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Title: A Phase 1/2 Open-Label, Dose-Escalation and Clinical Response Study of Quaratusugene Ozeplasmid in Combination With Osimertinib in Patients With Advanced, Metastatic EGFR-Mutant, Metastatic Non-Small Cell Lung Cancer | Condition: Carcinoma, Non-Small Cell Lung | Keywords: Epidermal growth factor receptor mutation (EGFR), osimertinib, Tumor suppressor gene 2 (TUSC2), Lipid nanoparticle (LNP), Gene therapy, Tagrisso, FUS1-nanoparticles, NSCLC, Reqorsa, quaratusugene ozeplasmid | Summary: | Description: Acclaim-1 is an open-label, multi-center, Phase 1/2 study evaluating quaratusugene ozeplasmid (Reqorsa) plus osimertinib (investigational arm) versus platinum-based chemotherapy (control arm) in patients with advanced metastatic or recurrent NSCLC.
Toxicities will be assessed by the Investigator using United States National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Serious Adverse Events and Dose Limiting Toxicities (DLT) will be reviewed by a Safety Review Committee.
Phase 1 - Dose Escalation: The RP2D of quaratusugene ozeplasmid when given in combination with osimertinib will be identified.
Phase 2a: Once the RP2D of quaratusugene ozeplasmid is identified in Phase 1, an expansion cohort will be enrolled to better characterize safety, tolerability, and preliminary anti-tumor activity of the combination therapy.
Phase 2b: Quaratusugene ozeplasmid in combination with osimertinib will be further evaluated using the RP2D identified in Phase 1. Patients may receive local therapy, such as radiation therapy, to progressing lesions prior to enrollment. Patients will be randomized to receive either the investigational arm or the control arm in a 1 to 1 ratio and stratified based on prior local radiotherapy. | ArmGroups: [{'label': 'Investigational', 'type': 'EXPERIMENTAL', 'description': 'In Phase 1, Phase 2a and the investigational arm of Phase 2b, patients will receive their assigned dose of quaratusugene ozeplasmid (intravenous administration once every 21 days) plus osimertinib (80 mg fixed dose oral tablet taken daily starting on Day 1 through Day 21 of every 21-day treatment cycle) until disease progression or unacceptable toxicity.', 'interventionNames': ['Biological: quaratusugene ozeplasmid', 'Drug: osimertinib']}, {'label': 'Control', 'type': 'ACTIVE_COMPARATOR', 'description': 'In the control arm of Phase 2b, patients will receive platinum-based chemotherapy until disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Platinum-Based Chemotherapy']}] | Interventions:[{'type': 'BIOLOGICAL', 'name': 'quaratusugene ozeplasmid', 'description': 'Quaratusugene ozeplasmid is an experimental non-viral immunogene therapy utilizing the TUSC2 gene, designed to target cancer cells by interrupting cell signaling pathways that allow cancer cells to grow, reestablishing pathways that promote cancer cell death and modulating the immune response against cancer cells.', 'armGroupLabels': ['Investigational'], 'otherNames': ['Reqorsa']}, {'type': 'DRUG', 'name': 'osimertinib', 'description': 'Osimertinib is a 3rd generation EGFR tyrosine kinase inhibitor (TKI) oral tablet administered daily, as indicated for treatment of patients with metastatic NSCLC whose tumors have EGFR genetic deletions or mutations.', 'armGroupLabels': ['Investigational'], 'otherNames': ['Tagrisso']}, {'type': 'DRUG', 'name': 'Platinum-Based Chemotherapy', 'description': 'Cisplatin and carboplatin are intravenously administered platinum agents that are combined with other cytotoxic chemotherapy agents such as pemetrexed.', 'armGroupLabels': ['Control'], 'otherNames': ['cisplatin', 'carboplatin']}] | PrimaryOutcomes: [{'measure': 'Recommended Phase 2 Dose (RP2D) - Phase 1', 'description': 'RP2D, which will be the maximum tolerated dose (MTD) or, if the MTD is not defined by the safety data, RP2D will be determined based on an integrated assessment of all available clinical safety and preliminary efficacy data.', 'timeFrame': 'First 21-day treatment cycle for each dose level cohort'}, {'measure': 'Overall Response Rate (ORR) - Phase 2a', 'description': 'ORR (complete response \\[CR\\]+ partial response \\[PR\\]) according to RECIST using best overall response.', 'timeFrame': 'Approximately 3 months'}, {'measure': 'Progression-free Survival (PFS) - Phase 2b', 'description': 'PFS from randomization to disease progression or death. Response according to RECIST.', 'timeFrame': 'Approximately 11 months'}] | SecondaryOutcomes: [{'measure': 'Progression-free Survival (PFS) - Phase 1', 'description': 'PFS from first dose to disease progression or death. Response according to RECIST.', 'timeFrame': 'Approximately 9 months'}, {'measure': 'Overall Response Rate (ORR) - Phase 1', 'description': 'ORR (CR+ PR) according to RECIST using best overall response.', 'timeFrame': 'Approximately 3 months'}, {'measure': 'Duration of Response (DOR) - Phase 1', 'description': 'DOR (CR + PR) from response to disease progression. Response according to RECIST.', 'timeFrame': 'Approximately 9 months'}, {'measure': 'Pharmacokinetics (PK) of Quaratusugene Ozeplasmid - Phase 1', 'description': 'Concentration of quaratusugene ozeplasmid in whole blood samples.', 'timeFrame': 'First 21-day treatment cycle'}, {'measure': 'Progression-free Survival (PFS) - Phase 2a', 'description': 'PFS from first dose to disease progression or death. Response according to RECIST.', 'timeFrame': 'Approximately 11 months'}, {'measure': 'Time to Progression (TTP) - Phase 2a', 'description': 'TTP from first dose to disease progression. Response according to RECIST.', 'timeFrame': 'Approximately 11 months'}, {'measure': 'Overall Survival (OS) - Phase 2a', 'description': 'OS from first dose until death or discontinuation due to withdrawal of consent.', 'timeFrame': 'Approximately 21 months'}, {'measure': 'Pharmacokinetics (PK) of Quaratusugene Ozeplasmid - Phase 2a', 'description': 'Concentration of quaratusugene ozeplasmid in whole blood samples.', 'timeFrame': 'Approximately 22 days'}, {'measure': 'Overall Response Rate (ORR) - Phase 2b', 'description': 'ORR (CR+ PR) according to RECIST using best overall response.', 'timeFrame': 'Approximately 3 months'}, {'measure': 'Time to Progression (TTP) - Phase 2b', 'description': 'TTP from first dose to disease progression. Response according to RECIST.', 'timeFrame': 'Approximately 11 months'}, {'measure': 'Duration of Response (DOR) - Phase 2b', 'description': 'DOR (CR + PR) according to RECIST from response to disease progression.', 'timeFrame': 'Approximately 11 months'}, {'measure': 'Overall Survival (OS) - Phase 2b', 'description': 'OS from randomization to death or discontinuation due to withdrawal of consent.', 'timeFrame': 'Approximately 21 months'}, {'measure': 'Incidence of Adverse Events - Phase 2b', 'description': 'Treatment-related adverse events (AEs) graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events.', 'timeFrame': 'Approximately 11 months'}, {'measure': 'Pharmacokinetics (PK) of Quaratusugene Ozeplasmid - Phase 2b', 'description': 'Concentration of quaratusugene ozeplasmid in whole blood samples.', 'timeFrame': 'Approximately 22 days'}] |
Title: Genotyping K-RAS and EGFR in Greek Non-small-cell Lung Cancer Patients: Incidence, Significance and Treatment Implications | Condition: Non Small Cell Lung Cancer | Keywords: | Summary: | Description: A retrospective analysis, performed by the Hellenic Co-operative Oncology Group (HeCOG), in samples from patients with histologically confirmed NSCLC, who had been treated within HeCOG-affiliated centres from March 2000 through December 2012, were centrally evaluated for the presence of KRAS and EGFR mutations. All patients had available clinicopathological data at diagnosis. Formalin-fixed, paraffin-embedded tissue blocks were retrospectively retrieved from the HeCOG tumor repository. Cytologic material was prospectively submitted for genotyping in more recent years (2010-2012). | ArmGroups: [{'label': 'K-RAS and EGFR mutated'}, {'label': 'Wild type'}] | Interventions:N/A | PrimaryOutcomes: [{'measure': 'Progression free survival', 'timeFrame': 'from the date of treatment start until verified disease progression, death from any cause or date of last contact whichever occurred first, up to 9 months'}, {'measure': 'Overall survival', 'timeFrame': 'from the date of treatment start until verified disease progression, death from any cause or date of last contact whichever occurred first, up to 36 months'}] | SecondaryOutcomes: N/A |
Title: A Prospective Assessment of Loss of Grip Strength by Baseline BMI in Breast Cancer Patients Receiving Adjuvant Third-generation Aromatase Inhibitors and Tamoxifen | Condition: Breast Cancer, Arthralgia | Keywords: breast cancer, postmenopausal, aromatase inhibitors, tamoxifen, arthralgia, IGF-I, BMI, grip strength | Summary: | Description: N/A | ArmGroups: [{'label': 'tamoxifen', 'description': '100 postmenopausal women with early breast cancer treated with tamoxifen in the adjuvant setting'}, {'label': 'aromatase inhibitors', 'description': '200 postmenopausal women with early breast cancer treated with an aromatase inhibitor in the adjuvant setting'}] | Interventions:N/A | PrimaryOutcomes: [{'measure': 'To assess the effect of BMI on loss of grip strength measured by a modified sphygmomanometer with baseline, month 3, month 6 and month 12 measurements.', 'description': 'measurements occur at baseline, 3 months, 6 months and 12 months', 'timeFrame': '1 year'}] | SecondaryOutcomes: [{'measure': 'IGF-I, GH and IGFBP-3 levels', 'description': 'Serum levels of IGF-I, GH and IGFBP-3 will be measured at baseline, 3, 6 and 12 months after start of treatment.', 'timeFrame': '1 year'}] |
Title: A Phase 1, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti- Tumor Activity of AZD9833 in Japanese Women With ER Positive, HER2 Negative Advanced Breast Cancer | Condition: ER+ HER2- Advanced Breast Cancer | Keywords: Breast Cancer, Phase 1, Safety, Tolerability, Pharmacokinetics, ER Positive, HER2 Negative, Advanced Breast Cancer | Summary: | Description: Objectives:
Primary objective:
To investigate the safety and tolerability of AZD9833 in Japanese women with ER+ HER2- advanced breast cancer
Secondary objective:
To assess the anti-tumor activity and efficacy of AZD9833
Exploratory objectives:
To investigate AZD9833 activity in tumor cells
Overall design:
This is a Phase 1, open-label study designed to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of AZD9833 in Japanese women with endocrineresistant ER+ HER2- breast cancer that is not amenable to treatment with curative intent. Eligible patients will receive AZD9833. In cohort 1 (for tolerability evaluation), a minimum of 3 to maximum 6 evaluable patients will be enrolled.
For cohort 2, if paired biopsy after administration of the study drug becomes inoperable during administration of the study drug, additional subjects can be added to obtain an evaluable biopsy sample.
In cohort 2 (for exploratory research), eligible patients will receive AZD9833 once daily and at least 6 to maximum 12 patients will be enrolled. In cohort 2, paired biopsy sample will be collected from at least 6 and maximum 12 patients. If paired biopsy after administration of the study drug becomes inoperable during administration of the study drug, additional subjects can be added to obtain an evaluable biopsy sample.
Number of Subjects:
Maximum 18 evaluable subjects will be enrolled in this study. | ArmGroups: [{'label': 'AZD9833 monotherapy', 'type': 'EXPERIMENTAL', 'description': 'Dose escalation of AZD9833 monotherapy for patients with ER+ HER2- advanced breast cancer', 'interventionNames': ['Drug: AZD9833']}] | Interventions:[{'type': 'DRUG', 'name': 'AZD9833', 'description': 'AZD9833 taken orally', 'armGroupLabels': ['AZD9833 monotherapy']}] | PrimaryOutcomes: [{'measure': 'The number of subjects with dose-limiting toxicity, as defined in the protocol.', 'description': 'Dose-limiting toxicity as described in the protocol that is not related to disease progression, intercurrent illness or concomitant medications and that, despite optimal therapeutic intervention, meets protocol-defined criteria.', 'timeFrame': 'From the first dose of study treatment up to and including Cycle1 Day28.'}, {'measure': 'The number of subjects with treatment-related adverse events as assessed by CTCAE v5.0.', 'description': 'Safety data will be assessed as the number of subjects with treatment-related adverse events.', 'timeFrame': 'Minimum observation period 28 days on treatment or 28 days with at least 75% of the required dose and will continue until the subject is off the study (approximately 1 year).'}] | SecondaryOutcomes: [{'measure': 'Objective Response Rate', 'description': 'Antitumour activity by evaluation of tumour response assessments using Response Evaluation Criteria in Solid Tumours (RECIST 1.1)', 'timeFrame': 'At Cycle3 Day1, Cycle5 Day1, Cycle7 Day1 (each cycle is 28 days) and every 12 weeks until the end of the study (approximately 1 year).'}, {'measure': 'Duration of Response', 'description': 'Antitumour activity by evaluation of tumour response assessments using Response Evaluation Criteria in Solid Tumours (RECIST 1.1)', 'timeFrame': 'At Cycle3 Day1, Cycle5 Day1, Cycle7 Day1 (each cycle is 28 days) and every 12 weeks until the end of the study (approximately 1 year).'}, {'measure': 'Clinical benefit rate at 24 weeks', 'description': 'Antitumour activity by evaluation of tumour response assessments using Response Evaluation Criteria in Solid Tumours (RECIST 1.1)', 'timeFrame': 'Up to 24 weeks'}, {'measure': 'Percentage Change in Tumour Size', 'description': 'Antitumour activity by evaluation of tumour response assessments using Response Evaluation Criteria in Solid Tumours (RECIST 1.1)', 'timeFrame': 'At Cycle3 Day1, Cycle5 Day1, Cycle7 Day1 (each cycle is 28 days) and every 12 weeks until the end of the study (approximately 1 year).'}, {'measure': 'Progression Free Survival', 'description': 'Antitumour activity by evaluation of tumour response assessments using Response Evaluation Criteria in Solid Tumours (RECIST 1.1)', 'timeFrame': 'Up to objective disease progression or death (approximately 1 year).'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of AZD9833', 'description': 'Blood samples will be collected to assess plasma concentrations of AZD9833 at a series of timepoints to derive Cmax', 'timeFrame': 'At predefined intervals throughout the AZD9833 treatment period (approximately 12 weeks )'}, {'measure': 'Time to observed Cmax (Tmax) for AZD9833', 'description': 'Blood samples will be collected to assess plasma concentrations of AZD9833 at a series of timepoints to derive Tmax', 'timeFrame': 'At predefined intervals throughout the AZD9833 treatment period (approximately 12 weeks )'}] |
Title: Protocol IL-2001: A Multi-Center, Open-Label, Randomized Study of the Efficacy and Safety of Multiple Intratumoral Injections of hIl-2 Plasmid (1.8 mg) Formulated With DOTMA/Cholesterol [Ratio 1:0.5(-/+)] Liposomes in Patients With Unresctable or Recurrent/Refractory Squamous Cell Carcinoma of the Head and Neck | Condition: Head and Neck Cancer | Keywords: recurrent metastatic squamous neck cancer with occult primary, stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, recurrent 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, recurrent squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the nasopharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity | Summary: | Description: OBJECTIVES: I. Compare the efficacy of interleukin-2 gene versus methotrexate in patients with recurrent or refractory squamous cell carcinoma of the head and neck. II. Determine the safety and tolerability of interleukin-2 gene in these patients. III. Compare the quality of life of these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive interleukin-2 gene intratumorally on days 1 and 4 of week 1, and then once weekly for 12 weeks in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive methotrexate IV once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at the beginning of the study and at weeks 5, 13, 17 and 25. Patients are followed every 2-3 weeks for up to 18 weeks.
PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this study. | ArmGroups: N/A | Interventions:[{'type': 'BIOLOGICAL', 'name': 'gene therapy'}, {'type': 'BIOLOGICAL', 'name': 'interleukin-2 gene'}, {'type': 'DRUG', 'name': 'methotrexate'}] | PrimaryOutcomes: N/A | SecondaryOutcomes: N/A |
Title: Effect of Elastic Abdominal Binder on Pain and Functional Recovery Following Gynecologic Cancer Surgery: a Randomized Controlled Trial | Condition: Gynecologic Cancer | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'Elastic abdominal binder', 'type': 'EXPERIMENTAL', 'interventionNames': ['Device: Elastic abdominal binder']}, {'label': 'No binder', 'type': 'NO_INTERVENTION'}] | Interventions:[{'type': 'DEVICE', 'name': 'Elastic abdominal binder', 'description': "Each woman in the intervention group is fitted with an elastic abdominal binder at the time of procedure completion just before leaving the operating room. The binder is placed snuggly tight (keeping in mind patient's comfort) on top of the hospital gown with the incision positioned at the middle part of the binder. The patients are encouraged to wear binders at all time. However, periods of break from wearing the binder are allowed at their convenience.", 'armGroupLabels': ['Elastic abdominal binder']}] | PrimaryOutcomes: [{'measure': 'Daily average postoperative pain scores', 'description': "The participants are asked to rate postoperative pain according to 10-cm visual analog scales from '0' (no pain) to '10' (worst possible pain).", 'timeFrame': 'An average of pain scores at 8:00 am and 4:00 pm, up to 7 days postoperation'}, {'measure': 'Six-minute walk test score change from baseline', 'description': 'Six-minute walk test (6MWT)', 'timeFrame': 'One day before operation and postoperative day 3'}] | SecondaryOutcomes: [{'measure': "Quality of life: EuroQol Group's ED-5D-5L questionnaire", 'description': 'The EuroQol Group\'s ED-5D-5L questionnaire is employed. The health dimensions assessed include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each dimension, the participants are asked to indicate their health state related to that dimension as no problems (score \'1\'), slight problems (score \'2\'), moderate problems (score \'3\'), severe problems (score \'4\'), and extreme problems (score \'5\'). For this study, a score of 1-2 is considered "normal" while a scores of 3-5 is regarded as "problem". In addition, the participants are asked to rate their overall health status according to a visual analog scale EQ VAS with \'0\' corresponding to "the worst health imaginable" and \'100\' indicating "the best health imaginable".', 'timeFrame': 'In the morning of postoperative day 3'}, {'measure': 'Rate of postoperative complications', 'description': 'The complications of interest include febrile morbidity, wound complication, bowel ileus', 'timeFrame': 'In the morning, up to 7 days postoperation'}] |
Title: Multicentric Prospective T1 Urinary Bladder Cancer (ROGUE-1) Registry | Condition: T1 Urinary Bladder Cancer | Keywords: | Summary: | Description: N/A | ArmGroups: N/A | Interventions:[{'type': 'OTHER', 'name': 'Prospective registry', 'description': 'Prospective registry of patients with primary diagnosis of T1 urinary bladder cancer'}] | PrimaryOutcomes: [{'measure': 'Therapy failure', 'description': 'Proportion of patients failing intravesical BCG Therapy and undergo radical cystectomy and the proportion of patients treated with upfront radical cystectomy', 'timeFrame': '2021 to 2028'}] | SecondaryOutcomes: N/A |
Title: A Randomized, Multicenter, Open-Label, Control, Clinical Trial to Evaluate the Efficacy and Safety of Edoxaban on Prevention of Catheter-related Thrombosis (CRT) in Cancer Patients | Condition: Thrombosis, Venous, Cancer, Catheter Complications | Keywords: Prevention, Catheter-related Thrombosis, Cancer, Edoxaban | Summary: | Description: This study was a prospective, interventional, open, randomized controlled clinical study. A total of 366 patients with cancers who will be assessed as high risk by the thrombosis risk prediction model (refer to Appendix 1) are planned to be enrolled. All patients are planned to undergo anti-tumor chemotherapy and receive CVC or PICC catheterization on the first day of chemotherapy. The patients are randomly divided into the experimental group and the control group at a ratio of 1:1. The experimental group is treated with edoxaban to prevent catheter-related thrombosis, and the control group won't be treated with edoxaban. Venous vascular ultrasound will be conducted before the start of each cycle of chemotherapy or whenever patients have any thrombosis-related symptoms to assess whether they have catheter-related thrombosis. The incidence of catheter-related thrombosis during catheter. 1. The safety of edoxaban.2. The death caused by catheter-related thrombosis.3. The time of non thrombotic events.4. The incidence of venous thrombosis. | ArmGroups: [{'label': 'The cohort 1', 'type': 'EXPERIMENTAL', 'description': 'The cohort 1 is treated with edoxaban to prevent catheter-related thrombosis.', 'interventionNames': ['Drug: Edoxaban']}, {'label': 'The cohort 2', 'type': 'NO_INTERVENTION', 'description': "The cohort 2 won't be treated with edoxaban."}] | Interventions:[{'type': 'DRUG', 'name': 'Edoxaban', 'description': 'Edoxaban, an oral selective factor Xa inhibitor, had been approved by the National Medical Products Administration in 2018. It is used for the treatment and recurrence prevention of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adults.', 'armGroupLabels': ['The cohort 1']}] | PrimaryOutcomes: [{'measure': 'The incidence of catheter-related thrombosis during catheter', 'timeFrame': '6 months'}] | SecondaryOutcomes: [{'measure': 'The incidence of bleeding caused by edoxaban', 'description': 'The incidence of bleeding caused by edoxaban including major bleeding, clinically relevant non-major bleeding and minor bleeding. The criteria is shown in Appendix 3.', 'timeFrame': '6 months'}, {'measure': 'The mortality rate caused by catheter-related thrombosis', 'timeFrame': '6 months'}, {'measure': 'The time of non thrombotic events', 'timeFrame': '6 months'}, {'measure': 'The incidence of venous thrombosis', 'timeFrame': '6 months'}] |
Title: A Phase 2 Study of EGF816 and Gefitinib in TKI-naïve EGFR-mutant Non-Small Cell Lung Cancer | Condition: Lung Cancer | Keywords: Lung Cancer | Summary: | Description: This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease or patient population. "Investigational" means that the drug or drugs are being studied and have not been approved together for patients.
The FDA (the U.S. Food and Drug Administration) has approved gefitinib as a treatment option for EGFR mutation-positive lung cancer.
The FDA has not approved EGF816 as a treatment for any disease at this time.
In this research study, the investigators are studying the safety and efficacy of the combination of the study drugs EGF816 and gefitinib.
Both EGF816 and gefitinib are inhibitors which target a specific mutation in cancer and may stop tumors growing and multiplying. | ArmGroups: [{'label': 'EGF816 + Gefitinib', 'type': 'EXPERIMENTAL', 'description': '* All patients will receive gefitinib orally once daily\n* EGF816 will be administered orally once daily\n* Participant will be requested to maintain a medication diary of each dose of medication', 'interventionNames': ['Drug: EGF816', 'Drug: Gefitinib']}] | Interventions:[{'type': 'DRUG', 'name': 'EGF816', 'description': 'EGF816 is an inhibitor which target a specific mutation in cancer and may stop tumors growing and multiplying', 'armGroupLabels': ['EGF816 + Gefitinib']}, {'type': 'DRUG', 'name': 'Gefitinib', 'description': 'Gefitinib is an inhibitor which target a specific mutation in cancer and may stop tumors growing and multiplying', 'armGroupLabels': ['EGF816 + Gefitinib'], 'otherNames': ['Iressa']}] | PrimaryOutcomes: [{'measure': 'Progression Free Survival at 9 months', 'description': 'The number of participants that are free from objective disease progression or death at 9 months. Progression is evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.\n\nProgressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).', 'timeFrame': '9 months'}] | SecondaryOutcomes: [{'measure': 'Response Rate', 'description': 'The number of participants that achieve either a complete response (CR) or a partial response (PR). Response is evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.\n\n* Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm.\n* Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.\n\nAll CRs and PRs must be confirmed by a second assessment not earlier than 4 weeks after the criteria for response are first met.', 'timeFrame': '2 years'}, {'measure': 'Overall Survival', 'description': 'Overall survival is defined as time from the start of treatment until death. Overall survival will be analyzed using the Kaplan-Meier method.', 'timeFrame': '2 years'}, {'measure': 'Safety and Tolerability of the EGF816/gefitinib combination (Summary of the adverse events experienced by study participants as evaluated by CTCAE v4)', 'description': 'Summary of the adverse events experienced by study participants as evaluated by Common Terminology Criteria for Adverse Events (CTCAE) v4.', 'timeFrame': '2 years'}] |
Title: A Phase I, Single Centre, Open-label Study of TLX592 to Assess the Safety and Tolerability, Pharmacokinetics, Biodistribution and Radiation Dosimetry in Patients Diagnosed With Prostate Cancer | Condition: Metastatic Prostate Cancer | Keywords: prostate cancer, biodistribution, 64Cu-TLX592, pharmacokinetics, dosimetery, safety | Summary: | Description: The optimisation dose and imaging conditions will be conducted in prostate cancer patients with with oligometastatic disease ( (defined as 5 sites or less outside of the prostate bed). On determining the optimal dose and imaging conditions, an additional cohort of patients with a higher tumour burden such as multiple metastatic sites across ≥10 regions will be assessed.
Study conduct:
Nine, prostate cancer patients with oligometastatic disease as detected using 68Ga-PSMA-11 or 18F-DCFPyl PSMA PET/CT scanning (defined as 5 sites or less outside of the prostate bed) will be randomised to one of three treatment groups to receive a single injection of:
* Group 1: 2mg of TLX592, labelled with 300 MBq (± 10%) 64Cu.
* Group 2: 2mg of TLX592, labelled with 300 MBq (± 10%) 64Cu combined with 8mg of unlabelled TLX592 (mass dose of 10mg).
* Group 3: 2mg of TLX592, labelled with 300 MBq (± 10%) 64Cu combined with 18mg of unlabelled TLX592 (mass dose of 20mg). If one of the three patients in a specific group experiences a dose-limiting toxicity, three more patients will be treated at the same dose level.
Patients with a higher tumour burden such as multiple metastatic sites across ≥10 regions \[regions: prostate bed, pelvic lumph nodes, skeleton, distant sites (including viscera)\] as detected on 68Ga-PSMA or 18F-DCFPyl PMSA imaging agent will be allocated to a fourth group.
• Group 4: based on the result of Groups 1-3, the optimal dose and imaging timepoints will be selected to treat 3 patients with higher tumour burden (≥10 metastatic sites and/or visceral disease as detected on a 68Ga-PSMA-11 or 18F-DCFPyl PSMA PET/CTscan).
For dosimetry analysis, biodistribution whole body PET/CT imaging will be performed at 1, 4 ± 0.5h, 20 ± 4h, with the option for a an additional two scans to be performed between the 36-120 hours post administration of the investigational product. The additional scans after the 20h timepoint will be at the discretion of the investigator. Patients will be imaged on a Siemens Biographe scanner, offering the possibility of TOF (time-of-flight) and non-TOF reconstruction.
Comparative tumour PET/CT imaging:
On Days 0, 1 and potentially at 36-120h the biodistribution and tumour imaging will be performed using gated or list mode acquisition, for generation of sub-partitioned data.Such data will allow the mathematical generation of statistically independent images for various dose levels, based on the actual dose administered in the trial.
An end of study visit will be conducted on Day 28 ± 2 days. 64Cu-TLX592 images will be centrally analysed for absorbed organ and whole body doses in a standardised fashion. In addition, tumour absorbed doses will be determined for scientific purposes (estimation of achievable tumour doses of therapeutic nuclides labelled to TLX592). All image data analyses will be performed / confirmed centrally.
Pharmacokinetic analysis:
Blood samples will be taken at the following times and counted in a gamma counter:
* Pre-dose
* 1, 4 ± 0.5h, 20 ± 4h and 48 ± 4h after the administration of 64Cu-TLX592. | ArmGroups: [{'label': 'Dose level 1 of 64Cu-TLX592', 'type': 'EXPERIMENTAL', 'description': 'Three patients will be intravenously administered with a single injection of 2mg of TLX592, labelled with 300 MBq (± 10%) 64Cu', 'interventionNames': ['Drug: 64Cu-DOTA-TLX592']}, {'label': 'Dose level 2 of 64Cu-TLX592', 'type': 'EXPERIMENTAL', 'description': 'Three patients will be intravenously administered with a single injection of 2mg of TLX592, labelled with 300 MBq (± 10%) 64Cu combined with 8mg of unlabelled TLX592 (mass dose of 10mg).', 'interventionNames': ['Drug: 64Cu-DOTA-TLX592']}, {'label': 'Dose level 3 of 64Cu-TLX592', 'type': 'EXPERIMENTAL', 'description': 'Three patients will be intravenously administered with a single injection of 2mg of TLX592, labelled with 300 MBq (± 10%) 64Cu combined with 18mg of unlabelled TLX592 (mass dose of 20mg).', 'interventionNames': ['Drug: 64Cu-DOTA-TLX592']}, {'label': 'Confirmation of optimal 64Cu-TLX592 dose', 'type': 'EXPERIMENTAL', 'description': 'Based on the result of Groups 1-3, the optimal dose and imaging timepoints will be selected to treat 3 patients with higher tumour burden (≥10 metastatic sites and/or visceral disease as detected on a 68Ga-PSMA-11 or 18F-DCFPyl PSMA PET/CT scan).\n\nThree patients will be intravenously administered with a single injection of 2mg of TLX592, labelled with 300 MBq (± 10%) 64Cu combined with 0, 8 or 18mg of unlabelled TLX592.', 'interventionNames': ['Drug: 64Cu-DOTA-TLX592']}] | Interventions:[{'type': 'DRUG', 'name': '64Cu-DOTA-TLX592', 'description': 'TLX592, a humanised, engineered monoclonal antibody HuX592r conjugated with a DOTA chelator and radiolabelled with 64Cu (64Cu-TLX592)', 'armGroupLabels': ['Confirmation of optimal 64Cu-TLX592 dose', 'Dose level 1 of 64Cu-TLX592', 'Dose level 2 of 64Cu-TLX592', 'Dose level 3 of 64Cu-TLX592'], 'otherNames': ['64Cu-TLX592']}] | PrimaryOutcomes: [{'measure': 'Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0', 'description': 'Treatment emergent adverse events (TEAE) will be classified according to MedDRA (Medical Dictionary for Regulatory Activities), frequency, severity according to NCI CTCAE V5.0, seriousness, and relationship of study treatment will be assessed. Laboratory abnormalities will be assessed according to the NCI CTCAE v.5.0', 'timeFrame': 'Day 1 to 28'}, {'measure': 'Pharmacokinetics of 64Cu-TLX592', 'description': 'Patient plasma samples at 0h, 1h, 4 ± 0.5h, 20 ± 4h and 48 ± 4h after the administration of 64Cu-TLX592 will be counted for radioactivity.', 'timeFrame': 'Day 1-4 after a single administration of 64Cu-TLX592'}, {'measure': 'Biodistribution of 64Cu-TLX592', 'description': 'On Days 0, Day 1 and potentially at 36-120h after administration of the investigational product, the biodistribution and tumour imaging will be performed. An end of study visit will be conducted on Day 28 ± 2 days. 64Cu-TLX592 images will be centrally analysed for absorbed organ and whole body doses in a standardised fashion. In addition, tumour absorbed doses will be determined for scientific purposes (estimation of achievable tumour doses of therapeutic nuclides labelled to TLX592)', 'timeFrame': 'Up to 24h after a single administration of 64Cu-TLX592'}, {'measure': 'Dosimetry of 64Cu-TLX592', 'description': 'For dosimetry analysis, biodistribution whole body PET/CT imaging will be performed at 1h, 4 ± 0.5h, 20 ± 4h, with the option for a an additional two scans to be performed between the 36-120 hours.', 'timeFrame': 'Up to 5 days after a single administration of 64Cu-TLX592'}] | SecondaryOutcomes: [{'measure': 'Optimal antibody dose of TLX592', 'description': 'The optimal antibody mass dose and its effect on the biological clearance of 64Cu- TLX592 from blood and radiation dose to tumour will be conducted on Day 0, Day 1 and potentially at 36-120h. The optimal antibody mass dose will be performed using gated or list mode acquisition, for generation of sub-partitioned data. Such data will allow the mathematical generation of statistically independent images for various dose levels, based on the actual dose administered in the trial.', 'timeFrame': 'Single diagnostic administration 1 day, followed by a diagnostic scan on Day 1'}, {'measure': 'Comparison of PSMA-targeting of different PMSA-imaging agents', 'description': 'To evaluate the comparability of PET images and PSMA-targeting characteristics between 64Cu-TLX592 and 68Ga-PSMA-11 and 18F-DCFPyl PSMA imaging agents.', 'timeFrame': 'Single diagnostic administration 1 day, followed by a diagnostic scan on Day 1.'}] |
Title: E-Interventions to Treat Fear of Cancer Recurrence for Patients With Localized Renal Cell Carcinoma | Condition: Renal Cell Carcinoma | Keywords: | Summary: | Description: PRIMARY OBJECTIVES:
I. To assess feasibility and acceptability of the iConquerFear program for patients with renal cell carcinoma (RCC).
II. To assess preliminary effects of the program on Fear of Cancer Recurrence-7 item scale (FCR-7), Patient-Reported Outcomes Measurement Information System (PROMIS)-anxiety, PROMIS-depression, and Functional Assessment of Chronic Illness Therapy-General (FACT-G).
III. Explore differences in feasibility and efficacy of iConquerFear by sociodemographic or clinical factors.
OUTLINE:
Patients complete 5 sessions of iConquerFear program online over 5 weeks. Patients also complete questionnaires at baseline, after the intervention, and 2 months later. | ArmGroups: [{'label': 'Supportive care (iConquerFear program, questionnaires)', 'type': 'EXPERIMENTAL', 'description': 'Patients complete 5 sessions of iConquerFear program online over 5 weeks. Patients also complete questionnaires at baseline, after the intervention, and 2 months later.', 'interventionNames': ['Other: Internet-Based Intervention - Complete iConquerFear program', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}] | Interventions:[{'type': 'OTHER', 'name': 'Internet-Based Intervention - Complete iConquerFear program', 'description': 'Online adaptation of a highly effective face-to-face treatment for fear of recurrence.', 'armGroupLabels': ['Supportive care (iConquerFear program, questionnaires)']}, {'type': 'OTHER', 'name': 'Quality-of-Life Assessment', 'description': 'Ancillary studies', 'armGroupLabels': ['Supportive care (iConquerFear program, questionnaires)'], 'otherNames': ['Quality of Life Assessment']}, {'type': 'OTHER', 'name': 'Questionnaire Administration', 'description': 'Complete questionnaires', 'armGroupLabels': ['Supportive care (iConquerFear program, questionnaires)']}] | PrimaryOutcomes: [{'measure': 'Feasibility - Accrual', 'description': 'at least 90% of the desired accrual goal is reached within 12 months', 'timeFrame': '1 year'}, {'measure': 'Feasibility - completion of Interventions', 'description': 'At least 70% of patients complete 3/5 intervention sessions, assessed as follows:\n\ni. ≥70% of patients complete first intervention session ii. ≥70% of patients complete second intervention session iii. ≥70% of patients complete third intervention session', 'timeFrame': '1 year'}, {'measure': 'Feasibility - retention/evaluation', 'description': '≥70% of patients have at least 2 of 3 evaluable time points, assessed as follows: i. All patients will have timepoint 1 assessment, which is required at time of accession ii. ≥70% of patients must be evaluable at timepoint 2 or timepoint 3 \\[in rare cases, patients will skip in intermediary time point but compelete a later timepoint evaluation\\]', 'timeFrame': '1 year'}] | SecondaryOutcomes: [{'measure': 'Preliminary effects of iConquerFear program - FCR 7', 'description': 'Analysis of Variance (ANOVA) will be used to explore changes in scores over time, separately for the metrics obtained from Fear of Cancer Recurrence-7 item scale (FCR-7)\n\nAll instruments will be scored according to validated instructions. All available time points will be used in each analysis.\n\nFear of Cancer Recurrence-7. This is a 7-item scale that assesses the degree of FCR, with a cutoff score of 17 or above indicative of moderate and a cutoff score of 27 or above indicative of severe FCR.', 'timeFrame': 'Baseline (T1), immediately after the intervention expected at 5 weeks after baseline (T2), and at 2 months follow-up (T3, 2 months following T2)]'}, {'measure': 'Preliminary effects of iConquerFear program - (PROMIS)-Anxiety', 'description': 'Analysis of Variance (ANOVA) will be used to explore changes in scores over time, separately for the metrics obtained from Patient-Reported Outcome Measurement Information System (PROMIS)-Anxiety.\n\nAll instruments will be scored according to validated instructions. All available time points will be used in each analysis.\n\nPROMIS Emotional Distress: Anxiety. This 8-item measure assesses symptoms of anxiety on a 5-point scale (1=never, 5=always). Scores range from 7-35 with higher scores indicating greater severity of anxiety.', 'timeFrame': 'Baseline (T1), immediately after the intervention expected at 5 weeks after baseline (T2), and at 2 months follow-up (T3, 2 months following T2)]'}, {'measure': 'Preliminary effects of iConquerFear program - PROMIS -depression', 'description': 'Analysis of Variance (ANOVA) will be used to explore changes in scores over time, separately for the metrics obtained from Patient-Reported Outcome Measurement Information System (PROMIS)-depression.\n\nAll instruments will be scored according to validated instructions. All available time points will be used in each analysis.\n\nPROMIS Emotional Distress: Depression. This 8-item measure assesses symptoms of depression on a 5-point scale (1=never, 5=always). Scores range from 8-40 with higher scores indicating greater severity of depression.', 'timeFrame': 'Baseline (T1), immediately after the intervention expected at 5 weeks after baseline (T2), and at 2 months follow-up (T3, 2 months following T2)]'}, {'measure': 'Preliminary effects of iConquerFear program - FACT-G', 'description': "Analysis of Variance (ANOVA) will be used to explore changes in scores over time, separately for the metrics obtained from Functional Assessment of Chronic Illness Therapy-General (FACT-G).\n\nAll instruments will be scored according to validated instructions. All available time points will be used in each analysis.\n\nFunctional Assessment of Chronic Illness Therapy-General (FACT-G). A 27-item self-related scale measure QoL across four domains of 'well-being' (physical, social/family, emotional and functional) on a 4-point Likert scale. Scores range from 0-28 for the physical, social/family and functional subscales, 0-24 for the emotional subscale and 0-108 for the total score. Higher scores indicate higher quality of life.", 'timeFrame': 'Baseline (T1), immediately after the intervention expected at 5 weeks after baseline (T2), and at 2 months follow-up (T3, 2 months following T2)]'}] |
Title: Assessing Financial Difficulty in Patients With Blood Cancers | Condition: Chronic Lymphocytic Leukemia, Plasma Cell Myeloma | Keywords: | Summary: | Description: The primary and secondary objectives of the study:
PRIMARY OBJECTIVES:
I. To estimate the proportion of patients with multiple myeloma (MM) or chronic lymphocytic leukemia (CLL) who report experiencing financial difficulty in the past 12 months.
SECONDARY OBJECTIVES:
I. To describe the association of patient report of financial difficulty with insurance status.
II. To describe the association of patient report of financial difficulty with receiving treatment at sites of care that report offering patients financial guidance through navigators or social workers, and controlling for patient socioeconomic status.
III. To describe the types of psychosocial, transportation and financial navigation interventions sites are developing.
IV. To identify distinct patterns of financial burden among patients undergoing treatment for MM or CLL.
V. To examine the relationship between distinct patterns of financial burden with patient report of financial difficulty, patient socio-demographics, and patient disease characteristics.
VI. To estimate the proportion of patients with MM or CLL undergoing treatment who report receiving financial support in the past 12 months.
VII. To describe the association of patient report of receiving financial support with receiving treatment at sites of care offering patients financial guidance through navigators or social workers, and with socioeconomic status.
VIII. To describe the magnitude of patient concerns regarding treatment and costs of care.
IX. To describe the association of patient concerns regarding treatment and costs of care with patient socio-demographics, disease and site of care characteristics.
X. To describe the association of financial difficulty with patient self-reported health and well-being.
Trial Design:
OUTLINE:
Participants undergo medical chart abstraction within 1 week and complete telephone interview over 30-45 minutes within 8 weeks after registration. | ArmGroups: [{'label': 'Observational (medical chart, interview)', 'description': 'Participants undergo medical chart abstraction within 1 week and complete telephone interview over 30-45 minutes within 8 weeks after registration.', 'interventionNames': ['Other: Medical Chart Review', 'Other: Interview', 'Other: Questionnaire', 'Other: Quality-of-Life Assessment']}] | Interventions:[{'type': 'OTHER', 'name': 'Medical Chart Review', 'description': 'Undergo medical chart abstraction', 'armGroupLabels': ['Observational (medical chart, interview)']}, {'type': 'OTHER', 'name': 'Interview', 'description': 'Complete telephone interview', 'armGroupLabels': ['Observational (medical chart, interview)']}, {'type': 'OTHER', 'name': 'Questionnaire', 'description': 'Ancillary studies', 'armGroupLabels': ['Observational (medical chart, interview)']}, {'type': 'OTHER', 'name': 'Quality-of-Life Assessment', 'description': 'Ancillary studies', 'armGroupLabels': ['Observational (medical chart, interview)']}] | PrimaryOutcomes: [{'measure': 'Proportion of patients with MM and/or CLL who report experiencing financial difficulties in the past 12 months', 'description': 'Financial difficulties will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) financial difficulty item #28 regarding financial difficulties with a modified recall period: "Has your physical condition or medical treatment caused you financial difficulties in the past year?", measured as "Not at all/A little/Quite a bit/Very much." Participant responses will be dichotomized as follows: "Not at all" or "A little" classified as "No", and "Quite a bit" and "very much" classified as "Yes." This dichotomized response will be assessed using Wilson score confidence interval (95%).', 'timeFrame': 'Up to 8 weeks'}] | SecondaryOutcomes: [{'measure': 'Association of insurance status with financial difficulties in the past 12 months assessed with the EORTC QLQ-C30 financial difficulty item', 'description': 'The association of patient report of financial difficulty as measured by the EORTC QLQ-C30 item #28 regarding financial difficulties with a modified recall period: "Has your physical condition or medical treatment caused you financial difficulties in the past year?" with insurance status (defined as those with Medicare/Medicaid v. those with commercial insurance) will be assessed using Mann-Whitney U test. Item #28 on the EORTC QLQ-C30 is measured as "Not at all/A little/Quite a bit/Very much", converted to 0, 1, 2 and 3 respectively for the purposes of analysis.', 'timeFrame': 'Up to 8 weeks'}, {'measure': 'Association of financial difficulties in the past 12 months assessed with the EORTC QLQ-C30 and receiving treatment at practices that report offering patients financial guidance.', 'description': 'The association of patient report of financial difficulty as measured by the EORTC QLQ-C30 item #28 with receiving treatment at sites of care that report offering patients financial guidance through navigators or social workers as measured by question 20 of the protocol practice survey will be tested using multinomial logistic regression modeling. In this model the outcome will be the patient report of financial difficulty, and the covariates will be the financial guidance questions from the protocol practice survey, along with disease/treatment characteristics and indicators of patient socioeconomic status. Question 20 of the protocol practice survey asks the site to state the financial navigation services that are currently offered at their practice to all cancer patients or their families. If a site offers at least one service, they will be treated as offering financial guidance (measured as "Yes/No").', 'timeFrame': 'Up to 8 weeks'}, {'measure': 'Association of financial difficulties in the past 12 months assessed with the EORTC QLQ-C30 and patient socioeconomic status', 'description': 'The association of patient socioeconomic status (as measured by part 3, question 6 of the patient protocol survey) and patient reported financial difficulty (as measured by item #28 of the EORTC QLQ-C30) will be tested using multinomial logistic regression modeling. In this model the outcome will be the patient report of financial difficulty, and the covariates will be the patient reported total household income. Item #28 on the EORTC QLQ-C30 is measured as "Not at all/A little/Quite a bit/Very much", converted to 0, 1, 2 and 3 respectively for the purposes of analysis. Part 3, question 6 of the patient protocol survey asks the patient to state the total income of the household they live in and is measured with the following options: less than $20,000, $20,000 - 39,999, $40,000 - 59,999, $60,000 - 79,999, $80,000 - 99,999, $100,000 or more, Don\'t know.', 'timeFrame': 'Up to 8 weeks'}, {'measure': 'Financial support evaluated using site-reported plans of developing psychosocial, transportation and financial navigation services found in the Site of Care Survey', 'description': 'Descriptive statistics will be used to describe the site-reported plans of developing psychosocial (question 46 of the protocol site survey), transportation (question 33 of the protocol site survey), and financial navigation services (question 24 of the protocol site survey). Each of these questions asks the site to state if they have plans to develop or enhance psychosocial, transportation or financial navigation services (all answered as "Yes/No" questions).', 'timeFrame': 'Up to 8 weeks'}, {'measure': 'Identify distinct patterns of financial burden assessed with the EORTC QLQ-C30 among patients undergoing treatment for MM and/or CLL', 'description': 'Patterns of financial difficulty (item #28 of the EORTC QLQ-C30) will be assessed utilizing measures of patient reported difficulties paying medical bills (part 1, question 1), delays or foregoing treatment (as measured by part 1, question 4), difficulties covering non-medical expenses due to costs of treatment (part 1, question 7), and financial worries (part 1,). Exploratory LCA will be conducted to assess these patterns. Question 1 asks the participant if they had any problems paying any medical bills in the last twelve months (Yes/No). Question 4 asks the participant if they y delayed medical care because they were worried about the cost (Yes/No). Question 7asks the participant if they had to make any sacrifices in the past 5 years because of debt related to medical care (Yes/No). Question 9 asks the participant if they get sicker or have an accident, how worried are they that they will not be able to pay for their medical bills (Very, Somewhat or Not worried).', 'timeFrame': 'Up to 8 weeks'}, {'measure': 'To examine the relationship between distinct patterns of patient-reported financial burden with patient report of financial difficulty, with patient socio-demographics, and with patient disease characteristics.', 'description': 'This analysis will identify the relationship between distinct patterns of financial burden (as measured by part 1, question 2 of the protocol patient survey) with patient report of financial difficulty (as measured by item #28 of the EORTC QLQ-C30). Financial difficulty will be modeled as a latent class predictor within a multinomial logistic regression in addition to the original LCA measurement model. Item #28 on the EORTC QLQ-C30 is measured as "Not at all/A little/Quite a bit/Very much", converted to 0, 1, 2 and 3 respectively for the purposes of analysis. Part 1, question 2 of the protocol patient survey asks the participant if they or anyone in their family have medical bills that they are unable to pay at all.', 'timeFrame': 'Up to 8 weeks'}, {'measure': 'Proportion of patients who report receiving financial support in the past 12 months', 'description': 'The proportion of patients who report receiving financial support (patient survey part 2 question 3 \\[yes/no\\]) in the past 12 months will be described using summary statistics.', 'timeFrame': 'Up to 8 weeks'}, {'measure': 'To describe the association of patient report of receiving financial support with receiving treatment at practices offering patients financial guidance through navigators or social workers, and with socioeconomic status.', 'description': 'Logistic regression with receipt of financial support in the past 12 months (patient survey part 2 question 3 \\[yes/no\\]) as the dependent variable will be used to test the hypothesis that individuals with multiple myeloma (MM) or chronic lymphocytic leukemia (CLL) will be more likely to report receipt of financial support if they are treated at practices reporting that they offer patients financial guidance through navigators or social workers compared to those treated at practices without these resources. The model will control for disease/treatment characteristics and indicators of patient socioeconomic status.', 'timeFrame': 'Up to 8 weeks'}, {'measure': 'Patient concerns regarding treatment and costs assessed using aggregate scores of the Valuing Dimensions of the Patient Experience Questionnaire', 'description': 'Aggregate scores of the Valuing Dimensions of the Patient Experience Questionnaire measuring patient concerns regarding treatment and costs of care (part 1, questions 22-36 of the protocol patient survey) will be analyzed descriptively. These questions are all assessed as "Very worried", "Somewhat worried" and "Not worried" will be scored as 2, 1 and 0 respectively and aggregated using standard practices.', 'timeFrame': 'Up to 8 weeks'}, {'measure': 'To describe the association of patient concerns regarding treatment and costs of care with patient socio-demographics, disease characteristics, and practice characteristics.', 'description': 'Aggregate scores of the Valuing Dimensions of the Patient Experience Questionnaire measuring patient concerns regarding treatment and costs of care (part 1, questions 22-36 of the protocol patient survey) will be stratified by demographics (e.g. gender, race/ethnicity), socioeconomic characteristics (e.g. education, income), disease characteristics (e.g. MM, CLL), and practice-specific factors (e.g. presence of a social worker/patient navigator). These questions are all assessed as "Very worried", "Somewhat worried" and "Not worried" will be scored as 2, 1 and 0 respectively and aggregated using standard practices. Differences in the aggregate scores between groups will be tested using t-tests. Adjustment for multiple comparisons will not be conducted, which is consistent with social science and/or preference based research.', 'timeFrame': 'Up to 8 weeks'}, {'measure': 'Association of financial difficulties in past 12 months assessed with EORTC QLQ-C30 and patient health/well-being assessed using Patient-Reported Outcomes Measurement Information System (PROMIS)-10, EuroQol EQ-5D-5L, Brief Appraisal Inventory (BAI)', 'description': "Aggregate scores of the PROMIS-10, EQ-5D-5L and the BAI will be utilized as covariates in a logistic regression model to assess if there is any association with them and the outcome of patient-reported financial difficulty (item #28 of the EORTC QLQ-C30). The PROMIS-10 is a 10-item instrument scored on a scale from 0 - 50 (higher scores = improved QOL). The EQ-5D-5L is a 5-item instrument (5 point scales scored 1-5, where higher scores = worse QOL) and the EQ Visual Analogue scale to score the patient's self-rated health on a scale from 0-100, where higher scores = better QOL. The BAI is a 23-item questionnaire asking patients to rate how often they thought about a variety of topics (Always, Often, Sometimes, Rarely, Never, Not Applicable and Refused to answer). Questions are scored on a scale from 1-5 (Not Applicable and Refused to answer are 88 and 99, respectively, and excluded from scoring), and the questionnaire is scored using standard scoring algorithms.", 'timeFrame': 'Up to 8 weeks'}] |
Title: Phase II Study: Stereotactic Ablative Radiotherapy for Renal Tumors | Condition: Renal Tumor | Keywords: Stereotactic Body Radiation Therapy, SABR, Radiation Therapy, Renal Cell Carcinoma, RCC | Summary: | Description: N/A | ArmGroups: [{'label': 'Stereotactic Ablative Radiotherapy', 'type': 'EXPERIMENTAL', 'description': 'Adult patients with Kidney mass (either primary or metastasis) amenable to SABR', 'interventionNames': ['Radiation: Stereotactic Ablative Radiotherapy']}] | Interventions:[{'type': 'RADIATION', 'name': 'Stereotactic Ablative Radiotherapy', 'description': 'Stereotactic Ablative Radiotherapy to renal tumors with a dose of 27.5-40 Gy in 5 fractions.', 'armGroupLabels': ['Stereotactic Ablative Radiotherapy']}] | PrimaryOutcomes: [{'measure': 'To evaluate the radiation induced renal impairments in patients receiving SABR.', 'description': 'The prevalence of nephron toxicity in patients treated with SABR, measured by the change in Glomerular Filtration Rate (GFR) every 4 months over 2 years.', 'timeFrame': '2 years'}] | SecondaryOutcomes: [{'measure': 'Chronic Kidney Disease Stage Progression', 'description': 'Chronic kidney disease stage progression after SABR, assessed by the Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines', 'timeFrame': '2 years'}, {'measure': '2-year Local recurrence rate', 'description': '2 year local recurrence rate of kidney tumors treated with SABR, measured by assessing the change of irradiated kidney function on functional imaging.', 'timeFrame': '2 years'}, {'measure': 'Patient Reported Outcomes', 'description': 'The change in quality of life of patients treated with SABR, assessed through the use of NCCN FKSI-19 questionnaire.', 'timeFrame': '2 years'}, {'measure': 'Incidence of acute and late toxicities', 'description': 'The incidence of acute (≤3 months) and late complication of interest (GI or GU complications, high blood pressure and adrenal insufficiency) as assessed by CTCAE version 5.0.', 'timeFrame': '2 years'}] |
Title: A Phase Ib Dose-finding Study of BYL719 Plus Everolimus and BYL719 Plus Everolimus Plus Exemestane in Patients With Advanced Solid Tumors, With Dose-expansion Cohorts in Renal Cell Cancer (RCC), Pancreatic Neuroendocrine Tumors (pNETs), and Advanced Breast Cancer (BC) Patients. | Condition: Neoplasms, Breast Neoplasms, Kidney Neoplasms, Pancreatic Neuroendocine Neoplasms (pNETs) | Keywords: Solid tumors, renal cell carcinoma (RCC), pancreatic neuroendocrine tumors, breast cancer, PI3K inhibitor, BYL719, alpelisib, everolimus, exemestane | Summary: | Description: The main purpose of the study was to determine the maximum tolerated dose/recommended dose for expansion (MTD/RDE) of alpelisib in combination with everolimus, and of alpelisib in combination with everolimus and exemestane, and additionally to describe safety, preliminary efficacy and the magnitude of the alpelisib-everolimus interaction. The study was conducted in patients with metastatic and/or recurrent solid tumors including renal cell carcinoma (RCC), pancreatic neuroendocrine tumor (pNET), and advanced solid tumors previously treated with an mTOR inhibitor, to evaluate everolimus and alpelisib, and in postmenopausal females with HR-positive HER2-negative advanced breast cancer to evaluate everolimus, alpelisib and exemestane.
This was a Phase Ib, open-label, multi-center, dose-finding study. The initial dose level of alpelisib was 300 mg every day (qd) and everolimus was initially administered at 2.5 mg qd. The dose-finding study (escalation phase) was followed by an expansion phase where safety and preliminary efficacy of the doublet (alpelisib and everolimus) as well as of the triplet (alpelisib, everolimus and exemestane) were assessed in selected subject populations.
Alpelisib, everolimus and exemestane were administered orally once daily on a continuous dosing schedule and dosed on a flat-fixed dose and not by body weight or body surface area, starting on Day 1 in a 28-day cycle.
In the doublet escalation phase, alpelisib was administered at 300 mg or 250 mg in combination with 2.5 mg everolimus. In the triplet escalation phase, alpelisib was administered at 200 mg in combination with 2.5 mg everolimus and 25 mg exemestane.
In the doublet expansion phase, alpelisib was administered at 250 mg in combination with 2.5 mg everolimus. In the breast cancer expansion phase, alpelisib was administered at 200 mg in combination with 2.5 mg everolimus and 25 mg exemestane or alpelisib was administered at 250 mg in combination with 25 mg exemestane.
No fixed treatment duration was specified. Patients in the study were planned to receive the treatment until disease progression (assessed by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)), unacceptable toxicity, death, or discontinuation from study treatment for any other reason. | ArmGroups: [{'label': 'alpelisib and everolimus', 'type': 'EXPERIMENTAL', 'description': 'alpelisib and everolimus administered once a day', 'interventionNames': ['Drug: alpelisib', 'Drug: everolimus']}, {'label': 'alpelisib, everolimus and exemestane', 'type': 'EXPERIMENTAL', 'description': 'alpelisib, everolimus and exemestane administered once a day', 'interventionNames': ['Drug: alpelisib', 'Drug: everolimus', 'Drug: exemestane']}, {'label': 'alpelisib and exemestane', 'type': 'EXPERIMENTAL', 'description': 'alpelisib and exemestane administered once a day', 'interventionNames': ['Drug: alpelisib', 'Drug: exemestane']}] | Interventions:[{'type': 'DRUG', 'name': 'alpelisib', 'description': 'alpelisib is administered orally once a day on a continuous dosing schedule and dosed on a flat-fixed dose and not adjusted by body weight or body surface area, starting on Day 8 of Cycle 1 in the dose escalation and Day 1 of Cycle 1 in the dose expansion.\n\nIn the doublet dose escalation, the alpelisib starting dose is 300 mg. The alpelisib dose may be escalated or de-escalated, as needed.\n\nIn the triplet dose escalation part, the alpelisib starting dose is one dose level lower of the MTD as determined during the doublet escalation. The alpelisib dose may be escalated or de-escalated, as needed.\n\nIn the doublet dose expansion and triplet dose expansion (patients assigned to alpelisib, everolimus and exemestane), alpelisib is administered at the recommended dose determined in the dose escalation.\n\nIn the triplet dose expansion (patients assigned to alpelisib and exemestane), alpelisib is administered at a dose of 250 mg daily.', 'armGroupLabels': ['alpelisib and everolimus', 'alpelisib and exemestane', 'alpelisib, everolimus and exemestane']}, {'type': 'DRUG', 'name': 'everolimus', 'description': 'everolimus is administered orally once a day on a continuous dosing schedule and dosed on a flat-fixed dose and not adjusted by body weight or body surface area, starting on Day 1 of cycle 1 in both the dose escalation and dose expansion parts.\n\nIn the dose escalation part, the everolimus starting dose is 2,5 mg. In the dose expansion part, everolimus is administered at the recommended dose determined in the dose escalation.', 'armGroupLabels': ['alpelisib and everolimus', 'alpelisib, everolimus and exemestane']}, {'type': 'DRUG', 'name': 'exemestane', 'description': 'exemestane is administered orally once a day on a continuous dose of 25 mg starting on Day 1 of Cycle 1 in both the dose escalation and dose expansion.', 'armGroupLabels': ['alpelisib and exemestane', 'alpelisib, everolimus and exemestane']}] | PrimaryOutcomes: [{'measure': 'Dose escalation : Incidence of dose Limiting Toxicity (DLTs)', 'description': 'To determine the MTD and/or RDE of alpelisib in combination with everolimus, and the MTD and/or RDE of alpelisib in combination with everolimus and exemestane.\n\nA dose-limiting toxicity (DLT) is an adverse event or abnormal laboratory value assessed as being unrelated to disease, disease progression, inter-current illness, or concomitant medications, and that occurs within the first 35 days of treatment with alpelisib plus everolimus or alpelisib plus everolimus plus exemestane and meets any of the pre-defined criteria.', 'timeFrame': 'First 35 days of treatment'}, {'measure': 'Dose expansion: Number of patients with adverse events as a measure of safety and tolerability', 'description': 'Type, intensity, severity and seriousness of adverse events according to the National Cancer Institute Common Terminology Criteria for Advers Events (NCI CTC AE) v4.03. Dose interruptions, reductions and dose intensity', 'timeFrame': 'Screening, every 28 days until 30 days after last dose'}] | SecondaryOutcomes: [{'measure': 'Dose escalation: Number of patients with adverse events as a measure of safety and tolerability', 'description': 'type, intensity, severity and seriousness of adverse events according to the NCI CTC AE v4.03. Dose interruptions, reductions and dose intensity', 'timeFrame': 'Screening, every 28 days, until 30 days after last dose'}, {'measure': 'Dose escalation : alpelisib, everolimus and exemestane (when applicable) Plasma concentrations', 'description': 'Plasma concentration time profiles of alpelisib , BZG791, everolimus and exemestane (when applicable). Plasma PK parameters of everolimus, alpelisib, BZG791 and exemestane (when applicable)', 'timeFrame': 'Cycle 1 Day 7, Cycle 1 Day 8, Cycle 1 Day 15, Cycle 1 Day 16, Cycle 1 Day 22, Cycle 2 Day 1, Cycle 2 Day 2, Cycle 2 Day 15, Day 1 of each subsequent cycle'}, {'measure': 'Dose escalation : alpelisib, everolimus drug-drug interaction', 'description': 'Plasma PK parameters of everolimus including AUC ratio (single agent vs. combination)', 'timeFrame': 'Cycle 1 Day 7, Cycle 1 Day 8, Cycle 1 Day 15, Cycle 1 Day 16, Cycle 1 Day 22, Cycle 2 Day 1, Cycle 2 Day 2, Cycle 2 Day 15, Day 1 of each subsequent cycle'}, {'measure': 'Dose expansion: Progression free survival (Doublet cohorts)', 'description': 'Progression-free survival is defined as the time from start date of study treatment until objective tumor progression or death from any cause.', 'timeFrame': 'Baseline, every 8 weeks until first documented disease progression up to 2.5 years.'}, {'measure': 'Dose expansion : Duration of Response (Doublet and breast cancer cohorts)', 'description': 'Duration of response is defined as the time of first occurrence of Complete Response or Partial Response until the date of the first documented disease progression or death due to the disease.', 'timeFrame': 'Baseline, every 8 weeks until first documented disease progressionup to 2.5 years.'}, {'measure': 'Dose expansion: Clinical benefit Rate (Doublet and breast cancer cohorts)', 'description': 'Clinical benefit rate is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) or stable disease (SD) for more than 24 weeks.', 'timeFrame': 'Baseline, every 8 weeks until first documented disease progression up to 2.5 years.'}, {'measure': 'Dose expansion: Overall response rate (Doublet and breast cancer cohorts)', 'description': 'Overall response rate is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR), based on RECIST 1.1 criteria and the investigator assessment.', 'timeFrame': 'Baseline, every 8 weeks until first documented disease progression up to 2.5 years.'}] |
Title: Protocol for Assessment of Gemcitabine and Paclitaxel for Metastatic Urothelial Cancer in Patients Aged 70 Years or Older (and in a Cohort of Patients Younger Than 60 Years) | Condition: Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer | Keywords: recurrent bladder cancer, stage IV bladder cancer, transitional cell carcinoma of the bladder, squamous cell carcinoma of the bladder, adenocarcinoma of the bladder, recurrent urethral cancer, anterior urethral cancer, posterior urethral cancer, urethral cancer associated with invasive bladder cancer, metastatic transitional cell cancer of the renal pelvis and ureter, regional transitional cell cancer of the renal pelvis and ureter, recurrent transitional cell cancer of the renal pelvis and ureter | Summary: | Description: OBJECTIVES:
* Determine the feasibility of enrolling patients aged 70 years and older with advanced or recurrent urothelial cancer to a structured phase II study.
* Determine the anticancer efficacy of gemcitabine and paclitaxel, in terms of objective response rate and 2-year survival, in these elderly patients.
* Assess the toxicity and tolerability of this regimen in these elderly patients.
* Determine the feasibility of using standardized self-report measures of comorbidity, depression, and functional status in these patients.
* Determine the pharmacokinetics of this regimen in these elderly patients and validate this data against similar parameters in patients aged under 60 years.
OUTLINE: This is a multicenter study. Patients are stratified according to age (70 and over vs under 60).
Patients receive paclitaxel IV over 3 hours on day 1 and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 80 patients (60 age 70 and over and 20 under age 60) will be accrued for this study. | ArmGroups: [{'label': 'gemcitabine, paclitaxel', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: gemcitabine hydrochloride', 'Drug: paclitaxel']}] | Interventions:[{'type': 'DRUG', 'name': 'gemcitabine hydrochloride', 'armGroupLabels': ['gemcitabine, paclitaxel']}, {'type': 'DRUG', 'name': 'paclitaxel', 'armGroupLabels': ['gemcitabine, paclitaxel'], 'otherNames': ['Taxol']}] | PrimaryOutcomes: [{'measure': 'Determine the Feasibility of Accruing Patients With Metastatic Bladder Cancer Who Are 70 and Older to Chemotherapy Protocols', 'description': 'Sixty patients aged 70 years and older were to be accrued to the study. The feasibility of accrual was determined that accrual of 3 patients per month in the age 70 and older range would allow for an expeditiously conducted phase II trial. If, after a 3 month start-up period, 3 or more patients aged 70 years and older were accrued per month for the duration of the trial, it was deemed reasonable to consider further trials in this elderly population.', 'timeFrame': '66 months (protocol activated on 7/1/2001 and closed to accrual on 12/15/2006)'}] | SecondaryOutcomes: [{'measure': 'Overall Confirmed Response Rate in the Patients Age 70 and Older (Complete and Partial Response)', 'description': 'Complete response (CR) is defined as complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Partial response (PR) applies only to patients with least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions.', 'timeFrame': 'every week for the first 4 weeks and then every 3 weeks for up to 19 weeks'}, {'measure': 'Progression-free Survival in Patients Aged 70 Years and Older', 'description': 'Measured form date of registration to date of first observation of progression disease, death due to any cause, symptomatic deterioration, or early discontinuation of treatment.', 'timeFrame': '0-5 years'}, {'measure': 'Overall Survival (OS) in Patients Aged 70 Years and Older', 'description': 'Measured from date of registration to date of death due to any cause.', 'timeFrame': '0-5 years'}, {'measure': 'Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug', 'description': 'Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.', 'timeFrame': 'Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment.'}, {'measure': 'Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Form Submission Rate', 'description': 'Patients were required to complete three self-administered questionnaires at entry, prior to the administration of any cytotoxic therapy: the Medical Conditions Questionnaire, Instrumental Activities of Daily Living Form that evaluates functional status, and the Feelings Questionnaire that evaluates depression status. Feasibility is defined in four ways: 1) submission rates for each of three patient self-administered questionnaires (\\> 60%); 2) the number of items missing within each scale (\\< 5%); 3) a description of the level of assistance required for self-administration of the questionnaires; and 4) the average amount of time it takes patients to complete each of the three questionnaires. Level of assistance is defined as the need to 1) read the questionnaire to the patient, 2) explain the meaning of items, 3) explain the response format, and 4) complete the questionnaire for the patient; an other category of assistance will be included.', 'timeFrame': 'at study entry (prior to administration of any treatment)'}, {'measure': 'Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Median Time of Complete Forms', 'description': 'Patients were required to complete three self-administered questionnaires at entry, prior to the administration of any cytotoxic therapy: the Medical Conditions Questionnaire, Instrumental Activities of Daily Living Form that evaluates functional status, and the Feelings Questionnaire that evaluates depression status. Feasibility is defined in four ways: 1) submission rates for the each of three patient self-administered questionnaires (\\> 60%); 2) the number of items missing within each scale (\\< 5%); 3) a description of the level of assistance required for self-administration of the questionnaires; and 4) the average amount of time it takes patients to complete each of the three questionnaires. Level of assistance is defined as the need to 1) read the questionnaire to the patient, 2) explain the meaning of items, 3) explain the response format, and 4) complete the questionnaire for the patient; an other category of assistance will be included.', 'timeFrame': 'at study entry (prior to administration of any treatment)'}, {'measure': 'Assess the Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: at Least One Type of Assistance Required', 'description': 'Patients were required to complete three self-administered questionnaires at entry, prior to the administration of any cytotoxic therapy: the Medical Conditions Questionnaire, Instrumental Activities of Daily Living Form that evaluates functional status, and the Feelings Questionnaire that evaluates depression status. Feasibility is defined in four ways: 1) submission rates for the three patient self-administered questionnaires (\\> 60%); 2) the number of items missing within each scale (\\< 5%); 3) a description of the level of assistance required for self-administration of the questionnaires; and 4) the average amount of time it takes patients to complete each of the three questionnaires. Level of assistance is defined as the need to 1) read the questionnaire to the patient, 2) explain the meaning of items, 3) explain the response format, and 4) complete the questionnaire for the patient; an other category of assistance will be included.', 'timeFrame': 'at study entry (prior to administration of any treatment)'}] |
Title: Tn-Miner: Technology for the Discovery of Tumor-specific Glycopeptide Immunotherapy Targets. | Condition: Estrogen Receptor Positive Breast Cancer | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'Standard of care tumor resection', 'type': 'OTHER', 'interventionNames': ['Procedure: Tumor resection']}] | Interventions:[{'type': 'PROCEDURE', 'name': 'Tumor resection', 'description': 'As the standard of care, estrogen receptor-positive breast tumors are surgically resected. From these resected tumors, small samples of both cancer tissue and healthy surrounding tissue will be analyzed using our patented Tn-Miner workflow to discover novel tumor-specific epitopes.', 'armGroupLabels': ['Standard of care tumor resection']}] | PrimaryOutcomes: [{'measure': 'Discovery of new, tumor-specific, glycopeptide epitopes.', 'description': 'The discovery of new antigens, comprising both glycan and peptide (=glycopeptide), on the outside of the plasma membrane of the breast cancer cells. These antigens should be absent on healthy cells. These new, glycopeptide antigens can be used as target for immunotherapeutics against cancer.', 'timeFrame': 'The patients are only involved during their standard of care surgery (one day). The discovered epitopes will not be shared with enrolled patients.'}] | SecondaryOutcomes: N/A |
Title: A Pilot Trial to Correlate Serum Levels of Calgranulin A and B With Estrogen Receptor Status Among Patients With Breast Cancer | Condition: Breast Cancer | Keywords: stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer | Summary: | Description: OBJECTIVES:
* Determine circulating levels of calgranulin A and calgranulin B in patients with estrogen receptor negative or estrogen receptor positive, newly diagnosed, primary stage I-III adenocarcinoma of the breast.
OUTLINE: This is a pilot study.
Patients undergo a blood draw following diagnosis of breast cancer to assess levels of circulating tumor markers, calgranulin A and calgranulin B. Serum samples are evaluated by enzyme-linked immunosorbent assay for tumor marker expression.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study. | ArmGroups: N/A | Interventions:[{'type': 'OTHER', 'name': 'immunoenzyme technique', 'description': 'Serum samples are evaluated by enzyme-linked immunosorbent assay for tumor marker expression.'}, {'type': 'OTHER', 'name': 'laboratory biomarker analysis', 'description': 'Blood draw following diagnosis of breast cancer to assess levels of circulating tumor markers, calgranulin A and calgranulin B.'}] | PrimaryOutcomes: [{'measure': 'Correlation between circulating levels of calgranulin A and calgranulin B and the presence of estrogen receptor negative breast cancer', 'timeFrame': 'upon diagnosis'}] | SecondaryOutcomes: N/A |
Title: Genomic Profiling of the Residual Disease of Advanced-stage Ovarian Cancer After Neoadjuvant Chemotherapy | Condition: Advanced-stage Ovarian Cancer | Keywords: advanced-stage ovarian cancer, neoadjuvant chemotherapy, residual disease, genomic profiling, immunohistochemistry | Summary: | Description: DNA extracted from FFPE block will be used. Capture sequencing and immunohistochemistry will be performed.
Immunohistochemistry The formalin-fixed, paraffin-embedded tissue blocks were sectioned at 4 µm thickness onto Superfrost Plus glass slides (Thermo Fisher Scientific, Waltham, MA, USA). These sections were deparaffinized in xylene and rehydrated through graded alcohols. Immunohistochemical staining was performed using an automatic immunostaining instrument (Ventana Benchmark XT; Ventana Medical Systems), according to the manufacturer's recommendations. Antigen retrieval was performed using a Cell Conditioning Solution (CC1; Ventana Medical Systems). The sections were incubated with antibodies against PD-L1 (prediluted, clone SP263, Ventana Medical Systems), CD8 (prediluted, clone C8/144B, Dako, Glostrup, Denmark), PD-1 (1:50, clone NAT105, Cell Marque, Rocklin, CA, USA), Foxp3 (1:50, clone 236A/E7, Abcam, Cambridge, UK), ICOS/CD278 (1:50, clone SP98, Thermo Fisher Scientific), and LAG-3 (1:100, clone EPR4392(2), Abcam). After chromogenic visualization using an ultraView Universal DAB Detection Kit (Ventana Medical Systems), the slices were counterstained with hematoxylin, dehydrated in graded alcohols and xylene, and then embedded in mounting solution. Appropriate positive and negative controls were concurrently stained to validate the staining method.
Targeted Capture Sequencing on NextSeq550 using SureSelect XT Sample Preparation DNA was extracted from microdissected tumor rich areas from formalin fixed paraffin embedded tumor sections using DNAeasy kit (QIAGEN, Venlo, Netherlands). Two hundred fifty nanogram of genomic DNA in 50μl TE buffer was fragmented to a median size of 150bp using the Covaris-E220 AFA instrument (Covaris, Woburn, MA) with the following settings: peak incident power 175 watts, duty factor 10.0%, cycles per burst 200 cycles, run time 500 sec at 4oC. DNA fragments were evaluated using capillary electrophoresis on High Sensitivity D1000 ScreenTape and Reagents (TapeSation4200, Cat.No.5067-5584, 5585; Agilent Technologies, Santa Clara, CA, USA). End repair, 3'-end adenylation and sequencing adapter ligation of DNA fragments were performed following the manufacture's protocol (SureSelect XT Reagent kit, HSQ Cat.No.G9611A, G9611B; Agilent Technologies, Santa Clara, CA, USA). After each steps, fragments were purified using AMPure XP beads (Cat. No. A63382; Beckman Coulter, High Wycombe, UK). The resulting DNA was amplified by 14 cycles PCR amplification (SureSelect Herculase Ⅱ Fusion Enzyme with dNTP Combo 200 RXN kit, Cat. No. 600677; Agilent Technologies, Santa Clara, CA, USA). The quality of the PCR product was assessed by capillary electrophoresis with DNA1000 TapeScreen and Reagents (TapeSation4200, Cat.No.5067-5582, 5583; Agilent Technologies, Santa Clara, CA, USA) and the concentration was measured by Qubit 2.0 Fluorometer (Qubit dsDNA HS Assay Kit, Cat. No. Q32854; Thermofisher Scientific, Inc, Waltham, MA).
Capture and Enrichment Target enrichment was performed according to the manufacturer's instructions (SureSelect XT Custom 0.5Mb-2.9Mb library, Cat. No. 5190-4816, 4817; Agilent Technologies, Santa Clara, CA, USA). The resulting captured libraries with indexing primers were amplified by 12 cycles of PCR (SureSelect Herculase Ⅱ Fusion Enzyme with dNTP Combo 200 RXN kit, Cat. No. 600677; Agilent Technologies, Santa Clara, CA, USA) and purified again. Quantity and quality of indexed library DNA were verified by capillary electrophoresis with High Sensitivity D1000 ScreenTape and Reagents (TapeSation4200, Cat.No.5067-5584, 5585; Agilent Technologies, Santa Clara, CA, USA) and Qubit 2.0 Fluorometer (Qubit dsDNA HS Assay Kit, Cat. No. Q32854; Thermofisher Scientific, Inc, Waltham, MA).
Sequencing We diluted resulting libraries to 4nmol/l and pooled by combining 5μl of each diluted library for normalization. Subsequently, pooled library was denatured into single strands by using fresh 0.2N NaOH and 200mM Tris-HCl, pH7. A PhiX control was denatured in the same way. The concentration of final loading library was 1.8pmol/l and Phix was spiked in at 1%. A standard flow cell was loaded on the Illumina NextSeq550 and sequencing was conducted with 2X100bp paired-end reads using NextSeq550 reagent v2 kit with high-output 300 cycles. (NextSeq550 System user guide part #15069765-V02 Mar 2016, NextSeq550 Reagent V2 Kit High-output 300 cycles Cat. No. FC-404-2004; Illumina, CA). | ArmGroups: [{'label': 'advanced-stage ovarian cancer group', 'description': '250 patients with pathologically confirmed epithelial ovarian cancer who received at least 1 cycle of NAC at Yonsei Cancer Hospital from 2006 to 2017.', 'interventionNames': ['Drug: chemotherapy']}] | Interventions:[{'type': 'DRUG', 'name': 'chemotherapy', 'description': 'All of the patients in this study underwent NAC regimens consisting of taxane and platinum combination chemotherapy. After NAC, all of the patients underwent interval debulking surgery. Subsequently, additional cycles of chemotherapy were administered after IDS to complete a total of 6 cycles at the discretion of the treating physician.', 'armGroupLabels': ['advanced-stage ovarian cancer group']}] | PrimaryOutcomes: [{'measure': 'genomic profiling', 'description': 'demonstrates the spectrum of genomic alterations/ profiling present in residual disease after neoadjuvant chemotherapy.', 'timeFrame': '3 months'}] | SecondaryOutcomes: [{'measure': 'immunohistochemistry', 'description': 'To evaluate the prognostic significance of BRCA-1 IHC in residual disease after neoadjuvant chemotherapy in ovarian cancer', 'timeFrame': '3 months'}] |
Title: Nivolumab With or Without Nab-Paclitaxel in Previously Treated, Advanced Stage, Non-small Cell Lung Cancer: A Randomized Phase II Study | Condition: Non-Small-Cell Lung Cancer Metastatic, Non-Small Cell Carcinoma of Lung, TNM Stage 4, Nonsmall Cell Lung Cancer, Non Small Cell Lung Cancer Recurrent | Keywords: | Summary: | Description: Nab-paclitaxel will be added to standard nivolumab therapy in previously treated advanced stage non-small cell lung cancer to help prevent early progression and to improve progression free survival. The primary endpoint will be to determine if the addition of nab-paclitaxel to nivolumab improves progression free survival compared to nivolumab alone. Retrospective studies will be conducted to analyze blood based immune biomarkers, and tumor biomarkers to better understand the effect that nivolumab combined with chemotherapy has on the immune system in NSCLC. Patients with advanced stage non-small cell lung cancer who have progression of cancer after receiving platinum doublet chemotherapy will be randomized to receive nivolumab with or without nab-paclitaxel. Patients on both arms will receive a maximum of one year of therapy with the option to retreat at progression. | ArmGroups: [{'label': 'Arm A', 'type': 'ACTIVE_COMPARATOR', 'description': 'Nivolumab q 14 days until disease progression/toxicity', 'interventionNames': ['Drug: Nivolumab']}, {'label': 'Arm B', 'type': 'ACTIVE_COMPARATOR', 'description': 'Nivolumab every 21 days until disease progression\n\nNab-paclitaxel every 21 days', 'interventionNames': ['Drug: Nivolumab', 'Drug: nab-paclitaxel']}] | Interventions:[{'type': 'DRUG', 'name': 'Nivolumab', 'description': 'Arm A: Nivolumab 240 mg via intravenous infusion (IV) over 30 minutes day 1 of each 14 day cycle until disease progression or not tolerated.\n\nArm B: Nivolumab 360 mg via intravenous infusion (IV) over 30 minutes day 1 of every 21 day treatment cycle until progression or not tolerated.', 'armGroupLabels': ['Arm A', 'Arm B'], 'otherNames': ['Opdivo']}, {'type': 'DRUG', 'name': 'nab-paclitaxel', 'description': 'Patients in arm B receive nab-paclitaxel at a dose of 100 mg/m2 over intravenous infusion on Days 1 and 8 of each 21 day cycle.', 'armGroupLabels': ['Arm B'], 'otherNames': ['abraxane']}] | PrimaryOutcomes: [{'measure': 'Progression-Free Survival', 'description': 'This study will compare the progression-free survival of patients with advanced stage non-small cell lung cancer whose cancer has progressed after standard first-line platinum based doublet chemotherapy is improved with nivolumab plus nab-paclitaxel compared to nivolumab alone. A progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.', 'timeFrame': '13 months'}] | SecondaryOutcomes: N/A |
Title: Anti-CD19 Donor-derived CAR-T Cells for Patients With Relapsed B Cell Malignancies After Hematopoietic Stem Cell Transplantation: a Multi-center, Uncontrolled Trial. | Condition: Relapsed Adult ALL, B Cell Leukemia | Keywords: | Summary: | Description: The stunning response rate of anti-CD19(cluster of differentiation antigen 19) auto-CAR(chimeric antigen receptor)-T cell therapy brings hope to patients with relapsed or refractory B-cell hematologic malignancies. However, for B-ALL patients suffered from relapse after allo-HSCT (hematopoietic stem cell transplant), the T cells derived from healthy donor seems like a better origin for CAR-T cells producing because T cells derived from healthy matched sibling or unrelated donors have not been restrained by tumor micro-environment and retain anti-leukemia ability. So after we designed a clinical trial to manifest the safety and efficacy of anti-CD19 CAR-T cells for patients with relapsed B cell ALL. | ArmGroups: [{'label': 'anti-CD19 allo-CAR-T', 'type': 'EXPERIMENTAL', 'description': 'The study will employ dose level cohorts of three patients that will be treated at each level described below, based on the number of T cells to be infused using the "3 + 3" dose-escalation strategy to find MTD followed by a dose-expansion phase at determining optimal dosage.\n\ndosage: the number of anti CD19+CD22 CAR T cells\n\n-1(if needed) 1×10\\^6/KG\n\n3×10\\^6 /KG 6×10\\^6 /KG 1×10\\^7/KG Treatment follows a lymphodepletion, chemotherapy regimen that consists of Fludarabine (30 mg/m2 per day) and Cyclophosphamide (300mg/m2 per day) for 3 days or bendamustione (90mg/m2 per day) for two days prior to cell infusion.', 'interventionNames': ['Biological: anti-CD19 allo-CAR-T cells']}] | Interventions:[{'type': 'BIOLOGICAL', 'name': 'anti-CD19 allo-CAR-T cells', 'description': 'The T cells collected from haploidentical donors have been manufactured to express CAR to binding CD19 on B-cell leukemia.', 'armGroupLabels': ['anti-CD19 allo-CAR-T']}] | PrimaryOutcomes: [{'measure': 'the safety of anti-CD19 allo CAR-T cells', 'description': 'Number of participants with treatment-related adverse events as assessed by CTCAE v5.0', 'timeFrame': 'within 4 weeks after infusion'}, {'measure': 'the efficacy of anti-CD19 allo CAR-T cells', 'description': 'ratio of bone marrow blast cells', 'timeFrame': '4 weeks after infusion'}] | SecondaryOutcomes: [{'measure': 'The long-term efficiency', 'description': 'ratio of bone marrow blast cells', 'timeFrame': 'up to 2 years after infusion'}] |
Title: A Study to Digitally Phenotype Mobility and Physical Activity in Adolescent and Young Adult (AYA) Patients at Risk for Cardiovascular Morbidity and Frailty: MOBILE AYA | Condition: Central Nervous System Neoplasm, Hodgkin Lymphoma, Malignant Solid Neoplasm, Non-Hodgkin Lymphoma, Sarcoma | Keywords: | Summary: | Description: PRIMARY OBJECTIVES:
I. To characterize patient mobility over time based upon smartphone sensor data, including dwell time at home and hospital, as well as time spent away from home or hospital, considering patients actively undergoing treatment (time referenced to treatment start) separately from those following treatment (time referenced to treatment end).
II. To characterize patient physical activity over time based upon smartphone sensor data, during and following treatment (separately), including inactivity time and activity level, at home and hospital and away from home or hospital, considering patients actively undergoing treatment (time referenced to treatment start) separately from those following treatment (time referenced to treatment end).
SECONDARY OBJECTIVES:
I. To characterize patient mobility over time based upon smartphone sensor data, including dwell time at home and hospital, as well as time spent away from home or hospital, considering patients actively undergoing treatment (time referenced to treatment start) separately from those following treatment (time referenced to treatment end), grouped by disease and treatment (chemotherapy, radiotherapy), controlling for age, sex, race, and body mass index (BMI).
II. To characterize patient physical activity over time based upon smartphone sensor data during and following treatment (separately), including inactivity time and activity level, at home and hospital and away from home or hospital, considering patients actively undergoing treatment (time referenced to treatment start) separately from those following treatment (time referenced to treatment end), grouped by disease and treatment (chemotherapy, radiotherapy), controlling for age, sex, race, and BMI.
OUTLINE:
Patients utilize smartphone application to monitor physical activity and mobility up to 180 days during treatment or post-treatment. | ArmGroups: [{'label': 'Observational (physical activity tracking)', 'description': 'Patients utilize smartphone application to monitor physical activity and mobility up to 180 days during treatment or post-treatment.', 'interventionNames': ['Other: Smartphone Application']}] | Interventions:[{'type': 'OTHER', 'name': 'Smartphone Application', 'description': 'Utilize smartphone application', 'armGroupLabels': ['Observational (physical activity tracking)'], 'otherNames': ['App', 'Smartphone App']}] | PrimaryOutcomes: [{'measure': 'To characterize patient mobility over time.', 'description': 'Will be analyzed by linear mixed-effect models with relation to time point (30, 60, 90, 120, 150, and 180 days), blocking on patient, with differences among time points assessed by Tukey-adjusted contrasts.', 'timeFrame': 'Through study completion, an average of 1 year'}] | SecondaryOutcomes: N/A |
Title: Prospective Controlled Trial of Narrow Band Imaging for Detection of Gastric Cancer Precursors | Condition: Gastric Cancer, Gastric Metaplasia, Gastric Dysplasia | Keywords: stomach neoplasms, narrow band imaging, gastroscopy | Summary: | Description: 1 BACKGROUND
Precursor Lesions
Gastric cancer is the fourth most common cancer and second leading cause of malignant death in the world. It often presents only with vague symptoms of dyspepsia and consequently is frequently diagnosed at advanced stages.
Gastric cancer develop in a series of steps beginning with H. pylori infection. 2-4 It induces an inflammatory reaction with the surrounding gut epithelium which is theorized to drive a subsequent progression in some patients to mucosal atrophy, intestinal metaplasia, dysplasia, and finally gastric adenonocarcinoma.
Systematic biopsy protocols
In the evaluation for precancerous gastric lesions and Helicobacter pylori, experts recommend that biopsies be obtained from the antrum (3cm from pylorus), body (8cm from the pylorus), and insisura/angle. Both the greater and lesser curvature should be sampled. Additionally, recently developed staging systems including OLGIM (operative clinic on intestinal metaplasia) scores require histologic assessment (via the updated Sydney score) from two sites (antrum and corpus).
Narrow Band Imaging in endoscopy
Patients with H. pylori gastritis, gastric atrophy, intestinal metaplasia most commonly have no visible lesions on white-light endoscopy, although endoscopic findings may include antral nodularity, absent rugae, prominent gastric vessels white mucosal deposits. However, the sensitivity and specificity of these gross findings for underlying histological findings is poor. Therefore a number of image-enhancement techniques including chromoendoscopy using mucosal dyes or endoscopy-based virtual chromo-endoscopy (e.g., narrow band imaging) have been proposed. Narrow band imaging is the most widely investigated.
Narrow band imaging is an electronic, noninvasive technique in which the illuminating light from the endoscope is filtered to enable passage primarily of two narrow bands of light, 415nm and 540nm. These wavelengths correspond to the hemoglobin absorption wavelength in the capillaries and submucosal vessels respectively. This enhances evaluation of the mucosal surface patterns and vascular irregularities. NBI has been shown to be useful in the detection of dysplasia in Barrett's esophagus and characterization of small colonic adenomas.
Recently, a simple NBI classification using high-definition white light endoscopy was proposed for gastric mucosal examination.18 The NBI interpretation using this classification was compared with histological examination of mucosal biopsies, with both NBI and histology determined in blinded fashion. This classification which defines the mucosal pattern of the stomach had an accuracy exceeding 80% and excellent interobserver agreement (kappa=0.75) for normal mucosa, intestinal metaplasia, and dysplasia. However, the study was done at a referral center where 34% of patients had dysplasia and NBI was not compared with a white light assessment or standardized gastric biopsy protocol. Additionally, the results were not provided on a per patient basis, which is the most relevant endpoint in clinical practice.
2.0 OBJECTIVES AND PURPOSE Prompt detection of gastric cancer precursors enables early detection and less invasive treatment options such as endoscopic resection. Narrow band imaging is a completely noninvasive technique which uses filtered light to enhance assessment of mucosa. Our aim is to gauge whether biopsies targeted by narrow band imaging improves the detection of gastric intestinal metaplasia and gastric dysplasia relative to standard white light techniques on a per patient basis. A secondary aim will be to assess whether the technique is amenable to standardization so that it might be used more broadly to identify patients with early gastric neoplasia. While NBI is built into the vast majority of endoscopes in use few physicians are aware of its potential use.
3.0 STUDY DESIGN
The study will be a prospective tandem endoscopy trial. All EGDs will have already been planned as part of standard clinical care.
High definition white light endoscopy will initially be performed. The specific location of all mucosal findings in the stomach such as ulceration or nodularity which require biopsy will be noted by the endoscopist and research coordinator but will not be biopsied until after NBI. This is done so that blood will not distort or bias NBI assessment. Any abnormal findings in other parts of the GI tract examined using the scope (esophagus and duodenum) will be noted and biopsied.
At the completion of the white light exam, while the scope is in the stomach, the white light endoscopist will press a button on the scope which changes the view to the narrow band imaging.
At this point the NBI endoscopist who is initially blinded to the white light findings will enter the procedure room and examine the stomach using NBI. The type and location of NBI abnormalities will be noted and biopsies obtained.
At the end of the NBI exam the NBI endoscopist will switch the scope view back to white light mode. The white light endoscopist will return to the room and biopsy any sites identified and recorded during the initial white-light endoscopy. A research coordinator present for the entire procedure will verify and record that all sites identified during the initial white light exam are biopsied.
Subsequently, random biopsies will be performed by taking 2 biopsies from the lesser curvature (body and antrum), 2 biopsies from the greater curvature (body and antrum), and one from the angle.
The biopsies obtained by white light exam, narrow band imaging exam, and random sampling will be separately coded and submitted to pathology. Histologic analysis will be performed by expert GI pathologists blinded to the acquisition approach.
Short 10 second video clips of each site targeted for biopsy by white light narrow band imaging will be recorded. They will be matched with the final biopsy results and stored WITHOUT personal health identifiers. These short videos may be used for training and shared with collaborators to assess inter-observer variability and standardize the interpretation of NBI of the stomach.
The primary outcome measure will be yield of NBI, high definition white light endoscopy, and random biopsy for the detection of atrophic gastritis, IM and dysplasia on a per patient basis. A secondary endpoint will be the number of regions found by each method to exhibit atrophic gastritis, IM, and dysplasia (per lesion (region) yield). The yields of H. Pylori by method and the total number of biopsies guided per method will be additional outcomes.
Patients will be enrolled at the Los Angeles County Hospital of the University of Southern California as well as the Gastroenterology Unit at the University of Porto in Porto Portugal. The protocol originates from and statistical analysis will be done at the University of Southern California. No personal health identifiers will be exchanged at any point between the two institutions.
Prior to the formal initiation of the study there will be a lead in period of 10-20 patients with gastric symptoms. The initial patients will be examined using the white light, NBI, and gastric biopsy protocol. After this the images will be discussed by the investigators at the two centers to make certain that NBI interpretation of gastric premalignant changes is standardized. The LAC+USC investigators will also review the Portugese video training library on gastric NBI. Any changes in performance of the lead in versus the study will be noted to address the secondary aim of developing a standardized approach to NBI which may help this technique be used widely to identify patients with early gastric neoplasia.
4 STATISTICAL CONSIDERATIONS
The Fisher's exact chi squared test will be used for dichotomous outcomes such as the accurate detection of the highest level histology and number of biopsies. Adverse reactions will be reported in a descriptive manner.
Based on previous research which showed 74% correction detection of gastric cancer precursors with white light endoscopy versus 89% with NBI and given our anticipated gastric cancer prevalence of 20% we performed preliminary sample size estimates for a range of OR using G\*Power (alpha=0.05, beta =0.20). We anticipate an N of 200 will be sufficient to show a significant difference between methods. | ArmGroups: [{'label': 'Gastric Symptoms', 'type': 'EXPERIMENTAL', 'description': 'Patients with gastric symptoms including dyspepsia undergoing upper endoscopy will undergo white light biopsy narrow band imaging guided biopsy protocolled biopsy', 'interventionNames': ['Procedure: White light biopsy', 'Procedure: Protocolled', 'Procedure: Narrow Band Imaging Guided Biopsy']}] | Interventions:[{'type': 'PROCEDURE', 'name': 'White light biopsy', 'description': 'Endoscopy with biopsies guided by high definition white light', 'armGroupLabels': ['Gastric Symptoms']}, {'type': 'PROCEDURE', 'name': 'Protocolled', 'description': 'Upper Endoscopy with Protocolled Biopsy (i.e. biopsy by predetermined guideline not influenced by white light or narrow band imaging findings)', 'armGroupLabels': ['Gastric Symptoms']}, {'type': 'PROCEDURE', 'name': 'Narrow Band Imaging Guided Biopsy', 'description': 'Upper Endoscopy with biopsy guided by narrow and imaging', 'armGroupLabels': ['Gastric Symptoms']}] | PrimaryOutcomes: [{'measure': 'Detection of Intestinal Metaplasia or Dysplasia', 'description': 'Confirmation of intestinal metaplasia in stomach per patient by each method-NBI versus white light-versus random', 'timeFrame': 'One Year'}] | SecondaryOutcomes: [{'measure': 'Number of Regions with Intestinal Metaplasia', 'description': 'Number of Region with Intestinal Metaplasia detected in the stomach (total not per patient) detected by each method-NBI versus white light-versus random', 'timeFrame': '1 year'}, {'measure': 'Number of regions with dysplasia', 'description': 'Number of regions with dysplasia detected in the stomach (total not per patient) detected by each method-NBI versus white light-versus random', 'timeFrame': 'one year'}, {'measure': 'Biopsies driven by method', 'description': 'Number of biopsies driven by each method. Number driven by each method-NBI versus white light-versus random will be compared.', 'timeFrame': 'One year'}, {'measure': 'Helicobacter pyrlori detection', 'description': 'Detection ofHelicobacter pylori by method', 'timeFrame': 'One year'}] |
Title: Dead Space Closure With Quilting Suture Versus Conventional Closure With Drainage in Prevention of Seroma Formation After Mastectomy for Breast Cancer : a Randomized Controlled Trial | Condition: Breast Cancer | Keywords: Breast cancer, Mastectomy, Seroma, Quilting suture | Summary: | Description: Eligible patients are patients with operable breast cancer (invasive carcinoma and/or carcinoma in situ) for whom mastectomy is recommended or preferred by the patient either alone or in association with sentinel lymph node biopsy or standard level I/II axillary node dissection
Randomization will be stratified by center and by type of surgery (mastectomy alone/ mastectomy with sentinel node biopsy / mastectomy with axillary lymph node dissection).
Two follow-up visits will be performed: at 21 days and 9 months after surgery, these appointments are conventional, thus our trial will not modify usual follow-up. | ArmGroups: [{'label': 'Closure with conventional technique with drainage', 'type': 'ACTIVE_COMPARATOR', 'description': 'The skin flaps are not fixed subcutaneously but sutured at the edges, a closed suction drain is inserted under the flaps in the dead space created by the dissection at the pectoral area. The drain is stitched to the skin.', 'interventionNames': ['Procedure: Conventional closure with drainage']}, {'label': 'Quilting suture without drainage', 'type': 'EXPERIMENTAL', 'description': 'In an attempt to obliterate the dead space, the skin flaps are sutured to the underlying pectoralis major with multiple parallel rows of 0/0 vicryl (or equivalent). Running sutures at periodic intervals (\\<2cm) are placed from the skin flaps to the underlying muscle.', 'interventionNames': ['Procedure: Quilting suture without drainage']}] | Interventions:[{'type': 'PROCEDURE', 'name': 'Quilting suture without drainage', 'description': 'In an attempt to obliterate the dead space, the skin flaps are sutured to the underlying pectoralis major with multiple parallel rows of 0/0 vicryl (or equivalent). Running sutures at periodic intervals (\\<2cm) are placed from the skin flaps to the underlying muscle. Minor dimpling is considered acceptable and is expected to resolve. If severe dimpling is observed, stitches are removed and replaced.\n\nEfficiency of quilting suture relies on a rigorous repartition of the sutures with a special attention taken to the obliteration of the largest potential dead spaces and the empty axillary apex.\n\nThe skin edges are sutured as stated before for the control group. Closed suction will not be used for draining the pectoral area.', 'armGroupLabels': ['Quilting suture without drainage'], 'otherNames': ['Quilting suture']}, {'type': 'PROCEDURE', 'name': 'Conventional closure with drainage', 'description': 'The skin flaps are not fixed subcutaneously but sutured at the edges, a closed suction drain is inserted under the flaps in the dead space created by the dissection at the pectoral area. The drain is stitched to the skin.\n\nThe skin is closed in two layers with absorbable sutures, a deep layer of 2.0 or 3.0 vicryl sutures or equivalent, and a subcuticular closure with absorbable 3.0 or 4.0 Monocryl sutures or equivalent.', 'armGroupLabels': ['Closure with conventional technique with drainage'], 'otherNames': ['Conventional closure']}] | PrimaryOutcomes: [{'measure': 'Wound seroma requiring aspiration or surgical intervention', 'description': 'A seroma is defined as a postoperative fluid collection via palpation on clinical examination. The Common Terminology Criteria for Adverse Events (CTCAE) which is a descriptive terminology that can be used for adverse event reporting provide a grading scale for seromas (lymphoceles).\n\nOnly grade 2 and 3 seromas i.e. seromas requiring one or more aspirations or a surgical intervention will be considered as primary outcome.', 'timeFrame': 'Within 21 days following mastectomy'}] | SecondaryOutcomes: [{'measure': 'Wound seroma requiring aspiration or surgical intervention', 'timeFrame': 'Within 9 months following mastectomy'}, {'measure': 'Wound seroma whatever their type (requiring or not intervention)', 'timeFrame': 'Within 21 days following mastectomy'}, {'measure': 'Wound seroma whatever their type (requiring or not intervention)', 'timeFrame': 'Within 9 months following mastectomy'}, {'measure': 'Other wound complications', 'timeFrame': 'Within 21 days following mastectomy'}, {'measure': 'Other wound complications', 'timeFrame': 'Within 9 months following mastectomy'}, {'measure': 'Surgical morbidity', 'timeFrame': 'During surgical intervention'}, {'measure': 'Pain', 'description': 'Visual Analogue Scale', 'timeFrame': 'Before surgery, day 1, 21 days and 9 months following mastectomy'}, {'measure': 'Homolateral shoulder movement', 'description': 'The range of arm movement scored from 1 to 4 according to estimated angles of arm abduction as 1 (less than 90°), 2 (90-134°), 3 (135-179°) and 4 (180°)', 'timeFrame': 'Before surgery, 21 days and 9 months following mastectomy'}, {'measure': 'Cosmesis results', 'description': 'Cosmetic results will be documented by patient,surgeon and by an blinded adjudication committee with possible response = poor, acceptable, good and excellent', 'timeFrame': '21 days, 9 months following mastectomy'}, {'measure': 'Health related quality of life : EQ-5D-5L', 'description': 'The descriptive system comprises 5 dimensions : mobility, self care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems', 'timeFrame': 'Before surgery, day 1, 21 days and 9 months following mastectomy'}, {'measure': 'Cost-effectiveness assessment', 'description': 'Incremental net monetary benefice', 'timeFrame': 'During the whole follow-up period i.e. 9 months following mastectomy'}] |
Title: N/A | Condition: Cervical Cancer | Keywords: Outcome of cervical cancer | Summary: | Description: N/A | ArmGroups: [{'label': 'cervical cancer'}] | Interventions:N/A | PrimaryOutcomes: [{'measure': 'determine whether G9a protein is a risk factor of overall survival of patients with cervical cancer', 'timeFrame': 'From the date of primary treatment until the date of death from any cause or the date of last follow-up, whichever came first, assessed up to 100 months'}] | SecondaryOutcomes: [{'measure': 'determine whether G9a protein is a risk factor of progression-free survival of patients with cervical cancer', 'timeFrame': 'From the date of primary treatment until the date of first documented progression or last follow-up, whichever came first, assessed up to 100 months'}] |
Title: Effect of Tramadol Hydrochnoride as Adjuvant to Local Anesthetic in Ultrasound Guided Erector Spinea Plane Block in Management of Chronic Chest Wall Cancer Pain: a Randomized Controlled Trial | Condition: Chronic Pain, Erector Spinea Plane Block | Keywords: chronic chest pain, tramadol hydrochroide, erector spinea plane block | Summary: | Description: Chest wall pain is a severe and distressing symptom.Interventional pain management aims to use invasive techniques such as joint injections, nerve blocks and/or neurolysis, neuromodulation, and cement augmentation techniques to diagnose and treat pain syndromes unresponsive to conventional medical management. The erector spinae plane block (ESPB) is an interfascial plane block where local anesthetic (LA) is injected between the erector spine muscle and the transverse process. It is a simple procedure, with easy sonographic landmarks, for postoperative analgesia in patients undergoing thoracic, abdominal, lumbar, and urologic surgery. The ESPB was initially described to relieve chronic pain from metastatic disease and rib fractures.
The ESPB provides blockade of ventral and dorsal ramus from T1-2 to T8-12 with easy insertion of a catheter into the distension induced by the injectate. It is performed away from the pleura and neuraxis, with low risk of complications in these structures.To our knowledge it is the first time study to evaluate the effectiveness of tramadol hydrochloride as adjuvant to local anaesthetic in ultrasound guided ESPB in the management of chronic chest wall cancer pain. Our hypothesis is that tramadol, when added to the local anaesthetic solution injected for ESPB, may improve analgesia and decrease the opioid consumption in patients with chronic chest wall cancer pain | ArmGroups: [{'label': 'control group', 'type': 'PLACEBO_COMPARATOR', 'description': 'patients will receive a solution of 28 ml of bupivacaine 0.25% and 2 ml of NaCl 0.9% will be added to the local anesthetic solution divided into two levels of injection T5 and T8 in ipsilateral ESPB', 'interventionNames': ['Procedure: Erector spinea plane block']}, {'label': 'tramadol 50', 'type': 'ACTIVE_COMPARATOR', 'description': 'patients will receive a solution of 28 ml of bupivacaine 0.25% and 2 ml of tramadol hydrochloride 50 mg will be added to the local anesthetic solution divided into two levels of injection T5 and T8 in ipsilateral ESPB.', 'interventionNames': ['Procedure: Erector spinea plane block']}, {'label': 'tramadol 100', 'type': 'ACTIVE_COMPARATOR', 'description': 'patients will receive a solution of 28 ml of bupivacaine 0.25% and 2 ml of tramadol hydrochloride 100 mg will be added to the local anesthetic solution divided into two levels of injection T5 and T8 in ipsilateral ESPB.', 'interventionNames': ['Procedure: Erector spinea plane block']}] | Interventions:[{'type': 'PROCEDURE', 'name': 'Erector spinea plane block', 'description': 'ESPPB will be performed at the T5 and T8 levels of the spine using an in-plane approach. A real-time ultrasound machine will be used to evaluate block performance. A high frequency linear ultrasound probe will be placed longitudinally at a distance of 3 cm from the midline. After identifying the erector spinae muscle and transverse processes, we will insert a 22 G, 100-mm needle after standard skin disinfection. It will be inserted in a caudal-to-cephalad direction using a sterile probe cover until the tip lay in the interfacial plane deep into the erector spinae muscle. This plane will be opened following hydrolocalization with normal saline then 30 mL of 0.25% bupivacaine will be injected slowly, with or without adjuvants, and aspirate every 5 ml to ensure block performance.', 'armGroupLabels': ['control group', 'tramadol 100', 'tramadol 50']}] | PrimaryOutcomes: [{'measure': 'changes in pain intensity measured by visual analog scale (VAS)', 'description': 'scored from 0 to 10 where 0 = no pain and 10 = the worst pain imaginable', 'timeFrame': '10 minute after injection, every week for one month after the procedure, 2 month after the procedure'}] | SecondaryOutcomes: [{'measure': 'a 7-point Likert- like verbal rating scale', 'description': 'extremely dissatisfied = 1, dissatisfied=2, somewhat dissatisfied=3, undecided=4, somewhat satisfied=5, satisfied=6, and extremely satisfied=7.', 'timeFrame': 'every week for one month after the procedure'}, {'measure': 'total analgesic requirement', 'description': 'tital amount of analgesia consumed by the patients after the procedure', 'timeFrame': 'every week for one month after the procedure, 2 month after the procedure'}] |
Title: Phase 3b/4 Safety Trial of Nivolumab Combined With Ipilimumab in Subjects With Previously Untreated, Advanced or Metastatic RCC (CheckMate 920: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 920) | Condition: Renal Cell Carcinoma | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'ccRCC KPS ≥ 70%', 'type': 'EXPERIMENTAL', 'description': 'Clear-Cell Renal Cell Carcinoma (ccRCC) with Karnofsky Performance Status (KPS) ≥ 70%', 'interventionNames': ['Drug: Nivolumab', 'Drug: Ipilimumab']}, {'label': 'Non-ccRCC, KPS ≥ 70%', 'type': 'EXPERIMENTAL', 'description': 'Non Clear-Cell Renal Cell Carcinoma (nccRCC) with KPS ≥ 70%', 'interventionNames': ['Drug: Nivolumab', 'Drug: Ipilimumab']}, {'label': 'RCC with non-active Brain Mets, KPS ≥70%', 'type': 'EXPERIMENTAL', 'description': 'Renal Cell Carcinoma (RCC) with non-active Brain Metastases, with KPS ≥70%', 'interventionNames': ['Drug: Nivolumab', 'Drug: Ipilimumab']}, {'label': 'any RCC with KPS 50%-60%', 'type': 'EXPERIMENTAL', 'description': 'Renal Cell Carcinoma (RCC), regardless of any histology or existing non-active brain metastasis, with KPS 50%-60%', 'interventionNames': ['Drug: Nivolumab', 'Drug: Ipilimumab']}] | Interventions:[{'type': 'DRUG', 'name': 'Nivolumab', 'description': 'Specified dose on specified day', 'armGroupLabels': ['Non-ccRCC, KPS ≥ 70%', 'RCC with non-active Brain Mets, KPS ≥70%', 'any RCC with KPS 50%-60%', 'ccRCC KPS ≥ 70%'], 'otherNames': ['BMS-936558', 'Opdivo']}, {'type': 'DRUG', 'name': 'Ipilimumab', 'description': 'Specified Dose on Specified Day', 'armGroupLabels': ['Non-ccRCC, KPS ≥ 70%', 'RCC with non-active Brain Mets, KPS ≥70%', 'any RCC with KPS 50%-60%', 'ccRCC KPS ≥ 70%'], 'otherNames': ['Yervoy', 'BMS-734016']}] | PrimaryOutcomes: [{'measure': 'Number of Participants With High Grade (Grade 3-4) Immune Mediated Adverse Events (IMAEs)', 'description': 'Number of participants with IMAEs in the following categories: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity', 'timeFrame': 'Approximately 39 Months'}, {'measure': 'Number of Participants With High Grade (Grade 5) Immune Mediated Adverse Events (IMAEs)', 'description': 'Number of participants with IMAEs in the following categories: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity', 'timeFrame': 'Approximately 39 Months'}] | SecondaryOutcomes: [{'measure': 'Time to Onset of Grade 3-5 Immune Mediated Adverse Events (IMAEs)', 'description': 'Time to onset is defined as the duration of time in weeks from the first dosing to the immune modulating adverse event onset date. Participants experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death', 'timeFrame': 'From first dose to the earliest IMAE (grade 3-5) event onset date (up to approximately 116 weeks)'}, {'measure': 'Time to Resolution of Grade 3-5 Immune Mediated Adverse Events (IMAEs)', 'description': 'Time to resolution is defined as the longest time from IMAE onset date to complete resolution or improvement to the grade at baseline experienced by the participant (the IMAE end date). Participants experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death', 'timeFrame': 'From the IMAE onset date to the IMAE end date, up to approximately 194 weeks'}, {'measure': 'Number of Participants Who Received Immune Modulating Medication for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs)', 'description': 'The number of participants who received immune modulating medication for participants experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death', 'timeFrame': 'From first dose up to 100 days post last dose (up to approximately 29 months)'}, {'measure': 'Number of Participants Who Received Hormone Replacement Therapy for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs)', 'description': 'The number of participants who received Hormone Replacement Therapy for experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death', 'timeFrame': 'From first dose up to 100 days post last dose (up to approximately 29 months)'}, {'measure': 'Number of Participants Who Received ≥ 40mg of Prednisone for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs)', 'description': 'The number of participants who received ≥ 40mg of prednisone for high grade (grades 3-5) IMAEs. Participants experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death', 'timeFrame': 'From first dose up to 100 days post last dose (up to approximately 29 months)'}, {'measure': 'Median Progression Free Survival (PFS)', 'description': 'PFS is defined as the time from first dose to the date of the first documented progressive disease (PD) as determined by the investigator (per RECIST 1.1 criteria or clinical) or death due to any cause whichever occur first. Progressive disease is defined as progression of existing non-target lesions or at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.', 'timeFrame': 'From first dose to the date of the first documented progressive disease, up to approximately 12 months'}, {'measure': 'Objective Response Rate (ORR)', 'description': "ORR is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of response evaluable participants. Best overall response is defined as the best response recorded from the start of the study treatment until the end of treatment. The participant's best overall response assignment will depend on the findings of both target and non-target disease and will also take into consideration the appearance of new lesions. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all lesions and normalization of tumor marker level. All lymph nodes (whether target or non-target) must be non-pathological in size (\\< 10mm short axis).", 'timeFrame': 'From first dose up to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (up to approximately 26 months)'}, {'measure': 'Time to Response Rate (TRR)', 'description': "TTR is defined as the median percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of response evaluable participants. Best overall response is defined as the best response recorded from the start of the study treatment until the end of treatment. The participant's best overall response assignment will depend on the findings of both target and non-target disease and will also take into consideration the appearance of new lesions. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all lesions and normalization of tumor marker level. All lymph nodes (whether target or non-target) must be non-pathological in size (\\< 10mm short axis).", 'timeFrame': 'From the date of first dose to first documented CR or PR, up to approximately 15 months'}, {'measure': 'Duration of Response (DOR)', 'description': 'DOR is defined as the time between the date of first confirmed response to the date of the first documented tumor progression per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, or death due to any cause, whichever occurs first. DOR will be computed for participants who achieve partial response (PR) or complete response (CR) only. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all lesions and normalization of tumor marker level. All lymph nodes (whether target or non-target) must be non-pathological in size (\\< 10mm short axis).', 'timeFrame': 'From first confirmed response to the date of the first documented tumor progression or death, up to approximately 48 months'}] |
Title: A Phase 1b Trial of M3814 (Peposertib) in Combination With Lutetium 177 Dotatate for Well-Differentiated Somatostatin Receptor-Positive Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) | Condition: Neuroendocrine Neoplasm | Keywords: | Summary: | Description: PRIMARY OBJECTIVE:
I. To evaluate the safety and to determine the recommended phase 2 dose (RP2D) of lutetium Lu 177 dotatate in combination with M3814 (peposertib).
SECONDARY OBJECTIVES:
I. To observe and record anti-tumor activity. II. To determine the overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at 4, 8, and 12 months post-therapy.
III. To measure duration of response (DOR) associated with the combination. IV. To evaluate progression-free survival (PFS).
CORRELATIVE OBJECTIVES:
I. Measure the somatostatin receptor uptake on gallium 68 dotatate or Copper 64 dotatate at baseline.
II. Perform lutetium Lu 177 dotatate dosimetry. III. Determine the pharmacokinetic (PK) parameters of M3814 (peposertib). IV. Describe the tumor molecular profile using whole exome sequencing (WES) and ribonucleic acid (RNA) sequencing (RNAseq) and correlate it with treatment outcome.
V. Collect plasma for circulating tumor deoxyribonucleic acid (DNA) (ctDNA) assessment.
VI. Collect blood for biobanking and future correlative studies. VII. Measure association of overall response rate with gallium 68 dotatate-positron emission tomography (PET)/computed tomography (CT) or Copper 64 dotatate measurements and Krenning score.
OUTLINE: This is a dose-escalation study of peposertib followed by a dose-expansion study.
Patients receive peposertib orally (PO) once daily (QD) or twice daily (BID) on days 1-21 and lutetium Lu 177 dotatate intravenously (IV) over 30 minutes on day 1. Treatment repeats every 56 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT/magnetic resonance imaging (MRI) throughout the trial and undergo collection of blood samples on study.
After completion of study treatment, patients are followed up every 4 months for 24 months. | ArmGroups: [{'label': 'Treatment (peposertib, lutetium Lu 177 dotatate)', 'type': 'EXPERIMENTAL', 'description': 'Patients receive peposertib PO QD or BID on days 1-21 and lutetium Lu 177 dotatate IV over 30 minutes on day 1. Treatment repeats every 56 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT/MRI throughout the trial and undergo collection of blood samples on study.', 'interventionNames': ['Procedure: Biospecimen Collection', 'Procedure: Computed Tomography', 'Drug: Lutetium Lu 177 Dotatate', 'Procedure: Magnetic Resonance Imaging', 'Drug: Peposertib']}] | Interventions:[{'type': 'PROCEDURE', 'name': 'Biospecimen Collection', 'description': 'Undergo collection of blood samples', 'armGroupLabels': ['Treatment (peposertib, lutetium Lu 177 dotatate)'], 'otherNames': ['Biological Sample Collection', 'Biospecimen Collected', 'Specimen Collection']}, {'type': 'PROCEDURE', 'name': 'Computed Tomography', 'description': 'Undergo CT', 'armGroupLabels': ['Treatment (peposertib, lutetium Lu 177 dotatate)'], 'otherNames': ['CAT', 'CAT Scan', 'Computed Axial Tomography', 'Computerized Axial Tomography', 'Computerized axial tomography (procedure)', 'Computerized Tomography', 'Computerized Tomography (CT) scan', 'CT', 'CT Scan', 'tomography']}, {'type': 'DRUG', 'name': 'Lutetium Lu 177 Dotatate', 'description': 'Given IV', 'armGroupLabels': ['Treatment (peposertib, lutetium Lu 177 dotatate)'], 'otherNames': ['177 Lu-DOTA-TATE', '177 Lu-DOTA-Tyr3-Octreotate', '177Lu-DOTA0-Tyr3-Octreotate', 'Lutathera', 'Lutetium (177Lu) Oxodotreotide', 'Lutetium Lu 177 DOTA(0)-Tyr(3)-Octreotate', 'Lutetium Lu 177-DOTA-Tyr3-Octreotate', 'lutetium Lu 177-DOTATATE', 'Lutetium Oxodotreotide Lu-177']}, {'type': 'PROCEDURE', 'name': 'Magnetic Resonance Imaging', 'description': 'Undergo MRI', 'armGroupLabels': ['Treatment (peposertib, lutetium Lu 177 dotatate)'], 'otherNames': ['Magnetic Resonance', 'Magnetic Resonance Imaging (MRI)', 'Magnetic resonance imaging (procedure)', 'Magnetic Resonance Imaging Scan', 'Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance', 'MR', 'MR Imaging', 'MRI', 'MRI Scan', 'MRIs', 'NMR Imaging', 'NMRI', 'Nuclear Magnetic Resonance Imaging', 'sMRI', 'Structural MRI']}, {'type': 'DRUG', 'name': 'Peposertib', 'description': 'Given PO', 'armGroupLabels': ['Treatment (peposertib, lutetium Lu 177 dotatate)'], 'otherNames': ['3-Pyridazinemethanol, alpha-(2-Chloro-4-fluoro-5-(7-(4-morpholinyl)-4-quinazolinyl)phenyl)-6-methoxy-, (alphaS)-', 'M 3814', 'M-3814', 'M3814', 'MSC 2490484A', 'MSC-2490484A', 'MSC2490484A', 'Nedisertib']}] | PrimaryOutcomes: [{'measure': 'Recommended phase 2 dose', 'timeFrame': 'Up to 8 weeks'}, {'measure': 'Dose limiting toxicity', 'description': 'Will be assessed by Common Terminology Criteria for Adverse Events version 5.0. The maximum grade of toxicity for each adverse event category of interest will be recorded for each patient and the summary results will be tabulated by category and grade. Will describe all serious (\\>= grade 3) toxicity events on a patient-by-patient basis. Frequency and incidence tables of toxicity and adverse events will be generated in the overall patient group and by dose level depending on patient enrollment.', 'timeFrame': 'Up to 24 months post-treatment'}] | SecondaryOutcomes: [{'measure': 'Overall response rate', 'description': 'Will be estimated along with 95% exact binomial confidence interval.', 'timeFrame': 'Up to 24 months post-treatment'}, {'measure': 'Progression free survival', 'description': 'Will be estimated using the Kaplan-Meier curve and median estimates and confidence intervals will be calculated.', 'timeFrame': 'Up to 24 months post-treatment'}, {'measure': 'Overall survival', 'description': 'Will be estimated using the Kaplan-Meier curve and median estimates and confidence intervals will be calculated.', 'timeFrame': 'Up to 24 months post-treatment'}] |
Title: Colorectal Cancer Dataset in Xijing Hospital From 2011 | Condition: Prognostic Cancer Model, Chemotherapy, Nutrition Related Cancer | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'colorectal cancer', 'description': 'Colorectal cancer patients are enrolled when patients were underwent surgeries.'}] | Interventions:N/A | PrimaryOutcomes: [{'measure': 'overall survival', 'description': 'to dead or lost to follow', 'timeFrame': 'from date of diagnosis until the date of death from any cause, assessed up to 120 months'}, {'measure': 'DFS', 'description': 'disease-free survival', 'timeFrame': 'from date of diagnosis until the first documented progression or recurrence, assessed up to 120 months'}] | SecondaryOutcomes: N/A |
Title: A Phase II Trial of Risk Enabled Therapy After Neoadjuvant Immunochemotherapy for Bladder Cancer | Condition: Muscle-Invasive Bladder Carcinoma | Keywords: | Summary: | Description: Muscle invasive bladder cancer (MIBC) constitutes 20-25% of all cases with 5 year survival estimated at 45% regardless of treatment.1-4 Although neoadjuvant cisplatin-based chemotherapy (NAC) followed by a radical cystectomy or cystoprostatectomy with a lymph node dissection is the preferred treatment choice for MIBC in the United States, there are several drawbacks and challenges with this approach. Patients must be fit to undergo a surgical intervention. Grade 2 through 5 complications have been documented in 53% of patients undergoing cystectomy at a tertiary care center, and the surgical mortality rate is 1.5%.5, 6 Furthermore, urinary diversion commonly requires an ileal conduit and an external appliance, impacting patient's quality of life.
By incorporating neoadjuvant nivolumab with AMVAC, our goal in RETAIN-2 is to increase the number of patients who would be eligible for bladder preservation while maintaining the long-term oncologic outcomes. Nivolumab, an anti-PD1 therapy, is FDA approved for treatment of metastatic urothelial carcinoma post platinum-based chemotherapy.20 Recently, neoadjuvant pembrolizumab (anti-PD1) and atezolizumab (anti-PDL1) was tested in MIBC in the PURE-01 and ABACUS studies, and a pT0 rate of 38.6% and 29%, respectively, was achieved.21, 22 Additionally, recent work by Kim et al. presented at AACR 2019 demonstrated that AMVAC induces gene signatures in luminal tumors and may have a synergistic response with immunotherapy. Given the impressive activity of both AMVAC and nivolumab in the neoadjuvant setting, in this study the investigators hypothesize that using the combination of neoadjuvant nivolumab and AMVAC will lead to higher cT0 rate and metastasis-free survival at 2 years. At the same time by using the risk adapted strategy, a select group of patients will be able to preserve their bladders and significantly improve their quality-of-life. | ArmGroups: [{'label': 'AMVAC + nivolumab', 'type': 'EXPERIMENTAL', 'description': 'This will be a single-arm, open-label, multicenter phase 2 study of neoadjuvant nivolumab with AMVAC. Approximately 70 evaluable patients will be enrolled into this study. Eligible patients will be those with diagnosis of muscle invasive urothelial carcinoma of the bladder who are cT2 or cT3 but not clinical N1 at diagnosis. Clinical stage is confirmed by transurethral resection of bladder tumor (TURBT#1).', 'interventionNames': ['Drug: AMVAC + Nivolumab']}] | Interventions:[{'type': 'DRUG', 'name': 'AMVAC + Nivolumab', 'description': 'Nivolumab 240mg will be administered intravenously for 3 doses - on days 1, 15 and 29. AMVAC will be dosed intravenously every 2 weeks for 3 doses on days 1, 15 and 29 with Neulasta or equivalent. Standard AMVAC dose is as follows: methotrexate 30mg/m2, vinblastine 3mg/m2, doxorubicin 30mg/m2, and cisplatin 70mg/m2.', 'armGroupLabels': ['AMVAC + nivolumab']}] | PrimaryOutcomes: [{'measure': 'Incidence of Metastasis-free survival (MFS)', 'description': 'MFS is defined as a recurrence of urothelial carcinoma that is \\>cN1 (more than one clinically suspicious pelvic lymph node) or surgically unresectable local recurrence (e.g., \\>cT4a) or M1 disease.', 'timeFrame': '2 years'}] | SecondaryOutcomes: [{'measure': 'Number of days of Overall survival', 'description': 'Overall Survival (OS) will be defined as the number of days from study entry to death. Individuals who are alive at last contact will be censored on the date of last contact.', 'timeFrame': 'up to 5 years'}, {'measure': 'Number of days of Progression free survival', 'description': 'Progression Free Survival (PFS) for this study will be defined as the number of days from study entry to date of first evidence of tumor progression (presence of muscle invasive disease, nodal or distant recurrence) or until death from any cause, whichever comes first. Individuals that are alive and remain free of muscle invasive disease, nodal recurrence and distant disease recurrence will be censored on the date of last clinical visit.', 'timeFrame': 'up to 5 years'}, {'measure': 'Number of patients erporting Toxicity of neoadjuvant nivolumab and AMVAC therapy', 'description': 'Toxicity, AEs, SAEs for all patients that are associated with nivolumab or AMVAC will be collected/reported at each cycle and until 100 days after lastnivolumab/AMVAC.\n\nToxicity, AEs, SAEs for the CRT arm specifically will be collected/reported as follows. Grade 1-5 toxicity at C1 (start of nivolumab/AMVAC), C2 (second cycle ofnivolumab/AMVAC), C3 (third cycle of nivolumab/AMVAC), start of chemoradiation, 1/2 completion chemoradiation, completion of chemoradiation, and up to 30 days after completion of chemoradiation.', 'timeFrame': 'until 100 days after the last nivolumab/AMVAC'}] |
Title: The Value of Palliative Primary Tumor Resection in Colon Cancer Patients With Initially Unresectable Metastases After Induction Chemotherapy: a Prospective, Multicenter, Randomized Controlled Clinical Trial | Condition: Metastatic Colon Cancer, Surgery | Keywords: palliative surgery, stage IV colon cancer, chemotherapy | Summary: | Description: N/A | ArmGroups: [{'label': 'Chemotherapy plus surgery', 'type': 'EXPERIMENTAL', 'description': 'Chemotherapy plus surgery: Four cycles of XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy accroding to gene testing. After 4 cycles, the patients are randomized to surgery group. Patients receive palliative resection of Primary tumor. Then the rest four cycles XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy are administrated.', 'interventionNames': ['Procedure: resection of primary tumor', 'Drug: XELOX', 'Drug: mFOLFOX6']}, {'label': 'Chemotherapy alone', 'type': 'ACTIVE_COMPARATOR', 'description': 'Chemotherapy alone: Four cycles of XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy accroding to gene testing. After 4 cycles, the patients are randomized to chemotherapy group. The rest four cycles XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy are administrated.', 'interventionNames': ['Drug: XELOX', 'Drug: mFOLFOX6']}] | Interventions:[{'type': 'PROCEDURE', 'name': 'resection of primary tumor', 'description': 'resection of primary lesion with unresectablely metastatic colon cancer', 'armGroupLabels': ['Chemotherapy plus surgery']}, {'type': 'DRUG', 'name': 'XELOX', 'description': 'Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle', 'armGroupLabels': ['Chemotherapy alone', 'Chemotherapy plus surgery']}, {'type': 'DRUG', 'name': 'mFOLFOX6', 'description': 'Oxaliplatin 85mg/m2, leucovorin 400mg/m2 ivgtt d1 and 5-FU 400 mg/m2 IV bolus d1，2400 mg/m2 CIV 46h, d1', 'armGroupLabels': ['Chemotherapy alone', 'Chemotherapy plus surgery']}] | PrimaryOutcomes: [{'measure': 'Overall survival', 'timeFrame': '5-year'}] | SecondaryOutcomes: [{'measure': 'Progression-free survival 1', 'description': 'The first progression time after diagnosis', 'timeFrame': '3-year'}, {'measure': 'Progression-free survival 2', 'description': 'The first progression time after randomization', 'timeFrame': '3-year'}, {'measure': 'The rate of adverse events resulted from chemotherapy', 'description': 'The ratio of the number of patients experienced adverse events to the total patients', 'timeFrame': '3-year'}, {'measure': 'The quality of life postoperatively', 'description': 'The European Organization for Research and Treatment (EORTC)-QLQ-C30 HRQL questionnaire was assessed with repeated measures at regular intervals postoperatively at months 3, 6, 9, 12, 18, and 24', 'timeFrame': '3-month, 6-month, 9-month, 12-month, 18-month, 24-month'}, {'measure': 'Objective response rate', 'timeFrame': '1-year'}, {'measure': 'The rate of postoperative complications', 'description': 'The ratio of the number of patients with postoperative complications to the total patients', 'timeFrame': '1-year'}, {'measure': 'The proportion of surgical intervention in control group', 'timeFrame': '1-year'}] |
Title: A Phase 1/2, Open Label, Dose Escalation and Expansion Study of TAC-001 in Patients With Select Advanced or Metastatic Solid Tumors | Condition: Advanced or Metastatic Solid Tumors | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'TAC-001 Single-Agent Dose-Escalation Cohorts', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: TAC-001']}] | Interventions:[{'type': 'DRUG', 'name': 'TAC-001', 'description': 'TAC-001 is a Toll-like Receptor Agonist Antibody Conjugate (TRAAC)', 'armGroupLabels': ['TAC-001 Single-Agent Dose-Escalation Cohorts']}] | PrimaryOutcomes: [{'measure': 'Dose-Escalation Stage: RP2D for TAC-001', 'description': 'To identify the recommended dose phase 2 dose (RP2D) for further evaluation of TAC-001 when administered as monotherapy in subjects with advanced or metastatic solid tumors', 'timeFrame': '2-years'}, {'measure': 'Dose Expansion: Characterization of ORR for TAC-001', 'description': 'To evaluate preliminary efficacy of TAC-001 by estimating the overall response rate (ORR; combined complete response \\[CR\\] and partial response \\[PR\\]) as assessed by the Investigator per RECIST 1.1 and iRECIST', 'timeFrame': '2 years'}, {'measure': 'Dose Expansion: Characterization of duration of response for TAC-001', 'description': 'To evaluate preliminary efficacy of TAC-001 by estimating the duration of response as assessed by the Investigator per RECIST 1.1 and iRECIST', 'timeFrame': '2 years'}, {'measure': 'Dose Expansion: Characterization of clinical benefit rate for TAC-001', 'description': 'To evaluate preliminary efficacy of TAC-001 by estimating the clinical benefit rate as assessed by the Investigator per RECIST 1.1 and iRECIST', 'timeFrame': '2 years'}] | SecondaryOutcomes: [{'measure': 'Incidence and Severity of Nonserious Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'description': 'To evaluate the safety of TAC-001 monotherapy through the evaluation of incidence and severity of nonserious AEs and SAEs, including immune-related adverse events (irAEs), as graded by investigators according to CTCAE version 5.0', 'timeFrame': '2 years'}, {'measure': 'Maximum Plasma Concentration (Cmax)', 'description': 'To evaluate the Cmax of TAC-001 monotherapy', 'timeFrame': '2 years'}, {'measure': 'Maximum Plasma Concentration (Tmax)', 'description': 'To evaluate the Tmax of TAC-001 monotherapy', 'timeFrame': '2 years'}, {'measure': 'Area Under the Plasma Concentration-Time Curve (AUC)', 'description': 'To evaluate the AUC of TAC-001 monotherapy', 'timeFrame': '2 years'}, {'measure': 'Terminal Half-Life', 'description': 'To evaluate the terminal half-life of TAC-001 monotherapy', 'timeFrame': '2 years'}, {'measure': 'Clearance of TAC-001', 'description': 'To evaluate the drug clearance of TAC-001 monotherapy', 'timeFrame': '2 years'}, {'measure': 'Evaluation of immunogenicity of TAC-001', 'description': 'Incidence of antidrug antibodies (ADA) against TAC-001', 'timeFrame': '2 years'}] |
Title: Efficacy Analysis of Neoadjuvant Treatment in Lung Cancer Using Low-Dose Nivolumab Combined With Chemotherapy | Condition: Lung Cancer, Nonsmall Cell, Non-Small Cell Lung Cancer NSCLC | Keywords: Low Dose Immunotherapy, Neoadjuvant immunotherapy, Non-Small-Cell-Lung-Cancer | Summary: | Description: N/A | ArmGroups: [{'label': 'Low-dose nivolumab combined with platinum-based doublet chemotherapy', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Low-dose nivolumab combined with platinum-based doublet chemotherapy']}] | Interventions:[{'type': 'DRUG', 'name': 'Low-dose nivolumab combined with platinum-based doublet chemotherapy', 'description': 'Platinum-based neoadjuvant chemotherapy (carboplatin at AUC 5 or 6 combined with either paclitaxel at 175 mg/m² or pemetrexed at 500 mg/m²), administered with nivolumab at 0.3 mg/kg every 21 days for 3 cycles.', 'armGroupLabels': ['Low-dose nivolumab combined with platinum-based doublet chemotherapy']}] | PrimaryOutcomes: [{'measure': 'Major Pathologic Response', 'description': 'MPR is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants who have completed the neoadjuvant therapy before surgery.', 'timeFrame': '2-3 months'}, {'measure': 'Pathologic Complete Response', 'description': 'Pathological complete response (pCR) is defined as having no residual cancer at the primary site or in regional lymph nodes on pathologic review of the surgical specimen.', 'timeFrame': '2-3 months'}] | SecondaryOutcomes: [{'measure': 'Adverse Events', 'description': 'TRAE is defined and classified according to NCI-CTCAE v5.0 in all participants.', 'timeFrame': 'Up to 3 months after the end of treatment'}, {'measure': 'Event-Free-Survival', 'description': "Event-free survival (EFS) is defined as the length of time (months) from randomization to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don't undergo surgery for reason other than progression will be considered to have an event at progression or death.", 'timeFrame': 'Up to 60 months'}, {'measure': 'R0 resection', 'description': 'R0 resection rate is defined as the proportion of participants who have achieved R0 resection (complete resection with no residual tumor cell in the resection margin) in all participants.', 'timeFrame': 'Up to 3 months'}] |
Title: The Application of Multimodal Artificial Intelligence Systems in Prostate Cancer Diagnosis and Prognosis Analysis | Condition: Healthy People, Benign Prostatic Hyperplasia, Prostate Cancer | Keywords: | Summary: | Description: Prostate cancer stands as one of the most prevalent malignancies among men across the globe. Global cancer statistics reveal that the number of new prostate cancer diagnoses rises annually.
In recent years, the advent of multimodal data fusion technology has paved the way for innovative diagnostic and prognostic approaches in prostate cancer. For instance, the synergy of MRI imaging with clinical indicators such as PSA levels and Gleason scores not only refines the staging of prostate cancer but also sheds light on a patient's likely response to treatment and survival outlook.
The exponential growth of artificial intelligence, particularly the broad adoption of deep learning and machine learning algorithms, has emerged as a formidable asset in the realm of multimodal data analysis. By developing an AI-driven multimodal data fusion system, vast medical datasets can be efficiently processed, laying the groundwork for a more nuanced auxiliary diagnostic and therapeutic decision-making framework. | ArmGroups: [{'label': 'Participants who are required to undergo prostatic or pelvic MR according to the investigators', 'interventionNames': ['Diagnostic Test: Prostatic or Pelvic MR', 'Diagnostic Test: Prostatic Biopsy']}] | Interventions:[{'type': 'DIAGNOSTIC_TEST', 'name': 'Prostatic or Pelvic MR', 'description': 'Participants are required to undergo prostatic or pelvic MR according to the investigators.', 'armGroupLabels': ['Participants who are required to undergo prostatic or pelvic MR according to the investigators']}, {'type': 'DIAGNOSTIC_TEST', 'name': 'Prostatic Biopsy', 'description': 'Participants are required to undergo prostatic biopsy according to the clinical indication and investigators.', 'armGroupLabels': ['Participants who are required to undergo prostatic or pelvic MR according to the investigators']}] | PrimaryOutcomes: [{'measure': 'Sensitivity of Prostate Cancer Multimodal Model in Predicting Prostate Biopsy Pathology Outcomes (Benign or Malignant)', 'timeFrame': 'Through completion of study and all data analysis which may take up to one year.'}, {'measure': 'Specificity of Prostate Cancer Multimodal Model in Predicting Prostate Biopsy Pathology Outcomes (Benign or Malignant)', 'timeFrame': 'Through completion of study and all data analysis which may take up to one year.'}, {'measure': 'ROC value of Prostate Cancer Multimodal Model in Predicting Prostate Biopsy Pathology Outcomes (Benign or Malignant)', 'timeFrame': 'Through completion of study and all data analysis which may take up to one year.'}] | SecondaryOutcomes: [{'measure': 'ROC value of a Prostate Cancer Multimodal Model in Predicting the Pathological Outcomes of Gleason Score Categories (≤6, 7, ≥8) in Men Underwent for Prostate Biopsy', 'timeFrame': 'Through completion of study and all data analysis which may take up to one year.'}, {'measure': 'Sensitivity of a Prostate Cancer Multimodal Model in Predicting the Pathological Outcomes of Gleason Score Categories (≤6, 7, ≥8) in Men Underwent for Prostate Biopsy', 'timeFrame': 'Through completion of study and all data analysis which may take up to one year.'}, {'measure': 'Specificity of a Prostate Cancer Multimodal Model in Predicting the Pathological Outcomes of Gleason Score Categories (≤6, 7, ≥8) in Men Underwent for Prostate Biopsy', 'timeFrame': 'Through completion of study and all data analysis which may take up to one year.'}, {'measure': 'ROC value of a Prostate Cancer Multimodal Model in Predicting Clinically Significant Prostate Cancer (csPCa) in Men Underwent Prostate Biopsy', 'timeFrame': 'Through completion of study and all data analysis which may take up to one year.'}, {'measure': 'Sensitivity of a Prostate Cancer Multimodal Model in Predicting Clinically Significant Prostate Cancer (csPCa) in Men Underwent Prostate Biopsy', 'timeFrame': 'Through completion of study and all data analysis which may take up to one year.'}, {'measure': 'Specificity of a Prostate Cancer Multimodal Model in Predicting Clinically Significant Prostate Cancer (csPCa) in Men Underwent Prostate Biopsy', 'timeFrame': 'Through completion of study and all data analysis which may take up to one year.'}] |
Title: Exploratory Study of Gastric Cancer Organoids in the Screening of Neoadjuvant Chemotherapy and Immunotherapy Drugs | Condition: Gastric Cancer, Organoid, Neoadjuvant Therapy | Keywords: | Summary: | Description: There is an important clinical problem in neoadjuvant chemotherapy, adjuvant chemotherapy and palliative chemotherapy for locally advanced gastric cancer, that is, insufficient effectiveness of chemotherapy. Among the patients with neoadjuvant therapy, some patients will have pathological complete remission, and the prognosis of these patients is better than that of other patients.
However, not all patients have a good pathological response after neoadjuvant chemotherapy, although many studies have reported uneven response rates and individual differences in patient sensitivity to chemotherapy drugs. At present, investigators still lack adequate methods to predict the effectiveness of chemotherapy and adjust treatment strategies in time to achieve the best clinical outcomes.
In addition, targeted therapy and immunotherapy are widely used in clinical practice, and gene sequencing is performed on tumor samples of patients to guide the selection of targeted drugs. However, according to clinical data feedback, this method has many limitations, for example, patients with a targeted gene mutation of a targeted drug cannot respond to the drug, while patients without the targeted gene mutation can respond very well to the drug. The reason is that the sequencing results based on some known proto-oncogenes or tumor suppressor genes cannot fully reflect the genomic background of the patient, including some unknown cancer-related genes, and even non-coding protein sequences play important regulatory roles in the process of cancer. Therefore, how to quickly select the most effective drug for this patient among the numerous cancer targeted drugs on the market is the decisive factor for the success or failure of cancer precision medicine.
In recent years, an important breakthrough in basic tumor research is the tumor organoid technology established in vitro, which directly obtains tumor tissue from patients, rapidly expands in vitro, and forms organoids with a high physiological and pathological state similar to the original tissue in a short time. This organoid is a three-dimensional assembly of cells containing more than one cell type. Since the cultured organoids are derived from the patient's own tumor tissue, they can well retain various characteristics of the tumor tissue in situ. Compared with the traditional 2D cell line culture, organoids are directly derived from patients, can retain the patient's genomic information and epigenetic information, maintain the heterogeneous components of the original tumor, and have a 3D structure that is more in line with the conditions in vivo, so it is more representative. Compared with the animal transplant tumor model derived from patients, organoids have the advantages of low cost, high success rate, short culture cycle and easy operation. In general, tumor organoids combine the advantages of 2D cell line culture and animal transplant tumor models, which can not only fully reflect the genetic information and tumor phenotype of patients, but also ensure the heterogeneity of tumors, and have high economic benefits. Therefore, they are favored in scientific research and clinical practice, and are effective tools for evaluating drug response and screening drugs. There are already some of the top cancer research institutes in the world, National Cancer Institute (Netherlands), Cancer Research UK (UK) and the Wellcome Trust Sanger Institute (UK) are working together to build a sample bank of various Tumor organoids that are already being used in precision medicine for cancer patients.
As such, investigators designed a single-center prospective, observational clinical trial for patients with locally advanced gastric cancer, aiming to explore the application of gastric cancer organoids in chemotherapy drug screening, so as to improve the efficacy of neoadjuvant chemotherapy for gastric cancer and provide a basis for the precision treatment of neoadjuvant therapy for gastric cancer. | ArmGroups: N/A | Interventions:[{'type': 'DRUG', 'name': 'Oxaliplatin', 'description': 'According to the first-line drugs provided by the NCCN guidelines, the concentration of each drug was added to the organoid culture medium after setting 5-6 concentration gradients according to literature reports. Chemo-sensitive and drug-resistant.\n\nConstruction of gastric cancer organoid T cell co-culture system to screen sensitive immunotherapy drugs.', 'otherNames': ['Irinotecan (SN-38)', '5-Fluorouracil', 'Paclitaxel', 'Pembrolizumab', 'Nivolumab']}] | PrimaryOutcomes: [{'measure': 'Predictive sensitivity of drug sensitivity', 'description': 'Consistency ratio between organoid drug screening results and actual clinical observation drug sensitivity.', 'timeFrame': 'At the end of Cycle 2 (each cycle is 21 days); At the end of Cycle 4 (each cycle is 21 days); Ten days after surgery;'}, {'measure': 'Predictive specificity of drug sensitivity', 'description': 'The proportion of inconsistencies between organoid drug screening results and actual clinical observation drug sensitivity.', 'timeFrame': 'At the end of Cycle 2 (each cycle is 21 days); At the end of Cycle 4 (each cycle is 21 days); Ten days after surgery;'}] | SecondaryOutcomes: [{'measure': 'Concordance between organoids and source tumor tissue', 'description': 'Concordance between organoids and source tumor tissue', 'timeFrame': 'Organoid models were established and compared after passaging 3-5 generations (Three weeks)'}] |
Title: Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study) | Condition: Liver Neoplasms, Primary Liver Cancer, Secondary Liver Cancer, Tumor Liver, Benign Liver Tumor | Keywords: histotripsy | Summary: | Description: BOOMBOX: Master Study is an observational, single arm, non-randomized, prospective master study. Following histotripsy treatment of liver tumor(s), subjects will undergo imaging ≤36 hours post-histotripsy treatment procedure to determine histotripsy success. Subjects will then be followed per standard clinical follow-up as determined at each site with regular review of adverse event data for up to 5 years or until completion of their follow-up in a sub-study, whichever is longer.
As an observational study, the master protocol does not direct the use of the HistoSonics Edison System towards any specific clinical intent or any specific disease state. Rather, it will uniformly enroll patients and capture real-world standard-of-care data on the usage of the HistoSonics Edison System as implemented by the treating physician on all subjects treated with histotripsy that meet the study criteria and agree to participate in the study. Sub-studies to the master protocol will investigate specific populations and/or clinical questions with more stringent enrollment criteria, standardized testing criteria, and/or follow-up schedule. Any subject enrolled in the master study who also qualifies for a sub-study may enroll in the sub-study in parallel to the master study. | ArmGroups: [{'label': 'HistoSonics Edison System', 'interventionNames': ['Device: HistoSonics Edison System']}] | Interventions:[{'type': 'DEVICE', 'name': 'HistoSonics Edison System', 'description': 'Histotripsy with the HistoSonics Edison System for the full or partial destruction of liver tumors', 'armGroupLabels': ['HistoSonics Edison System'], 'otherNames': ['Histotripsy']}] | PrimaryOutcomes: [{'measure': 'Histotripsy Technical Success', 'description': 'Histotripsy technical success, defined as completion of histotripsy on the target tumor(s) according to the histotripsy treatment plan, assessed by the treating physician on CT or MR imaging at ≤36 hours post-histotripsy treatment procedure. The histotripsy treatment plan will include identification of the intended complete or partial treatment of the tumor(s). The histotripsy treatment zone must provide target tumor coverage greater than or equal to the degree of treatment intended.', 'timeFrame': '≤36 hours post-histotripsy treatment procedure'}] | SecondaryOutcomes: N/A |
Title: Phase I Clinical Trial of Recombinant Viscumin (rViscumin, rMistletoe Lectin, rML) Administered Twice Weekly By The Intravenous Route In Patients With Solid Tumors After Failure of Standard Therapy | Condition: Unspecified Adult Solid Tumor, Protocol Specific | Keywords: unspecified adult solid tumor, protocol specific | Summary: | Description: OBJECTIVES:
* Determine the maximum tolerated dose and dose-limiting toxicity of mistletoe lectin (recombinant viscumin) in patients with advanced solid tumors who have failed standard therapy.
* Determine the pharmacokinetics of this regimen in these patients.
* Determine whether induction of antibodies against recombinant viscumin occurs in these patients.
* Determine whether immunological stimulation at the RNA level of immune cells occurs in patients treated with this regimen.
* Determine whether modification of endothelial parameters occurs in patients treated with this regimen.
* Determine the objective response rates in patients treated with this regimen.
OUTLINE: This is a dose-escalation study.
Patients receive mistletoe lectin (recombinant viscumin) IV over 1 hour twice weekly. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 1-3 patients receive escalating doses of recombinant viscumin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 20% of patients experience dose-limiting toxicity during the first course. Additional patients are treated at the MTD.
Patients are followed every 3 months until disease progression or initiation of another therapy.
PROJECTED ACCRUAL: A minimum of 37 patients will be accrued for this study. | ArmGroups: N/A | Interventions:[{'type': 'DIETARY_SUPPLEMENT', 'name': 'mistletoe extract'}] | PrimaryOutcomes: N/A | SecondaryOutcomes: N/A |
Title: Frailty and Body Composition in the Elderly Cancer Patients Treated With Chemotherapy | Condition: Cancer | Keywords: Cancer, Chemotherapy toxicity, Elderly patients, DEXA, muscle mass | Summary: | Description: However none of the studies relating body composition and chemotoxicity included elderly as a specific subpopulation. Furthermore in the majority of studies, body composition analyses are based on the estimation of muscle mass by CT scanner (axial L3 section). This method is to date not validated in the elderly cancer patients. Nevertheless some studies used Dual Energy X-ray Absorptiometry (DEXA), which is considered the gold standard in the assessment of body composition in older adults.
The investigators main hypothesis is that the appendicular muscle mass (I.e. muscle mass of the 4 limbs) operationalized as an index by dividing the muscle mass by squared height following Baumgartners' approach (Baumgartner, 1998) measured by DEXA (total of muscle mass of 4 limbs / height ²) represents a predictive factor of chemotoxicity in the elderly.
The finding that body composition is associated with poor tolerance of chemotherapy could lead to consider these parameters in the treatment decision of the elderly cancer patients and improve the current decision-making algorithms when treating older adults. | ArmGroups: [{'label': 'Elderly cancer patients', 'description': 'Elderly cancer patients treated with chemotherapy will have DEXA', 'interventionNames': ['Other: DEXA']}] | Interventions:[{'type': 'OTHER', 'name': 'DEXA', 'description': 'The appendicular muscle mass measured by DEXA', 'armGroupLabels': ['Elderly cancer patients'], 'otherNames': ['Dual Energy X-ray Absorptiometry']}] | PrimaryOutcomes: [{'measure': "Number of Participants With Treatment-Related Adverse Events as Assessed by National Cancer Institute's - Common Toxicity Criteria (NCI-CTC) v4.0", 'description': 'Toxicity event defined by : first occurrence of grade 4 hematologic or grade 3-4 non hematologic toxicity as defined by the National Cancer Institute-Common Toxicity Criteria (NCI-CTC version 4) and/or disruption of chemotherapy because of inacceptable toxicity.', 'timeFrame': 'Up to 12 months'}] | SecondaryOutcomes: [{'measure': 'Functional autonomy impairment', 'description': 'defined as a loss of ≥ 0.5 point in Activities of Daily Living Scale.', 'timeFrame': 'Up to 12 months'}, {'measure': 'Functional physical performances impairment', 'description': 'defined as a loss ≥ 1 point in the Short Physical Performance Battery', 'timeFrame': 'Up to 12 months'}, {'measure': 'Quality of life impairment', 'description': 'defined as a loss ≥ 10 points in the EORTC quality of life questionnaire (QLQ) QLQ-C30 questionnaire', 'timeFrame': 'Up to 12 months'}, {'measure': 'Early death', 'description': 'defined by a death occuring during the 3 first months from the initiation of the treatment', 'timeFrame': 'Up to 12 months'}] |
Title: Phase I Study of Chemoradiation Therapy With Epitope Peptide Vaccine Therapy in Treating Patients With Unresectable, Advanced or Recurrent Esophageal Cancer | Condition: Esophageal Cancer | Keywords: Epitope peptide, Vaccination, Chemoradiation, Esophageal cancer | Summary: | Description: Up-regulated ling cancer 10 (URLC10), TTK protein kinase (TTK) and K homology domain containing protein over expressed in cancer (KOC1) were identified as new targets of tumor associated antigens using cDNA microarray technologies combined with the expression profiles of normal and cancer tissues. Furthermore, anti-angiogenic therapy is now considered to be one of promising approaches for treating cancer. Vascular endothelial growth factor receptor 1 (VEGFR1) and vascular endothelial growth factor receptor 2 (VEGFR2) are essential targets for tumor angiogenesis. Epitope peptides for these targets are able to induce cytotoxic T lymphocytes (CTL) restricted to HLA-A \*2402 in vivo. On the other hand, chemotherapy (CDDP, 5-FU) plus radiation therapy has been to be a standard treatment for unresectable advanced esophageal cancer. In this clinical trial, we evaluate the safety and immune responses of different doses of multiple peptides (URLC10, TTK, KOC1, VEGFR1, and VEGFR 2) emulsified with Montanide ISA 51 in combination with chemotherapy (CDDP, 5-FU) plus radiation therapy in treating patients with unresectable, advanced or recurrent esophageal cancer. | ArmGroups: [{'label': '1', 'type': 'EXPERIMENTAL', 'interventionNames': ['Biological: URLC10, TTK, KOC1, VEGFR1, VEGFR2, cisplatin, fluorouracil']}] | Interventions:[{'type': 'BIOLOGICAL', 'name': 'URLC10, TTK, KOC1, VEGFR1, VEGFR2, cisplatin, fluorouracil', 'description': 'Escalating dose of multiple peptides (URLC10, TTK, KOC1 VEGFR1, and VEGFR2) emulsified with Montanide ISA51 will be administered by subcutaneous injection on days 15, 22, 28 and 35 of treatment cycle. Doses of each peptide are planning 0.5mg, 1mg and 3mg/body. Chemotherapy plus radiation therapy will be done as follows: fluorouracil (400mg/m2) on day1-5 and 8-12, cisplatin (40mg/m2) on days 1 and 8, radiation (2Gy) on days 1-5, 8-12 and 15-19. Two cycles of combination of chemoradiation therapy and epitope peptide vaccine therapy will be done.', 'armGroupLabels': ['1'], 'otherNames': ['CDDP', '5-FU']}] | PrimaryOutcomes: [{'measure': 'Safety(toxicities as assessed by NCI CTCAE version3)', 'timeFrame': '3 months'}] | SecondaryOutcomes: [{'measure': 'Peptide specific CTL induction', 'timeFrame': '3 months'}, {'measure': 'DTH to peptide', 'timeFrame': '3 months'}, {'measure': 'Changes in levels of regulatory T cells', 'timeFrame': '3 months'}, {'measure': 'Objective response rate as assessed by RECIST criteria', 'timeFrame': '1 year'}, {'measure': 'Time to progression', 'timeFrame': '1 year'}, {'measure': 'survival', 'timeFrame': '1 year'}] |
Title: An Open-Label Randomized International Multi-Center Phase III Study of Capecitabine (Xeloda) in Combination With Cisplatin Versus FU/Cisplatin in Patients With Advanced and/or Metastatic Gastric Cancer | Condition: Gastric Cancer | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': '5-Fluorouracil + Cisplatin', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants will receive 5-FU in combination with cisplatin upto disease progression.', 'interventionNames': ['Drug: 5-Fluorouracil', 'Drug: Cisplatin']}, {'label': 'Capecitabine + Cisplatin', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive capecitabine in combination with cisplatin upto disease progression.', 'interventionNames': ['Drug: Capecitabine', 'Drug: Cisplatin']}] | Interventions:[{'type': 'DRUG', 'name': '5-Fluorouracil', 'description': 'Participants will receive 5-FU, 800 milligrams per meter-squared (mg/m\\^2) per day via IV infusion during Days 1 to 5 of each 3-week cycle, for a total of 6 cycles in combination with cisplatin or upto disease progression.', 'armGroupLabels': ['5-Fluorouracil + Cisplatin']}, {'type': 'DRUG', 'name': 'Capecitabine', 'description': 'Participants will receive oral capecitabine, 1000 mg/m\\^2 twice daily on Days 1 to 14 of each 3-week cycle, for a total of 6 cycles in combination with cisplatin or upto disease progression.', 'armGroupLabels': ['Capecitabine + Cisplatin']}, {'type': 'DRUG', 'name': 'Cisplatin', 'description': 'Participants will receive cisplastin, 80 mg/m\\^2 via IV infusion on Day 1 of each 3-week cycle, for a total of 6 cycles or upto disease progression in combination with either capecitabine or 5-FU.', 'armGroupLabels': ['5-Fluorouracil + Cisplatin', 'Capecitabine + Cisplatin']}] | PrimaryOutcomes: [{'measure': 'Time to disease progression', 'timeFrame': 'Up to approximately 7.3 years'}] | SecondaryOutcomes: [{'measure': 'Objective tumor response rate', 'timeFrame': 'Up to approximately 7.3 years'}, {'measure': 'Overall survival', 'timeFrame': 'Up to approximately 7.3 years'}, {'measure': 'Duration of response', 'timeFrame': 'Up to approximately 7.3 years'}, {'measure': 'Time to response', 'timeFrame': 'Up to approximately 7.3 years'}, {'measure': 'Incidence of adverse events', 'timeFrame': 'Up to approximately 7.3 years'}] |
Title: Phase I Trial of 5,6 Dimethylxanthenone - 4 - Acetic Acid (DMXAA) in Solid Tumors | Condition: Solid Tumors | Keywords: | Summary: | Description: This is a dose escalation study conducted at a single center in New Zealand. Patients received dimethylxanthenone acetic acid (DMXAA) IV over 20 minutes once every three weeks, up to a maximum of 12 courses.
Cohorts of 3 patients received escalated doses of DMXAA until the maximum tolerated dose (MTD) was determined. The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose limiting toxicity.
Patients had solid tumors for which there was no standard therapy or were refractory to conventional therapy. | ArmGroups: N/A | Interventions:[{'type': 'DRUG', 'name': 'DMXAA', 'description': 'Administered as a 20 minute IV infusion, once every three weeks at doses ranging from 6 mg/m2 to 4900 mg/m2', 'otherNames': ['5,6 Dimethylxanthenone-4-Acetic Acid', 'ASA404', 'AS1404', 'NSC-640488']}] | PrimaryOutcomes: [{'measure': 'Toxicity of DMXAA'}, {'measure': 'Maximum tolerated dose of DMXAA'}, {'measure': 'Pharmacokinetics of DMXAA'}, {'measure': 'Effect of DMXAA on coagulation parameters, TNF and other cytokine production, nitric oxide, and serotonin production'}] | SecondaryOutcomes: [{'measure': 'Efficacy of DMXAA'}, {'measure': 'Effect of DMXAA on tumor vasculature'}] |
Title: FDG-PET Based Chemotherapy Selection for Metastatic Non-Small Cell Lung Cancer | Condition: Malignant Pleural Effusion, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer | Keywords: | Summary: | Description: PRIMARY OBJECTIVES:
I. Assess the response rate in patients who do not demonstrate an early response to carboplatin/paclitaxel as determined by FDG-PET ("initial non-responders") who are subsequently treated with three additional courses of docetaxel/gemcitabine.
SECONDARY OBJECTIVES:
I. Evaluate the ability of FDG-PET to predict response to therapy as measured by computed tomography (CT).
II. Evaluate the early and late changes in tumor FDG uptake (change in standardized uptake value \[SUV\]) in all patients and correlate with overall survival (OS).
OUTLINE: All patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Patients undergo FDG-PET/CT scan between days 18-21.
Patients are then assigned to 1 of 2 treatment groups.
GROUP I (Responders): Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 3 additional courses in the absence of disease progression or unacceptable toxicity.
GROUP II (Initial non-responders): Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG-PET/CT scan between days 18-21 of course 2.
After completion of study treatment, patients are followed up at days 81-84 and then periodically thereafter. | ArmGroups: [{'label': 'Chemotherapy', 'type': 'EXPERIMENTAL', 'description': 'Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients undergo FDG PET/CT (fludeoxyglucose F 18 positron emission tomography/computed tomography) scan between days 18-21. The FDG PET/CT is an imaging biomarker analysis. Patients that are responding to treatment receive paclitaxel IV and carboplatin IV on day 1. Treatment repeats every 3 weeks for up to 3 additional courses in the absence of disease progression or unacceptable toxicity.Patients that are not responding to chemotherapy per FDG PET then receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Non-responding patients undergo an additional FDG PET/CT scan between days 18-21 of course 2.', 'interventionNames': ['Drug: carboplatin', 'Drug: docetaxel', 'Drug: gemcitabine hydrochloride', 'Drug: paclitaxel', 'Procedure: computed tomography', 'Procedure: positron emission tomography', 'Radiation: fludeoxyglucose F 18', 'Other: imaging biomarker analysis']}] | Interventions:[{'type': 'DRUG', 'name': 'carboplatin', 'description': 'Given IV', 'armGroupLabels': ['Chemotherapy'], 'otherNames': ['Carboplat', 'CBDCA', 'JM-8', 'Paraplat', 'Paraplatin']}, {'type': 'DRUG', 'name': 'docetaxel', 'description': 'Given IV', 'armGroupLabels': ['Chemotherapy'], 'otherNames': ['RP 56976', 'Taxotere', 'TXT']}, {'type': 'DRUG', 'name': 'gemcitabine hydrochloride', 'description': 'Given IV', 'armGroupLabels': ['Chemotherapy'], 'otherNames': ['dFdC', 'difluorodeoxycytidine hydrochloride', 'gemcitabine', 'Gemzar']}, {'type': 'DRUG', 'name': 'paclitaxel', 'description': 'Given IV', 'armGroupLabels': ['Chemotherapy'], 'otherNames': ['Anzatax', 'Asotax', 'TAX', 'Taxol']}, {'type': 'PROCEDURE', 'name': 'computed tomography', 'description': 'Undergo FDG PET/CT', 'armGroupLabels': ['Chemotherapy'], 'otherNames': ['tomography, computed']}, {'type': 'PROCEDURE', 'name': 'positron emission tomography', 'description': 'Undergo FDG PET/CT', 'armGroupLabels': ['Chemotherapy'], 'otherNames': ['FDG-PET', 'PET', 'PET scan', 'tomography, emission computed']}, {'type': 'RADIATION', 'name': 'fludeoxyglucose F 18', 'description': 'Given IV', 'armGroupLabels': ['Chemotherapy'], 'otherNames': ['18FDG', 'FDG']}, {'type': 'OTHER', 'name': 'imaging biomarker analysis', 'description': 'Correlative studies', 'armGroupLabels': ['Chemotherapy']}] | PrimaryOutcomes: [{'measure': 'Overall Response Rate (Patients That Achieve a CR or PR)', 'description': 'Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: 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': 'At the end of 4 cycles of treatment, up to 24 weeks.'}] | SecondaryOutcomes: N/A |
Title: Diagnosis Value of SEMA4C in Breast Cancer | Condition: Breast Neoplasm Female | Keywords: | Summary: | Description: Breast cancer remains the most common cancer in women worldwide, with approximately 1.68 million new cases, and 0.52 million deaths, annually. Meanwhile the incidence of breast cancer continues to increase. Early diagnosis and access to optimum treatment are crucial to reduce mortality associated with breast cancer. Currently, mammography and breast ultrasonography are essential for the detection and diagnosis of disease, and breast magnetic resonance imaging is the choice to estimate the extent of disease and guide appropriate treatment. However, there is no robust biomarkers for early detection of breast cancer.
Semaphorin4C (SEMA4C) has been previously identified as a highly expressed protein by breast cancer-associated lymphatic endothelial cells (LECs) using in situ laser capture microdissection of lymphatic vessels, followed by cDNA microarray analysis. Moreover, membrane-bound SEMA4C is cleaved by matrix metalloproteinase (MMPs) to release a soluble form of this protein. Therefore, this prospective project aims to assess the early diagnostic value of SEMA4C as a biomarker for breast cancer. | ArmGroups: [{'label': 'Breast cancer group', 'description': 'Patients who have histologically confirmed new diagnosis of breast cancer are recruited.', 'interventionNames': ['Diagnostic Test: Breast cancer group']}, {'label': 'Benign breast tumor group', 'description': 'Patients who have histologically confirmed new diagnosis of benign breast tumors are recruited.', 'interventionNames': ['Diagnostic Test: Benign breast tumor group']}] | Interventions:[{'type': 'DIAGNOSTIC_TEST', 'name': 'Breast cancer group', 'description': 'All the serum samples are collected before any treatments and will be tested in single center in order to decrease bias. Serum SEMA4C levels were measured using a double antibody sandwich ELISA method using in-house SEMA4C detection kits.', 'armGroupLabels': ['Breast cancer group']}, {'type': 'DIAGNOSTIC_TEST', 'name': 'Benign breast tumor group', 'description': 'All the serum samples are collected before any treatments and will be tested in single center in order to decrease bias. Serum SEMA4C levels were measured using a double antibody sandwich ELISA method using in-house SEMA4C detection kits.', 'armGroupLabels': ['Benign breast tumor group']}] | PrimaryOutcomes: [{'measure': 'Diagnostic potential of SEMA4C as a biomarker for breast cancer', 'description': 'Analyzing the predictive value of SEMA4C in the diagnosis of breast cancer.', 'timeFrame': 'At the time of inclusion'}] | SecondaryOutcomes: [{'measure': 'Serum SEMA4C, Mammography, breast US and MRI in comparison and combination to distinguish breast cancer from benign breast tumor', 'description': 'Compare and combine the diagnostic performances of Serum SEMA4C, traditional mammography, ultrasonography, and contrast-enhanced MR imaging in the assessment of breast cancer', 'timeFrame': 'At the time of inclusion'}] |
Title: MR Guided Focused Ultrasound Surgery of Metastatic Bone Tumors | Condition: Bone Metastases | Keywords: Bone Tumors, Bone Cancer, Prostate Cancer, lung cancer | Summary: | Description: Bone is the third most common organ involved by metastasic disease behind lung and liver. In breast cancer, bone is the second most common site of metastatic spread, and 90% of patients dying of breast cancer have bone metastasis. Breast and prostate cancer metastasize to bone most frequently, which reflects the high incidence of both these tumors, as well as their prolonged clinical courses.
Post cancer survival has increased with improvement in early detection and treatments. As a consequence, the number of patients developing metastatic bone disease during their lifetime has also increased. Patients with bone metastasis from breast cancer have an average 2-year survival from the time of presentation with their first bone lesion. In patients who die from breast, prostate, and lung cancer, autopsy studies have shown that up to 85% have evidence of bone metastases at the time of death.
Current treatments for patients with bone metastases are primarily palliative and include localized therapies (radiation and surgery), systemic therapies (chemotherapy, hormonal therapy, radiopharmaceutical, and bisphosphanates), and analgesics (opioids and non-steroidal anti-inflammatory drugs). Recently, radiofrequency ablation has been tested as a treatment option for bone metastases. The main goals of these treatments are improvement of quality of life and functional level. These goals can be further described: 1) Pain relief, 2) Preservation and restoration of function, 3) Local tumor control, 4) Skeletal stabilization.
The study hypothesis is that MRgFUS is a safe and potentially effective non-invasive treatment for metastatic bone tumors with a low incidence of co-morbidity. Based on the result of this study the Sponsor will initiate a larger study in an effort to approve metastatic bone tumors as an indication for its MRgFUS ExAblate device. | ArmGroups: [{'label': 'ExAblate MRgFUS', 'type': 'EXPERIMENTAL', 'interventionNames': ['Device: ExAblate 2000']}] | Interventions:[{'type': 'DEVICE', 'name': 'ExAblate 2000', 'armGroupLabels': ['ExAblate MRgFUS']}] | PrimaryOutcomes: [{'measure': 'Determine safety of MRgFUS of Bone Metastases', 'timeFrame': 'Within 1 month of Treatment'}] | SecondaryOutcomes: N/A |
Title: Performance of the American College of Surgeons Surgical Risk Calculator in Patients Undergoing Hepatectomy for Liver Tumors | Condition: Liver Surgery, Hepatectomy, Outcome After Hepatectomy | Keywords: | Summary: | Description: This is an observational retrospective study conducted in a tertiary-referral university hospital. An established classification of complications, including post-hepatectomy insufficiency and bile leak, was adopted. The endpoint was the rate of complications, mortality and LOS as expected by the ACS-NSQIP calculator and as observed within 90-day after surgery. | ArmGroups: N/A | Interventions:[{'type': 'PROCEDURE', 'name': 'Liver resection', 'description': 'Surgery for the liver', 'otherNames': ['Hepatectomy']}] | PrimaryOutcomes: [{'measure': "ACS-NSQIP calculator's ability", 'description': "The primary study endpoint was to assess the ACS-NSQIP calculator's ability to predict complications, mortality and length of stay in patients undergoing hepatectomy for liver tumors", 'timeFrame': 'From the date of surgery up to three months from the date of surgery'}] | SecondaryOutcomes: N/A |
Title: A Phase II Study for Stereotactic Body Radiation Therapy (SABR) for Definitive Treatment of Locally Advanced Cervical Cancer (LACC) | Condition: Locally Advanced Cervical Cancer | Keywords: | Summary: | Description: Patients enrolled in this study will receive 45 Gray (Gy) in 25 fractions of intensity modulated external beam radiation therapy + weekly cisplatinum . Following the completion of Intensity Modulated Radiation Therapy (IMRT), patients will receive 28 Gy in 4 fractions using stereotactic body radiation therapy techniques. | ArmGroups: [{'label': 'SABR Boost Therapy', 'type': 'EXPERIMENTAL', 'interventionNames': ['Radiation: SABR Boost Therapy']}] | Interventions:[{'type': 'RADIATION', 'name': 'SABR Boost Therapy', 'description': '1. Initial Pelvic (+/- Para-aortic) fractionated external beam Radiation with 45 Gy to combined PTV with a boost to 55Gy for PET positive/CT enlarged nodes;\n2. Image Guided Hypofractionated Radiation Treatment boost to Cervix High risk CTV/PTV 28GY/4 fx.\n\nPatients will receive 4 fractions of 7 Gy each via stereotactic body radiation as boost therapy to a volume that encompasses the cervical tumor. A minimum of 40 hours should separate each treatment.', 'armGroupLabels': ['SABR Boost Therapy']}] | PrimaryOutcomes: [{'measure': 'Time Taken to Induce Primary Tumor Control', 'description': 'The primary objective is to improve primary tumor local control of eligible LACC using SABR as the mechanism for delivering boost therapy to 85% at 2 years post treatment', 'timeFrame': '2 years'}] | SecondaryOutcomes: N/A |
Title: Image Guided Intensity Modulated External Beam Radiochemotherapy and MRI Based Adaptive BRAchytherapy in Locally Advanced CErvical Cancer | Condition: Uterine Cervical Neoplasms | Keywords: | Summary: | Description: The standard treatment of locally advanced cervical cancer is radio-chemotherapy including external beam radiotherapy (EBRT), brachytherapy (BT) and concomitant chemotherapy with weekly Cisplatin. Image Guided Adaptive Brachytherapy (IGABT), with repetitive MRI regarded as gold standard, is increasingly recognized as the new paradigm replacing 2D BT and spreading throughout the world. This spread is at present predominantly in Europe, North America and in many places in Asia. The Gyn GEC ESTRO Recommendations I-IV have been used as the conceptual frame for these developments during the last decade and are now embedded into the new ICRU/GEC ESTRO report 88 (International Commission on Radiation and Units) which is being published in 2015.
Beside increasing mono-institutional clinical experience - also reported in literature - there is increasing clinical evidence and analyses from multi-institutional studies, in particular RetroEMBRACE (n=731) and EMBRACE (n\>1350) about dose volume effects and outcome. The mature RetroEMBRACE clinical outcome data and dose volume effect analysis for disease outcome show an improved excellent local and pelvic control and survival and significant dose volume effects for IGABT. Overall treatment time was found to have significant impact on local control, and in addition, volume effects of EBRT were found (IMRT vs. 3D CRT) with impact on morbidity and quality of life. Furthermore, dose effects of chemotherapy (≥5 cycles) were found to have impact on survival in advanced disease. Comprehensive analyses from both large patient cohorts reveal further relevant treatment parameters with major impact on disease outcome, morbidity and quality of life. In the international community the results from the EMBRACE studies are regarded as benchmark for future clinical research in this field. Based on the large success of the RetroEMBRACE and EMBRACE studies, the EMBRACE study and research group decided to continue the clinical research work and to initiate a consecutive EMBRACE II study with interventions derived from the evidence collected within the EMBRACE studies.
INTERVENTIONS, AIMS AND HYPOTHESES
The EMBRACE II interventions address local, nodal and systemic treatment as well as exposure of organs at risk:
* Increased use of IC/IS (intracavitary/interstitial) technique in BT
* Reduction of vaginal source loading
* Systematic utilisation of IMRT
* Utilisation of daily IGRT (set-up according to bony structures)
* EBRT target concept related to the primary tumour; concepts for organ at risk (OAR) contouring
* EBRT dose prescription and reporting
* Adaptation of EBRT nodal elective CTV according to risk of nodal and systemic recurrence
* Systematic application of simultaneous chemotherapy
* Reduction of overall treatment time
The general aims of the EMBRACE II study are:
* To systematically apply IMRT with daily IGRT as well as advanced image guided adaptive BT in a prospective multi-centre setting
* To systematically implement a dose prescription protocol for IGABT
* To implement systematic contouring, prescription and reporting for EBRT CTV and OARs.
* To administer EBRT in different targets which are adapted to the risk of nodal and systemic failure: to improve para-aortic and
* systemic control in high risk patients and not to decrease lymph node control in low risk and intermediate risk patients
* To systematically administer simultaneous chemotherapy to EBRT to reach prescribed dose in as many patients as possible, in particular in high risk patients
* To benchmark an outstanding high level of local, nodal and systemic control as well as survival with application of advanced EBRT, BT and chemotherapy within limited overall treatment time
* To benchmark a low incidence of intermediate and major morbidity as well as a high level of quality of life with application of advanced EBRT, BT and chemotherapy
Beside these general aims, there is a significant number of specific aims which refer to the prospective validation of dose volume parameters from the EMBRACE analyses (e.g. dose escalation for large tumors with increased application of IC/IS techniques), to explore and evaluate dose volume parameters for EBRT and to identify prognostic parameters.
General and specific hypotheses were formulated for the various interventions (BT, EBRT, chemotherapy) and endpoints (disease, morbidity, quality of life).
TYPE OF DESIGN The study is a multicenter prospective interventional study with some areas for observational research (e.g. dose-volume histogram (DVH) for IMRT). Reporting on the key patient, tumor, treatment and outcome parameters is mandatory including disease, morbidity and quality of life. Sub-studies as on adaptive IMRT and translational research are optional for cooperation between individual departments. Patient registration and reporting will be performed by the individual investigator via the internet to a central database.
PATIENTS TO BE INCLUDED Patients with newly biopsy proven squamous carcinoma, adenocarcinoma or adeno-squamous carcinoma of the uterine cervix, International Federation of Gynecology and Obstetrics (FIGO) stage IB, IIA, IIB, IIIA, IIIB and IVA (and nodal status according to TNM) in whom definitive radio-chemotherapy with curative intent is planned are qualified for the study. Treatment has to include IGABT with MRI and IMRT with IGRT and ≥5 cycles of cis-Platin. Patients with para-aortic metastatic nodes (stage IVB) to the level of L2 are also eligible but patients with further dissemination are not (M0). Patient work up and staging includes as a minimum patient characteristics with performance status and blood tests (e.g. haemoglobin, lymphocytes), tumor status (biopsy), gynaecological examination, MRI of the pelvis, abdominal CT or MRI, whole body FDG PET-CT (preferably) or at least chest CT. Further investigations are applied if necessary (e.g. cystoscopy, rectoscopy) or done according to institutional practice (e.g. laparoscopic lymph node assessment). Baseline morbidity scoring and quality of life questionnaire are mandatory.
TREATMENT OF PATIENTS IN THE TRIAL All patients will receive both EBRT and concomitant chemotherapy and BT. Summation of EBRT and BT doses will be performed by calculation of a biologically equivalent dose in 2 Gy per fraction (EQD2) using the linear-quadratic model with alpha/beta = 10 Gy for tumour effects and alpha/beta = 3 Gy for late normal tissue damage. The repair half time is assumed to be 1.5 hrs. EBRT has to be delivered as IMRT/VMAT (Volumetric Modulated Arc Therapy) with daily cone beam CT (IGRT) in 25 fractions with 1.8 Gy to a total dose of 45 Gy given in 5 weeks. Target definition is MRI based (initial GTV) for the CTV-T with an initial HR and LR CTV-T and an ITV-T (Internal Target Volume). CT or MRI based nodal Target (CTV-E) is according to risk of nodal spread "Small Pelvis", "Large Pelvis" or "Large Pelvis + Para-aortic Region". Overall CTV/ITV to PTV margin is 5 mm. Involved nodes are boosted preferably based on Positron Emission Tomography (PET) CT with 10-15 Gy and treated as simultaneous integrated boost within 5 weeks (2.2-2.4 Gy per fraction). A range for DVH parameters for the various OARs - contoured according to specific protocols - is taken into account for treatment planning. The LR CTV-T and the CTV- E will be treated with 45 Gy by use of EBRT (PTV45). Maximal treatment time including both EBRT and BT is 50 days. Brachytherapy is prescribed with dose escalation for advanced disease with large adaptive CTV-THR including IC/IS techniques and dose de-escalation for limited size CTV-THR to spare organs at risk and in particular the upper vagina. The primary imaging method is MRI with the applicator in place which enables definition of the relevant volumes of interest directly on the images for treatment planning: GTVres, adaptive CTVHR, CTVIR and organ volumes. The applicator and the reference points are reconstructed in the same image series. All treatment plans have to be optimized to achieve defined planning aims for dose and volume parameters for tumor (D98 for GTVres) and target volumes (e.g. D90-95 Gy for adaptive CTV-THR) and for 2cm3 reference volumes for OARs (e.g. \<80 Gy for bladder, \<65 Gy for rectum) and for vaginal reference points (recto-vaginal point \< 65 Gy, PIBS). If the planning aims cannot be achieved, limits for the finally prescribed dose levels are defined for GTVres, CTVHR, CTVIR, point A, bladder, rectum, sigmoid bowel and vagina. Planning aim doses and limits for the finally prescribed dose levels are based on the experience of the previous retroEMBRACE and EMBRACE trials. For chemotherapy weekly concomitant Cisplatin (40 mg/m2) for 5-6 courses is standard unless chemotherapy is precluded by patient age, co-morbidity and toxicity. Aim is to apply minimum 5 cycles of cis-Platin, in particular in advanced disease.
QUALITY ASSURANCE Only approved departments and investigators can enroll patients into the protocol. This approval is under the responsibility of the study coordinators. The approved departments are at present those that have contributed continuously to EMBRACE in a considerable number of patients. These departments have to go additionally through a QA procedure for IMRT/IGRT. New departments will have to go through a quality assurance (QA) procedure both for IGABT and IMRT/IGRT. Approval requires a compliance questionnaire, successful training, registration and submission of cases and positive evaluation by the study coordinators for each centre. There is no formal on site monitoring, but patient files and treatment plans must be kept at least until closure of the protocol and final analysis of the results is obtained. Continuous data monitoring is performed through the study offices in Vienna and Aarhus and through Utrecht for the centres in the Netherlands. Continuous education will be offered through ACT and annual workshops and EMBRACE meetings.
OUTCOME MEASURES Local and nodal (pelvic) control within the specific EBRT and BT targets (HR-CTV-T, IR-CTV, LR CTV-T; CTV-E, CTV-N) and morbidity related to OAR in the pelvis and the para-artic region as well as overall survival, cancer specific survival and systemic control are the primary outcome measures. All endpoints will be evaluated by actuarial statistics. Morbidity will be scored by use of the Common Terminology Criteria for Adverse Events (CTCAE v3.0/4.0). QoL will also be systematically recorded in all patients.
EVALUATION OF OUTCOME MEASURES Tumor and nodal remission status (complete, uncertain complete, partial, stable \& progressive disease) will be evaluated 3 months after treatment by pelvic (para-aortic, CT) MRI and gynaecological examination. Regular follow-up including gynaecological examination will then be instituted with planned appointments 6, 9, 12, 18, 24, 30, 36, 48 and 60 months after treatment. Pelvic (para-aortic, CT) MRI will be repeated at 12 months after treatment or in case of suspected recurrence. Morbidity and quality of life will be scored systematically at base line and at each time point during follow-up.
SAMPLE SIZE AND DATA MATURITY The study aims at recruiting 1000 patients in 4 years and to follow them for at least 5 years to allow for a meaningful assessment of the endpoints by univariate and multivariate analysis. | ArmGroups: [{'label': 'Standard arm', 'type': 'OTHER', 'description': 'General and specific aims of EMBRACEII as well as the multiple quantitative hypotheses are based on technical data, dose volume parameters and clinical results of the prospective observational study EMBRACEI (NCT00920920, 3 year data 2015) and the retrospective RetroEMBRACE (3/5 year data 2015). The performance of EMBRACE II interventions and clinical outcome in terms of disease- (local, nodal, systemic control, OS, CSS) and morbidity-outcome (various organs and endpoints) is thus based on recent clinical evidence with radiochemotherapy and image guided adaptive brachytherapy. The expected effect of EMBRACE II interventions on clinical outcome is estimated from comparative analyses of interventions in subgroups of Retro-/EMBRACE (partly published). Based on the Retro-/EMBRACE benchmark, the estimated outcome including a confidence interval is quantified for each clinical endpoint in the overall cohort as well as different subgroups for an overall expected patient number of 1000.', 'interventionNames': ['Radiation: Increased use of IC/IS technique in BT', 'Radiation: Reduction of vaginal source loading', 'Radiation: Systematic utilisation of IMRT', 'Radiation: Utilisation of daily IGRT (set-up according to bony structures)', 'Radiation: EBRT target concept related to the primary tumor (CTV-T) and internal motion; concepts for OAR contouring', 'Radiation: EBRT dose prescription and reporting', 'Radiation: Adaptation of EBRT nodal elective CTV according to risk of nodal and systemic recurrence', 'Drug: Systemic application of simultaneous chemotherapy', 'Other: Reduction of overall treatment time']}] | Interventions:[{'type': 'RADIATION', 'name': 'Increased use of IC/IS technique in BT', 'description': 'In EMBRACE II, the improved therapeutic window (through increased application of IC/IS) will be exploited for tumour dose-(de-)escalation and/or OAR dose de-escalation. In tumours with large residual CTVHR volumes at time of brachytherapy, dose-escalation has the potential to improve local control significantly. In limited size CTVHR volumes dose-de-escalation will be performed since dose de-escalation has minor impact on local control while it has potential to reduce morbidity. The strategy of EMBRACEII is to aim for an application of the IC/IS technique in at least 20% of the patients in each institution. The threshold of 20% is relevant for a classical stage distribution of \\~20% IB, \\~50% IIB, \\~20% IIIB and \\~10% others. If a given patient population includes significantly higher proportions of limited or extensive disease, the threshold of 20% IC/IS applications must be adapted.', 'armGroupLabels': ['Standard arm']}, {'type': 'RADIATION', 'name': 'Reduction of vaginal source loading', 'description': 'A multicenter investigation in 50 EMBRACE patients from 3 institutions (Mohamed SM. et al, in submission 2015) shows that reduced loading in ring/ovoids and increased loading in tandem (and needles when available) can be applied without compromising CTVHR and GTVres dose. Decrease of relative vaginal loading from a mean of 50% to 33% had potential to reduce ICRU recto-vaginal dose by a mean of 4±4Gy, and furthermore, bladder and rectum doses could be reduced by 2-3Gy with the same re-arrangement of loading. Similar evidence is available from a study on simulation of different intracavitary standard loading patterns in EMBRACE patients, where it was shown that limited size tumours could often be covered by tandem loading alone (Nkiwane KS. et al. 2013).', 'armGroupLabels': ['Standard arm']}, {'type': 'RADIATION', 'name': 'Systematic utilisation of IMRT', 'description': 'Many institutions deliver 3D conformal radiotherapy (3D CRT) based on a four-field box technique although IMRT has been available for a number of years. The practice in EMBRACEI has been utilisation of IMRT and 3D CRT in 27% and 73% of the patients, respectively. However, EMBRACE morbidity data as well as data published by Mundt et al (Mundt AJ. et al. 2003) indicate that IMRT significantly reduces the incidence of bowel morbidity, and therefore IMRT is considered as instrumental for reducing the incidence of bowel morbidity and with a potential also to be beneficial for urinary morbidity.', 'armGroupLabels': ['Standard arm']}, {'type': 'RADIATION', 'name': 'Utilisation of daily IGRT (set-up according to bony structures)', 'description': 'PTV margins of 10 mm to the elective lymph node target are currently applied in many institutions. This margin is related to set-up uncertainties with patient positioning performed based on skin marks. However, currently, most institutions have in-room imaging available which makes it possible to perform daily imaging and couch correction according to fusion on bony anatomy. With daily imaging, bony image fusion, and couch correction, a margin reduction from 10mm to 5mm can be performed without compromising target coverage (Laursen LV. et al. 2012). The 5mm margin reduction has potential to decrease the volume irradiated to 43Gy by approximately 500cm, which is expected to decrease bowel morbidity by \\~50%.', 'armGroupLabels': ['Standard arm']}, {'type': 'RADIATION', 'name': 'EBRT target concept related to the primary tumor (CTV-T) and internal motion; concepts for OAR contouring', 'description': 'New target concepts are introduced for EBRT related to primary tumor: initial CTV-T, initial CTV-HR, initial CTV-LR and ITV-LR. Use of this novel contouring approach in conjunction with available MRI allows to target safely the visible tumor (CTV-T) and the high risk region (CTV-HRintitial) while consenting for dose to a low risk region (CTV-LRinitial). Anatomical changes due to organ filling variation and cervix/uterus position are considered. ITV-LR is outlined using planning scan and MR images in patients with MRI in treating position while a fixed margin is added to the CTV-LR initial in patients with only diagnostic MRI. New concepts are introduced for OAR contouring. Bowel loops are outlined in one volume restricted to the outer contour, including the mesenterium, for better approximation of the bowel volume and dose constraints. Rectum/sigmoid structures are contoured distinctly. Vaginal lower border is 2,5cm from the caudal extend of the tumor (2cm ITV-LR initial + 0,5cm PTV).', 'armGroupLabels': ['Standard arm']}, {'type': 'RADIATION', 'name': 'EBRT dose prescription and reporting', 'description': 'There is currently a significant variation with regard to EBRT dose and fractionation in the EMBRACE study with doses ranging from 45Gy to 50Gy and being delivered in 25-30 fractions. Furthermore, there is a wide variety of lymph node boosting strategies. In EMBRACEII, the EBRT dose and fractionation to the elective lymph node CTV and initial CTV-T is fixed at 45Gy in 25 fractions, and lymph node boosting must be performed as a simultaneous integrated boost. The dose de-escalation from 50Gy to 45Gy has potential to reduce morbidity. A system of reporting dose to targets and OARs is introduced in terms of dose volume parameters and a system of point dose reporting for the vagina.', 'armGroupLabels': ['Standard arm']}, {'type': 'RADIATION', 'name': 'Adaptation of EBRT nodal elective CTV according to risk of nodal and systemic recurrence', 'description': 'EMBRACEII applies a risk adapted target concept for nodal CTV. This target concept is based on pattern of nodal recurrence analysis which shows 50% of recurrences beyond the classical L5/S1 cranial pelvic field border. A target volume "Large Pelvis" is defined for intermediate risk patients and includes internal, external, common iliac, obturator and presacral nodes. For high risk patients, defined as common iliac or \\>2 nodes involved, the para-aortic region is included. For low risk patients, defined as stage IA/IB1/IIA1, N0, small cell carcinoma (SCC), no uterine invasion, "Small Pelvis" is defined which is "Large Pelvis" without common iliac nodes. Intermediate risk is defined as not high and not low risk.', 'armGroupLabels': ['Standard arm']}, {'type': 'DRUG', 'name': 'Systemic application of simultaneous chemotherapy', 'description': 'According to international standard and evidence, simultaneous chemotherapy (CHT) (min. 5x40 mg/m2 cis Platinum) was prescribed in the EMBRACE protocol for all patients, who qualify for its administration. Certain rules were given for adaption according to international guidelines. 90-95% of EMBRACE patients received simultaneous CHT. Most of the EMBRACE cohort is consecutive patients representing the cervix cancer patient population in the respective centers. About 70% of patients received ≥5 cycles, while 30% received 0-4 cycles. CHT has impact on systemic control, which is pronounced in high risk patients (node positive and/or stage III/IV) with a 20% difference in systemic recurrence. A center effect has been found in the ability to administer chemotherapy with 15-85% of the patients receiving ≥5 cycles of CHT. To reach optimal outcome, particularly in the high risk group, the EMBRACEII protocol also focusses on appropriate administration of CHT following international guidelines.', 'armGroupLabels': ['Standard arm']}, {'type': 'OTHER', 'name': 'Reduction of overall treatment time', 'description': 'Several studies indicate that maintaining an overall treatment time (OTT) of \\<=50 days is important for local control. RetroEMBRACE data confirms that OTT remains of importance in the realm of IGABT. As there is significant variation of OTT across patients and institutions in retroEMBRACE, the EMBRACEII study aims to reduce the OTT so that the majority of patients (\\>80%) will adhere to the \\<=50 day threshold. The measures to reduce OTT in EMBRACE is to systematically apply 25 fractions of EBRT including lymph node boost, and furthermore to carefully plan the BT schedule, so that brachytherapy is delivered towards the end of EBRT and/or directly after EBRT.', 'armGroupLabels': ['Standard arm']}] | PrimaryOutcomes: [{'measure': 'local control', 'timeFrame': '5 years'}, {'measure': 'nodal control', 'timeFrame': '5 years'}, {'measure': 'systemic control', 'timeFrame': '5 years'}, {'measure': 'overall survival', 'timeFrame': '5 years'}, {'measure': 'overall morbidity', 'timeFrame': '5 years'}, {'measure': 'health-related quality of life: physical functioning', 'description': 'European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire. Scores ranging from 0 to 100, higher scores indicating better functioning.', 'timeFrame': '5 years'}, {'measure': 'health-related quality of life: role functioning', 'description': 'European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire. Scores ranging from 0 to 100, higher scores indicating better functioning.', 'timeFrame': '5 years'}, {'measure': 'health-related quality of life: social functioning', 'description': 'European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire. Scores ranging from 0 to 100, higher scores indicating better functioning.', 'timeFrame': '5 years'}] | SecondaryOutcomes: [{'measure': 'cancer specific survival', 'timeFrame': '5 years'}, {'measure': 'disease specific survival', 'timeFrame': '5 years'}] |
Title: A Pilot Study of High Dose Rate Brachytherapy as Definitive Management for Intermediate Risk Prostate Cancer | Condition: Prostate Cancer | Keywords: adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer | Summary: | Description: OBJECTIVES:
Primary
* To assess the feasibility of high-dose rate (HDR) brachytherapy (without the use of external-beam radiotherapy) as definitive treatment for patients with intermediate-risk prostate cancer.
* To assess acceptable toxicity, defined as treatment related toxicity (urinary and rectal), no worse than that seen by patients treated with conventional therapy (grade 3 urinary toxicity \< 10% and grade 3 rectal toxicity \< 10%).
Secondary
* To achieve adequate dosimetric coverage of the prostate comparable to current standards.
* To assess the effect of treatment on sexual function.
OUTLINE: Patients undergo 4 high-dose rate brachytherapy treatments over 2 days.
Patients complete bladder, bowel, sexual function, and quality of life questionnaires, including the International Index of Erectile Function (IIEF) questionnaire, the International Prostate Symptom Score Index (IPSS), and the MSKCC Prostate Quality of Life questionnaire at baseline and then at every follow-up visit.
After completion of study treatment, patients are followed every 3 months for 1 year. | ArmGroups: [{'label': 'HDR Brachytherapy', 'type': 'EXPERIMENTAL', 'description': '9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days', 'interventionNames': ['Other: questionnaire administration', 'Procedure: quality-of-life assessment', 'Radiation: brachytherapy']}] | Interventions:[{'type': 'OTHER', 'name': 'questionnaire administration', 'armGroupLabels': ['HDR Brachytherapy']}, {'type': 'PROCEDURE', 'name': 'quality-of-life assessment', 'armGroupLabels': ['HDR Brachytherapy']}, {'type': 'RADIATION', 'name': 'brachytherapy', 'armGroupLabels': ['HDR Brachytherapy']}] | PrimaryOutcomes: [{'measure': 'Number of Patients With an Acceptable Level of Severe Toxicity as Defined at < Grade 3 CTC Toxicity', 'description': 'Feasibility will be defined as an acceptable level of severe toxicity (both acute and late effects), and adequate dosimetric coverage. Severe toxicity will be defined as \\> or = grade 3 NCI CTC toxicity', 'timeFrame': 'At scheduled 3 month intervals for one year'}, {'measure': 'Number of Patients With an Acceptable Level of Treatment Related Urinary and Rectal Toxicity as Defined at < Grade 3 CTC Toxicity', 'description': 'urinary and rectal toxicity-see the adverse event tables', 'timeFrame': 'Within 90 days of treatment (early toxicities) or after 90 days (late toxicities)'}] | SecondaryOutcomes: N/A |
Title: Two Arm, Multicentric, Randomized, Open Label, Parallel, Multiple Dose Study Subcutaneous Injection of Goserelin 3.6 mg (Eurofarma) vs ZOLADEX 3.6 mg (AstraZeneca) Administered Subcutaneously in Premenopausal Patients With Breast Cancer. | Condition: Breast Cancer | Keywords: | Summary: | Description: A phase III, two arm, multi centric, randomized, open label, parallel, multiple dose pharmacodynamic study in premenopausal patients with breast cancer | ArmGroups: [{'label': 'Goserelin acetate 3.6 mg Injection', 'type': 'EXPERIMENTAL', 'description': '3.6 mg, Subcutaneously at every 28 days', 'interventionNames': ['Drug: Goserelin acetate 3.6 mg Injection']}, {'label': 'ZOLADEX® 3.6mg Injection.', 'type': 'ACTIVE_COMPARATOR', 'description': '3.6 mg, Subcutaneously at every 28 days', 'interventionNames': ['Drug: ZOLADEX® 3.6mg Injection']}] | Interventions:[{'type': 'DRUG', 'name': 'Goserelin acetate 3.6 mg Injection', 'description': '3.6 mg, Subcutaneously at every 28 days', 'armGroupLabels': ['Goserelin acetate 3.6 mg Injection'], 'otherNames': ['Goserelin acetate']}, {'type': 'DRUG', 'name': 'ZOLADEX® 3.6mg Injection', 'description': '3.6 mg, Subcutaneously at every 28 days', 'armGroupLabels': ['ZOLADEX® 3.6mg Injection.'], 'otherNames': ['Zoladex']}] | PrimaryOutcomes: [{'measure': 'To evaluate and compare the pharmacodynamics', 'description': 'Percentage of patients with a mean estradiol concentration \\<30 pg/mL at day 85 days (EOS)', 'timeFrame': '85 days'}] | SecondaryOutcomes: N/A |
Title: The Clinical and Pathological Significance of Allelic Imbalance of 8p in Patients With Colorectal Cancer | Condition: Colorectal Cancer | Keywords: stage II colon cancer, stage III colon cancer, adenocarcinoma of the colon | Summary: | Description: OBJECTIVES:
* Determine the adverse prognostic significance of 8p allelic imbalance (AI) in patients with colon cancer.
* Determine if patient prognosis is dependent on the region of 8p AI.
* Perform fine mapping studies to further localize the putative tumor suppressor gene(s) on 8p.
* Perform multicolor FISH to examine the role that 8p loss and 8q gain play in the prognosis of patients whose tumors exhibit 8p AI.
OUTLINE: Matched normal and tumor DNA is analyzed for 8p allelic imbalance with at least 8 markers: D8S262 and D8S1825 localized to 8p23, D8S254 and D8S261 at 8p22, D8S560 and D8S136 at 8p21, and D8S1820 and D8S283 at 8p12. Normal/tumor tissue pairs are used for fine mapping studies. | ArmGroups: [{'label': 'Normal and tumor tissue pairs', 'description': 'Matched normal and tumor DNA is analyzed for 8p allelic imbalance with at least 8 markers: D8S262 and D8S1825 localized to 8p23, D8S254 and D8S261 at 8p22, D8S560 and D8S136 at 8p21, and D8S1820 and D8S283 at 8p12. Normal/tumor tissue pairs are used for fine mapping studies.', 'interventionNames': ['Genetic: DNA stability analysis', 'Genetic: gene mapping']}] | Interventions:[{'type': 'GENETIC', 'name': 'DNA stability analysis', 'armGroupLabels': ['Normal and tumor tissue pairs']}, {'type': 'GENETIC', 'name': 'gene mapping', 'armGroupLabels': ['Normal and tumor tissue pairs']}] | PrimaryOutcomes: [{'measure': 'overall survival', 'timeFrame': 'Up to 10 years'}] | SecondaryOutcomes: N/A |
Title: Quality of Life in Thai Women Diagnosed Cervical Cancer at King Chulalongkorn Memorial Hospital | Condition: Quality of Life, Cervical Cancer, Cervical Intraepithelial Neoplasia | Keywords: | Summary: | Description: In Thailand, age standardized incidence is 20.9 per 100,000 women-year. Treatment-related survival gain are experienced by side-effect that may reduce quality of life (QoL). We therefore, study the quality of life of patients earlier diagnosed for cervical cancer patients. | ArmGroups: N/A | Interventions:N/A | PrimaryOutcomes: N/A | SecondaryOutcomes: N/A |
Title: A Phase 1 Study to Evaluate the Safety, Proliferation and Persistence of GEN-011, an Autologous Adoptive Cell Therapy Targeting Neoantigens in Solid Tumors | Condition: Melanoma, Non-small Cell Lung Cancer, Squamous Cell Carcinoma of Head and Neck, Urothelial Carcinoma, Renal Cell Carcinoma, Small-cell Lung Cancer, Cutaneous Squamous Cell Carcinoma, Anal Squamous Cell Carcinoma, Merkel Cell Carcinoma | Keywords: Personalized, Immunotherapy, Solid Tumor, Personal, Cell Therapy, Carcinoma, Melanoma, Lung, Bladder, Cancer, Kidney, Anal, Squamous, TiTAN, ATLAS, PLANET, TiTAN-1, Autologous, Neoantigen | Summary: | Description: TiTAN-1 is an open-label, multicenter, first-in-human Phase 1 study of GEN-011 in patients with melanoma, non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), urothelial carcinoma (UC, bladder, ureter, urethra, or renal pelvis), renal cell carcinoma (RCC), small cell lung cancer (SCLC), cutaneous squamous cell carcinoma (CSCC), or anal squamous cell carcinoma (ASCC). Patients will be enrolled into one of 2 cohorts. One cohort will receive a multiple low dose (MLD) regimen of GEN-011 to be given without lymphodepletion, and a second cohort will receive a single high dose (SHD) regimen of GEN-011 after lymphodepletion. Regardless of cohort, each dose of GEN-011 will be followed by a course of interleukin-2 (IL-2) as costimulatory therapy.
GEN-011 is an investigational, personalized neoantigen adoptive cell therapy (ACT) that is being developed by Genocea for the treatment of adult patients with advanced solid tumors. A proprietary tool developed by Genocea called ATLAS™ (Antigen Lead Acquisition System) will be used to identify true immunogenic neoantigens from each patient's tumor that are recognized by their own CD4 and/or CD8 T cells. ATLAS-identified neoantigens will be used to stimulate and select autologous T cells collected by apheresis to generate an adoptive cell product ex vivo. | ArmGroups: [{'label': 'Multiple Low Dose (MLD)', 'type': 'EXPERIMENTAL', 'description': 'GEN-011 is administered by IV infusion at 4-week intervals, up to 5 doses maximum. Each dose is followed by IL-2 administration. MLD patients will not undergo lymphodepletion.', 'interventionNames': ['Biological: GEN-011', 'Drug: IL-2']}, {'label': 'Single High Dose (SHD)', 'type': 'EXPERIMENTAL', 'description': 'GEN-011 is administered as a single IV infusion at the maximum available cell yield, after the patient completes a fludarabine/cyclophosphamide lymphodepletion regimen. The single GEN-011 dose is followed by IL-2 administration.', 'interventionNames': ['Biological: GEN-011', 'Drug: IL-2', 'Drug: Fludarabine', 'Drug: Cyclophosphamide']}] | Interventions:[{'type': 'BIOLOGICAL', 'name': 'GEN-011', 'description': 'Personalized neoantigen adoptive cell therapy (ACT)', 'armGroupLabels': ['Multiple Low Dose (MLD)', 'Single High Dose (SHD)']}, {'type': 'DRUG', 'name': 'IL-2', 'description': 'Cytokine', 'armGroupLabels': ['Multiple Low Dose (MLD)', 'Single High Dose (SHD)'], 'otherNames': ['Interleukin-2']}, {'type': 'DRUG', 'name': 'Fludarabine', 'description': 'Lymphodepletion drug', 'armGroupLabels': ['Single High Dose (SHD)']}, {'type': 'DRUG', 'name': 'Cyclophosphamide', 'description': 'Lymphodepletion drug', 'armGroupLabels': ['Single High Dose (SHD)']}] | PrimaryOutcomes: [{'measure': 'Incidence of Treatment-Emergent Adverse Events', 'description': 'Adverse events will be graded according to the NC Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0', 'timeFrame': '2 years after first GEN-011 infusion'}] | SecondaryOutcomes: [{'measure': 'T cell responses to GEN-011', 'description': 'Antigen-specific immunogenicity assays', 'timeFrame': '2 years after first GEN-011 infusion'}, {'measure': 'Duration of response', 'description': 'Measured by RECIST', 'timeFrame': '2 years after first GEN-011 infusion'}, {'measure': 'Progression-free survival', 'description': 'Length of time without disease progression', 'timeFrame': '2 years after first GEN-011 infusion'}, {'measure': 'Overall survival', 'description': 'Length of time patient remains alive', 'timeFrame': 'From first GEN-011 infusion through study completion, at least 2 years'}] |
Title: Dosimetric Limitation of Pelvic Bone and Peritoneal Space in Rectal Cancer Patients During During Neoadjuvant Chemoradiation With Capecitabine and Irinotecan | Condition: Rectal Cancer | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'experimental arm', 'type': 'EXPERIMENTAL', 'description': 'peritoneal space V15\\<850cc，pelvic bone V10\\<80% and normal dosimetric limitation', 'interventionNames': ['Radiation: dosimetric limitation of pelvic bone and peritoneal space during radiotherapy']}, {'label': 'control arm', 'type': 'NO_INTERVENTION', 'description': 'normal dosimetric limitation'}] | Interventions:[{'type': 'RADIATION', 'name': 'dosimetric limitation of pelvic bone and peritoneal space during radiotherapy', 'description': 'dosimetric limitation of pelvic bone and peritoneal space during radiotherapy', 'armGroupLabels': ['experimental arm']}] | PrimaryOutcomes: [{'measure': 'Number of Participants Experiencing Adverse Events', 'timeFrame': 'up to 3 years'}] | SecondaryOutcomes: [{'measure': 'Number of Participants in Who Experienced Tumor Down-staging', 'timeFrame': 'up to 3 years'}] |
Title: Pifenidone is Used to Reduce Radiation Lung Injury in Lung Cancer Patients Previously Treated With Immune Checkpoint Inhibitors: A Single-arm, Open-label, Phase II Study | Condition: Lung Cancer | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'Pirfenidone combined with radiotherapy', 'type': 'EXPERIMENTAL', 'description': 'Pirfenidone: synchronized with RT, 200 mg TID in the first week, 300 mg TID in the second week, and maintenance treatment of 400 mg TID from the third week until 3 months\n\nRadiotherapy: no limitation, TD≥50Gy (BED/ α/β： 10）', 'interventionNames': ['Drug: Pirfenidone']}] | Interventions:[{'type': 'DRUG', 'name': 'Pirfenidone', 'description': '200 mg TID in the first week, 300 mg TID in the second week, and maintenance treatment of 400 mg TID from the third week until 3 months', 'armGroupLabels': ['Pirfenidone combined with radiotherapy'], 'otherNames': ['PFD', 'AiSiRui']}] | PrimaryOutcomes: [{'measure': 'Incidence rate of radiation pneumonia ≥ grade 2 (1 month, 3 month, 6 month)', 'description': 'Incidence rate of radiation pneumonia ≥ grade 2 (1 month, 3 month, 6 month)', 'timeFrame': 'up to 6 month'}] | SecondaryOutcomes: [{'measure': 'Objective Response Rate (ORR)', 'description': 'Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.', 'timeFrame': 'up to 6 month'}, {'measure': 'Disease Control Rate （DCR）', 'description': 'DCR was defined as the percentage of participants who have a confirmed complete response（CR） or partial response（PR） or stable disease（SD） per RECIST 1.1 as assessed by investigator', 'timeFrame': 'up to 6 month'}, {'measure': '6 month progression-free-survival (PFS) rate', 'description': 'PFS is defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator', 'timeFrame': 'up to 6 month'}, {'measure': 'Treatment-related adverse events', 'description': 'overall incidence of adverse events (AE); incidence of grade 3 or higher AE; incidence of severe adverse events (SAE); incidence of AEs leading to discontinuation of drug use; incidence of AEs leading to suspension of drug use.', 'timeFrame': 'up to 6 month'}] |
Title: A Training Set for the Homologous Recombination Deficiency Scoring Model With Loss of Heterozygosity Status in Epithelial Ovarian Cancer | Condition: Epithelial Ovarian Cancer, BRCA Mutation, Loss of Heterozygosity, Prognosis, Platinum Resistance, Homologous Recombination Deficiency | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'Epithelial ovarian cancer patients sensitive to platinum based chemotherapy', 'interventionNames': ['Genetic: Homologous recombination deficiency model']}, {'label': 'Epithelial ovarian cancer patients resistant to platinum based chemotherapy', 'interventionNames': ['Genetic: Homologous recombination deficiency model']}] | Interventions:[{'type': 'GENETIC', 'name': 'Homologous recombination deficiency model', 'description': 'A homologous recombination deficiency (HRD) scoring model based on loss of heterozygosity (LOH)', 'armGroupLabels': ['Epithelial ovarian cancer patients resistant to platinum based chemotherapy', 'Epithelial ovarian cancer patients sensitive to platinum based chemotherapy']}] | PrimaryOutcomes: [{'measure': 'Homologous recombination deficiency (HRD) score', 'description': 'The HRD score for individual patient is a scale describing her HRD status. The score model is calculated by the analysis for loss of heterozygosity (LOH), and the minimum value is 0, but the maximun value is not available. Higher scores mean more sensitivity to poly-ADP-ribose polymerase inhibitor', 'timeFrame': 'Two years'}] | SecondaryOutcomes: [{'measure': 'Progression-free survival', 'description': 'Progression-free survival in recruited patients', 'timeFrame': 'Five years'}, {'measure': 'Overall survival', 'description': 'Overall survival in recruited patients', 'timeFrame': 'Five years'}] |
Title: Characterization Of Acquired Pyruvate Kinase Deficiency In Clonal Myeloid Neoplasms | Condition: Pyruvate Kinase Deficiency, Pyruvate Kinase Deficiency Anemia, Hereditary Hemolytic Anemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasm, Clonal Myeloid Neoplasm, Myeloproliferative Neoplasm, Acute Myeloid Leukemia, Clonal Cytopenia of Undetermined Significance, Other Clonal Myeloid Neoplasm, Unexplained Coombs-negative Non-immune Hemolytic Anemia | Keywords: Pyruvate Kinase Deficiency, Pyruvate Kinase Deficiency Anemia, Hereditary Hemolytic Anemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasm, Clonal myeloid neoplasm, Myeloproliferative Neoplasm, Acute Myeloid Leukemia, Clonal Cytopenia of Undetermined Significance, Other clonal myeloid neoplasm, Unexplained Coombs-negative non-immune hemolytic anemia | Summary: | Description: This cross-sectional prevalence assessment study involves a single blood draw in specific patient populations to assess for enzymatic and genomic evidence for acquired pyruvate kinase deficiency.
* Red cell pyruvate kinase enzyme activity and next-generation sequencing (NGS) hereditary hemolytic anemia panels will be performed on samples from all recruited participants.
* The study will recruit patients to two separate cohorts.
* Cohort 1 will recruit approximately 75 anemic (Hgb \<11.0 g/dL) MDS participants without overt clinical evidence of hemolysis.
* Cohort 2 will recruit approximately 25 participants with clonal myeloid disorders of any type with evidence of non-immune, otherwise unexplained hemolytic anemia
* Participation in the study involves a single blood draw. Basic information about the participant's blood disorder will also be collected.
It is expected that about 100 people will take part in this research study | ArmGroups: [{'label': 'Cohort I', 'description': 'Approximately 75 anemic (Hgb \\<11.0 g/dL) MDS Participants without overt clinical evidence of hemolysis.\n\n- Single Blood Draw', 'interventionNames': ['Procedure: Blood Draw']}, {'label': 'Cohort 2', 'description': '25 Participants with clonal myeloid disorders of any type with evidence of non-immune, otherwise unexplained hemolytic anemia\n\n-Single Blood Draw', 'interventionNames': ['Procedure: Blood Draw']}] | Interventions:[{'type': 'PROCEDURE', 'name': 'Blood Draw', 'description': 'Blood specimen 2-4 teaspoons', 'armGroupLabels': ['Cohort 2', 'Cohort I']}] | PrimaryOutcomes: [{'measure': 'Overall prevalence of possible or likely acquired pyruvate kinase deficiency', 'description': 'defined by PK enzyme activity or PK:HK ratio \\>1 SD below the control mean (healthy subject mean) as measured by enzyme assay, or potentially pathogenic mutations in the PKLR gene as found on PKLR sequencing', 'timeFrame': 'Day 1'}] | SecondaryOutcomes: [{'measure': 'Overall prevalence of definite acquired pyruvate kinase deficiency', 'description': 'Defined by PK enzyme activity below normal (or a PK:HK ratio \\<8.7) as measured by enzyme assay, or known pathogenic mutations in the PKLR gene as found on PKLR sequencing', 'timeFrame': 'Day 1'}, {'measure': 'Red cell pyruvate kinase enzyme activity', 'description': 'Red cell pyruvate kinase enzyme activity in patients not receiving red cell transfusion in the 60 days prior to blood draw', 'timeFrame': '60 days'}, {'measure': 'Red cell pyruvate kinase', 'description': 'hexokinase enzyme activity ratio in patients not receiving red cell transfusion in the 60 days prior to blood draw', 'timeFrame': '60 Day'}, {'measure': 'Somatic mutations in PKLR (and other genes associated with acquired PKD) detected in the hematopoietic clone', 'timeFrame': 'Day 1'}, {'measure': 'Somatic mutations in other genes associated with hemolytic anemia detected in the hematopoietic clone', 'timeFrame': 'Day 1'}, {'measure': 'Characterization of pyruvate kinase-related red cell metabolites (ATP, 2,3-DPG) and pyruvate kinase-R protein in patients with clonal myeloid disorders', 'timeFrame': 'Day 1'}, {'measure': 'Impact of pyruvate kinase activators on PK activity in vitro', 'timeFrame': 'Day 1'}] |
Title: Durvalumab With Chemotherapy Followed by Sequential Radiotherapy for Limited Stage Small Cell Lung Cancer: A Single-arm Phase II Trial. | Condition: Limited Stage Small Cell Lung Cancer | Keywords: Limited Stage Small Cell Lung Cancer, Durvalumab | Summary: | Description: Primary Outcome Measures:
Progression free survival
Secondary Outcome Measures:
Overall survival Safety analysis | ArmGroups: [{'label': 'Study arm', 'type': 'EXPERIMENTAL', 'description': 'Patients with limited stage small cell lung cancer receive durvalumab with chemotherapy (Etoposide and Cisplatin) for receive 6 cycles, and then receive thoracic radiotherapy.', 'interventionNames': ['Drug: Durvalumab']}] | Interventions:[{'type': 'DRUG', 'name': 'Durvalumab', 'description': 'Durvalumab (IV 1000mg on day 1) with chemotherapy (Etoposide and Cisplatin) for 6 cycles', 'armGroupLabels': ['Study arm'], 'otherNames': ['Etoposide and Cisplatin']}] | PrimaryOutcomes: [{'measure': 'Progression free survival', 'description': 'The PFS time is defined as time from enrollment to locoregional or systemic', 'timeFrame': 'Each 42 days up to intolerance the toxicity or PD (up to 24 months)'}] | SecondaryOutcomes: [{'measure': 'OS（Overall Survival）', 'description': 'OS was defined as time from date of enrollment to date of death due to any cause.', 'timeFrame': 'From enrollment until death (up to 24 months)'}, {'measure': 'Safety analysis', 'description': 'Number of Participants with Adverse Events as a Measure of Safety and Tolerability', 'timeFrame': '1 year'}] |
Title: Magnetic Resonance Breast Tissue Characterisation to Improve Risk Stratification for Breast Cancer | Condition: BRCA1 Mutation, BRCA2 Mutation, Mammography, MRI | Keywords: Breast cancer, BRCA1/2 mutation carriers, Breast screening, Magnetic Resonance Imaging (MRI), X-ray mammography (XRM), Background Parenchymal Enhancement (BPE) | Summary: | Description: Arm 1 :To establish the accuracy of MRI measurements from clinical MRI sequences
Cohort 1: Participants attending MRI \& XRM for a clinical indication with at least one normal breast
Women attend MRI and XRM at the Royal Marsden NHS Foundation Trust for a wide range of clinical indications, including screening, staging and disease monitoring. Investigators will retrospectively analyse MRI and XRM examinations from women with at least one normal breast. This will enable a comparison of clinical and research MRI techniques to measure MRI Breast Density and BPE together with a correlation against PMD. This cohort should cover a wide range of ages and breast densities which will enable a useful comparison of measurement techniques.
Arm 2 To compare breast tissue between women at varying risk of breast cancer
Cohort 2: BRCA1 or BRCA2 mutation carriers attending MRI \& XRM for breast screening Genetic risk of breast cancer
BRCA1 and BRCA2 mutation carriers have a significant cumulative lifetime risk of developing breast cancer, estimated to be 65% and 45%, respectively by the age of 70 \[42\]. NICE guidelines recommend that these high risk women receive annual MRI screening from the age of 30, with the addition of annual XRM from the age of 40. At 50, continuation of MRI screening is dependent on breast density \[43\]\[44\]. The Royal Marsden NHS Foundation Trust screened a large number of these women until 2013, when they were repatriated back into the NHS Breast Screening Service. At St George's Hospital NHS Trust, screening is currently taking place as a part of the NHS Breast Screening Service. Investigators will retrospectively analyse MRI and XRM examinations from women who were aged between 40 and 50 years at screening.
Cohort 3: Participants attending MRI \& XRM for breast screening post mantle radiotherapy Environmental risk of breast cancer
Treatment with high dose mantle radiotherapy at a young age also confers a much higher risk of breast cancer than that of the general population, estimated to result in an increased relative risk of 14.4 in comparison with the general population. NICE guidelines recommend that these high risk women receive annual MRI screening from the age of 30, with the addition of annual XRM from the age of 40. At 50, continuation of MRI screening is dependent on breast density. The Royal Marsden NHS Foundation Trust screened a large number of these women until 2013, when they were repatriated back into the NHS Breast Screening Service. At St George's Hospital NHS Trust, screening is currently taking place as a part of the NHS Breast Screening Service. Investigators will retrospectively analyse MRI and XRM examinations from women who were aged between 40 and 50 years at screening.
Cohort 4: General population attending XRM for breast investigation Population risk of breast cancer
Symptomatic women within the general population are referred to the Rapid Diagnostic and Assessment Centre (RDAC) for breast investigations. A series of diagnostic tests are performed at the RDAC which can include XRM if the women are 40 years of age or above. MRI is not normally performed in this setting. Significant numbers of these women are found to have normal breast tissue at XRM. These are women who have a population (low) risk of breast cancer but who might potentially benefit from an MRI investigation. Investigators will prospectively invite these women for a clinical MRI breast screening examination.
The aim of this study is to develop quantitative MRI measurements of breast tissue from clinical MRI breast protocols and to demonstrate that these descriptors have potential value for breast cancer risk prediction. | ArmGroups: [{'label': 'Arm 1: Cohort 1 - Retrospective Analysis', 'description': 'Participants attending MRI \\& XRM for a clinical indication with at least one normal breast', 'interventionNames': ['Diagnostic Test: MRI']}, {'label': 'Arm 2: Cohort 2 - Retrospective Analysis', 'description': 'BRCA1 or BRCA2 mutation carriers attending MRI \\& XRM for breast screening:\n\nGenetic risk of breast cancer', 'interventionNames': ['Diagnostic Test: MRI']}, {'label': 'Arm 2: Cohort 3 - Retrospective Analysis', 'description': 'Participants attending MRI \\& XRM for breast screening post mantle radiotherapy:\n\nEnvironmental risk of breast cancer', 'interventionNames': ['Diagnostic Test: MRI']}, {'label': 'Arm 2: Cohort 4 - Prospective', 'description': 'General population attending XRM for breast investigation:\n\nPopulation risk of breast cancer MRI', 'interventionNames': ['Diagnostic Test: MRI']}] | Interventions:[{'type': 'DIAGNOSTIC_TEST', 'name': 'MRI', 'description': 'Clinical MRI breast screening examination', 'armGroupLabels': ['Arm 1: Cohort 1 - Retrospective Analysis', 'Arm 2: Cohort 2 - Retrospective Analysis', 'Arm 2: Cohort 3 - Retrospective Analysis', 'Arm 2: Cohort 4 - Prospective']}] | PrimaryOutcomes: [{'measure': 'Arm 1 (Cohort 1), Arm 2 (Cohorts 2 & 3) : breast density', 'description': 'Breast density is measured in standard clinical sequences and in research sequences, expected to be the gold standard, as a %volume.', 'timeFrame': 'After retrospective selection of subject groups (approximately 6 months).'}, {'measure': 'Arm 1 (Cohort 1), Arm 2 (Cohorts 2-3) : breast parenchyma enhancement (BPE)', 'description': 'BPE is measured as a % of pre-contrast image intensity on dynamic contrast-enhanced examinations.', 'timeFrame': 'After retrospective selection of subject groups (approximately 6 months).'}, {'measure': 'Arm 2 (Cohort 4): breast density', 'description': 'Breast density is measured in standard clinical sequences and in research sequences, expected to be the gold standard, as a %volume.', 'timeFrame': 'Six months after recruitment'}, {'measure': 'Arm 2 (Cohort 4): breast parenchyma enhancement (BPE)', 'description': 'BPE is measured as a % of pre-contrast image intensity on dynamic contrast-enhanced examinations.', 'timeFrame': 'Six months after recruitment'}] | SecondaryOutcomes: N/A |
Title: Phase III Randomized Study of Sorafenib Plus Doxorubicin Versus Sorafenib in Patients With Advanced Hepatocellular Carcinoma (HCC) | Condition: Advanced Adult Hepatocellular Carcinoma, Recurrent Hepatocellular Carcinoma, Stage III Hepatocellular Carcinoma AJCC v7, Stage IIIA Hepatocellular Carcinoma AJCC v7, Stage IIIB Hepatocellular Carcinoma AJCC v7, Stage IIIC Hepatocellular Carcinoma AJCC v7, Stage IV Hepatocellular Carcinoma AJCC v7, Stage IVA Hepatocellular Carcinoma AJCC v7, Stage IVB Hepatocellular Carcinoma AJCC v7, Unresectable Hepatocellular Carcinoma | Keywords: | Summary: | Description: PRIMARY OBJECTIVES:
I. Compare the overall survival (OS) of patients treated with sorafenib (sorafenib tosylate) and doxorubicin (doxorubicin hydrochloride) to that of those treated with sorafenib.
SECONDARY OBJECTIVES:
I. Compare time to progression (TTP) of patients treated with sorafenib and doxorubicin to that of those treated with sorafenib.
II. Compare progression-free-survival (PFS) of patients treated with sorafenib and doxorubicin to that of those treated with sorafenib.
III. Compare tumor response using Response Evaluation Criteria in Solid Tumors (RECIST) criteria of patients treated with sorafenib and doxorubicin to that of those treated with sorafenib.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive doxorubicin hydrochloride intravenously (IV) on day 1 and sorafenib tosylate orally (PO) once daily (QD) or twice daily (BID) on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After 6 courses, patients may continue to receive sorafenib tosylate PO QD or BID in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive sorafenib tosylate PO QD or BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months for 2 years. | ArmGroups: [{'label': 'Arm I (doxorubicin hydrochloride, sorafenib tosylate)', 'type': 'EXPERIMENTAL', 'description': 'Patients receive doxorubicin hydrochloride IV on day 1 and sorafenib tosylate PO QD or BID on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After 6 courses, patients may continue to receive sorafenib tosylate PO QD or BID in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Doxorubicin Hydrochloride', 'Other: Laboratory Biomarker Analysis', 'Other: Pharmacogenomic Study', 'Drug: Sorafenib Tosylate']}, {'label': 'Arm II (sorafenib tosylate)', 'type': 'EXPERIMENTAL', 'description': 'Patients receive sorafenib tosylate PO QD or BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Other: Laboratory Biomarker Analysis', 'Other: Pharmacogenomic Study', 'Drug: Sorafenib Tosylate']}] | Interventions:[{'type': 'DRUG', 'name': 'Doxorubicin Hydrochloride', 'description': 'Given IV', 'armGroupLabels': ['Arm I (doxorubicin hydrochloride, sorafenib tosylate)'], 'otherNames': ['5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)', 'ADM', 'Adriacin', 'Adriamycin', 'Adriamycin Hydrochloride', 'Adriamycin PFS', 'Adriamycin RDF', 'ADRIAMYCIN, HYDROCHLORIDE', 'Adriamycine', 'Adriblastina', 'Adriblastine', 'Adrimedac', 'Chloridrato de Doxorrubicina', 'DOX', 'DOXO-CELL', 'Doxolem', 'Doxorubicin HCl', 'Doxorubicin.HCl', 'Doxorubin', 'Farmiblastina', 'FI 106', 'FI-106', 'hydroxydaunorubicin', 'Rubex']}, {'type': 'OTHER', 'name': 'Laboratory Biomarker Analysis', 'description': 'Correlative studies', 'armGroupLabels': ['Arm I (doxorubicin hydrochloride, sorafenib tosylate)', 'Arm II (sorafenib tosylate)']}, {'type': 'OTHER', 'name': 'Pharmacogenomic Study', 'description': 'Correlative studies', 'armGroupLabels': ['Arm I (doxorubicin hydrochloride, sorafenib tosylate)', 'Arm II (sorafenib tosylate)'], 'otherNames': ['PHARMACOGENOMIC']}, {'type': 'DRUG', 'name': 'Sorafenib Tosylate', 'description': 'Given PO', 'armGroupLabels': ['Arm I (doxorubicin hydrochloride, sorafenib tosylate)', 'Arm II (sorafenib tosylate)'], 'otherNames': ['BAY 43-9006 Tosylate', 'BAY 54-9085', 'Nexavar', 'sorafenib']}] | PrimaryOutcomes: [{'measure': 'Overall Survival', 'description': 'Overall survival is defined as the time from study entry to death from any cause. The median OS was estimated using the Kaplan-Meier method.', 'timeFrame': 'Up to 3 years'}] | SecondaryOutcomes: [{'measure': 'Incidence of Toxicities, as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0', 'description': 'Toxicity is defined as a grade 3 or higher adverse events that is classified as either possibly, probably, or definitely related to study treatment. The assignment of attribution to study treatment and grade (or degree of severity) of the adverse event are classified using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. The percentage of patients with a maximum grade 3 or higher adverse event at least possibly related to the study treatment are reported below.', 'timeFrame': 'Up to 3 years'}, {'measure': 'Progression Free Survival', 'description': 'Progression free survival is defined as the time from study entry to earliest date of disease progression. Progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: The appearance of one or more new lesions is also considered progression).', 'timeFrame': 'Up to 3 years'}, {'measure': 'Time to Progression (TTP)', 'description': 'Time to Progression (TTP) is defined as the time from on study to progression. Progression is defined by the RECIST criteria as Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: The appearance of one or more new lesions is also considered progression). Median and 95% confidence intervals are provided for each arm below.', 'timeFrame': 'Up to 3 years'}, {'measure': 'Best Overall Response Rate', 'description': 'Best Overall Response Rate is defined as is the best response recorded from the start of the treatment until disease progression/recurrence. Complete Response: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \\< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: The appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum diameters while on study.', 'timeFrame': 'Up to 3 years'}] |
Title: Optimized Cord Blood Transplantation for the Treatment of High-Risk Hematologic Malignancies in Adults | Condition: Acute Myelogenous Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Chronic Myelogenous Leukemia (CML), Myelodysplastic Syndromes (MDS), Myeloproliferative Disorder, Non-Hodgkin's Lymphoma | Keywords: Cord Blood Transplant, CYCLOPHOSPHAMIDE (CYTOXAN), CYCLOSPORINE A, FLUDARABINE, MYCOPHENOLATE MOFETIL (MMF), THIOTEPA, 23-143 | Summary: | Description: N/A | ArmGroups: [{'label': 'Cord Blood Transplant', 'type': 'EXPERIMENTAL', 'description': 'Adult patients with high-risk hematologic malignancies and a suitable double-unit CB graft will undergo work-up to assess protocol eligibility. CB graft selection will be based on established MSKCC guidelines. Patients will receive standard conditioning with Cy 50 mg/kg, Flu 150 mg/m2, Thio 10 mg/kg, and TBI 400 cGy according to the eligibility criteria. GVHD prophylaxis will consist of CSA and MMF starting day -3. The double-unit CB graft will be infused on day 0 per standard practice. Optimized CBT practices, will be implemented in this protocol.', 'interventionNames': ['Drug: Conditioning Chemotherapy', 'Biological: Cord blood graft']}] | Interventions:[{'type': 'DRUG', 'name': 'Conditioning Chemotherapy', 'description': 'Conditioning: Cyclophosphamide (CY) 50 mg/kg x1 (day -6), Fludarabine (FLU) 30 mg/m2 x5 (days -6 to -2), Thiotepa (THIO) 5 mg/kg x2 (days -5 \\& -4), Total Body Irradiation (TBI) 200 cGy x2 (days -2 \\& -1). GVHD prophylaxis: Cyclosporine (CSA) 3 mg/kg q12 hours \\& Mycophenolate Mofetil (MMF) 15 mg/kg q8 hours (starting IV day -3).', 'armGroupLabels': ['Cord Blood Transplant']}, {'type': 'BIOLOGICAL', 'name': 'Cord blood graft', 'description': 'The double-unit CB graft will be infused on day 0 per standard practice.', 'armGroupLabels': ['Cord Blood Transplant']}] | PrimaryOutcomes: [{'measure': 'Overall survival (OS)', 'timeFrame': '1 year post transplant'}] | SecondaryOutcomes: [{'measure': 'Time to neutrophil engraftment', 'description': 'The day of neutrophil recovery is the 1st day of 3 consecutive days of absolute neutrophil count (ANC) at or above 500 after the first post-CBT nadir.', 'timeFrame': 'Up to day 45 post-transplant'}] |
Title: Medical Treatment of Solid Tumors at the Lyon University Hospital Cancer Institute During the First Wave of COVID-19 in France: A Conservative Approach | Condition: Cancer, Solid Tumor, Covid19 | Keywords: COVID-19, Cancer, Solid Tumor, Qualitative study, First pandemic wave | Summary: | Description: N/A | ArmGroups: [{'label': 'Solid Tumor and COVID-19', 'description': "Patients with a solid tumor followed by an oncologist of Lyon University Hospital Cancer Institute (LUHCI) who have been hospitalized at LUHCI for the COVID-19 between March and May 2020 and who didn't oppose the reuse of their medical file data for research purpose.", 'interventionNames': ['Other: COCA is an observational study based on retrospective data issued from patient medial file.']}] | Interventions:[{'type': 'OTHER', 'name': 'COCA is an observational study based on retrospective data issued from patient medial file.', 'description': 'The following parameters will be collected from the medical files of the patients involved in this study:\n\n* Age\n* Gender\n* Cancer type\n* Cancer Stage\n* Cancer Treatment\n* COVID-19 severity (based on chest X-Ray damage. Low ≤25%, Middle: between 25-50%, High above 50%)\n* Living Status\n* Attribution of Mortality to COVID status\n* Comorbidities', 'armGroupLabels': ['Solid Tumor and COVID-19']}] | PrimaryOutcomes: [{'measure': 'Illustration of the repartition of COVID+ patient severity (Low/Medium/Severe status) depending on cancer nature, stage and patient age.', 'description': 'COVID-19 severity will be determined based on chest X-Ray damage as follow. Low severity : ≤25% of chest X-Ray damage, Middle severity: between 25-50% of chest X-Ray damage, High Severity : above 50% of chest X-Ray damage.\n\nA graphic will then be drafted to present the relationship between Covid-19 severity depending on patient age, cancer nature, and cancer stage.', 'timeFrame': 'At the end of Month 1'}] | SecondaryOutcomes: N/A |
Title: International Validation and Testing of a Supplementary Questionnaire Module for Assessment of Oral and Dental Health in Cancer; the QLQ-OH17 | Condition: Quality of Life, Adverse Effects, Late Effects, Cancer, Xerostomia | Keywords: EORTC QLQ-C30, Oral health, Quality of life, Questionnaires, Patient reported, outcomes | Summary: | Description: The EORTC guidelines will be strictly followed also in phase IV of the module development. Eligible patients will be contacted by the local study coordinator or a study nurse and informed about the study. After having provided written informed consent, they will be presented with the following two questionnaires for self-report of general symptoms, specific dental and oral symptoms, and quality of life issues; the EORTC QLQ-C30 and the QLQ-OH17. In addition to these two, a short debriefing interview will be conducted by study coordinator / study nurse for assessment of feasibility and patients' opinion about the questionnaires.
The case report form (CRF) on medical and demographic data will be completed by the study coordinator / study nurse before or after the patients have completed their part.
A subset of the patients will be assessed twice, as examination of test - retest reliability is important in phase IV of the development process. | ArmGroups: [{'label': 'Group 1- in active treatment', 'description': 'Questionnaires only'}, {'label': 'Group 2 - 2-6 months post-treatment', 'description': 'Questionnaires only'}, {'label': 'Group 3 - 6 mos-3yrs post-treatment', 'description': 'Questionnaires only'}, {'label': 'Group 4 - Palliative treatment', 'description': 'Questionnaires only'}, {'label': 'Group 5 - Referred to dentist/oral team', 'description': 'Questionnaires only'}] | Interventions:N/A | PrimaryOutcomes: [{'measure': 'Oral morbidity', 'description': 'The study aims to validate a questionnaire for assessment of oral morbidity, oral health , and quality of life in relation to cancer treatment. Specific outcomes are prevalence of patients with moderate to severe oral morbidity due to cancer treatment (mucositis,stomatitis, taste change, decayed /loose teeth, osteoradionecrosis, ulcers), to investigate if the severity varies with certain background variables , for example, diagnostic group, age, sex, stage of disease, type of treatment, and to investigate the discriminant validity, reliability and responsiveness of the specific items in patient subgroups', 'timeFrame': 'Up to two years'}] | SecondaryOutcomes: [{'measure': 'Quality of life', 'description': 'The questionnaire module that is subject to testing of psychometric properties, will be used together with a well-validated quality of life questionnaire, to investigate if oral morbidity affects overall quality of life', 'timeFrame': 'Up to two years'}] |
Title: A Study of Hairy Cell and Other Leukemias With a Focus on Recombinant Immunotoxins for Cancer Treatment | Condition: Hairy Cell Leukemia (HCL), Chronic Lymphocytic Leukemia (CLL), Non-Hodgkins Lymphoma (NHL), Cutaneous T Cell Lymphoma (CTCL), Adult T Cell Lymphoma (ATL) | Keywords: Cytotoxicity Assay, Neutralizing Antibodies, Apheresis, Flow Cytometry, Hemolytic Uremic Syndrome (HUS), Natural History | Summary: | Description: Background
* Hairy cell leukemia (HCL) is highly responsive to but not curable by standard chemotherapy, and also responds well to investigational agents called recombinant immunotoxins which have been developed by the Laboratory of Molecular Biology (LMB).
* HCL variants often resemble classic HCL but are more aggressive and less responsive to treatments, such as HCLv and IGHV4-34+ HCL that are immunophenotypically indistinguishable from classic HCL and highly aggressive and resistant like HCLv.
* The investigators on this protocol are studying molecular and clinical aspects of HCL, and how they compare to normal or to other disorders, including other hematologic malignancies and solid tumors.
* The LMB are also studying agents for HCL/HCLv, including recombinant immunotoxins developed in the LMB. Specific targets and agents include BL22 and a high affinity variant, HA22 or Moxetumomab Pasudotox (Moxe), targeting CD22, LMB-2, targeting CD25, and SS1P, targeting Mesothelin as well as single agents and combinations of purine analogs (e.g., cladribine, pentostatin, and bendamustine), anti-CD20 monoclonal antibodies (e.g., rituximab), and small molecule inhibitors (e.g., BRAF V600E inhibitors dabrafenib and encorafenib, MEK inhibitors trametinib and binimetinib, and Bruton s tyrosine kinase (BTK) inhibitor ibrutinib).
* Longitudinal evaluation of HCL is needed as a basis to identify more effective treatments.
Objective
-To allow the collection and analysis of a variety of samples, including blood, tumor and other tissues from individuals with and without cancer to better understand the disease processes which are being studied, particularly hairy cell leukemia, or to determine eligibility and/or optimal timing for clinical testing
Eligibility
* Greater than or equal to 18 years of age
* Diagnosis of a hematologic malignancy or solid tumor; or normal donors (i.e., individuals without a known malignancy).
Design
* Collection of data and samples for research, including blood, tumor, and other tissues from participants and normal volunteers.
* Samples may be obtained prior to/after treatment, during disease assessments, and at the time of response/relapse. This protocol does not involve treatment, although participants may receive treatment as standard of care or as part of another research protocol during participation.
* Samples can be obtained at NIH or at local providers (and sent to NIH).
* Systematic follow-up of participants with HCL, in particular those who have completed prior treatment.
* We anticipate accruing 1263 participants on this protocol. | ArmGroups: [{'label': '1', 'description': 'Patients with hematologic malignancies or solid tumors.'}, {'label': '2', 'description': 'Normal Donors who are defined as individuals without a diagnosis of or history of any cancer.'}] | Interventions:N/A | PrimaryOutcomes: [{'measure': 'Tissue Acquisition', 'description': 'Collection of a variety of clinical samples, including blood, urine, lymphapheresis samples, and other tissues and associated data', 'timeFrame': '4 weeks'}] | SecondaryOutcomes: [{'measure': 'HCL follow-up', 'description': 'Assess long-term treatment complications and disease outcomes in participants with HCL/HCLv', 'timeFrame': 'about every 2 years'}] |
Title: Phase II Trial of Oral Colchicine in Men With Castrate-Resistant Prostate Cancer Who Have Failed Taxotere-Based Chemotherapy | Condition: Prostate Cancer | Keywords: oral colchicine, castrate-resistant prostate cancer, failed taxotere based chemotherapy | Summary: | Description: The investigators propose a simple phase II trial of oral colchicine at the standard prophylactic dose utilized for gout in men with CRPCa who have failed taxotere based chemotherapy. The investigators will utilize a simple modified Simon 2-stage design. The investigators plan to enroll 40 men for the study. The men should have completed prior taxotere based therapy or any other therapy post-taxotere including cabazitaxel one month prior to receipt of colchicine on trial. Staging with a baseline bone scan, CT and PSA as well as routine CBC, CMP and PAP. The dose of the drug can be escalated as tolerated to a maximum of 1.2 mg bid. The patient would be seen at 21 day intervals. After every 3 cycles of treatment, patient would be restaged with CT and bone scan. Patients with stable disease, partial response or complete response would continue therapy until either disease progression or intolerable toxicity after which the patient would be taken off study. | ArmGroups: [{'label': 'Single arm', 'type': 'EXPERIMENTAL', 'description': 'Colchicine 0.5 mg BID x 21 days', 'interventionNames': ['Drug: Colchicine']}] | Interventions:[{'type': 'DRUG', 'name': 'Colchicine', 'description': 'Colchicine 0.6 mg bid to a maximum of 1.2 mg bid', 'armGroupLabels': ['Single arm'], 'otherNames': ['Colcrys']}] | PrimaryOutcomes: [{'measure': 'PSA Response rate', 'description': 'Determine the PSA response rate to continuous low dose oral colchicine', 'timeFrame': '63 days (3 cycles of treatment)'}] | SecondaryOutcomes: [{'measure': 'Response rate', 'description': 'Determine the progression free survival', 'timeFrame': '63 days (3 cycles)'}, {'measure': 'Toxicity grading', 'description': 'Determine the safety and tolerability of continuous low dose oral colchicine', 'timeFrame': 'One year'}] |
Title: Phase 2 Study of Androgen Deprivation Therapy (ADT) Plus Chemotherapy as Initial Treatment for Local Failures or Advanced Prostate Cancer | Condition: Prostatic Neoplasms | Keywords: Prostate Cancer, Advanced, Local Failures | Summary: | Description: As a working hypothesis, investigators suspect that the transformation from an androgen-dependent to an androgen-independent phenotype is mediated by expansion of an androgen-independent clone already present at the time of ADT that continues to grow while androgen-sensitive clones are being suppressed. It is thus desirable to bring treatment to bear on the androgen-independent component while the corresponding tumor burden remains minimal and prolong the time to hormone resistance. Investigators view the androgen-independent component as analogous to "microscopic residual" or "micro-metastatic" disease, for which adjuvant chemotherapy has been shown to be effective in other contexts, even when the same drugs had little or no impact on survival in the setting of more advanced disease.
By treating all components of the tumor initially, investigators anticipate that the emergence of androgen-independent growth will be delayed, ultimately prolonging patient survival. Additionally, instead of treating patients empirically with an identical regimen, as in investigator's previous work, these patient subsets were designed to ensure a level of treatment appropriate to their individual disease, thus potentially lessening the burden of treatment (such as the long-term adverse effects of ADT). Investigators have chosen 3, 4, or 5 cycles of chemotherapy to be administered on the basis of tumor burden, a treatment selection method long established in germ cell tumors and used by this PI. Sub-analyses of previous data have raised the concern that treating patients with varying levels of disease the same way does not produce optimal results. Therefore, investigators seek to improve outcomes by tailoring treatment to tumor burden. In this study, patients with less tumor burden will receive 3 cycles of chemotherapy and 12 months of ADT, those with moderate tumor burden will receive 4 cycles and 18 months of treatment, and those with the greatest tumor burden will receive 5 cycles and 24 months of treatment. Additionally, this regimen of administering treatment sequentially, including a 2-week break, reduces toxicity. | ArmGroups: [{'label': 'Definitive local therapy', 'type': 'ACTIVE_COMPARATOR', 'description': '3 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 12 months ADT (degarelix)', 'interventionNames': ['Drug: Doxorubicin', 'Drug: Ketoconazole', 'Drug: Docetaxel', 'Drug: Estramustine', 'Drug: Degarelix']}, {'label': 'Nodal only/Low-volume bone', 'type': 'ACTIVE_COMPARATOR', 'description': '4 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 18 months ADT (degarelix)', 'interventionNames': ['Drug: Doxorubicin', 'Drug: Ketoconazole', 'Drug: Docetaxel', 'Drug: Estramustine', 'Drug: Degarelix']}, {'label': 'High volume/no prior tx', 'type': 'ACTIVE_COMPARATOR', 'description': '5 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 24 months ADT (degarelix)', 'interventionNames': ['Drug: Doxorubicin', 'Drug: Ketoconazole', 'Drug: Docetaxel', 'Drug: Estramustine', 'Drug: Degarelix']}] | Interventions:[{'type': 'DRUG', 'name': 'Doxorubicin', 'description': 'In weeks 1, 3, and 5 of each 8-week cycle, participants will receive doxorubicin (20 mg/m2 as a 24-hour intravenous infusion on day 1 of each applicable week)', 'armGroupLabels': ['Definitive local therapy', 'High volume/no prior tx', 'Nodal only/Low-volume bone'], 'otherNames': ['Adriamycin', 'Rubex']}, {'type': 'DRUG', 'name': 'Ketoconazole', 'description': 'In weeks 1, 3, and 5 of each 8-week cycle, participants will receive ketoconazole (400 mg orally 3 times daily for 7 days)', 'armGroupLabels': ['Definitive local therapy', 'High volume/no prior tx', 'Nodal only/Low-volume bone'], 'otherNames': ['Nizoral']}, {'type': 'DRUG', 'name': 'Docetaxel', 'description': 'In weeks 2, 4, and 6 of each 8-week cycle, participants will receive docetaxel (35 mg/m2 intravenously on day 1 of each applicable week)', 'armGroupLabels': ['Definitive local therapy', 'High volume/no prior tx', 'Nodal only/Low-volume bone'], 'otherNames': ['Taxotere', 'Docecad']}, {'type': 'DRUG', 'name': 'Estramustine', 'description': 'In weeks 2, 4, and 6 of each 8-week cycle, participants will receive estramustine (280 mg orally 3 times daily for 7 days)', 'armGroupLabels': ['Definitive local therapy', 'High volume/no prior tx', 'Nodal only/Low-volume bone'], 'otherNames': ['Emcyt']}, {'type': 'DRUG', 'name': 'Degarelix', 'description': 'The starting dose (240 mg given as two injections of 120 mg each) is followed by maintenance doses of 80 mg administered as a single injection every 28 days', 'armGroupLabels': ['Definitive local therapy', 'High volume/no prior tx', 'Nodal only/Low-volume bone'], 'otherNames': ['Firmagon']}] | PrimaryOutcomes: [{'measure': 'Efficacy as Measured by Number Who Progressed', 'description': 'Progression defined as increase in Prostate Specific Antigen (PSA) \\>0.3 ng/mL over 2 measurements or larger/new lesion', 'timeFrame': 'From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 10 months'}] | SecondaryOutcomes: [{'measure': 'Efficacy as Measured by Number of Participants With Pathology/Biopsy Positive for Disease', 'timeFrame': 'about 10 months after treatment initiation'}, {'measure': 'Efficacy as Measured by PSA Level', 'description': "Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood.", 'timeFrame': 'baseline'}, {'measure': 'Efficacy as Measured by PSA Level', 'description': "Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood.", 'timeFrame': 'Cycle 1 Day 1, which is the day of treatment initiation'}, {'measure': 'Efficacy as Measured by PSA Level', 'description': "Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood.", 'timeFrame': 'Cycle 2 Day 1, which is about 8 weeks after treatment initiation'}, {'measure': 'Efficacy as Measured by PSA Level', 'description': "Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood.", 'timeFrame': 'Cycle 3 Day 1, which is about 16 weeks after treatment initiation'}, {'measure': 'Efficacy as Measured by PSA Level', 'description': "Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood.", 'timeFrame': 'Cycle 4 Day 1, which is about 24 weeks after treatment initiation'}, {'measure': 'Efficacy as Measured by PSA Level', 'description': "Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood.", 'timeFrame': 'Cycle 5 Day 1, which is about about 32 weeks after treatment initiation'}, {'measure': 'Efficacy as Measured by PSA Level', 'description': "Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood.\n\nThe time point is the end of treatment, which is about about 8 weeks after the start of the last cycle. For the arm completing 3 cycles, the time point is 24 weeks after treatment initiation. For the arm completing 4 cycles, the time point is 32 weeks after treatment initiation. For the arm completing 5 cycles, the time point is 40 weeks after treatment initiation.", 'timeFrame': 'end of treatment, which is about about 8 weeks after the start of the last cycle'}, {'measure': 'Efficacy as Measured by Number Who PSA Progressed', 'description': 'PSA progression defined as increase in Prostate Specific Antigen (PSA) \\>0.3 ng/mL over 2 measurements', 'timeFrame': 'From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 10 months'}, {'measure': 'Quality of Life Measure by FACT-P Scale', 'description': 'The Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale is a tool used for assessing the health-related quality of life (QoL) in men with prostate cancer. It consists of 27 core items which assess patient function in four domains (Physical, Social/Family, Emotional, and Functional well-being), and it is further supplemented by 12 site specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce a global QoL score, with a range of scores of 0 to 156. Higher scores represent better QoL.', 'timeFrame': 'post cycle 1, which is about 8 weeks after treatment initiation'}, {'measure': 'Quality of Life Measure by FACT-P Scale', 'description': 'The Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale is a tool used for assessing the health-related quality of life (QoL) in men with prostate cancer. It consists of 27 core items which assess patient function in four domains (Physical, Social/Family, Emotional, and Functional well-being), and it is further supplemented by 12 site specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce a global QoL score, with a range of scores of 0 to 156. Higher scores represent better QoL.', 'timeFrame': 'post cycle 2, which is about 16 weeks after treatment initiation'}, {'measure': 'Quality of Life Measure by FACT-P Scale', 'description': 'The Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale is a tool used for assessing the health-related quality of life (QoL) in men with prostate cancer. It consists of 27 core items which assess patient function in four domains (Physical, Social/Family, Emotional, and Functional well-being), and it is further supplemented by 12 site specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce a global QoL score, with a range of scores of 0 to 156. Higher scores represent better QoL.', 'timeFrame': 'post cycle 3, which is about 24 weeks after treatment initiation'}, {'measure': 'Quality of Life Measure by FACT-P Scale', 'description': 'The Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale is a tool used for assessing the health-related quality of life (QoL) in men with prostate cancer. It consists of 27 core items which assess patient function in four domains (Physical, Social/Family, Emotional, and Functional well-being), and it is further supplemented by 12 site specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce a global QoL score, with a range of scores of 0 to 156. Higher scores represent better QoL.', 'timeFrame': 'post cycle 4, which is about 32 weeks after treatment initiation'}, {'measure': 'Quality of Life Measure by FACT-P Scale', 'description': 'The Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale is a tool used for assessing the health-related quality of life (QoL) in men with prostate cancer. It consists of 27 core items which assess patient function in four domains (Physical, Social/Family, Emotional, and Functional well-being), and it is further supplemented by 12 site specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce a global QoL score, with a range of scores of 0 to 156. Higher scores represent better QoL.', 'timeFrame': 'post cycle 5, which is about about 40 weeks after treatment initiation'}, {'measure': 'Quality of Life Measure by FACT-P Scale', 'description': 'The Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale is a tool used for assessing the health-related quality of life (QoL) in men with prostate cancer. It consists of 27 core items which assess patient function in four domains (Physical, Social/Family, Emotional, and Functional well-being), and it is further supplemented by 12 site specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce a global QoL score, with a range of scores of 0 to 156. Higher scores represent better QoL.\n\nThe time point is about 12 weeks after completion of the last cycle. For the arm completing 3 cycles, the time point is 36 weeks after treatment initiation. For the arm completing 4 cycles, the time point is 44 weeks after treatment initiation. For the arm completing 5 cycles, the time point is 52 weeks after treatment initiation.', 'timeFrame': 'about 12 weeks after completion of the last cycle'}, {'measure': 'Safety of Drug Regimen as Measured by Number of Adverse Events', 'timeFrame': 'From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 10 months'}] |
Title: Phase 1b, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of RMC-6291 in Combination with RMC-6236 in Participants with Advanced KRAS G12C Mutant Solid Tumors | Condition: Non-Small Cell Lung Cancer (NSCLC), Colorectal Cancer, Pancreatic Ductal Adenocarcinoma | Keywords: RMC-6291, RAS (ON), KRAS, KRASG12C, KRASG12C (ON), Targeted therapy, Metastatic Cancer, Lung Cancer, Lung Neoplasms, Thoracic Neoplasms, Non-small Cell Lung Cancer, Carcinoma, Non-Small Cell Lung, NSCLC, Colorectal Cancer, Colonic Neoplasms, CRC, Appendiceal Cancer, KRAS mutation, STK11/LKB1, KEAP1, Bronchial neoplasms, Respiratory tract neoplasms, Neoplasms by site, Neoplasms, Colon Cancer, Rectal Cancer, Lung disease, Respiratory tract diseases, Pancreatic Cancer, Carcinoma, Pancreatic Ductal, PDAC, Gastrointestinal Neoplasms, Intestinal Neoplasms, Esophageal Cancer, Ampullary Cancer, Gastric Cancer, Gynecological Cancer, Ovarian Cancer, Endometrial Cancer, RMC-6236 | Summary: | Description: This is an open-label, multicenter, Phase 1b study of RMC-6291 in combination with RMC-6236 in participants with advanced KRAS G12C-mutated solid tumors, to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose and schedule (RP2DS) and provide a preliminary assessment of the antitumor activity of RMC-6291 in participants with KRASG12C tumors.
The study consists of two parts: Part 1 - Dose-Escalation and Part 2 Dose-Expansion. | ArmGroups: [{'label': 'RMC-6291 and RMC-6236', 'type': 'EXPERIMENTAL', 'description': 'Dose escalation and Dose expansion', 'interventionNames': ['Drug: Assigned interventions']}] | Interventions:[{'type': 'DRUG', 'name': 'Assigned interventions', 'description': 'Drug: RMC-6291 and RMC-6236 Oral tablets', 'armGroupLabels': ['RMC-6291 and RMC-6236']}] | PrimaryOutcomes: [{'measure': 'Adverse events', 'description': 'Incidence and severity of treatment-emergent Adverse Events (AEs) and serious AEs and clinically significant changes in laboratory values, ECGs and vitals signs', 'timeFrame': 'up to 3 years'}, {'measure': 'Dose Limiting Toxicities', 'description': 'Number of participants with dose limiting toxicities', 'timeFrame': '21 days'}] | SecondaryOutcomes: [{'measure': 'Maximum Observed Blood Concentration of RMC-6291 and RMC-6236', 'description': 'Cmax', 'timeFrame': 'up to 21 weeks'}, {'measure': 'Time to Reach Maximum Blood Concentration of RMC-6291 and RMC-6236', 'description': 'Tmax', 'timeFrame': 'up to 21 weeks'}, {'measure': 'Area Under Blood Concentration Time Curve of RMC-6291 and RMC-6236', 'description': 'AUC', 'timeFrame': 'up to 21 weeks'}, {'measure': 'Elimination Half-Life of RMC-6291 and RMC-6236', 'description': 't1/2', 'timeFrame': 'up to 21 weeks'}, {'measure': 'Ratio of accumulation of RMC-6291 and RMC-6236 from a single dose to steady state with repeated dosing', 'description': 'accumulation ratio', 'timeFrame': 'up to 21 weeks'}, {'measure': 'Overall Response Rate (ORR)', 'description': 'Overall response rate RECIST v1.1', 'timeFrame': 'up to 3 years'}, {'measure': 'Duration of Response (DOR)', 'description': 'Duration of response per RECIST v1.1', 'timeFrame': 'up to 3 years'}, {'measure': 'Disease Control Rate', 'description': 'Disease Control rate per RECIST v1.1', 'timeFrame': 'up to 3 years'}, {'measure': 'Time to Response (TTR)', 'description': 'Time to response per RECIST v1.1', 'timeFrame': 'up to 3 years'}, {'measure': 'Progression-Free Survival (PFS)', 'description': 'Progression-free survival per RECIST v1.1', 'timeFrame': 'up to 3 years'}] |
Title: Intra-individual Comparison Study of Intravenously Administered Magnevist (SH L 451A) on Lesion Detection Ability in MRI After an Initial Dose of 0.1 mmol/kg and After an Additional Dose of 0.1 mmol/kg in Patients With Metastatic Brain Tumor | Condition: Brain Neoplasms | Keywords: Detection of brain metastasis by MRI, Magnevist, Brain metastasis, Meglumine gadopentetate | Summary: | Description: N/A | ArmGroups: [{'label': 'Arm 1', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Drug: Magnevist (SH L 451A)']}, {'label': 'Arm 2', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Magnevist (SH L 451A)']}] | Interventions:[{'type': 'DRUG', 'name': 'Magnevist (SH L 451A)', 'description': 'Magnevist at a dose of 0.1 mmol/kg', 'armGroupLabels': ['Arm 1']}, {'type': 'DRUG', 'name': 'Magnevist (SH L 451A)', 'description': 'Magnevist at a dose of 0.1 mmol/kg and another 0.1 mmol/kg 30minutes later.', 'armGroupLabels': ['Arm 2']}] | PrimaryOutcomes: [{'measure': 'Diagnostic ability', 'timeFrame': 'MRI image in blinded read'}] | SecondaryOutcomes: [{'measure': 'Visibility', 'timeFrame': 'MRI image in blinded read'}, {'measure': 'Diagnostic confidence', 'timeFrame': 'MRI image in blinded read'}] |
Title: Neoadjuvant Camrelizumab, Nab-paclitaxel and Carboplatin in Patients With Stage IB-IIIA Non-small Cell Lung Cancer (NANE-LC): A Prospective, Single-arm, Multicenter, Phase II Study | Condition: Lung Cancer, Non-small Cell, Artificial Intelligence | Keywords: Non-small cell lung cancer, Neoadjuvant therapy, Immune checkpoint inhibitor, Major pathological response, Artificial intelligence | Summary: | Description: N/A | ArmGroups: [{'label': 'Camrelizumab + Nab-paclitaxel + Carboplatin', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Camrelizumab + Nab-paclitaxel + Carboplatin']}] | Interventions:[{'type': 'DRUG', 'name': 'Camrelizumab + Nab-paclitaxel + Carboplatin', 'description': 'The patients will receive three cycles (one cycle is defined as every 21 days +/- 3 days) of neoadjuvant therapy with camrelizumab 200 mg, nab-paclitaxel 260 mg/m2, and carboplatin AUC 5. This will then be followed by surgery.', 'armGroupLabels': ['Camrelizumab + Nab-paclitaxel + Carboplatin']}] | PrimaryOutcomes: [{'measure': 'Major pathologic response (MPR) Rate', 'description': 'MPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy.', 'timeFrame': 'After surgery (approximately 10 weeks)'}] | SecondaryOutcomes: [{'measure': 'Evaluation of the pathological complete response (pCR)', 'description': 'pCR rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.', 'timeFrame': 'After surgery (approximately 10 weeks)'}, {'measure': 'Evaluation of complete resection (R0) rate', 'description': 'Proportion of patients with no residual resection margin under the microscope after tumor resection', 'timeFrame': 'After surgery (approximately 10 weeks)'}, {'measure': 'Disease free survival (DFS)', 'description': 'From the date of surgery to any of the following events: disease progression, disease recurrence or death from any cause.', 'timeFrame': '36 months'}, {'measure': 'Overall survival (OS)', 'description': 'From the date of participated in study to the date of death.', 'timeFrame': '36 months'}, {'measure': 'Objective response rate(ORR)', 'description': 'The proportion of patients achieved complete or patial remission(Imageological) according to RECIST 1.1 prior to definitive surgery', 'timeFrame': 'approximately 9 weeks'}, {'measure': 'Adverse events (AEs)', 'description': 'The number of participants experiencing an AE will be assessed.An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy can be determined', 'timeFrame': 'approximately 9 weeks'}, {'measure': 'Serious adverse events (SAEs)', 'description': 'The number of participants experiencing an serious AE will be assessed', 'timeFrame': 'approximately 9 weeks'}, {'measure': 'Qol Quality of Life', 'description': 'Quality of life asscesed by Quality of Life Questionnare-Core 30(EORTC QLQ-C30）of The European O-rganization for Reasearch and Functional Assessment of Cancer Therapy-Lung (FACT-L)', 'timeFrame': '36 months'}] |
Title: A Phase I Trial of Single-Agent LY2780301 in Patients With Advanced or Metastatic Cancer | Condition: Metastases, Neoplasm | Keywords: Advanced Cancer, Metastatic Cancer, Solid Tumors | Summary: | Description: JWAA will consist of the following treatment phases parts:
Part A - Dose escalation phase using a once-daily dosing schedule. Part B - Dose escalation phase using a twice-daily dosing schedule. Part C - Dose expansion phase using the maximum tolerated dose from either Part A or Part B. | ArmGroups: [{'label': 'LY2780301', 'type': 'EXPERIMENTAL', 'description': 'Part A: daily dosing\n\nPart B (if determined as needed by pharmacokinetic, pharmacodynamic, and safety data): twice daily dosing\n\nPart C: Dose and frequency as determined by Parts A and B of the study.', 'interventionNames': ['Drug: LY2780301']}] | Interventions:[{'type': 'DRUG', 'name': 'LY2780301', 'description': 'Administered orally, daily for two 28-day cycles.\n\nStarting dose is 100mg. The dose will be subsequently increased to 200mg, 300mg, 400mg, 500mg, and 600mg if no dose limiting toxicity is observed at the prior dose levels. Patients who, in the opinion of the investigator, demonstrate clinical benefit may receive treatment beyond two cycles until disease progression.', 'armGroupLabels': ['LY2780301']}] | PrimaryOutcomes: [{'measure': 'Recommended dose for Phase 2 Studies', 'timeFrame': 'Baseline to study completion'}] | SecondaryOutcomes: [{'measure': 'Clinically significant effects', 'timeFrame': 'Baseline to study completion'}, {'measure': 'Pharmacokinetics, area under the concentration-time curve', 'timeFrame': 'Baseline, Days 1, 2, 8, 15, and 22 of Cycle 1, Day 1 of Cycle 2'}, {'measure': 'Best overall response (CR+PR+SD)', 'timeFrame': 'Baseline to measured disease progression. Tumor assessments are performed every 2 cycles until disease progression and during post-study follow-up period.'}, {'measure': 'Progression-free survival', 'timeFrame': 'Baseline to measured disease progression or death. Tumor assessments are performed every 2 cycles until disease progression and during post-study follow-up period.'}, {'measure': 'Duration of response', 'timeFrame': 'Time of response to disease progression or death. Tumor assessments are performed every 2 cycles until disease progression and during post-study follow-up period.'}, {'measure': 'Pharmacokinetics, maximum concentration (Cmax)', 'timeFrame': 'Baseline, Days 1, 2, 8, 15, and 22 of Cycle 1, Day 1 of Cycle 2'}] |
Title: Mobile Delivery of a Coping and Adherence Program for Head and Neck Cancer Patients Being Treated in Community Care Settings | Condition: Throat Carcinoma | Keywords: Head and neck cancer, swallowing, trismus, adherence, coping, rural, website, access | Summary: | Description: PRIMARY OBJECTIVE:
I. To determine the impact of a web-based adherence program (PREPARE) on self-reported swallowing function in head and neck cancer patients during radiation.
SECONDARY OBJECTIVE:
I. To determine community participant adherence to targeted swallowing and trismus exercises delivered by the PREPARE website video demonstrations.
EXPLORATORY OBJECTIVE:
I. To promote the long-term dissemination of the Dysphagia Prevention program through measurement of patient satisfaction and engagement metrics, training and continual feedback between the MD Anderson Cancer Center (MDACC) research site and community collaborative research sites.
OUTLINE:
Patients use the password-protected Project Prepare website on a computer, tablet, or phone over 10 weeks to view: videos of the swallowing and trismus exercises, tips and stories from former patients, what to expect each week of treatment, recipes and cooking demonstrations, how to take care of their teeth during treatment, strategies for stress relief, and strategies for dry mouth and nausea. This website is designed to reach underserved populations who do not have ready access to specialized preventive care.
After completion of study, patients are followed up at 6 months. | ArmGroups: [{'label': 'Supportive Care (Project Prepare website)', 'type': 'EXPERIMENTAL', 'description': 'Patients use the password-protected Project Prepare website on a computer, tablet, or phone over 10 weeks to view: videos of the swallowing and trismus exercises, tips and stories from former patients, what to expect each week of treatment, recipes and cooking demonstrations, how to take care of their teeth during treatment, strategies for stress relief, and strategies for dry mouth and nausea. This website is designed to reach underserved populations who do not have ready access to specialized preventive care.', 'interventionNames': ['Other: Internet-Based Intervention', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}] | Interventions:[{'type': 'OTHER', 'name': 'Internet-Based Intervention', 'description': 'Use Project Prepare website', 'armGroupLabels': ['Supportive Care (Project Prepare website)']}, {'type': 'OTHER', 'name': 'Quality-of-Life Assessment', 'description': 'Ancillary studies', 'armGroupLabels': ['Supportive Care (Project Prepare website)'], 'otherNames': ['Quality of Life Assessment']}, {'type': 'OTHER', 'name': 'Questionnaire Administration', 'description': 'Ancillary studies', 'armGroupLabels': ['Supportive Care (Project Prepare website)']}] | PrimaryOutcomes: [{'measure': 'Changes in self-reported swallowing function', 'description': 'Assessed with the MD Anderson Dysphagia Inventory (MDADI). Will first test for changes in self-reported swallowing function outcome with the MDADI between baseline and follow-up using one-tailed paired t-tests. Correlations and multivariate analyses regressing self-reported adherence to exercises against self-reported swallowing function will be analyzed similarly and appropriately.', 'timeFrame': 'Baseline up to 6 months post-radiation'}] | SecondaryOutcomes: [{'measure': 'Website usage data', 'description': 'Piwik analytics will be used to record usage data regarding patient engagement with the website (e.g. whether the patient looked at the website that week, number of minutes and number of navigations and pages visited).', 'timeFrame': 'Up to 6 months post-radiation'}] |
Title: A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter, International Study of Osimertinib as Maintenance Therapy in Patients With Locally Advanced, Unresectable EGFR Mutation-positive Non-Small Cell Lung Cancer (Stage III) Whose Disease Has Not Progressed Following Definitive Platinum-based Chemoradiation Therapy (LAURA). | Condition: Non Small Cell Lung Cancer (Stage III) | Keywords: Phase III, Osimertinib, Non Small Cell Lung Cancer (Stage III), Unresectable NSCLC, EGFR, chemoradiation therapy | Summary: | Description: This is a phase 3 double-blind, randomized, placebo-controlled, study to assess the efficacy and safety of osimertinib following chemoradiation in patients with stage III unresectable EGFR mutation-positive NSCLC, including the most common EGFR sensitising mutations (Ex19Del and L858R), either alone or in combination with other EGFR mutations. Chemoradiation may have been given either given concurrently or sequentially. Patients whose disease has not progressed following chemoradiation will be randomised within 6 weeks of completion of chemoradiation to receive osimertinib or placebo in a 2:1 ratio, and treatment will be continued until disease progression, unacceptable toxicity or other discontinuation criteria are met. After progression, patients can be unblinded and may receive open-label osimertinib. After the final OS analysis, the study blind will be broken and patients still receiving open-label osimertinib will be supplied with open-label osimertinib by AstraZeneca for as long as their treating physician considers they are deriving clinical benefit. | ArmGroups: [{'label': 'Osimertinib', 'type': 'EXPERIMENTAL', 'description': 'Osimertinib (80mg or 40mg orally, once daily), in accordance with the randomization schedule.', 'interventionNames': ['Drug: Osimertinib 80mg/40mg']}, {'label': 'Placebo Osimertinib', 'type': 'PLACEBO_COMPARATOR', 'description': 'Matching placebo for Osimertinib (80mg or 40mg orally, once daily), in accordance with the randomization schedule', 'interventionNames': ['Drug: Placebo Osimertinib 80mg/40mg']}] | Interventions:[{'type': 'DRUG', 'name': 'Osimertinib 80mg/40mg', 'description': 'The initial dose of Osimertinib 80mg once daily can be reduced to 40mg once daily. Treatment can continue until disease progression, unacceptable toxicity or other discontinuation criteria are met.', 'armGroupLabels': ['Osimertinib']}, {'type': 'DRUG', 'name': 'Placebo Osimertinib 80mg/40mg', 'description': 'The initial dose of Placebo Osimertinib 80mg once daily can be reduced to 40mg once daily.\n\nTreatment can continue until disease progression, unacceptable toxicity or other discontinuation criteria are met', 'armGroupLabels': ['Placebo Osimertinib']}] | PrimaryOutcomes: [{'measure': 'Progression-free survival (PFS)', 'description': 'Defined as the time from randomisation until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from randomised therapy or receives another anti-cancer therapy prior to progression, based on blinded independent central review assessment according to RECIST 1.1', 'timeFrame': 'Approximately 13 months'}] | SecondaryOutcomes: [{'measure': 'PFS in patients with EGFR Ex19del or L858R mutation', 'description': "Defined as the time from randomisation until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from randomised therapy or receives another anti-cancer therapy prior to progression.' based on blinded independent central review assessment according to RECIST 1.1", 'timeFrame': 'Approximately 13 months'}, {'measure': 'PFS in patients with EGFR mutations Ex19del or L858R detectable in plasma-derived ctDNA', 'description': "Defined as the time from randomisation until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from randomised therapy or receives another anti-cancer therapy prior to progression.' based on blinded independent central review assessment according to RECIST 1.1", 'timeFrame': 'Approximately 13 months'}, {'measure': 'Time to CNS PFS', 'description': 'Defined as earlier event of CNS progression or death based on blinded independent central review assessment according to RECIST 1.1', 'timeFrame': 'Approximately 13 months'}, {'measure': 'Overall survival (OS)', 'description': 'Defined as the time from randomization until death from any cause', 'timeFrame': 'Approximately 45 months'}, {'measure': 'Objective response rate (ORR)', 'description': 'Defined as the number (%) of patients with measurable disease with at least 1 visit response of CR (Complete response) or PR (Partial response) based on blinded independent central review assessment according to RECIST 1.1', 'timeFrame': 'Approximately 13 months'}, {'measure': 'Duration of response (DoR)', 'description': 'Defined as the time from the date of first documented response (i.e., subsequently confirmed) until the date of documented progression or death in the absence of disease progression based on blinded independent central review assessment according to RECIST 1.1', 'timeFrame': 'Approximately 13 months'}, {'measure': 'Disease control rate (DCR)', 'description': 'Defined as Disease control rate is defined as the percentage of subjects who have a best overall response of CR or PR or SD based on blinded independent central review assessment according to RECIST 1.1', 'timeFrame': 'Approximately 13 months'}, {'measure': 'Tumor shrinkage', 'description': 'Defined as the relative change in the sum of the longest diameters of RECIST target lesions at the nadir in the absence of new lesions or progression of non-target lesions compared to baseline based on blinded independent central review assessment according to RECIST 1.1', 'timeFrame': 'Approximately 13 months'}, {'measure': 'Time to death or distant metastases (TTDM)', 'description': 'Defined as the time from the date of randomization until the first date of distant metastasis or date of death in the absence of distant metastasis based on blinded independent central review assessment according to RECIST 1.1', 'timeFrame': 'Approximately 13 months'}, {'measure': 'Time to treatment discontinuation', 'description': 'Defined as the time from randomization to the earlier of the date of study treatment discontinuation (regardless of the reason for study treatment discontinuation) or death', 'timeFrame': 'Approximately 13 months'}, {'measure': 'Second progression free survival on a subsequent treatment (PFS2)', 'description': 'Time from randomisation to second progression (PFS2) is defined as the time from the date of randomisation to the earliest of the progression event subsequent to that used for the primary variable PFS or date of death after starting subsequent anti-cancer treatment.', 'timeFrame': 'Approximately 13 months'}, {'measure': 'Time to first subsequent therapy (TFST)', 'description': 'Defined as the time from the date of randomization to the earlier of the date of anti-cancer therapy start date following study drug discontinuation or death', 'timeFrame': 'Approximately 13 months'}, {'measure': 'Time to second subsequent therapy (TSST)', 'description': 'Defined as the time from the date of randomization to the earlier of the date of second subsequent anti-cancer therapy start date following study drug discontinuation or death.', 'timeFrame': 'Approximately 21 months'}, {'measure': 'Patients reported disease-related symptoms and HRQoL by EORTC QLQ-LC13 and EORTC QLQ-30 questionnaires', 'description': 'Change in symptoms from baseline', 'timeFrame': 'Approximately 21 months'}, {'measure': 'Incidence of Adverse Events (AEs)', 'description': 'AEs graded by CTCAE version 5.0', 'timeFrame': 'Approximately 13 months'}, {'measure': 'Plasma concentrations of osimertinib and AZD5104', 'description': 'The pharmacokinetics exposure parameters derived from plasma concentrations of osimertinib and AZD5104', 'timeFrame': 'Trough concentrations at Week 4,12 and 24'}] |
Title: A Phase 2 Randomized, Open-Label Study of RRx-001 vs Regorafenib in Subjects With Metastatic Colorectal Cancer | Condition: Colorectal Neoplasms | Keywords: | Summary: | Description: Purpose This two-stage study is designed to compare the safety and activity between RRx-001 against regorafenib followed by irinotecan-based therapies in a parallel comparative study.
Patients who are suffering from advanced or metastatic (meaning the disease has spread) colorectal cancer are invited to participate in this study. There will be two groups of patients (Randomized, open label study), one of these will receive RRx-001 and the other one will receive regorafenib. Qualifying patients will be randomly assigned (like the flip of a coin) to the 'interventional arm' and receive the experimental drug, RRx-001, or the 'control arm' where they will receive the current standard-of-care, Regorafenib. Patients will have a 66% chance (2 out of 3) of receiving RRx-001 and a 33 % chance (1 out of 3) of receiving regorafenib.
On progression in the first part of the study, provided ECOG performance status is adequate, and if clinically appropriate i.e. there are no absolute or relative contraindications in the opinion of the Investigator, all subjects will enter the second part of the study receive irinotecan plus bevacizumab.
Whether patients are given RRx-001 or regorafenib, they will also receive best supportive care, which includes treatments to help manage side effects and symptoms of cancer. This is an open label study, which means patients will know to which of these treatments, RRx-001 or regorafenib, they are assigned.
Background Oxygen is vital to life, we need it to breathe, for example, but at the same time it gives rise to byproducts that are toxic called free radicals. Free radicals are defined as "oxidants". Similarly, substances that interact with and neutralize free radicals, thus preventing them from causing damage, are called "antioxidants". Examples of recognizable antioxidants are Vitamin E, Vitamin C and beta-carotene. Antioxidants are also known as "free radical scavengers." When free radicals are present in excess of antioxidants damage may occur.
A free radical is an unstable molecule with an unpaired electron, an electrically charged particle, which seeks out another electron to return to a state of balance. An example of a free radical is hydrogen peroxide, recognizable as the household product that "bubbles" when it's poured on wounds. These bubbles come from oxygen free radicals, which are toxic to bacteria and all living cells, including cancer. The fact that these free radicals are toxic has to do with how reactive they are-imagine free radicals as high-speed ball bearings that smash into other molecules in order to "steal" back an electron and end their radical state, which sets off a chain reaction that transforms once stable compounds into a string of reactive radicals.
As new free radicals are created in this chain reaction, they randomly slam into whatever molecules they are closest to and steal their electrons, corroding them, like a biological form of rust. This process is repeated over and over, picking up speed, until an antioxidant can "neutralize" the free radicals and put a stop to the snowball effect. In the same way that this free radical bombardment can damage not only bacteria but also healthy tissues in the body, it is also capable of destroying cancer cells.
The current consensus is that compared to normal tissue tumor cells may accumulate elevated levels of free radicals, which contribute to the development of cancer. This is potentially a fatal weakness, a form of biological "Kryptonite", which can be used to advantage since the addition of even a small amount of free radicals may push the tumor over the edge, past the tipping point, above tolerable thresholds, breaking the camel's back. Similar to the expression "live by the sword, die by the sword", free radicals may lead to the development of cancer but they also are capable of harming it when present in excess.
RRx-001 is a completely new type of drug that comes from the U.S. aerospace or rocket science industry. It is activated to deliver free radicals to tissues that have low levels of oxygen. Compared to normal tissues, which have higher levels of oxygen, most, if not all, tumors exist in a low-oxygen environment, perhaps to prevent oxidation. In this way the free radicals delivered by RRx-001 to cancer cells under low oxygen conditions are able, in theory, to cause their targeted destruction without harming normal cells.
In general, colorectal tumors have low levels of antioxidants and, without this antioxidant protection, these tumors are more likely to be harmed by free radicals, so a treatment like RRx-001, which is able to increase the free radicals in the tumor, may benefit patients with colorectal cancer; this is a reason for studying RRx-001 in colorectal cancer. So far, in a Phase 1 study, 25 men and women with advanced, incurable cancer have received RRx-001 for different lengths of time and at doses that ranged from 10 mg/m2 to 83 mg/m2 once a week.
Regorafenib is a drug approved by the FDA to treat colon cancer after previous chemotherapy is no longer effective. It belongs to a class of targeted drugs known as tyrosine kinase inhibitors. Tyrosine kinases, which play a key role in many cell functions including cell growth and division, are commonly mutated or changed in cancer cells, becoming super-active and producing cells that have uncontrolled growth, and, therefore, blocking them with drugs like regorafenib may keep the cancer cells from growing. | ArmGroups: [{'label': 'RRx-001 followed by irinotecan', 'type': 'EXPERIMENTAL', 'description': 'Once-weekly intravenous RRx-001 at a dose of 4 mg on Days 1, 8, 15, and 22 of a 4-week cycle. On progression and if eligible, patients will receive irinotecan (with or without bevacizumab)', 'interventionNames': ['Drug: RRx-001', 'Drug: Irinotecan']}, {'label': 'Regorafenib followed by irinotecan', 'type': 'ACTIVE_COMPARATOR', 'description': 'Regorafenib daily on Days 1- 21 of a 4-week cycle. On progression and if eligible, patients will receive irinotecan (with or without bevacizumab)', 'interventionNames': ['Drug: Regorafenib', 'Drug: Irinotecan']}] | Interventions:[{'type': 'DRUG', 'name': 'RRx-001', 'armGroupLabels': ['RRx-001 followed by irinotecan']}, {'type': 'DRUG', 'name': 'Regorafenib', 'armGroupLabels': ['Regorafenib followed by irinotecan'], 'otherNames': ['Stivarga']}, {'type': 'DRUG', 'name': 'Irinotecan', 'description': 'To be dosed after RRx-001 or regorafenib', 'armGroupLabels': ['RRx-001 followed by irinotecan', 'Regorafenib followed by irinotecan'], 'otherNames': ['With or without bevacizumab']}] | PrimaryOutcomes: [{'measure': 'Overall Survival', 'description': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 47 months', 'timeFrame': 'From date of enrollment until death or censorship.'}] | SecondaryOutcomes: [{'measure': 'Progression Free Survival', 'description': 'Progression-free survival (PFS) will be defined as the elapsed time from the from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 77 months', 'timeFrame': 'Baseline, every 6-8 weeks while on study.'}, {'measure': 'Number of Adverse Events', 'description': 'Incidence of related Adverse Events (AEs). SAEs and all other non-serious AEs are located in the Reported Adverse Event Module. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 is used to grade adverse events.', 'timeFrame': 'Baseline through end of treatment (28 days after last dose of study drug). Approximately 24 weeks.'}, {'measure': 'Objective Response Rate', 'description': 'Percentage of participants with ORR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target and non-target disease. PR applied only to participants with at least one measurable lesion. Greater than or equal to 30 % decrease under baseline of the sum of longest diameters of all target measurable lesions.', 'timeFrame': 'Up to 2 years'}, {'measure': 'Clinical Benefit Rate', 'description': 'The period from study entry through Disease Control. Disease Control Rate (DCR) also correlates to Clinical Benefit Rate (CBR), defined as the percentage of subjects with CR, PR or SD relative to the total number of treated subjects', 'timeFrame': 'Up to 2 years'}] |
Title: Tumor Metabolism of Lung Cancer Underwent Percutaneous Radiation Measured With F-18-FDG-PET | Condition: Lung Cancer | Keywords: radiation therapy, F-18-FDG, NSCLC | Summary: | Description: N/A | ArmGroups: N/A | Interventions:N/A | PrimaryOutcomes: N/A | SecondaryOutcomes: N/A |
Title: Phase I Pharmacokinetic and Pharmacodynamic, Open-Label, Dose Escalation Study of Triciribine Phosphate Monohydrate (TCN-PM, VD-0002) in Adult Subjects With Metastatic Cancer Which Have Activated Akt Demonstrated by Immunohistochemistry | Condition: Cancer | Keywords: Phase I, Pharmacokinetics, TCN-PM, VD-0002, Immunohistochemistry, Serum tumor marker, Akt phosphorylation, Ex vivo testing, metastatic | Summary: | Description: Phase I dose escalation study of Triciribine Phosphate Monohydrate (TCN-PM) in patients with metastatic cancer. Study patients will be recruited from a companion study \[MCC-14474 "Immunohistochemical study of phosphorylated Akt in solid malignancies"\], and potential subjects tumors' must be shown to be p-Akt positive.
Pretreatment evaluations are chest roentgenogram (CXR) and CT/MRI scans of the sites of known disease, performance status, tumor biopsy, MUGA (EF only), and a pregnancy test. A CT/MRI scan of the chest, abdomen, and pelvis known sites of disease is required at baseline and an immunohistochemical (IHC) assay for determination of akt expression (positive) prior to study drug administration.
Each treatment cycle will consist of four weeks with TCN-PM being administered weekly(days 1, 8 and 15 every 28 days). Labs, vital signs (BP, HR, Resp Rate, Temp), and hematology and serum chemistry profile are to be performed weekly and/or prior to each treatment dose. Body Surface Area (BSA) should be calculated approximately every 8 weeks. Imaging studies (CT/MRI of chest, abdomen, and pelvis) and tumor response assessments will be performed every eight weeks or more frequently if indicated.
Palliative and supportive care for other disease-related symptoms and for toxicity associated with treatment will be offered to all patients on this trial. Unless unacceptable toxicity occurs, the duration of treatment will be based on tumor reassessment done every eight weeks. | ArmGroups: [{'label': 'Dose Escalation', 'type': 'EXPERIMENTAL', 'description': 'Phase I: Triciribine Phosphate Monohydrate', 'interventionNames': ['Drug: Triciribine Phosphate Monohydrate']}] | Interventions:[{'type': 'DRUG', 'name': 'Triciribine Phosphate Monohydrate', 'description': '8 Cycles @ 28 days. Level 1: 15 mg/m\\^2; Level 2: 25 mg/m\\^2; 35 mg/m\\^2; 45 mg/m\\^2.', 'armGroupLabels': ['Dose Escalation'], 'otherNames': ['TCN-PM, BD-0002']}] | PrimaryOutcomes: [{'measure': 'Maximum Tolerated Dose (MTD)', 'description': 'To determine the dose of TCN-PM (VD-0002) (administered as a one-hour infusion days 1, 8, 15 every 28 days) which will inhibit by at least 50% Akt phosphorylation by ex vivo testing of tumor tissue samples', 'timeFrame': 'Dependent upon results of periodic testing'}] | SecondaryOutcomes: [{'measure': 'Pharmacokinetics of TCN-PM,VD-0002', 'description': 'To characterize the pharmacokinetics of TCN-PM (VD-0002) when administered as a one-hour infusion days 1, 8 and 15 every 28 days', 'timeFrame': 'Dependent upon results of periodic testing'}, {'measure': 'Radiologic response rate', 'description': 'To monitor for drug efficacy, as determined by: radiologic response rate (RECIST criteria)', 'timeFrame': 'Dependent upon results of periodic testing'}, {'measure': 'Biochemical response rate', 'description': 'To monitor for drug efficacy, as determined by: biochemical response rate (if a serum tumor marker is present)', 'timeFrame': 'Dependent upon results of periodic testing'}] |
Title: A Registry of Caris Life Sciences® Molecular Intelligence™ Service (Biomarker Assessment Results) Intended for Correlation With Cancer Clinical Outcomes | Condition: Solid Tumors | Keywords: | Summary: | Description: N/A | ArmGroups: N/A | Interventions:[{'type': 'OTHER', 'name': 'No intervention required, purely observational'}] | PrimaryOutcomes: [{'measure': 'Documentation of the frequency of specific clinical events in relation to risk factors, diagnosis and treatments provided.', 'timeFrame': '5 years per patient'}] | SecondaryOutcomes: N/A |
Title: A Phase 2 Study of IMGN901 (Lorvotuzumab Mertansine; NSC#: 783609) in Children With Relapsed or Refractory Wilms Tumor, Rhabdomyosarcoma, Neuroblastoma, Pleuropulmonary Blastoma, Malignant Peripheral Nerve Sheath Tumor (MPNST) and Synovial Sarcoma | Condition: Pleuropulmonary Blastoma, Recurrent Malignant Peripheral Nerve Sheath Tumor, Recurrent Neuroblastoma, Recurrent Rhabdomyosarcoma, Recurrent Synovial Sarcoma, Wilms Tumor | Keywords: | Summary: | Description: PRIMARY OBJECTIVES:
I. To assess the efficacy of IMGN901 (lorvotuzumab mertansine) in Wilms tumor, rhabdomyosarcoma, neuroblastoma and other cluster of differentiation (CD)56-expressing tumors such as pleuropulmonary blastoma, malignant peripheral nerve sheath tumor (MPNST) and synovial sarcoma.
II. To determine the tolerability of the adult recommended phase 2 dose (RP2D) of IMGN901 administered as an intravenous infusion, administered on days 1 and 8 of a 21-day cycle, to children with refractory Wilms tumor, rhabdomyosarcoma, neuroblastoma, pleuropulmonary blastoma, MPNST, or synovial sarcoma.
III. To define and describe the toxicities of IMGN901 administered on this schedule.
EXPLORATORY OBJECTIVES:
I. To correlate tumor response with tumor CD56+ expression. II. To characterize the pharmacokinetics of IMGN901 in children with refractory cancer, including an assessment of impact on circulating CD56+ peripheral blood cells.
OUTLINE:
Patients receive lorvotuzumab mertansine intravenously (IV) over 1-1.5 hours on days 1 and 8. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 5 years. | ArmGroups: [{'label': 'Treatment (lorvotuzumab mertansine)', 'type': 'EXPERIMENTAL', 'description': 'Patients receive lorvotuzumab mertansine IV over 1-1.5 hours on days 1 and 8. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Other: Laboratory Biomarker Analysis', 'Biological: Lorvotuzumab Mertansine', 'Other: Pharmacological Study']}] | Interventions:[{'type': 'OTHER', 'name': 'Laboratory Biomarker Analysis', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (lorvotuzumab mertansine)']}, {'type': 'BIOLOGICAL', 'name': 'Lorvotuzumab Mertansine', 'description': 'Given IV', 'armGroupLabels': ['Treatment (lorvotuzumab mertansine)'], 'otherNames': ['Anti-Human NCAM-1 Monoclonal Antibody N901', 'BB-10901', 'huN901-DM1', 'IMGN901']}, {'type': 'OTHER', 'name': 'Pharmacological Study', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (lorvotuzumab mertansine)']}] | PrimaryOutcomes: [{'measure': 'Objective Response by Response Evaluation Criteria in Solid Tumors Version 1.1', 'description': 'The best response of disease will be examined separately in each stratum. A responder is defined as a patient who achieves a best response of partial response or complete response on the study. Response rates will be calculated as the percent of evaluable patients who are responders, and Clopper-Pearson confidence intervals will be constructed.', 'timeFrame': 'Up to 18 weeks (6 courses)'}, {'measure': 'Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0', 'description': 'Toxicity tables will be constructed to summarize the observed incidence by type of toxicity and grade for toxicities with Possible, Probable, or Definite attribution to the study drug. Tables will summarize incidence by cycle.', 'timeFrame': 'Up to 12 months (17 courses)'}] | SecondaryOutcomes: N/A |
Title: A Phase 1, Sequential Cohort, Dose Escalation Trial to Determine the Safety, Tolerability, and Maximum Tolerated Dose of Daily Oral Administration of AV-412 in Patients With Refractory or Relapsed Solid Tumor Malignancies | Condition: Tumor | Keywords: Solid Tumors, Tyrosine Kinases | Summary: | Description: Although progress has been made, patients with malignancies often either progress after the traditional approach of chemotherapy, surgery, or radiotherapy, or are not candidates for these approaches because of the advances stage of disease. Novel therapies that may offer greater potential than those currently available are urgently needed.
AV 412 is a potent inhibitor of human epidermal growth factor family receptor tyrosine kinases (TKIs) and represents a growing class of anti-cancer agents. The recent introduction of TKIs has opened the door to new approaches to cancer treatment in which the goals of therapy are to halt disease progression, ameliorate symptoms, and improve patient quality of life. AV412 may inhibit growth of solid tumors, with fewer and less debilitating side effects.
This study is designed to determine the safety, tolerability and maximum tolerated dose of daily oral administration of AV 412. Patients will be assigned to escalating drug dose cohorts to determine the optimal dose. Evaluations to determine tolerability include PK, PD, and the adverse events which occur during the course of study drug administration. | ArmGroups: [{'label': 'A', 'type': 'EXPERIMENTAL', 'description': 'Daily oral administration of AV-412', 'interventionNames': ['Drug: AV-412']}] | Interventions:[{'type': 'DRUG', 'name': 'AV-412', 'description': 'Solid oral dosage; 4 dosage strengths; 25, 50, 100, or 200 mg per capsule Dosing Frequency: Once daily dosing for 4 weeks (4 weeks equals 1 cycle)', 'armGroupLabels': ['A']}] | PrimaryOutcomes: [{'measure': 'To evaluate the safety, tolerability, and dose-limiting toxicities (DLT), and determine the maximum tolerated dose (MTD) of AV-412 when administered once daily by the oral route for 4 weeks (4 weeks equals one dosing cycle)', 'timeFrame': 'one year'}] | SecondaryOutcomes: [{'measure': 'To characterize the pharmacokinetic (PK) profile of AV-412 in all patients. Extensive PK collection and assay to be performed in expanded MTD Cohorts', 'timeFrame': '18 months'}, {'measure': 'Evaluate potential pharmacodynamic (PD) markers of AV-412 action, in expanded MTD Cohorts ONLY', 'timeFrame': 'two years'}, {'measure': 'Preliminary evaluation of the antineoplastic activity of AV-412 (assessed by evidence and duration of disease stabilization or objective response, and time to disease progression)', 'timeFrame': 'two years'}] |
Title: Assessment of Overall Survival of FOLFOX6m Plus SIR-Spheres Microspheres Versus FOLFOX6m Alone as First-line Treatment in Patients With Non-resectable Liver Metastases From Primary Colorectal Carcinoma in a Randomised Clinical Study | Condition: Colorectal Cancer Metastatic | Keywords: colon, rectum, metastatic colorectal cancer, liver metastases | Summary: | Description: N/A | ArmGroups: [{'label': 'Control Arm', 'type': 'ACTIVE_COMPARATOR', 'description': 'Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure.', 'interventionNames': ['Drug: FOLFOX6m']}, {'label': 'Experimental Arm', 'type': 'EXPERIMENTAL', 'description': 'Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres.', 'interventionNames': ['Drug: FOLFOX6m', 'Device: SIR-Spheres microspheres']}] | Interventions:[{'type': 'DRUG', 'name': 'FOLFOX6m', 'armGroupLabels': ['Control Arm', 'Experimental Arm']}, {'type': 'DEVICE', 'name': 'SIR-Spheres microspheres', 'armGroupLabels': ['Experimental Arm']}] | PrimaryOutcomes: [{'measure': 'Overall Survival (OS)', 'description': 'OS defined as the time interval between the date of randomization and the date of death from any cause.', 'timeFrame': 'From date of randomization until the date of death from any cause assessed up 3 yrs 8 months'}] | SecondaryOutcomes: [{'measure': 'Progression-free Survival', 'description': 'PFS defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as an increase in the sum of the longest diameters of ≥ 20% and an absolute increase in the sum of the longest diameters of ≥ 5 mm, or the appearance of a new lesion.', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years 8 months.'}] |
Title: Pilot Trial of Dose-Volume Constraints for Reirradiation of Recurrent Brain Tumors | Condition: Recurrent Brain Neoplasm | Keywords: | Summary: | Description: PRIMARY OBJECTIVES:
I. To estimate the rate of grade 3 or higher central nervous system (CNS) necrosis 6 months after reirradiation of the brain for recurrent tumor.
SECONDARY OBJECTIVES:
I. To evaluate acute and late toxicities of reirradiation. II. To evaluate longitudinal changes in symptom burden of patients undergoing reirradiation.
III. To use Advanced Brain Tumor Imaging (ABTI) to evaluate changes in the brain after reirradiation, including progression, pseudoprogression, and radionecrosis.
IV. To estimate progression-free survival (PFS) and overall survival (OS) following reirradiation.
OUTLINE: Patients are assigned to 1 of 2 arms based on age.
ARM I (Age 0-18 years): Patients undergo radiation therapy with conventional fractionation and dose constraints. Treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity.
ARM II (Age \> 18 years): Patients undergo radiation therapy with conventional fractionation and dose constraints. Patients also receive bevacizumab concurrently at the discretion of the treating neuro-oncologist. Treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1 month, then every 2 months for 1 year, then every 3 months for 1 year. | ArmGroups: [{'label': 'Arm I (conventional fractionation)', 'type': 'EXPERIMENTAL', 'description': 'Patients undergo radiation therapy with conventional fractionation and dose constraints. Treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Other: Quality-of-Life Assessment', 'Radiation: Radiation Therapy']}, {'label': 'Arm II (conventional fractionation, bevacizumab)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients undergo radiation therapy with conventional fractionation and dose constraints. Patients also receive bevacizumab concurrently at the discretion of the treating neuro-oncologist. Treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Biological: Bevacizumab', 'Other: Quality-of-Life Assessment', 'Radiation: Radiation Therapy']}] | Interventions:[{'type': 'BIOLOGICAL', 'name': 'Bevacizumab', 'armGroupLabels': ['Arm II (conventional fractionation, bevacizumab)'], 'otherNames': ['Anti-VEGF', 'Anti-VEGF Humanized Monoclonal Antibody', 'Anti-VEGF rhuMAb', 'Avastin', 'Bevacizumab Biosimilar BEVZ92', 'Bevacizumab Biosimilar BI 695502', 'Bevacizumab Biosimilar CBT 124', 'Bevacizumab Biosimilar FKB238', 'Bevacizumab Biosimilar HD204', 'Bevacizumab Biosimilar HLX04', 'Bevacizumab Biosimilar IBI305', 'Bevacizumab Biosimilar LY01008', 'Bevacizumab Biosimilar MIL60', 'Bevacizumab Biosimilar QL 1101', 'Bevacizumab Biosimilar SCT501', 'HD204', 'Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer', 'Recombinant Humanized Anti-VEGF Monoclonal Antibody', 'rhuMab-VEGF', 'SCT501']}, {'type': 'OTHER', 'name': 'Quality-of-Life Assessment', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (conventional fractionation)', 'Arm II (conventional fractionation, bevacizumab)'], 'otherNames': ['Quality of Life Assessment']}, {'type': 'RADIATION', 'name': 'Radiation Therapy', 'description': 'Undergo radiation therapy with conventional fractionation', 'armGroupLabels': ['Arm I (conventional fractionation)', 'Arm II (conventional fractionation, bevacizumab)'], 'otherNames': ['Cancer Radiotherapy', 'Irradiate', 'Irradiated', 'irradiation', 'Radiation', 'Radiotherapeutics', 'RADIOTHERAPY', 'RT', 'Therapy, Radiation']}] | PrimaryOutcomes: [{'measure': 'Highest grade of central nervous system (CNS) necrosis', 'description': 'The outcome will be categorized as (death within 6 months), (alive at month 6 with necrosis), (alive at month 6 without necrosis). The probabilities of these outcomes will be estimated using 95% posterior credible intervals assuming a Dirichlet (.33, .33, .33) prior.', 'timeFrame': 'At 6 months'}] | SecondaryOutcomes: [{'measure': 'Incidence of acute and late toxicities', 'timeFrame': 'Up to 3.5 years'}, {'measure': 'Overall survival (OS) time', 'description': 'Will be estimated by Kaplan-Meier method, and the relationship of OS to baseline covariates will be evaluated by Bayesian survival time regression.', 'timeFrame': 'Up to 3.5 years'}, {'measure': 'Progression-free survival (PFS) time', 'description': 'Will be estimated by Kaplan-Meier method, and the relationship of PFS to baseline covariates will be evaluated by Bayesian survival time regression.', 'timeFrame': 'Up to 3.5 years'}, {'measure': 'Quality of life', 'description': 'Will be assessed using the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) and patient-reported outcomes measurement information system (PROMIS) instrument.', 'timeFrame': 'Up to 3.5 years'}, {'measure': 'Imaging changes as measured by Advanced Brain Tumor Imaging (ABTI)', 'timeFrame': 'Up to 3.5 years'}] |
Title: Phase II Randomized Study Measuring the Interest of Pursuing or Not the CT for Non-progressive Patients With Metastatic Esophageal Squamous-cell Cancer After 6 Weeks of LV5FU2-paclitaxel Given After a 1st Line Fluoropyrimidine/Pt Salt CT | Condition: Esophageal Cancer, Squamous Cell | Keywords: | Summary: | Description: Initial phase: this part of the trial consist of 3 cycles of LV5FU2 (Bolus 5-FU 400mg/m² - 5-FU continuously during 46h: 3000 mg/m², calcium levofolinate 200 mg/m²) - paclitaxel (100 mg/m² at day 1) every 14 days. After 6 weeks,the phase will end with a check-up (clinical exam, tumor evaluation and biological test). Then, if the disease is non-progressive, the patient will proceed to the randomized phase.
Randomized phase:
* Arm A : pursuit of chemotherapy and best supportive care
* Arm B : interruption of chemotherapy and best supportive care | ArmGroups: [{'label': 'Arm A', 'type': 'EXPERIMENTAL', 'description': 'Pursuit of chemotherapy.', 'interventionNames': ['Drug: pursuit of chemotherapy']}, {'label': 'Arm B', 'type': 'NO_INTERVENTION', 'description': 'Interruption of chemotherapy, best supportive care'}] | Interventions:[{'type': 'DRUG', 'name': 'pursuit of chemotherapy', 'description': 'Treatment with LV5FU2 (5-FU, Calcium Levofolinate) - paclitaxel, regular tumor evaluation, best supportive care Other authorized treatment : usual paclitaxel pre-treatment consisting of Dexamethasone, Chlorpheniramine and ranitidine, at 15 and 1 day before the actual paclitaxel treatment', 'armGroupLabels': ['Arm A'], 'otherNames': ['LV5FU2-paclitaxel CT']}] | PrimaryOutcomes: [{'measure': 'Estimate the overall survival for patients suffering from Esophageal cancer', 'description': 'Non-progressive disease at and after 6 weeks of treatment until progression', 'timeFrame': 'From date of randomization until the date of death from any cause, up to 8 months after the beginning of the treatment'}] | SecondaryOutcomes: [{'measure': 'Estimate efficiency in term of overall survival, of pursuing chemotherapy', 'description': 'beyond 6 weeks of treatment compared to a group that interrupted the treatment at 6 weeks', 'timeFrame': 'From date of randomization until the date of death from any cause, up to 8 months after the beginning of the treatment'}, {'measure': 'Estimate the efficiency in term of progression-free of pursuing chemotherapy', 'description': 'beyond 6 weeks of treatment', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, up to 8 months after the beginning of the treatment'}, {'measure': 'Estimate the rate of non progressive patients', 'description': 'after the 6 firsts weeks of treatment', 'timeFrame': 'From date of inclusion until the date of the end the 6 firsts weeks of treatment'}, {'measure': 'Estimate the overall survival of the whole study population', 'description': 'beyond the inclusion', 'timeFrame': 'From date of inclusion until the date of death from any cause, up to 8 months after the beginning of the treatment'}, {'measure': 'Measure the toxicity of chemotherapy', 'description': 'during the initial treatment phase compared to the 2 treatment arms after randomization', 'timeFrame': 'from baseline up to 12 months'}, {'measure': 'Estimate the consequences of pursuing chemotherapy', 'description': 'beyond 6 weeks of treatment in term of time until degradation of life quality and in term of overall benefits', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, up to 8 months after the beginning of the treatment'}] |
Title: N/A | Condition: Rhabdomyosarcoma, Neuroblastoma, Sarcoma, Sarcoma, Ewing, Osteosarcoma, Desmoid | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'Doxil + MR-HIFU Hyperthermia', 'type': 'EXPERIMENTAL', 'description': 'Liposomal doxorubicin (Doxil) 50mg IV every 4 weeks followed by Magnetic Resonance High Intensity Focused Ultrasound hyperthermia (MR-HIFU) with Philips Sonalleve System to 42C for 30 minutes every 4 weeks', 'interventionNames': ['Drug: Doxorubicin HCl liposomal injection', 'Device: Philips Sonalleve MR-HIFU Hyperthermia']}] | Interventions:[{'type': 'DRUG', 'name': 'Doxorubicin HCl liposomal injection', 'description': '50mg IV every 4 weeks', 'armGroupLabels': ['Doxil + MR-HIFU Hyperthermia'], 'otherNames': ['Doxil']}, {'type': 'DEVICE', 'name': 'Philips Sonalleve MR-HIFU Hyperthermia', 'description': 'Hyperthermia to 42C for 30 minutes every 4 weeks', 'armGroupLabels': ['Doxil + MR-HIFU Hyperthermia']}] | PrimaryOutcomes: [{'measure': 'Rate of dose limiting toxicities (DLTs) during cycle 1 of therapy with MR-HIFU hyperthermia directed liposomal doxorubicin', 'description': 'Dose limiting toxicities are generally CTCAE v4.03 grade 3-5 toxicities with specific exceptions detailed in the protocol.', 'timeFrame': '4 weeks'}] | SecondaryOutcomes: [{'measure': 'Terminal half-life (T1/2) of Doxil when delivered with MR-HIFU hyperthermia', 'timeFrame': '48 hours following first dose'}, {'measure': 'Volume of distribution (L/m2) of Doxil when delivered with MR-HIFU hyperthermia', 'timeFrame': '48 hours following first dose'}, {'measure': 'Clearance (mL/min) of Doxil when delivered with MR-HIFU hyperthermia', 'timeFrame': '48 hours following first dose'}, {'measure': 'Adverse events associated with Doxil when administered in combination with MR-HIFU hyperthermia', 'timeFrame': '6 months'}, {'measure': 'Percentage of patients with relapsed or refractory solid tumors treated with MR-HIFU hyperthermia and Doxil who demonstrate disease progression at a MR-HIFU treated lesion', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'Tumor response to MR-HIFU with liposomal doxorubicin', 'timeFrame': '6 months'}, {'measure': 'Percentage of patients treated with MR-HIFU hyperthermia who are able to receive hyperthermia (41-45C) to greater than 75% of the predetermined treatment volume for greater than 75% of the planned treatment duration', 'timeFrame': 'Day 1'}] |
Title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab as Adjuvant Treatment for Women With Early-Stage Breast Cancer at High Risk of Recurrence (D-CARE) | Condition: Breast Cancer | Keywords: Early Stage Breast Cancer, Bone Metastasis, Adjuvant treatment, Neoadjuvant treatment, Denosumab, Stage II breast cancer, Stage III breast cancer, Stage IIA breast cancer, Stage IIB breast cancer, Stage IIIA breast cancer, Stage IIIB breast cancer, Stage IIIC breast cancer, Early breast cancer, Breast Tumors, Breast Neoplasms | Summary: | Description: Eligible participants were randomized in a 1:1 ratio to receive denosumab 120 mg or placebo subcutaneously (SC) for up to 5 years. Randomization was stratified based on:
1. Breast cancer therapy/lymph node (LN) status: neoadjuvant therapy/any LN status versus adjuvant therapy/LN negative (based on axillary LN dissection, or based on sentinel node status) versus adjuvant therapy/LN positive
2. Hormone receptor (estrogen receptor \[ER\]/progesterone receptor \[PR\]) status: ER and/or PR positive versus ER and PR negative
3. Human epidermal growth factor receptor 2 (HER-2) status: HER-2 positive versus HER-2 negative
4. Age: \< 50 years versus ≥ 50 years
5. Geographic Region: Japan versus Other regions.
The primary analysis was conducted after all enrolled participants had the opportunity to complete 5 years of treatment from study day 1. | ArmGroups: [{'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Participants received placebo subcutaneous injections once every 4 weeks for 6 months followed by placebo subcutaneous injections once every 3 months for 4.5 years.', 'interventionNames': ['Drug: Placebo']}, {'label': 'Denosumab', 'type': 'EXPERIMENTAL', 'description': 'Participants received denosumab 120 mg subcutaneous injections once every 4 weeks for 6 months followed by denosumab 120 mg subcutaneous injections once every 3 months for 4.5 years.', 'interventionNames': ['Drug: Denosumab']}] | Interventions:[{'type': 'DRUG', 'name': 'Placebo', 'description': 'Administered subcutaneously for up to 5 years', 'armGroupLabels': ['Placebo']}, {'type': 'DRUG', 'name': 'Denosumab', 'description': 'Administered subcutaneously for up to 5 years', 'armGroupLabels': ['Denosumab'], 'otherNames': ['XGEVA®']}] | PrimaryOutcomes: [{'measure': 'Bone Metastasis-free Survival (BMFS)', 'description': 'BMFS time was defined as the time interval from the randomization date to the first occurrence of bone metastasis or death from any cause, whichever came first. Participants last known to be alive with no bone metastasis were censored at their last assessment date, or at the primary analysis data cut-off date, whichever was first. Participants who had first occurrence of bone metastasis before randomization were censored at their randomization date.\n\nBone metastasis must have been confirmed by central imaging analysis or by biopsy, Evidence of disseminated tumor cells in bone marrow was not sufficient for determination of disease recurrence. Development of new primary malignancy in bone was not considered as bone metastasis.\n\nSince the median BMSF time could not be estimated due to low number of events, the percentage of participants with an event (i.e., bone metastasis or death) is reported.', 'timeFrame': 'From randomization until the primary analysis data cut-off date of 31 August 2017; median (minimum, maximum) time on study was 67.2 (0.0, 85.9) and 67.0 (0.0, 86.6) months in each treatment group respectively.'}] | SecondaryOutcomes: [{'measure': 'Disease-free Survival (DFS)', 'description': 'DFS time was defined as the time interval from the randomization date to the date of first observation of disease recurrence or death from any cause, whichever was first. Participants last known to be alive with no disease recurrence were censored at their last assessment date, or at the primary analysis data cut-off date, whichever was first. Participants who had first disease recurrence before randomization were censored at their randomization date.\n\nDisease recurrence includes bone metastasis and extraosseous disease (EOD) confirmed by central imaging analysis or by biopsy/cytology. Development of non-breast cancer new primary malignancy was not considered as disease recurrence.\n\nSince the median DFS time could not be estimated due to low number of events, the percentage of participants with an event (i.e., disease recurrence or death) is reported.', 'timeFrame': 'From randomization until the primary analysis data cut-off date of 31 August 2017; median (minimum, maximum) time on study was 67.2 (0.0, 85.9) and 67.0 (0.0, 86.6) months in each treatment group respectively.'}, {'measure': 'Disease-free Survival (DFS) in the Postmenopausal Subset', 'description': 'DFS time was defined as the time interval from the randomization date to the date of first observation of disease recurrence or death from any cause, whichever was first. Participants last known to be alive with no disease recurrence were censored at their last assessment date, or at the primary analysis data cut-off date, whichever was first. Participants who had first disease recurrence before randomization were censored at their randomization date.\n\nDisease recurrence includes bone metastasis and extraosseous disease (EOD) confirmed by central imaging analysis or by biopsy/cytology. Development of non-breast cancer new primary malignancy was not considered as disease recurrence.\n\nSince the median DFS time in the postmenopausal subset could not be estimated due to low number of events, the percentage of participants with an event (i.e., disease recurrence or death) is reported.', 'timeFrame': 'From randomization until the primary analysis data cut-off date of 31 August 2017; median (minimum, maximum) time on study was 67.2 (0.0, 85.9) and 67.0 (0.0, 86.6) months in each treatment group respectively.'}, {'measure': 'Overall Survival', 'description': 'Overall survival (OS) time was defined as the time interval from the randomization date to the date of death from any cause. Participants last known to be alive were censored at their last contact date.\n\nSince the median time to overall survival could not be estimated at the time of the final analysis due to low numbers of events, the percentage of participants with an event (i.e., death) is reported.', 'timeFrame': 'From randomization until the end of study; median (minimum, maximum) time on study was 72.7 (0, 92) and 72.3 (0, 92) months in each treatment group respectively.'}, {'measure': 'Distant Recurrence-free Survival', 'description': 'Distant recurrence-free survival (DRFS) was defined as the time interval from the randomization date to the date of first observation of distant disease recurrence or death from any cause, whichever came first. Participants last known to be alive, who had not experienced distant disease recurrence, were censored at their last assessment date, or at the primary analysis data cut-off date, whichever was first. Participants who had first distant recurrence before randomization were censored at their randomization date.\n\nDistant disease recurrence includes confirmed bone metastasis and extraosseous disease other than local-regional disease recurrence. Development of non-breast cancer new primary malignancy was not considered as distant disease recurrence.\n\nSince the median time to DRFS could not be estimated due to the low number of events, the percentage of participants with an event (i.e., distant recurrence or death) is reported.', 'timeFrame': 'From randomization until the primary analysis data cut-off date of 31 August 2017; median (minimum, maximum) time on study was 67.2 (0.0, 85.9) and 67.0 (0.0, 86.6) months in each treatment group respectively.'}] |
Title: A Phase II Study of Neoadjuvant Sotorasib in Combination with Cisplatin or Carboplatin and Pemetrexed for Surgically Resectable Stage IIA-IIIB Non-Squamous Non-Small Cell Lung Cancer with a KRAS P.G12C Mutation | Condition: Lung Cancer | Keywords: | Summary: | Description: Objectives
Primary:
* To evaluate the efficacy of induction with sotorasib (AMG 510) in combination with cisplatin (or carboplatin) and pemetrexed in patients with surgically resectable KRAS p.G12C-mutant non-squamous NSCLC as assessed by major pathologic response rate in resected tumor specimens.
* To determine the safety, tolerability and RP2D of sotorasib in combination with cisplatin (or carboplatin) and pemetrexed as induction therapy in patients with surgically resectable KRAS p.G12C-mutant nonsquamous NSCLC
Secondary:
* To evaluate the efficacy of induction sotorasib in combination with cisplatin (or carboplatin) and pemetrexed in patients with surgically resectable KRAS p.G12C mutant non-squamous NSCLC as assessed by : Objective response rate (ORR), Eventfree survival, Recurrence-free survival, Overall Survival (OS), Complete Resection (R0) and Pathologic complete response rate (pCR)
* To determine the safety and tolerability of sotorasib in combination with cisplatin (or carboplatin) and pemetrexed as induction therapy in patients with surgically resectable KRAS p.G12C-mutant nonsquamous NSCLC.
Exploratory:
* To evaluate biomarkers of response to induction sotorasib in combination with cisplatin (or carboplatin) and pemetrexed in surgically resectable KRAS p.G12C-mutant non-squamous NSCLC.
* To assess modulation of tissue and/or blood markers in response to induction with sotorasib in combination with cisplatin (or carboplatin) and pemetrexed in surgically resectable KRAS p.G12C-mutant nonsquamous NSCLC.
* To evaluate mechanisms of adaptation and/or resistance to sotorasib in combination with cisplatin (or carboplatin) and pemetrexed in surgically resectable KRAS p.G12C-mutant non-squamous NSCLC.
* To evaluate immune modulation in tissue and the periphery in response to induction sotorasib in combination with cisplatin (or carboplatin) and pemetrexed in surgically resectable KRAS p.G12C-mutant nonsquamous NSCLC. | ArmGroups: [{'label': 'Sotorasib in Combination with Cisplatin/Carboplatin and Pemetrexed', 'type': 'EXPERIMENTAL', 'description': '4 cycles of at least one dose of sotorasib plus cisplatin (or carboplatin) and pemetrexed can be administered safely', 'interventionNames': ['Drug: AMG 510', 'Drug: Cisplatin', 'Drug: Carboplatin', 'Drug: Pemetrexed']}] | Interventions:[{'type': 'DRUG', 'name': 'AMG 510', 'description': 'Given by IV', 'armGroupLabels': ['Sotorasib in Combination with Cisplatin/Carboplatin and Pemetrexed']}, {'type': 'DRUG', 'name': 'Cisplatin', 'description': 'Given by IV', 'armGroupLabels': ['Sotorasib in Combination with Cisplatin/Carboplatin and Pemetrexed'], 'otherNames': ['Platinol®-AQ', 'Platinol®', 'CDDP']}, {'type': 'DRUG', 'name': 'Carboplatin', 'description': 'Given by IV', 'armGroupLabels': ['Sotorasib in Combination with Cisplatin/Carboplatin and Pemetrexed']}, {'type': 'DRUG', 'name': 'Pemetrexed', 'description': 'Given by IV', 'armGroupLabels': ['Sotorasib in Combination with Cisplatin/Carboplatin and Pemetrexed'], 'otherNames': ['LY231514', 'Alimta®', 'MTA', 'Multitargeted Antifolate', 'NSC-698037']}] | PrimaryOutcomes: [{'measure': 'Patients with surgically resectable KRAS p.G12C-mutant non-squamous NSCLC as assessed by major pathologic response rate in resected tumor specimens', 'timeFrame': 'through study completion, an average of 1 year'}] | SecondaryOutcomes: N/A |
Title: A Randomised, Double-Blind, Multicentre Phase Ⅲ Study to Evaluate Abiraterone Acetate Versus Placebo Combined With Prednisone in Subjects With Asymptomatic or Mild Symptoms Without Chemotherapy, Metastatic Castration Resistant Prostate Cancer. | Condition: Metastatic Castration Resistant Prostate Cancer | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'Abiraterone acetate group', 'type': 'EXPERIMENTAL', 'description': 'Subjects in this group administered 4 tablets abiraterone acetate once daily and 5mg prednisone twice daily, in 28-day cycle on fasting conditions.', 'interventionNames': ['Drug: Abiraterone Acetate', 'Drug: Prednisone']}, {'label': 'Placebo group', 'type': 'PLACEBO_COMPARATOR', 'description': 'Subjects in this group administered 4 tablets abiraterone acetate blank analog tablet once daily and 5mg prednisone twice daily, in 28-day cycle on fasting conditions.', 'interventionNames': ['Drug: Placebo', 'Drug: Prednisone']}] | Interventions:[{'type': 'DRUG', 'name': 'Abiraterone Acetate', 'description': 'Subjects administered 4 tablets abiraterone acetate twice daily in 28-day cycle.', 'armGroupLabels': ['Abiraterone acetate group']}, {'type': 'DRUG', 'name': 'Placebo', 'description': 'Subjects administered 4 tablets abiraterone acetate blank analog tablet twice daily in 28-day cycle.', 'armGroupLabels': ['Placebo group']}, {'type': 'DRUG', 'name': 'Prednisone', 'description': 'Subjects administered 5mg prednisone twice daily in 28-day cycle.', 'armGroupLabels': ['Abiraterone acetate group', 'Placebo group']}] | PrimaryOutcomes: [{'measure': 'Time to PSA progression (TTPP）', 'description': 'The time interval between the administration of the drug and the progression of serum prostate specific antigen (PSA).', 'timeFrame': 'Baseline up to 24 months'}] | SecondaryOutcomes: [{'measure': 'Prostate specific antigen remission time', 'description': 'It was ≥50% lower than the baseline, and was confirmed as remission after re-testing after ≥4 weeks.', 'timeFrame': 'Baseline up to 24 months'}, {'measure': 'Objective Response Rate (ORR)', 'description': 'The percentage of participants with a best overall response defined as complete response (CR) or partial response (PR).', 'timeFrame': 'Baseline up to 24 months'}, {'measure': 'Eastern Cooperative Oncology Group (ECOG)', 'description': "The ECOG scoring standard is an indicator of the general health status and tolerance to treatment from the patient's physical strength. ECOG physical status score standard from 0 to 5. Starting with the dose until the score increases from the baseline.", 'timeFrame': 'Baseline up to 24 months'}, {'measure': 'Overall Survival (OS)', 'description': 'Time from date of randomization to date of death due to any cause.', 'timeFrame': 'Baseline up to 24 months'}, {'measure': 'To pain progression time', 'description': 'Time from the start of medication to the progression of pain.', 'timeFrame': 'Baseline up to 24 months'}, {'measure': 'Quality of life assessment scale (FACT-P)', 'description': 'Functional Assessment of Cancer Therapy- Prostate Cancer (FACT-P) total score, Functional Assessment of Cancer Therapy- General (FACT-G) total score, trial outcome index, functional well-being, physical well-being, prostate cancer subscale, and Functional Assessment of Cancer Therapy (FACT) Advanced Prostate Symptom Index-6 (FAPSI-6).', 'timeFrame': 'Baseline up to 24 months'}, {'measure': 'Prostate specific antigen remission rate', 'description': 'The remission rate was defined as the proportion of remissions to the total number of people.', 'timeFrame': 'Baseline up to 24 months'}] |
Title: Safety and Results of Thoracoscopic Lobectomy Using Nonintubated Anesthesia Versus Intubated General Anesthesia for Lung Cancer Patients. | Condition: Lung Cancer | Keywords: thoracoscopy, lung cancer, lobectomy, epidural anesthesia | Summary: | Description: Lung cancer is the leading cause of cancer death in Taiwan. Traditionally, open thoracotomy has been the standard approach for lung cancer surgery, including lobectomy and pneumonectomy. With the advance of thoracoscopic technique, thoracoscopic lobectomy has emerged as a reasonable option for the management of early-stage non-small cell lung cancer (NSCLC), and is supported by evidence-based treatment guidelines. Advantages of thoracoscopic lobectomy compared with thoracotomy include less postoperative pain, shorter hospitalization, and decreased postoperative pulmonary complications.
Traditionally, general anesthesia (GA) with one-lung ventilation using double-lumen endotracheal intubation has been considered mandatory in both open and thoracoscopic surgery. However, adverse effects of GA may occur after the operation, including ventilator-induced lung injury, impaired cardiac performance, postoperative nausea and vomiting, and residual neuromuscular blockade.
In order to reduce the adverse effects of GA, nonintubated anesthesia has been recently employed to perform thoracic surgery procedures including coronary artery bypass, management of pneumothorax, resection of pulmonary nodules and solitary metastases, lung volume reduction (LVR), and even transsternal thymectomy. The results achieved in these early series have been encouraging. In Taiwan, nonintubated thoracic surgery has also been performed at Taipei Veteran General Hospital in a high risk patient with satisfactory results.
The role of nonintubated anesthesia in thoracoscopic lobectomy is rarely investigated. There is a report showed that lobectomy using nonintubated anesthesia is safe and feasible, although only 3 cases were reported \[13\]. In our hospital, we also performed 6 thoracoscopic lobectomy using nonintubated anesthesia between August and October, 2009 with satisfactory results. Until now, the safety and effects of nonintubated anesthesia in thoracoscopic lobectomy has been unclear and comparison between nonintubated and intubated general anesthesia has never been reported. We hypothesize that nonintubated thoracoscopic lobectomy will be associated with a comparable oncological results, lower cardiopulmonary complications, and shorter intensive care unit (ICU) and hospital stays. To this end, we will compare safety and results of thoracoscopic lobectomy using nonintubated anesthesia versus intubated general anesthesia for lung cancer patients.
This study will be performed at National Taiwan University Hospital. A total of 100 patients will be included (50 patients in each arm). | ArmGroups: [{'label': 'nonintubated anesthesia', 'type': 'EXPERIMENTAL', 'description': 'Thoracoscopic lobectomy using nonintubated anesthesia', 'interventionNames': ['Procedure: thoracoscopic lobectomy and mediastinal lymph node dissection']}, {'label': 'intubated general anesthesia', 'type': 'ACTIVE_COMPARATOR', 'description': 'Thoracoscopic lobectomy using intubated general anesthesia', 'interventionNames': ['Procedure: thoracoscopic lobectomy and mediastinal lymph node dissection']}] | Interventions:[{'type': 'PROCEDURE', 'name': 'thoracoscopic lobectomy and mediastinal lymph node dissection', 'armGroupLabels': ['intubated general anesthesia', 'nonintubated anesthesia'], 'otherNames': ['VATS lobectomy']}] | PrimaryOutcomes: [{'measure': 'Comparing the safety after intervention of each group.', 'description': 'Comparing the complication and morbidity after intervention of each group', 'timeFrame': '1 month'}] | SecondaryOutcomes: [{'measure': 'Short-term outcome', 'description': 'including ICU stay, period of ventilator use, hospital stay, number of days with chest drainage, adverse events, etc.', 'timeFrame': 'one month'}, {'measure': 'Oncological outcome', 'description': 'Number of LN dissection and overall survival after the operation', 'timeFrame': '5 years'}] |
Title: A Randomized, Multicenter, Open-label, Phase III Trial Comparing Anthracyclines Followed by Taxane Versus Anthracyclines Followed by Taxane Plus Carboplatin as (Neo) Adjuvant Therapy in Patients With Triple-negative Breast Cancer | Condition: Breast Cancer | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'control group', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Drug: Taxane']}, {'label': 'carboplatin group', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: taxane plus carboplatin']}] | Interventions:[{'type': 'DRUG', 'name': 'taxane plus carboplatin', 'description': "Doxorubicin (60 mg/m2) IV + cyclophosphamide (600 mg/m2) IV every 3 weeks for 4 cycles followed by taxane plus carboplatin for 4 cycles The taxane plus carboplatin regimen can be selected based on the investigator's discretion from among the following two regimens.\n\n* Docetaxel (75 mg/m2) IV plus carboplatin (AUC 5) IV every 3 weeks for 4 cycles\n* Paclitaxel (80 mg/m2) IV weekly for 12 doses plus carboplatin (AUC 5) IV every 3 weeks for 4 cycles", 'armGroupLabels': ['carboplatin group']}, {'type': 'DRUG', 'name': 'Taxane', 'description': "Doxorubicin (60 mg/m2) IV + cyclophosphamide (600 mg/m2) IV every 3 weeks for 4 cycles followed by taxane for 4 cycles The taxane regimen can be selected at the investigator's discretion from among the following two regimens.\n\n* Docetaxel (75 mg/m2) IV every 3 weeks for 4 cycles\n* Paclitaxel (80 mg/m2) IV weekly for 12 doses", 'armGroupLabels': ['control group']}] | PrimaryOutcomes: [{'measure': '5-year event-free survival (EFS)', 'description': 'time from Cycle1 Day1 to the occurrence of the following events\n\n: loco-regional recurrence, distant recurrence, death from any cause, contralateral invasive breast cancer, second primary cancer, and cancer after surgery (not R0 resection), definitive disease progression during neoadjuvant chemotherapy, inoperable status after neoadjuvant chemotherapy', 'timeFrame': '5 year'}] | SecondaryOutcomes: [{'measure': 'overall survival', 'description': 'Time from C1D1 until death from any cause', 'timeFrame': '5 year'}, {'measure': 'Distant recurrence free survival', 'description': 'Time from C1D1 until distant recurrence', 'timeFrame': '5 year'}, {'measure': 'loco-regional recurrence free survival', 'description': 'Time from C1D1 until locoregional recurrence', 'timeFrame': '5 year'}, {'measure': 'pathologic complete response rate', 'description': 'no evidence of invasive carcinoma in both breast and axillary lymph nodes, regardless of ductal carcinoma in situ (ypT0isN0)', 'timeFrame': '5 year'}] |
Title: Take Heart: Exercise & Diet Intervention for Heart Failure in Cancer Survivors | Condition: Heart Failure | Keywords: Heart Failure, Lifestyle Intervention, Exercise, Diet | Summary: | Description: Baseline Study Procedures:
If you agree to take part in the pretest portion of this study, your cardiology team will look at a number of tests performed on your heart as part of your usual care, as well as your complete medical history, to find out if you are eligible to take part in this study.
If you are found to be eligible to take part in this study, you will be scheduled for a visit to the Behavioral Research and Treatment Center (BRTC) at MD Anderson.
Before your first visit to the BRTC, you will complete the following tasks at home:
-You will wear an accelerometer to measure your physical activity for 1 week. An accelerometer is a small device that you wear on your waist during the day. It records how active you are. You will bring the accelerometer with you when you come for your first visit in the BRTC.
During your first visit to the BRTC, the following tests and procedures will be performed:
* You will have an electrocardiogram (ECG), which takes about 10 minutes. An ECG is a test used to measure the electrical activity of the heart.
* You will have your blood pressure and heart rate measured.
* You will complete questionnaires about your symptoms, quality-of-life, psychological distress, and exercise. These should take about 60 minutes to complete.
* You will complete 2 reaction time tasks on the computer. In one task, you will press a button on the keyboard to indicate the color of a word on the screen. In the other task, the computer will present a statement and you will press a button on the keyboard to indicate whether you think it is true or false. The statements are all opinions. It is not a test of knowledge. The 2 reaction time tasks together should take a total of about 10 minutes.
* You will do an exercise test on the stationary bicycle. You will ride on the stationary bicycle for about 10-15 minutes while your heart rate, blood pressure, and breathing are recorded by certified exercise specialists. While you are pedaling, the difficulty level will be changed by the study staff. First, you will pedal at a low difficulty level. After a 5-minute warm up period, the difficulty level will be slowly increased for about 3-5 minutes until you reach the point you cannot continue at that difficulty level. After that point, the difficulty level will be lowered for about 5 minutes to allow you to cool down. You can stop the test at any time.
* Then, you will repeat completing the exercise questionnaires and the reaction time tasks on the computer, which should take about another 10 minutes.
Study Groups:
After the above test and procedures, you will be randomly assigned (as in the flip of a coin) to be in 1 of 2 groups. You will have an equal chance of being in either group.
If you are in Group 1, you will receive the usual care as provided by the cardiology service, and a booklet about coping with heart failure. Dietary counseling will be provided once a month to encourage you to follow to a low sodium diet, with the goal of limiting sodium to 2 grams per day. The dietary counseling will include education about the effects of sodium for patients with heart failure, sources of sodium in the diet, reading food labels, identifying low-sodium alternatives to high-sodium foods, and using other types of flavorings rather than salt and other high-sodium condiments. You will be given the booklet How to Follow a Low Sodium Diet from the Heart Failure Society of America (appendix S and a copy of the American Heart Association Low-Salt Cookbook, 3rd edition. If you are a tobacco user or have recently quit, you will be referred to the MD Anderson Tobacco Treatment program. At the end of 16 weeks, after you have completed your 4 month visit in the BRTC, you will be offered exercise training described below. If you want to participate in the exercise training, you may do so at that time.
If you are in Group 2, you will receive all the components of usual care, plus exercise training.
Exercise Training:
If you are in Group 2, you will visit the BRTC 3 times a week for exercise training. For the first 12 sessions, you will exercise on a stationary bicycle while your heart rate, ECG, and blood pressure are recorded.
After the cardiologist finds that you are able to exercise safely, you will use part of the exercise session to do exercise without having your heart rate, ECG, and blood pressure recorded. Your exercise sessions at the BRTC will be supervised by a study staff member at all times. After you have exercised safely for at least 4 weeks, you will begin at-home exercise program, which will be a series of exercises developed individually for you, in addition to the supervised exercise sessions in the BRTC. You will be given an exercise log to describe your at-home exercise, and any problems or symptoms you experience during or after the at-home exercise sessions.
The visits to the BRTC for exercise training will last about 1 hour. You will come to the BRTC for these visits 3 times a week for 16 weeks.
If you are in Group 1, you have the option of choosing the exercise training described above or a 12-week home-based exercise training program that you will start after your 4 - month visit to the BRTC. You will be scheduled for an in-person exercise session with the exercise physiologist at the BRTC at MD Anderson. During this visit, you will receive instructions on how to complete your exercise sessions safely and effectively at home. This visit will take about 1 hour to complete. You will be provided with an exercise recommendation that will help you work up to 30 minutes of exercise, at least 3 times a week.
The exercise physiologist will call you once a week for 12 weeks to check on your progress and answer any questions you may have about your exercise program. You will also have the opportunity to come back to MD Anderson up to 1 time a week if you would like help from the exercise physiologist.
You will be given a pedometer to wear. A pedometer is a small device (about the size of a deck of cards) that is worn on the belt and measures the number of steps you take each day. You will record the number of steps and minutes of exercise for each day on an exercise log sheet.
At Weeks 4 and 8 (+/- 7 days), you will have a telephone interview about any side effects you may be having and how well you are able to function in daily activities.
You will also be counseled on limiting how much sodium you consume. The dietary counseling will include education about the effects of sodium on patients with heart failure, sources of sodium in the diet, reading food labels, identifying low-sodium alternatives to high-sodium foods, and using other types of flavorings rather than salt and other high-sodium condiments.
These calls should take about 45 minutes.
Follow-Up Visits:
If you are in either Group 1 or Group 2, you will have an appointment with the MD Anderson cardiology team 4 months from the baseline assessment. At this visit you will be asked about your symptoms. Blood (about 1 teaspoon) will be drawn to measure biomarkers at baseline and at the 4 month visit. Biomarkers are chemical "markers" in the blood that may be related to your heart failure.
If you are in Group 1 or Group 2, you will have a follow-up visit in the BRTC about 16-18 weeks after your baseline visit.
Ten (10) days before this visit, you will receive a new accelerometer in the mail. You will be called and reminded to wear the accelerometer. You will wear the accelerometer for 7 days and then bring it to the last visit to the BRTC.
At your last follow up visit to the BRTC, the following tests and procedures will be performed:
* You will complete questionnaires about your symptoms, quality of life, psychological distress, and exercise.
* You will complete 2 reaction time tasks on the computer.
* After these questionnaires and reaction tests, you will have an ECG and your blood pressure and heart rate will be measured.
* You will have an echocardiogram.
* You will then do an exercise test on the stationary bicycle.
* Then you will repeat the exercise questionnaires and the reaction time tasks on the computer.
* You will also be asked to take part in an interview about what you thought of the exercise program and the tasks you performed at home. This interview should take about 15 minutes.
After your 16-week visit, information about your cardiac tests, health problems, and hospitalizations will be collected from your medical record.
Participants in the waiting list group who choose to participate in the exercise program after their 16 week assessment will complete questionnaires once a month to measure symptoms. After 4 months of exercise (3 months for home-based) they will repeat all the follow-up tests described above.
This is an investigational study.
Up to 80 participants will be take part in this study. All will be enrolled at MD Anderson. | ArmGroups: [{'label': 'Group 1', 'type': 'OTHER', 'description': 'Usual Care', 'interventionNames': ['Other: Usual Care']}, {'label': 'Group 2', 'type': 'EXPERIMENTAL', 'description': 'Exercise Training + Dietary Counseling', 'interventionNames': ['Other: Usual Care', 'Behavioral: Exercise Training', 'Behavioral: Dietary Counseling']}] | Interventions:[{'type': 'OTHER', 'name': 'Usual Care', 'description': 'Monthly visits with the cardiology team and a booklet about coping with heart failure.', 'armGroupLabels': ['Group 1', 'Group 2']}, {'type': 'BEHAVIORAL', 'name': 'Exercise Training', 'description': 'Exercise training 3 times a week.', 'armGroupLabels': ['Group 2']}, {'type': 'BEHAVIORAL', 'name': 'Dietary Counseling', 'description': 'Food log, booklet, and a cookbook to help decrease the salt content in your diet.', 'armGroupLabels': ['Group 2']}] | PrimaryOutcomes: [{'measure': 'Recruitment/Attendance/Drop-Out Rates', 'timeFrame': '1 Year'}] | SecondaryOutcomes: N/A |
Title: Phase II Study of a Biochemically Synergistic Regimen for Metastatic Pancreatic Cancer (Stage IVB) With Gemzar, Taxotere and Xeloda (GTX) | Condition: Metastatic Pancreatic Cancer | Keywords: Stage IVB | Summary: | Description: This Phase II multicenter study is designed to determine the response rate to a biochemically synergistic regimen with Gemzar, Taxotere, and Xeloda in patients with Stage IVB metastatic pancreatic cancer. It will further determine the overall and one year survival rates, the diseasefree interval, and the toxicities for this regimen in patients with metastatic pancreatic cancer. | ArmGroups: [{'label': 'Gemzar, Taxotere, Xeloda', 'type': 'EXPERIMENTAL', 'description': 'Gemcitabine, Docetaxel, Capecitabine:\n\nGemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days', 'interventionNames': ['Drug: Gemcitabine, Docetaxel, Capecitabine']}] | Interventions:[{'type': 'DRUG', 'name': 'Gemcitabine, Docetaxel, Capecitabine', 'description': '1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11\n\nThis 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles.', 'armGroupLabels': ['Gemzar, Taxotere, Xeloda'], 'otherNames': ['Gemzar', 'Xeloda', 'Taxotere']}] | PrimaryOutcomes: [{'measure': 'To Determine Response Rate to the GTX Regimen in Patients With Pancreatic Cancer', 'description': 'Data was not analyzed because original PI left institution before data analysis was completed.', 'timeFrame': '10 weeks'}] | SecondaryOutcomes: [{'measure': 'Determine Overall and One Year Survival Rates', 'description': 'Data was not analyzed because original PI left institution before data analysis was completed.', 'timeFrame': 'One year'}, {'measure': 'Toxicity Assessment', 'description': 'Data was not analyzed because original PI left institution before data analysis was completed.', 'timeFrame': 'Every month'}] |
Title: The LINFU® (A Noninvasive Method for Increasing Exfoliation of Pancreatic Ductal Cells Into Pancreatic Fluid) U.S. Registry for the Detection of PanIn-2, PanIn-3, and Early, Asymptomatic Pancreatic Ductal Adenocarcinoma (PDAC) | Condition: Pancreatic Ductal Adenocarcinoma | Keywords: Pancreatic Intraepithelial Neoplasia | Summary: | Description: Adenocyte has developed a proprietary pancreatic cancer detection method, LINFU®, (Low Intensity Non-Focused Ultrasound excitation of the pancreas) to increase the sensitivity of pancreatic juice cytology. LINFU® consists of analysis of pancreatic fluid collected with the help of low intensity non-focused ultrasound excitation of the pancreas. A contrast agent will be used to create bubbles and possibly increase the number of pancreatic cell we collect for the study. Secretin is also used to increase the number of pancreatic cell excretion to maximize the number of cells collected. A neural network-based computer-assisted system may be used to enhance the analysis of specimens.
In this registry, LINFU® will be studied in patients who are at increased risk for developing pancreatic cancer as well as those with signs or symptoms of disease.
In this registry, a standardized Case Report Form will be completed for every subject enrolled. Information obtained at baseline will include patient history, clinical and demographic information including relevant comorbidities and pancreatic disease history, and screening and pathology test results. The results of all diagnostic tests, surgeries, and biopsies performed after the LINFU® technique for a period of 5 years will be recorded and maintained as clinical registry data. This includes testing and procedures received since enrollment including EUS- FNA, MRI/MRCP, ERCP, CT, CEUS, treatments performed, pathology results, and pancreatic disease history since enrollment.
The registry case report form is the primary data collection instrument for the registry. All data requested on the form must be recorded and these forms will be monitored carefully by the sponsor to ensure they are completely filled out properly.
. | ArmGroups: [{'label': 'Patients at increased risk for developing pancreatic cancer', 'description': 'Patients being screened for pancreatic cancer because they have known risk factors (i.e. smoking, diabetes, chronic pancreatitis, family history of pancreatic cancer, or certain genetic syndromes) or have signs or symptoms of disease and are undergoing other imaging diagnostic tests to determine if they have pancreatic cancer', 'interventionNames': ['Combination Product: LINFU™ Technique']}] | Interventions:[{'type': 'COMBINATION_PRODUCT', 'name': 'LINFU™ Technique', 'description': 'Non-focused ultrasound excitation of the pancreas with IV Lumason and IV secretin injected during the ultrasound procedure.', 'armGroupLabels': ['Patients at increased risk for developing pancreatic cancer']}] | PrimaryOutcomes: [{'measure': 'The number of pancreatic ductal adenocarcinomas and their noninvasive precursor', 'description': 'The total number of asymptomatic pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU® by analysis of pancreatic fluid will be compared to the number of these lesions identified with current screening tests, including EUS- FNA, MRI/MRCP, ERCP, CT and CEUS.', 'timeFrame': '5 years'}] | SecondaryOutcomes: [{'measure': 'The change in size of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® will be determined.', 'description': 'Patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® and not detected with other diagnostic tests will be monitored long- term (5 years) by EUS- FNA, MRI/MRCP, ERCP, CT and CEUS to assess whether these tumors increase in size (measured in mm) and to determine how many require medical or surgical intervention.', 'timeFrame': '5 years'}, {'measure': 'Determine the number of patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® that require medical or surgical intervention.', 'description': 'Patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® and not detected with other diagnostic tests will be monitored long- term (5 years) by EUS- FNA, MRI/MRCP, ERCP, CT and CEUS to assess whether these tumors increase how many require medical or surgical intervention.', 'timeFrame': '5 years'}] |
Title: Influence of High Dose Vitamin D3 Intake on Outcome in Pancreatic Cancer Surgery: Prospective, Randomized, Open, Controlled Pilot Study | Condition: Pancreas Cancer, Vitamin D Deficiency, Quality of Life | Keywords: V | Summary: | Description: N/A | ArmGroups: [{'label': 'High-dose', 'type': 'EXPERIMENTAL', 'description': 'Intervention with high dose oral vitamin D3 supplementation.\n\n1 drop equals 400 I.U. This group will get 180.000 I.U. on day 1, and then 4000 I.U. per day for 60 days.', 'interventionNames': ['Drug: High-dose']}, {'label': 'Standard-dose', 'type': 'ACTIVE_COMPARATOR', 'description': 'Intervention with standard dose oral vitamin D3 supplementation.\n\n1 drop equals 400 I.U. This group will get 800 I.U. per day for 60 days.', 'interventionNames': ['Drug: Standard dose']}] | Interventions:[{'type': 'DRUG', 'name': 'High-dose', 'description': 'Patients will receive a high dose - 180.000 I.U. (1 drop equals 400 I.U.) of Vitamin D3 orally on day 1, and then 4000 I.U. for 60 days', 'armGroupLabels': ['High-dose']}, {'type': 'DRUG', 'name': 'Standard dose', 'description': 'Patients will receive a standard dose - 800 I.U. (equals 2 drops) of Vitamin D3 orally for 60 days', 'armGroupLabels': ['Standard-dose']}] | PrimaryOutcomes: [{'measure': '25(OH) vitamin D', 'description': 'Blood level of Vitamin D3', 'timeFrame': 'Day 60'}] | SecondaryOutcomes: [{'measure': '25(OH) vitamin D', 'description': 'Blood level of Vitamin D3', 'timeFrame': 'Day 30'}, {'measure': '1,25(OH)2D vitamin D', 'description': 'Blood level of 1,25(OH)2D vitamin D', 'timeFrame': 'Day 30'}, {'measure': '1,25(OH)2D vitamin D', 'description': 'Blood level of 1,25(OH)2D vitamin D', 'timeFrame': 'Day 60'}, {'measure': 'Urine Calcium', 'description': 'Calcium level in urine', 'timeFrame': 'Day 30'}, {'measure': 'Urine Calcium', 'description': 'Calcium level in urine', 'timeFrame': 'Day 60'}, {'measure': 'Osteocalcin', 'description': 'Bone marker measured in blood', 'timeFrame': 'Day 30'}, {'measure': 'Osteocalcin', 'description': 'Bone marker measured in blood', 'timeFrame': 'Day 60'}, {'measure': 'Beta-crosslaps', 'description': 'Bone marker measured in blood', 'timeFrame': 'Day 30'}, {'measure': 'Beta-crosslaps', 'description': 'Bone marker measured in blood', 'timeFrame': 'Day 60'}, {'measure': 'Calcium', 'description': 'blood measurement', 'timeFrame': 'Day 60'}, {'measure': 'Calcium', 'description': 'blood measurement', 'timeFrame': 'Day 30'}, {'measure': 'ionized calcium', 'description': 'blood measurement', 'timeFrame': 'Day 30'}, {'measure': 'ionized calcium', 'description': 'blood measurement', 'timeFrame': 'Day 60'}, {'measure': 'creatinine', 'description': 'blood measurement', 'timeFrame': 'Day 30'}, {'measure': 'creatinine', 'description': 'blood measurement', 'timeFrame': 'Day 60'}, {'measure': 'phosphate', 'description': 'blood measurement', 'timeFrame': 'Day 60'}, {'measure': 'phosphate', 'description': 'blood measurement', 'timeFrame': 'Day 30'}, {'measure': '60-day mortality', 'description': 'Number of patients who die in the specified timeframe', 'timeFrame': 'Day 60'}, {'measure': 'hospital stay', 'description': 'Hospital stay in days', 'timeFrame': 'Day 60'}, {'measure': 'hospital readmission', 'description': 'Number of readmissions', 'timeFrame': 'Day 60'}, {'measure': 'hepcidin', 'description': 'blood level marker for iron status', 'timeFrame': 'Day 30'}, {'measure': 'hepcidin', 'description': 'blood level marker for iron status', 'timeFrame': 'Day 60'}, {'measure': 'Quality of Life questionnaire', 'description': 'evaluated by EORTC questionnaire', 'timeFrame': 'Day 30'}, {'measure': 'Quality of Life questionnaire', 'description': 'evaluated by EORTC questionnaire', 'timeFrame': 'Day 60'}] |
Title: A Phase 2 Study of Tarceva for Untreated, Good Prognosis Patients With Advanced Non-Small Cell Lung Cancer | Condition: Lung Cancer | Keywords: | Summary: | Description: Primary Objective To determine Time to Chemotherapy Progression (ie includes time on Tarceva monotherapy and chemotherapy) in advanced NSCLC
Secondary Objectives To evaluate survival and response rate associated with Tarceva treatment To study the frequency of symptom improvement (Lung Cancer Subscale) | ArmGroups: [{'label': 'A', 'type': 'OTHER', 'interventionNames': ['Drug: Erlotinib (Tarceva)']}] | Interventions:[{'type': 'DRUG', 'name': 'Erlotinib (Tarceva)', 'description': 'Erlotinib', 'armGroupLabels': ['A'], 'otherNames': ['Tarceva']}] | PrimaryOutcomes: [{'measure': 'Survival Rate at 6-months Chemotherapy-progression-free (CP-free)', 'description': 'Will determine if 6-month chemotherapy-progression-free (CP-free) survival rate (using RECIST) is significantly higher than the historically observed 31%. A one-sided binomial test at a 5% nominal significance was used.', 'timeFrame': '6 months'}] | SecondaryOutcomes: [{'measure': 'Overall Survival', 'description': 'Estimated via a Kaplan-Meier curves. Survival will be counted from the first dose of Tarceva.', 'timeFrame': '24 months'}] |
Title: Safety of TAS-102 in Combination With Temozolomide for Metastatic Pancreatic Neuroendocrine Tumors | Condition: Neuroendocrine Tumors, Neoplasms, Cancer, Tumors | Keywords: Pancreatic neuroendocrine tumors (pNETs), Pancreatic neuroendocrine tumors, pNETs, NETs | Summary: | Description: The study is a two part phase 1B clinical trial consisting of three study periods: a screening period of 14 days or less, a treatment period, and a safety follow-up period 30 days after treatment discontinuation.
Part 1 is a dose finding phase with the objective to assess the safety and tolerability of the proposed drug combination and to identify the maximum tolerated dose (MTD) and a recommended phase 2 dose.
Part 2 is an open-label expansion study, which will enroll patients with metastatic pNETs who have not been previously treated with chemotherapy. Part 2 will obtain further safety data of the proposed drug combination. | ArmGroups: [{'label': 'TAS-102 and TMZ', 'type': 'EXPERIMENTAL', 'description': 'Part 1: dose-escalation phase to determine MTD of TAS-102 in combination with Temozolomide (TMZ). Treatment cycles are 28 days, with TAS-102 administered orally twice daily days 1-5 and 8-12, and TMZ administered orally days 8-12. No treatment medications administered days 13-28 of each cycle. Growth factor support is required during Part 1 and should be dosed per institutional standards.\n\nPart 2: expansion phase to evaluate preliminary efficacy of MTD. Subjects treated with the recommended phase 2 drug doses determined in part 1. Treatment will continue for up to 13 cycles (approx. 12 months). Growth factor support is allowed during Part 2 and should be dosed per institutional standards.', 'interventionNames': ['Drug: TAS-102', 'Drug: Temozolomide', 'Drug: Filgrastim', 'Drug: Pegfilgrastim']}] | Interventions:[{'type': 'DRUG', 'name': 'TAS-102', 'description': 'Anti-metabolite agent, taken orally.', 'armGroupLabels': ['TAS-102 and TMZ']}, {'type': 'DRUG', 'name': 'Temozolomide', 'description': 'Oral chemotherapy drug.', 'armGroupLabels': ['TAS-102 and TMZ'], 'otherNames': ['TMZ']}, {'type': 'DRUG', 'name': 'Filgrastim', 'description': 'Filgrastim provides growth factor support in multiple doses. It stimulates bone marrow to create neutrophils for patients undergoing chemotherapy.', 'armGroupLabels': ['TAS-102 and TMZ']}, {'type': 'DRUG', 'name': 'Pegfilgrastim', 'description': 'Pegfilgrastim provides growth factor support in a single dose. It stimulates bone marrow to create neutrophils for patients undergoing chemotherapy.', 'armGroupLabels': ['TAS-102 and TMZ']}] | PrimaryOutcomes: [{'measure': 'Part 1: Maximum Tolerated Dose (MTD) of TAS-102', 'description': 'Investigate the safety and determine the MTD of TAS-102 administered in combination with TMZ in patients with advanced NETs. Treatments will continue to disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST).', 'timeFrame': 'Up to 2 years'}, {'measure': 'Part 2: Overall Response Rate', 'description': 'Response rate defined as the percentage of subjects with a confirmed complete response (CR) or partial response (PR), assessed as per RECIST criteria. Assessments performed using RECIST criteria.', 'timeFrame': 'Up to 5 years'}] | SecondaryOutcomes: [{'measure': 'Part 2: Progression Free Survival (PFS)', 'description': 'Defined as the time from the start of treatment to the date of first documented progression or any cause of death during the study, assessed according to RECIST. Analyzed using the Kaplan-Meier method.', 'timeFrame': 'Up to 5 years'}, {'measure': 'Part 2: Overall Survival', 'description': 'Defined as the time from the start of treatment to the date of expiration. Analyzed using the Kaplan-Meier method.', 'timeFrame': 'Up to 5 years'}, {'measure': 'Part 2: Disease Control Rate', 'description': 'Defined as the percentage of patients who achieved complete response, partial response, and stable disease by investigator assessment as per RECIST.', 'timeFrame': 'Up to 5 years'}, {'measure': 'Part 2: Duration of Response', 'description': 'Analyzed using the Kaplan-Meier method.', 'timeFrame': 'Up to 5 years'}, {'measure': 'Part 2: Safety and Tolerability, Assessed per RECIST Criteria', 'description': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0', 'timeFrame': 'Up to 5 years'}, {'measure': 'Part 2: Biochemical Response defined as normalization or >50% reduction in levels of Chromogranin A', 'description': 'A major biochemical response will be defined as normalization or \\>50% reduction in levels of Chromogranin A. Chromogranin A is elevated in up to 60% of functioning and nonfunctioning pancreatic endocrine tumors.', 'timeFrame': 'Up to 5 years'}] |
Title: An Intensive QT/QTc Study to Investigate the Effects of SGN-35 (Brentuximab Vedotin) on Cardiac Ventricular Repolarization in Patients With CD30-Positive Malignancies | Condition: Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin | Keywords: Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD30, Disease, Hodgkin, Drug Therapy, Hematologic Diseases, Immunotherapy, Lymphoma, monomethylauristatin E, Lymphoma, Large-Cell, Anaplastic | Summary: | Description: N/A | ArmGroups: [{'label': '1', 'type': 'EXPERIMENTAL', 'description': 'brentuximab vedotin', 'interventionNames': ['Drug: brentuximab vedotin']}] | Interventions:[{'type': 'DRUG', 'name': 'brentuximab vedotin', 'description': '1.8 mg/kg IV every 21 days', 'armGroupLabels': ['1'], 'otherNames': ['SGN-35']}] | PrimaryOutcomes: [{'measure': 'QTc interval', 'timeFrame': '2-4 days postdose'}] | SecondaryOutcomes: [{'measure': 'ECG parameters', 'timeFrame': '2-4 days postdose'}, {'measure': 'Blood MMAE levels', 'timeFrame': 'Through 4 days postdose'}, {'measure': 'Incidence of proarrhythmic adverse events', 'timeFrame': 'Through 1 month following last dose'}, {'measure': 'Incidence of adverse events and laboratory abnormalities', 'timeFrame': 'Through 1 month following last dose'}] |
Title: Multi-tracer PET Assessment of Response in Various Malignancies in Investigational and Recently Approved Therapeutic Agents | Condition: Malignant Neoplasm | Keywords: | Summary: | Description: PRIMARY OBJECTIVES:
I. Provide a reliable and validated cadre of positron emission tomography (PET) imaging derived biomarkers that yield a better understanding of: 1) early clinical benefit from various therapeutic agents in investigational and recently approved therapies; 2) efficacy during novel therapeutics in investigational therapeutics and recently approved therapeutics at Huntsman Cancer Institute (HCI); and 3) possible predict prognosis or other long-term outcomes.
II. Reveal a more detailed understanding of: (1) the in vivo biologic mechanisms of various therapeutic drugs in investigational therapies and recently approved therapies at HCI (2) information on why particular functional imaging profiles are seen in treated patients.
III. Reveal a more detailed understanding of how the combination of molecular imaging derived biomarkers will be potentially useful to physicians for decision making and for explanation of efficacy or outcomes for patients with cancer.
IV. Implement and evaluate a new imaging technology for multi-tracer PET imaging of these tracers.
OUTLINE:
Patients undergo PET scans with fludeoxyglucose (FDG) F 18 (18FDG), fluorine F 18 fluorothymidine (FLT), and water (H2O) O-15 (15O) tracers at baseline and within 7 days of completion of 1 or 2 (if the course is less than 3 weeks) therapeutic agent courses. | ArmGroups: [{'label': 'Diagnostic (multi-tracer PET scans)', 'type': 'EXPERIMENTAL', 'description': 'Patients undergo Positron Emission Tomography (PET) scans with \\[F-18\\]fluorodeoxyglucose and \\[F-18\\]fluorothymidine at baseline and within 7 days of completion of 1 or 2 (if the course is less than 3 weeks) therapeutic agent courses.', 'interventionNames': ['Radiation: [F-18]fluorodeoxyglucose', 'Radiation: [F-18]fluorothymidine', 'Procedure: Positron Emission Tomography', 'Radiation: Water O-15']}] | Interventions:[{'type': 'RADIATION', 'name': '[F-18]fluorodeoxyglucose', 'description': 'Undergo PET scans with \\[F-18\\]fluorodeoxyglucose', 'armGroupLabels': ['Diagnostic (multi-tracer PET scans)'], 'otherNames': ['18FDG', 'FDG', 'fludeoxyglucose F 18', 'Fludeoxyglucose F-18', 'Fludeoxyglucose F18', 'Fluorine-18 2-Fluoro-2-deoxy-D-Glucose', 'Fluorodeoxyglucose F18']}, {'type': 'RADIATION', 'name': '[F-18]fluorothymidine', 'description': 'Undergo PET scans with fluorine \\[F-18\\]fluorothymidine', 'armGroupLabels': ['Diagnostic (multi-tracer PET scans)'], 'otherNames': ['18F-FLT', "3'-Deoxy-3'-(18F) Fluorothymidine", "3'-deoxy-3'-[18F]fluorothymidine", 'ALOVUDINE F-18', 'fluorothymidine F 18', 'FLT', 'Fluorothymidine F-18']}, {'type': 'PROCEDURE', 'name': 'Positron Emission Tomography', 'description': 'Undergo PET scans with 3 radiotracers (fludeoxyglucose F 18, fluorine F 18 fluorothymidine, and water O-15)', 'armGroupLabels': ['Diagnostic (multi-tracer PET scans)'], 'otherNames': ['Medical Imaging, Positron Emission Tomography', 'PET', 'PET Scan', 'Positron Emission Tomography Scan', 'Positron-Emission Tomography', 'proton magnetic resonance spectroscopic imaging']}, {'type': 'RADIATION', 'name': 'Water O-15', 'description': 'Undergo PET scans with water O-15 tracers', 'armGroupLabels': ['Diagnostic (multi-tracer PET scans)'], 'otherNames': ['[15O] Water', '[15O]-H2O']}] | PrimaryOutcomes: [{'measure': 'FDG Therapeutic Response', 'description': 'The patients underwent baseline and repeat PET/CT imaging (after one to two cycles of treatment) with \\[F-18\\]fluorodeoxyglucose (FDG) and \\[F-18\\]fluorothymidine (FLT). The percent change in the SUVmax for FDG was calculated and used to determine the response. Partial response (PR) was defined as 35% or greater reduction in SUVmax, Progressive Disease (PD) was defined as 35% or greater increase in SUVmax, and Stable Disease (SD) was defined as all other changes in SUVmax.', 'timeFrame': '1-2 cycles of treatment - approximately one month'}, {'measure': 'FLT Therapeutic Response', 'description': 'The patients underwent baseline and repeat PET/CT imaging (after one to two cycles of treatment) with \\[F-18\\]fluorodeoxyglucose (FDG) and \\[F-18\\]fluorothymidine (FLT). The percent change in the SUVmax for FLT was calculated and used to determine the response. Partial response (PR) was defined as 35% or greater reduction in SUVmax, Progressive Disease (PD) was defined as 35% or greater increase in SUVmax, and Stable Disease (SD) was defined as all other changes in SUVmax.', 'timeFrame': '1-2 cycles of treatment - approximately one month'}, {'measure': 'Standard Therapeutic Response', 'description': "The patients underwent baseline and repeat PET/CT imaging (after one to two cycles of treatment) with \\[F-18\\]fluorodeoxyglucose (FDG) and \\[F-18\\]fluorothymidine (FLT). Percent change in lesion measurements according to standard response criteria for the patient's tumor type were obtained. For brain tumors, Response Assessment in Neuro-Oncology (RANO) criteria were used. Partial Response (PR) was defined as 50% or greater reduction in lesion measurements, Progressive Disease (PD) was 25% or greater increase in measurements, and Stable Disease (SD) was neither PD or PR. Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria were used for solid tumors, with PR defined as 30% or greater reduction in measurements, PD was 20% or greater increase in measurements, and SD was all other changes.", 'timeFrame': '1-2 cycles of treatment - approximately one month'}] | SecondaryOutcomes: N/A |
Title: A Phase II Study Investigating CHFR Methylation Status As A Biomarker For Taxane Sensitivity Using Modified Docetaxel, Cisplatin and 5 Fluorouracil In Patients With Metastatic Esophageal, Gastroesophageal And Gastric Cancer. | Condition: Metastatic Esophageal Cancer, Gastroesophageal Cancer, Gastric Cancer | Keywords: | Summary: | Description: To estimate and compare the response rates in patients treated with mDCF based on methylation status of CHFR. The overall response rates in the un-methylated and methylated patient groups will be reported with a exact 95% binomial confidence interval. A chi-square test will be used for comparison. | ArmGroups: [{'label': 'Metastatic Esophageal, Gastroesophageal & Gastric Cancer', 'type': 'EXPERIMENTAL', 'description': 'Participants receive Modified Docetaxel 40mg/m2, Leucovorin 400mg/m2 and Fluorouracil 400mg/m2 on day 1, Fluorouracil 1000mg/m2 per day on days 1 and 2 and Cisplatin 40mg/m2 (or Carboplatin) on day 3 in Patients With Metastatic Esophageal, Gastroesophageal And Gastric Cancer.', 'interventionNames': ['Drug: Docetaxel', 'Drug: Leucovorin', 'Drug: Fluorouracil', 'Drug: Cisplatin']}] | Interventions:[{'type': 'DRUG', 'name': 'Docetaxel', 'description': 'Modified Docetaxel 40mg/m2 on Day 1', 'armGroupLabels': ['Metastatic Esophageal, Gastroesophageal & Gastric Cancer'], 'otherNames': ['Modified DCF']}, {'type': 'DRUG', 'name': 'Leucovorin', 'description': 'Leucovorin 400mg/m2 on Day 1', 'armGroupLabels': ['Metastatic Esophageal, Gastroesophageal & Gastric Cancer']}, {'type': 'DRUG', 'name': 'Fluorouracil', 'description': 'Fluorouracil 400mg/m2 on Day 1 Fluorouracil 1000mg/m2/day on Days 1 and 2', 'armGroupLabels': ['Metastatic Esophageal, Gastroesophageal & Gastric Cancer'], 'otherNames': ['FU']}, {'type': 'DRUG', 'name': 'Cisplatin', 'description': 'Cisplatin (or Carboplatin) 40mg/m2 on Day 3', 'armGroupLabels': ['Metastatic Esophageal, Gastroesophageal & Gastric Cancer'], 'otherNames': ['Carboplatin']}] | PrimaryOutcomes: [{'measure': 'Response', 'description': 'Number of participants treated with mDCF with progressive disease (PD), stable disease (SD), partial response (PR), non-complete response and non-progressive disease (non-CR/non-PD), and partial response with progressive disease clinically (PR/PD) as defined by RECIST criteria. Response is compared based on CHFR-methylation status.', 'timeFrame': '4 months'}] | SecondaryOutcomes: [{'measure': 'CHFR Methylation Status', 'description': 'Number of participants with advanced esophagogastric cancer that are CHFR-methylated or unmethylated at baseline.', 'timeFrame': 'Baseline'}, {'measure': 'Overall Survival', 'description': 'Number of participants alive at 2 years.', 'timeFrame': '2 Years'}] |
Title: Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy for the Treatment of Liver Metastases and Primary Liver Tumors | Condition: Liver Metastases, Hepatocellular Carcinoma, Intrahepatic Cholangiocarcinoma | Keywords: liver metastases, stereotactic radiotherapy | Summary: | Description: This study is a single site, non-randomized, prospective, phase IV trial.
Composed of 4 patient groups:
1. Oligometastases (1-3) with aggregate tumor diameter \< 6 cm
2. Metastases from neuroendocrine tumors with functional endocrine syndromes
3. Unresectable hepatocellular carcinoma (HCC)
4. Unresectable intrahepatic cholangiocarcinoma (IHCC) Data collected will include patient demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose received by adjacent critical normal tissues, tumor recurrence data, and acute and late toxicities. Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years. | ArmGroups: [{'label': 'liver metastases', 'type': 'OTHER', 'description': 'Oligometastases (1-3) with aggregate tumor diameter \\< 6 cm Metastases from neuroendocrine tumors with functional endocrine syndromes', 'interventionNames': ['Radiation: Stereotactic body radiosurgery']}, {'label': 'Primary Liver Tumors', 'type': 'OTHER', 'description': 'Hepatocellular Carcinoma Intrahepatic Cholangiocarcinoma', 'interventionNames': ['Radiation: Stereotactic Body Radiotherapy']}] | Interventions:[{'type': 'RADIATION', 'name': 'Stereotactic body radiosurgery', 'description': '36-60 Gy / 3 fractions (12-20 Gy per fraction) OR 45-50 Gy / 5 fractions (9-10 Gy per fraction)', 'armGroupLabels': ['liver metastases']}, {'type': 'RADIATION', 'name': 'Stereotactic Body Radiotherapy', 'description': '26-30 Gy / 1 fraction OR 36-45 Gy / 3 fractions (12-15 Gy per fraction) OR 40-50 Gy / 5 fractions (8-10 Gy per fraction)', 'armGroupLabels': ['Primary Liver Tumors']}] | PrimaryOutcomes: [{'measure': 'Local Tumor Recurrence Rate', 'description': 'Primary endpoint will be local tumor recurrence rate. Local recurrence is defined as tumor recurrence within the planning target volume.', 'timeFrame': '5 years'}] | SecondaryOutcomes: [{'measure': 'Late Complication Rates', 'description': 'Toxicities will be assessed using CTCAE grading criteria at specified timepoints.', 'timeFrame': '5 years'}] |
Title: Phase III Study in the Conservative Management of Breast Carcinoma by Tumorectomy and Radiotherapy: Assessment of the Role of a Booster Dose of Radiotherapy (Joint Study of the European Organisation for Research and Treatment of Cancer Radiotherapy Cooperative Group and Breast Cancer Cooperative Group) | Condition: Breast Cancer | Keywords: Boost versus no boost irradiation of early breast cancer | Summary: | Description: This is a randomized study. Patients are stratified by participating institution, menopausal status, clinical tumor size, nodal status, presence of Ductal Carcinoma In Situ, age, and resection margin status.
The objective of this trial is to assess the local recurrence rate and the cosmetic result in women who have had conservative resection of small breast cancers and who are randomly assigned after postoperative whole-breast irradiation to no boost vs. 15-16 Gy boost (patients with microscopically complete resections) or 10 Gy vs. 25-26 Gy boost (patients with microscopically incomplete resections).
Following tumorectomy, all patients receive radiotherapy for 5 weeks.
Patients with microscopically negative resection margins are randomized to one of 2 groups: no further radiotherapy; or a radiotherapy boost with either external-beam radiotherapy or an interstitial implant.
Patients with microscopically positive resection margins are also randomized to receive either lower dose or higher dose radiotherapy boosts by external beam or interstitial implant.
Patients with positive lymph nodes are encouraged to receive at least 6 courses of adjuvant or perioperative chemotherapy prior to radiotherapy provided radiotherapy is initiated within 6 months of surgery. All other patients begin radiotherapy within 9 weeks of surgery. All postmenopausal women with positive lymph nodes receive oral tamoxifen daily for 2 years. | ArmGroups: [{'label': 'Boost irradiation', 'type': 'EXPERIMENTAL', 'interventionNames': ['Radiation: Boost irradiation']}, {'label': 'No boost irradiation', 'type': 'NO_INTERVENTION'}] | Interventions:[{'type': 'RADIATION', 'name': 'Boost irradiation', 'armGroupLabels': ['Boost irradiation']}] | PrimaryOutcomes: [{'measure': 'Time to local recurrence', 'timeFrame': '25 years from first patient in'}] | SecondaryOutcomes: N/A |
Title: An Exploratory, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Anti-minor Histocompatibility Complex (MiHA) Donor T-lymphocytes Expanded ex Vivo, in Patients With a Hematologic Malignancy, With Molecular or Clinical Relapse After Hematopoietic Stem Cell Transplantation From a Matched Donor | Condition: Hematologic Cancer, Relapse Leukemia, Relapsed Adult ALL, Relapsed Adult AML, Relapsed CLL, Relapsed Non Hodgkin Lymphoma, Relapsed Hodgkin's Lymphoma, Relapsed Myelodysplastic Syndromes, Relapsed Multiple Myeloma | Keywords: allogeneic hematopoietic stem cell transplantation, relapsed hematopoietic malignancy, HLA matched donor, minor histocompatibilty antigen (MiHA) | Summary: | Description: The GLIDE-201/44 trial primarily aims to test the safety of anti-MiHA T cell line in patients suffering from an hematologic malignancy that has relapsed following hematopoietic stem cell transplantation from a matched donor. The anti-MiHA T cell lines are derived from the matched donor for the patient, the original donor for a given patient. Both the patient and the matched donor will undergo screening to determine the expression of targetable MiHAs. Upon identification of the target MiHAs, donor cells will be collected through apheresis and primed against the selected MiHA. In this setting, the GLIDE 201/44 product will be cryopreserved, thawed and administered as a single infusion at a target dose of 4x10E+07 viable T cells/m2 (range of dose is 0.4 4x10E+07 viable T cells/m2). A second infusion can be offered to the patients after an observation period of 42 days upon clinical evaluation by the treating physician. In the absence of secondary adverse events following the initial infusion, a second infusion of the GLIDE 201/44 product could be administered at a dose level up to 3-5 fold the original dose. | ArmGroups: [{'label': 'GLIDE', 'type': 'EXPERIMENTAL', 'description': 'GLIDE single infusion at a target dose of 4x107 viable T-cells/m2', 'interventionNames': ['Biological: GLIDE']}] | Interventions:[{'type': 'BIOLOGICAL', 'name': 'GLIDE', 'description': 'Gudide Lymphocyte by Immunopeptide Derived Expansion (GLIDE) is an anti- Minor histocompatibility (MiHA) cell line', 'armGroupLabels': ['GLIDE']}] | PrimaryOutcomes: [{'measure': 'Non-hematologic toxicity related to GLIDE post injection', 'description': 'No death or other toxic events directly related to GLIDE injection', 'timeFrame': '6 months'}] | SecondaryOutcomes: [{'measure': 'Response of hematologic malignancy (acute leukemia (ALL, AML, biphenotypic), CLL, HL, NHL, MM or MDS) post-injection', 'description': 'Disease progression following GLIDE injection', 'timeFrame': 'up to 12 months'}, {'measure': 'Incidence and severity of acute and chronic graft versus host disease (GvHD)', 'description': 'Progression (if any) or induction of GvHD', 'timeFrame': 'up to 12 months'}, {'measure': 'Persistence of GLIDE in the host and homing to peripheral blood, bone marrow and other tissues', 'description': 'Monitoring of GLIDE product persistence in host', 'timeFrame': 'up to 12 months'}, {'measure': 'Non-Relapse mortality (NRM)', 'description': 'Time to deaths without relapse/recurrence', 'timeFrame': 'up to 12 months'}, {'measure': 'Relapse-incidence (RI)', 'description': 'Time to relapse', 'timeFrame': 'up to 12 months'}, {'measure': 'Overall survival (OS)', 'description': 'Time to death, irrespective of the cause', 'timeFrame': 'up to 12 months'}, {'measure': 'Progression-free survival (PFS)', 'description': 'It is time to any of the following: OS, RI, NRM, Time to relapse, Relapse free survival', 'timeFrame': 'up to 12 months'}] |
Title: A Pragmatic Randomized Study to Evaluate the Comparative Effectiveness of AKYNZEO® and Standard of Care (Including EMEND®) for the Prevention of Nausea and Vomiting (CINV) in Cancer Patients Receiving Moderately Emetogenic Chemotherapy in France. | Condition: Oncology | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'AKYNZEO', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Akynzeo']}, {'label': 'Standard of Care', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Drug: Standard of Care']}] | Interventions:[{'type': 'DRUG', 'name': 'Akynzeo', 'description': '1 single oral dose of NEPA (capsule) on Day 1 to be administered approximately 1 hour prior chemotherapy (containing 300 mg netupitant and 0.5 mg palonosetron).\n\n- Dexamethasone 12 mg on Day 1 and 8 mg daily from Day 2 to Day 4', 'armGroupLabels': ['AKYNZEO']}, {'type': 'DRUG', 'name': 'Standard of Care', 'description': '* oral aprepitant 125mg (Day 1) and 80mg daily (on Day 2 and Day 3)\n* IV ondansetron 8 mg on Day 1\n* Dexamethasone 12 mg on Day 1 and 8 mg daily from Day 2 to Day 4', 'armGroupLabels': ['Standard of Care']}] | PrimaryOutcomes: [{'measure': 'Anti-emetic response', 'description': 'Complete Response (no emetic episodes and no rescue medication) during overall phase for 1st cycle among patients with MEC non AC or AC chemotherapy regimen', 'timeFrame': '1 cycle (cycle length is 28 days). Primary outcome will be assessed at the end of the chemotherapy cycle.'}] | SecondaryOutcomes: N/A |
Title: Early Recognition and Optimal Treatment of Delirium in Patients With Advanced Cancer | Condition: Delirium, Advanced Cancer | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'Olanzapine', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Olanzapine']}, {'label': 'Haloperidol', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Drug: Haloperidol']}] | Interventions:[{'type': 'DRUG', 'name': 'Olanzapine', 'description': 'After randomisation to olanzapine treatment, olanzapine will be started at an initial dose of 2,5 - 5 mg orally or intramuscularly, after 2 hours subsequent titration of dosage will be based on clinical judgement with a maximum of 20 mg per 24 hours divided over a maximum of 3 gifts. Sustenance dose will consist of half of the total titrated dose per 24 hours in one gift.', 'armGroupLabels': ['Olanzapine'], 'otherNames': ['Zyprexa']}, {'type': 'DRUG', 'name': 'Haloperidol', 'description': 'After randomisation to haloperidol treatment, haloperidol dosing will be titrated, with repeated dosing of 0,5 - 2mg orally or subcutaneously every 40 minutes until signs of delirium diminish, with a maximum of 20 mg orally or 10 mg subcutaneously per 24 hours. Sustenance dose will consist of half of the total titrated dose per 24 hours in one or two gifts.', 'armGroupLabels': ['Haloperidol'], 'otherNames': ['Haldol']}] | PrimaryOutcomes: [{'measure': 'DRS-R-98 severity rating score', 'description': 'Primary endpoint for this trial is a DRS-R-98 severity rating score \\<15,25, as this is a measure for establishing clearance of delirium.', 'timeFrame': 'Until clearance of the delirium signs or for a maximum of 2 weeks'}] | SecondaryOutcomes: [{'measure': 'Delirium resolution rate', 'description': 'Secondary endpoint is the amount of time elapsed between start of treatment and diminishing of the signs of delirium (DOS \\<3, DSR-R-98 \\<15,25).', 'timeFrame': 'Until clearance of the delirium signs or for a maximum of 2 weeks'}] |
Title: Non-Small-Cell Lung Cancer Patients Treated With Erlotinib Six Months or Longer: Demographics, Treatment and Outcome Characteristics of Patient Cases in a Community-Based Setting | Condition: Non Small Cell Lung Cancer | Keywords: NSLCL, Erlotinib, Tarceva | Summary: | Description: N/A | ArmGroups: [{'label': 'Cohort A', 'description': 'EGFR Wild Type patients'}, {'label': 'Cohort B', 'description': 'EGFR mutation patients'}] | Interventions:N/A | PrimaryOutcomes: [{'measure': 'demographics', 'description': 'To describe patient demographic characteristics of patients with erlotinib (single-agent) treatment duration of six months or longer, including patients who are EGFR-wt. Demographic characteristics include age, race,ethnicity, date of initial diagnosis, age at initial diagnosis, location of biopsy at diagnosis, extent of disease with description and location of metastatic sites, histology,and smoking history.', 'timeFrame': '24 months'}, {'measure': 'treatment characteristics', 'description': 'To describe patient treatment and characteristics of patients with erlotinib (single-agent) treatment duration of six months or longer, including patients who are EGFR-wt. Including number and kind of prior therapies, disease stage at initial diagnosis, sites of metastasis at time of erlotinib treatment, prior surgery, and radiation.', 'timeFrame': '24 months'}, {'measure': 'outcome characteristics', 'description': 'To describe patient outcome characteristics of patients with erlotinib (single-agent) treatment duration of six months or longer, including patients who are EGFR-wt including the reason for discontinuing erlotinib treatment, best response to erlotinib treatment and did patient receive any dose modifications while receiving erlotinib treatment.', 'timeFrame': '24 months'}] | SecondaryOutcomes: [{'measure': 'Biomarker characteristics', 'description': 'To explore biomarker (BM) characteristics of EGFR-wt erlotinib responders.', 'timeFrame': '24 months'}, {'measure': 'Exploratory genetic analysis', 'description': 'Biopsy specimens from enrolled patient cases who are EGFR-wt will be evaluated via exploratory genetic analysis for correlated biomarkers.', 'timeFrame': '24 months'}] |
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