samples will be collected to identify tumors as routine procedure. Study Visits: Each week that you receive PNC or FEC therapy, before each dose of chemotherapy, blood (about 1 1/2 tablespoons) will be drawn for routine tests. Before Week 2, an optional breast core biopsy will be performed to collect tumor samples for biomarker testing On Week 2, every 4 weeks after that until the end of PNC, and again before FEC, the following tests and procedures will be performed before each dose of chemotherapy. * You will have a physical exam, including measurement of your vital signs and weight, and breast exam. * Blood (about 1 1/2 tablespoons) will be drawn for routine tests. * You will be asked how well you are able to perform the normal activities of daily living (performance status). During Weeks 2 and 9, and before FEC therapy, the study doctor will take pictures of both of your breasts. Before FEC (after Cycle 4 of PNC) and again before surgery, the following tests and procedures will be performed: * To check the status of the disease, imaging studies including mammogram, breast MRI, breast ultrasound, and digital photograph will be performed. * You will have a physical exam, including vital signs, weight, and breast exam * Blood (about 3 tablespoons) will be drawn for routine tests. * You will be asked about any symptoms that you may have. * The ECGs and ECHO/MUGA scans will be repeated, when the doctor thinks it is necessary. This schedule may be changed if the study doctor thinks that it is necessary. Length of the study: You may remain on study treatment for up to 10 months. You will be taken off study early if the disease gets worse or you experience intolerable side effects. This is an investigational study. Panitumumab is FDA approved and commercially available for the treatment of EGFR-expressing metastatic colorectal cancer with disease progression. It's use in this study is considered to be investigational. Nab-paclitaxel is FDA approved and commercially available for the treatment of breast cancer after the failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. The use of Nab-paclitaxel in this study is considered to be investigational. Carboplatin is FDA approved and commercially available for the treatment of IBC. FEC is FDA approved for breast cancer in general, but not specifically for inflammatory breast cancer. The use of PNC and FEC together before surgery is investigational. Up to 40 patients will take part in this study. All will be enrolled at MD Anderson. \| ArmGroups: [{'label': 'PNC + FEC', 'type': 'EXPERIMENTAL', 'description': 'PNC = Panitumumab + Nab-paclitaxel + Carboplatin, and\n\nFEC = 5-fluorouracil, epirubicin, and cyclophosphamide', 'interventionNames': ['Drug: Panitumumab', 'Drug: Nab-paclitaxel', 'Drug: Carboplatin', 'Drug: 5-Fluorouracil', 'Drug: Epirubicin', 'Drug: Cyclophosphamide']}] \| Interventions:[{'type': 'DRUG', 'name': 'Panitumumab', 'description': '2.5 mg/kg IV on Day 1 of Week 1 over 60 minutes, followed by 2.5 mg/kg weekly Weeks 2-12.', 'armGroupLabels': ['PNC + FEC'], 'otherNames': ['Vectibix']}, {'type': 'DRUG', 'name': 'Nab-paclitaxel', 'description': '100 mg/m2 IV over 30 min on Day 1 of Weeks 2-13 over 30 minutes.', 'armGroupLabels': ['PNC + FEC'], 'otherNames': ['Paclitaxel (protein-bound)', 'Abraxane', 'ABI-007']}, {'type': 'DRUG', 'name': 'Carboplatin', 'description': 'AUC 2 IV over 30 min on Day 1 of Weeks 2-13 after completion of Abraxane through separate IV line.', 'armGroupLabels': ['PNC + FEC'], 'otherNames': ['Paraplatin']}, {'type': 'DRUG', 'name': '5-Fluorouracil', 'description': '500 mg/m2 IV every 3 weeks, starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).', 'armGroupLabels': ['PNC + FEC'], 'otherNames': ['5-FU', 'Adrucil', 'Efudex']}, {'type': 'DRUG', 'name': 'Epirubicin', 'description': '100 mg/m2 IV over 30 min every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).', 'armGroupLabels': ['PNC + FEC'], 'otherNames': ['Ellence']}, {'type': 'DRUG', 'name': 'Cyclophosphamide', 'description': '500 mg/m2 IV every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).', 'armGroupLabels': ['PNC + FEC'], 'otherNames': ['Cytoxan', 'Neosar']}] \| PrimaryOutcomes: [{'measure': 'Number of Participants That Achieved Pathologic Complete Response (CR)', 'description': 'Pathologic complete response was defined as absence of invasive carcinoma in the breast, axillary lymph nodes, and skinand absence of tumor emboli within the surgical field.', 'timeFrame': 'Assessed after 14 weeks (following PNC and FEC preoperative chemotherapy treatment).'}] \| SecondaryOutcomes: [{'measure': 'Number of Participants With Treatment-related Adverse Events (AEs)', 'description': "AEs were graded according to the National Cancer Institute's Common Terminology Criteria (CTCAE), version 3.0. All AEs (\\>/=2 non-hematological and \\>/=3 hematological AEs) occurring after informed consent signing observed by the investigator or reported by the subject whether or not attributed to investigational product. Full AE reporting can be found in the Adverse Event Section.", 'timeFrame': 'Before each cycle of Panitumumab, nab-paclitaxel and carboplatin (PNC) & fluorouracil, epirubicin and cyclophosphamide (FEC) until 30 days after the last dose of drug, an average of 8 months, unless the participant withdraw consent.'}]
Title: Neoadjuvant Apalutamide (ARN509) and Radical Prostatectomy in the Treatment of Intermediate to High Risk Prostate Cancer \| Condition: Cancer of the Prostate \| Keywords: prostate cancer, prostatectomy, retropubic, Androgen Receptor Antagonists \| Summary: \| Description: This is a phase II single arm study looking at the efficacy of 12 weeks of neoadjuvant apalutamide (ARN 509), combined with standard-of-care radical prostatectomy, for D'Amico intermediate to high risk prostate cancer patients. The phases of the study will include: screening, treatment and follow-up phases. Safety will be monitored throughout the study. \| ArmGroups: [{'label': 'Neoadjuvant apalutamide', 'type': 'EXPERIMENTAL', 'description': 'Oral apaluatmide 240mg daily for 12 weeks followed by standard of care robotic radical prostatectomy and pelvic node dissection', 'interventionNames': ['Drug: Apalutamide']}] \| Interventions:[{'type': 'DRUG', 'name': 'Apalutamide', 'description': 'Participants will receive oral apalutamide 240mg daily for 12 weeks', 'armGroupLabels': ['Neoadjuvant apalutamide'], 'otherNames': ['ARN509']}] \| PrimaryOutcomes: [{'measure': 'Proportion of patients with pathological downstaging after neodjuvant apalutamide followed by radical prostatectomy', 'description': 'This is described as residual cancer burden and treatment response group on histopathology after neoadjuvant apalutamide and radical prostatectomy', 'timeFrame': '24 weeks'}, {'measure': 'Proportion of patients with biochemical treatment response following neoadjuvant apalutamide and radical prostatectomy', 'description': 'Patients who attain serum PSA levels below 0.03microg/L', 'timeFrame': '24 weeks'}] \| SecondaryOutcomes: [{'measure': 'Proportion of patients who report significant adverse effects after 12 weeks of neoadjuvant apalutamide', 'description': 'Adverse effects as defined by CTCAE criteria grade 3 and above', 'timeFrame': '12 weeks'}, {'measure': 'The proportion of patients with peri-operative complications following neoadjuvant apalutamide and radical prostatectomy', 'description': 'The level of complications defined by Clavien-Dindo classification', 'timeFrame': '24 weeks'}]
Title: Investigating the Prognostic Importance of Bioelectrical Impedance Phase Angle in Adults Treated for Small Cell Lung Cancer \| Condition: Extensive Stage Small Cell Lung Cancer \| Keywords: \| Summary: \| Description: PRIMARY OBJECTIVES: I. To evaluate the association between phase angle (PA) measurement and progression-free survival (PFS). SECONDARY OBJECTIVES: I. To evaluate the association between PA measurement and treatment-related outcomes of treatment response, adverse treatment events, and overall survival (OS). II. To determine the feasibility of obtaining PA measurements at a single time point in patients undergoing evaluation in thoracic oncology clinics. OUTLINE: Patients undergo bioelectrical impedance phase angle measurement on day 1 of treatment. After completion of study treatment, patients are followed up every 2-3 months for two years. \| ArmGroups: [{'label': 'Diagnostic (bioelectric impedance analysis)', 'type': 'EXPERIMENTAL', 'description': 'Patients undergo bioelectrical impedance phase angle measurement on day 1 of treatment.', 'interventionNames': ['Procedure: bioelectric impedance analysis']}] \| Interventions:[{'type': 'PROCEDURE', 'name': 'bioelectric impedance analysis', 'description': 'Undergo bioelectric impedance analysis', 'armGroupLabels': ['Diagnostic (bioelectric impedance analysis)'], 'otherNames': ['BIA', 'bioelectric impedance', 'bioelectric impedance test', 'bioimpedance analysis']}] \| PrimaryOutcomes: [{'measure': 'Progression-free survival', 'description': 'Analyzed using Kaplan-Meier plots and a log-rank test to test the difference in progression-free survival and high/low phase angle measures.', 'timeFrame': 'From the start of treatment to the time of progression, death, or date of last contact, assessed up to 2 years'}, {'measure': 'Standardized phase angle measure', 'description': 'A Cox proportional hazards model will be used. The standardized phase angle measure will be treated as a continuous measure and baseline characteristics will be included as covariates in the survival model.', 'timeFrame': 'Baseline'}] \| SecondaryOutcomes: [{'measure': 'Best overall response (complete, partial, progressive disease, stable disease) using the Response Evaluation Criteria in Solid Tumors (RECIST)', 'description': 'Logistic regression will be used to analyze the association between standardized phase angle and best overall response.', 'timeFrame': 'Up to 2 years'}, {'measure': 'Overall survival', 'description': 'A Cox proportional hazards model will be used.', 'timeFrame': 'From the start of treatment to date of death or date of last contact, assessed up to 2 years'}, {'measure': 'Incidence of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0', 'description': 'For those events that are the most common, the mean standardized phase angle for those experiencing the condition will be presented.', 'timeFrame': 'Up to 2 years'}]
Title: A Phase II Multicentric Study of Olaparib in PALB2-related Advanced Pancreatic Cancer (PALBOLA) \| Condition: Advanced Pancreatic Cancer, Metastatic Pancreatic Cancer \| Keywords: \| Summary: \| Description: This is a Phase II, non-randomized, multicenter, unblinded open-label study of Olaparib in monotherapy in participants with advanced (locally advanced/metastatic) PALB2-related pancreatic cancer that have progressed after at least one treatment for advanced disease. After screening, 16 eligible participants with germline or somatic PALB2 mutations will be enrolled in this study. All participants will receive Olaparib 300 mg twice a daily (BID). Study intervention will continue until documented PD, unacceptable AEs, intercurrent illness that prevents further administration of the study intervention, investigator's decision to discontinue the participant, participant withdrawal of consent, pregnancy of the participant, administrative reasons requiring cessation of study intervention. After documented PD, each participant will be contacted by telephone every 12 weeks (+-14 days) to assess for survival status until withdrawal of consent to participate in the study, becoming lost to follow up, death or end of the study, whichever occurs first. During treatment, efficacy will be evaluated using ORR, PFS, DOC and DCR using RECIST 1.1 Efficacy will also be evaluated by assessing OS. Participants will be evaluated with radiographic imaging to assess response to intervention at regular intervals throughout the study. \| ArmGroups: [{'label': 'Olaparb', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Olaparib 150 MG']}] \| Interventions:[{'type': 'DRUG', 'name': 'Olaparib 150 MG', 'description': 'Olaparib should be dosed 2 x 150 mg tablets (300 BID)', 'armGroupLabels': ['Olaparb']}] \| PrimaryOutcomes: [{'measure': 'To evaluate the ORR according to RECIST 1.1 following Olaparib administration', 'description': 'Objective response rate (ORR), defined as the percentage of patients with response of either Complete Response or Partial Response.', 'timeFrame': '2-3 years'}] \| SecondaryOutcomes: [{'measure': 'To evaluate the PFS according to RECIST 1.1 following Olaparib administration', 'description': 'PFS, defined as the time from the date of the first dose until either disease progression or death due to any cause, whichever occurs first. .', 'timeFrame': '2-3 years'}, {'measure': 'To evaluate the Incidence of Treatment-Emergent Adverse Events of Olaparib', 'description': 'measument of Adverse events (AEs)', 'timeFrame': '2-3 years'}, {'measure': 'To evaluate the DOR according to RECIST 1.1 following Olaparib', 'description': 'DOR defined as the time from the date a response was first documented until either disease progression or death due to any cause, whichever occurs first.', 'timeFrame': '2-3 years'}, {'measure': 'To evaluate the DRC according to RECIST 1.1 following Olaparib', 'description': 'DCR defined as the percentage of patients with ORR and stable disease', 'timeFrame': '2-3 years'}, {'measure': 'To evaluate the OS according to RECIST 1.1 following Olaparib', 'description': 'OS definied as overall survival', 'timeFrame': '2-3 years'}]
Title: A Randomized Phase II Study of ADT + Abiraterone Versus ADT + Docetaxel + Abiraterone in Patients With Low Volume Metastatic Hormone Sensitive Prostate Cancer \| Condition: Prostate Cancer \| Keywords: \| Summary: \| Description: Primary Objective: 1. To assess Progression Free Survival (PFS) for each treatment arms (abiraterone+docetaxel+ADT and abiraterone+ADT) to compare for any difference in efficacy Secondary Objective: 1. To assess Overall Survival (OS) for each treatment arm (abiraterone+docetaxel+ADT and abiraterone+ADT) to compare for any difference in efficacy 2. To assess PSA Response Rate for each treatment arm (abiraterone+docetaxel+ADT and abiraterone+ADT) to compare for any difference in efficacy 3. To assess ORR with measurable disease at baseline for each treatment arm for (abiraterone+docetaxel+ADT and abiraterone+ADT) to compare for any difference in efficacy 4. Assessment of Time to castration resistant prostate cancer for each treatment arm (abiraterone+docetaxel+ADT and abiraterone+ADT) to compare for any difference in efficacy 5. Assess time to initiation of subsequent anti-neoplastic therapy for each treatment arm (abiraterone+docetaxel+ADT and abiraterone+ADT) to compare for any difference in efficacy Exploratory Objectives: 1. Assess Quality of Life (QoL) via the FACT-P QoL assessment tool (Appendix A QoL Survey FACT-P) for each treatment arm (abiraterone+docetaxel+ADT and abiraterone+ADT) to compare for any difference in efficacy 2. Assessment of Rates of Adverse Events (AEs)/Serious adverse events (SAEs) for each treatment arm (abiraterone+docetaxel+ADT and abiraterone+ADT) to compare for any difference in safety \| ArmGroups: [{'label': 'Triplet Arm', 'type': 'EXPERIMENTAL', 'description': 'Abiraterone+Docetaxel+ADT\n\nAbiraterone Abiraterone acetate will be four (250 mg) tablets (total dose/day 1000 mg). Abiraterone administration is per a 12-week cycle.\n\nAbiraterone must be taken with prednisone. Prednisone will be provided as 5 mg tablets.\n\nDocetaxel Docetaxel on day 1 of each 21-day cycle, 75 mg/m2 via IV. Dexamethasone will be self-administered by the patient at 16 mg per day for 3 days starting 1 day prior to docetaxel infusion.\n\nADT Patients may be started on an LHRH agonist or antagonist , the selection of the agent is left to the treating investigator for ADT.', 'interventionNames': ['Drug: Docetaxel', 'Drug: ADT', 'Drug: Abiraterone']}, {'label': 'Doublet Arm', 'type': 'ACTIVE_COMPARATOR', 'description': "Abiraterone+ADT\n\nAbiraterone Abiraterone acetate will be four (250 mg) tablets (total dose/day 1000 mg). Abiraterone administration is per a 12-week cycle.\n\nTreatment of abiraterone should start ≤14 days after patient randomization.\n\nAbiraterone must be taken with prednisone. Prednisone will be provided as 5 mg tablets.\n\nDocetaxel Docetaxel on day 1 of each 21-day cycle, 75 mg/m2 via IV. Prior to docetaxel, dexamethasone administration is recommended as discussed, but can be adjusted or altered per the treating investigator's discretion. Dexamethasone will be self-administered by the patient at 16 mg per day for 3 days starting 1 day prior to docetaxel infusion.", 'interventionNames': ['Drug: ADT', 'Drug: Abiraterone']}] \| Interventions:[{'type': 'DRUG', 'name': 'Docetaxel', 'description': '75 mg/m2 via IV', 'armGroupLabels': ['Triplet Arm']}, {'type': 'DRUG', 'name': 'ADT', 'description': 'Prior to randomization as part of standard of care.', 'armGroupLabels': ['Doublet Arm', 'Triplet Arm']}, {'type': 'DRUG', 'name': 'Abiraterone', 'description': '1000 mg by mouth', 'armGroupLabels': ['Doublet Arm', 'Triplet Arm']}] \| PrimaryOutcomes: [{'measure': 'Assess Progression Free Survival (PFS)', 'description': 'Calculated the progression-free survival time as the time that elapses between the date of randomization and the day of first documented disease progression (per RECIST 1.1 or PCWG3) or death from any cause for all evaluable patients. PFS will be calculated based on the Kaplan-Meier estimates of PFS for each treatment arm (abiraterone+docetaxel+ADT compared to abiraterone+ADT).', 'timeFrame': 'Up to 1 year after completion of study treatment'}] \| SecondaryOutcomes: [{'measure': 'Assess Overall Survival (OS)', 'description': 'To assess the OS, this is defined as the time from date of randomization until time to death from any cause for all evaluable patients. OS will be calculated based on the Kaplan-Meier estimates of OS.', 'timeFrame': 'Up to 1 year after completion of study treatment'}, {'measure': 'Assess PSA Response Rate', 'description': 'The PSA level drawn 6 months (+/- 30 days) after randomization will be used to assess PSA response.', 'timeFrame': '6 months (+/- 30 days) after randomization'}, {'measure': 'Assessment of Time to castration resistant prostate cancer', 'description': 'This endpoint will calculate the time to the development of castration resistance from date of randomization to the time of PSA progression with serum testosterone level being at ≤ 50 ng/ml', 'timeFrame': 'Up to 1 year after completion of study treatment'}, {'measure': 'Assess time to compare for any difference in efficacy between arms', 'description': 'This endpoint will calculate the time to the initiation of the subsequent anti-neoplastic therapy for each treatment arm from the date of randomization to the date of initiation of the next (non-study) anti-neoplastic agent for prostate cancer.', 'timeFrame': 'Up to 1 year after completion of study treatment'}]
Title: Fresolimumab and Stereotactic Ablative Radiotherapy in Early Stage Non-small Cell Lung Cancer \| Condition: Stage IA Non-Small Cell Lung Carcinoma, Stage IB Non-Small Cell Lung Carcinoma \| Keywords: \| Summary: \| Description: PRIMARY OBJECTIVES: Phase 1: Evaluate the safe dose of fresolimumab in combination with stereotactic ablative radiotherapy (SABR) in patients. Phase 2. Evaluate the rate of radiation induced pulmonary fibrosis after SABR plus fresolimumab. SECONDARY OBJECTIVES: I. Evaluate potential adverse events in patients receiving fresolimumab plus SABR. (Phase I) II. Evaluate post treatment changes in pulmonary function. (Phase I) III. Evaluate recurrence rates and progression free survival. (Phase I) IV. Assess pharmacokinetics (PK) of fresolimumab in combination with SABR (optional for patient). (Phase I) V. Evaluate the rate and severity of radiation induced pulmonary fibrosis after SABR plus fresolimumab. (Phase I) VI. Evaluate the severity of radiation induced pulmonary fibrosis after SABR plus fresolimumab. (Phase II) VII. Evaluate potential adverse events in patients receiving fresolimumab plus SABR. (Phase II) VIII. Evaluate post treatment changes in pulmonary function. (Phase II) IX. Evaluate recurrence rates and progression free survival. (Phase II) OUTLINE: This is a phase I, dose escalation study of fresolimumab followed by a phase II study. * Phase 1: A cohort of 5 patients receive the pre-selected dose of 3mg/kg of fresolimumab. If one patient experiences a DLT, an additional 5 patients will be enrolled at 3 mg/kg. If no more patients experience a DLT, then 3 mg/kg will be the dose for the Phase 2 component. If 2 or more patients experience a DLT in the total expanded cohort (or 2 or more patients in the initial cohort experience DLT), then the investigational dose of fresolimumab will be changed to 1 mg/kg. If 2 or more patients in the initial cohort experience DLT before all 5 patients have been enrolled, the remaining patients will receive the lower dose of 1 mg/kg. * Phase 2: Patients receive fresolimumab intravenously (IV) on days 1, 15, and 36 and undergo SABR in 4 fractions between days 8 and 12. After completion of study treatment, patients are followed up at 3, 6, and 12 months. \| ArmGroups: [{'label': '(Phase 1) Fresolimumab 3 mg/kg', 'type': 'EXPERIMENTAL', 'description': 'Patients receive fresolimumab 3 mg/kg IV on days 1, 15, and 36 and undergo SABR in 4 fractions between days 8 and 12.', 'interventionNames': ['Biological: Fresolimumab', 'Radiation: Stereotactic Body Radiation Therapy']}, {'label': '(Phase 1) Fresolimumab 1 mg/kg', 'type': 'EXPERIMENTAL', 'description': 'Patients receive fresolimumab 1 mg/kg IV on days 1, 15, and 36 and undergo SABR in 4 fractions between days 8 and 12.', 'interventionNames': ['Biological: Fresolimumab', 'Radiation: Stereotactic Body Radiation Therapy']}, {'label': '(Phase 2) Fresolimumab', 'type': 'EXPERIMENTAL', 'description': 'Fresolimumab will be administered IV at the dose selected in the preceding Phase 1 on Days 1, 15 and 36 and SABR will be administered in 4 fractions between Days 8 and 12.', 'interventionNames': ['Biological: Fresolimumab', 'Radiation: Stereotactic Body Radiation Therapy']}] \| Interventions:[{'type': 'BIOLOGICAL', 'name': 'Fresolimumab', 'description': 'Given IV', 'armGroupLabels': ['(Phase 1) Fresolimumab 1 mg/kg', '(Phase 1) Fresolimumab 3 mg/kg', '(Phase 2) Fresolimumab'], 'otherNames': ['Anti-TGF-Beta Monoclonal Antibody GC1008', 'GC1008', 'Human Anti-TGF-Beta Monoclonal Antibody GC1008', 'Immunoglobulin G4, anti-(transforming growth factor beta) (human monoclonal GC-1008 heavy chain), disulfide with human monoclonal GC-1008 light chain, Dimer']}, {'type': 'RADIATION', 'name': 'Stereotactic Body Radiation Therapy', 'description': 'Undergo SABR', 'armGroupLabels': ['(Phase 1) Fresolimumab 1 mg/kg', '(Phase 1) Fresolimumab 3 mg/kg', '(Phase 2) Fresolimumab'], 'otherNames': ['SBRT']}] \| PrimaryOutcomes: [{'measure': 'Number of Participants Experiencing Dose Limiting Toxicities (DLTs) of Fresolimumab When Combined With SABR (Phase I)', 'description': 'DLT is defined as CTCAE grade 3 or higher radiation pneumonitis or bronchopulmonary hemorrhage.', 'timeFrame': 'Up to 30 days'}, {'measure': 'Number of Participants With Late Radiation Induced Fibrosis', 'description': 'Presence of radiation induced pulmonary fibrosis is defined as presence of a moderate-to-severe level of fibrosis. This outcome is primary in phase 2 patients.', 'timeFrame': '12 months'}] \| SecondaryOutcomes: [{'measure': 'Number of Participants With Late Radiation Induced Fibrosis (Phase 1 Patients)', 'description': 'Presence of radiation induced pulmonary fibrosis is defined as presence of a moderate-to-severe level of fibrosis. This outcome is secondary for phase 1 patients.', 'timeFrame': '12 months'}]

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