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Title: A Retrospective Clinical Study of Stereotactic Body Radiotherapy Combined With PD-1 Blockers for Locally Advanced or Locally Recurrent Pancreatic Carcinoma. | Condition: Stereotactic Body Radiotherapy, PD-1 Inhibitors, Pancreatic Cancer | Keywords: | Summary: | Description: The goal of this observational study is to investigate the efficacy and safety of stereotactic body radiotherapy (SBRT) combined with PD-1 blockers for LAPC and LRPC. The patients, diagnosed with locally advanced pancreatic cancer (LAPC) or locally recurrent pancreatic cancer (LRPC). LRPC or LAPC, undergoing SBRT and PD-1 blockers in our hospital from December 2020 to April 2023 were reviewed consecutively. The schedule of SBRT is 25 to 50 Gy in 5 fractions and the PD-1 blockers are monoclonal antibodies targeted to PD-1 molecules on the T lymphocytes.
All patients provided written informed consent before treatment. The study was conducted in accordance with the Declaration of Helsinki, and it was approved by the Institutional Ethics Committee of Peking University Third Hospital. | ArmGroups: [{'label': 'SBRT+PD-1 blockers', 'description': 'pembrolizumab (200 mg every 3 weeks), carelizumab (200 mg every 3 weeks), tislelizumab (200 mg every 3 weeks), sintilimab (200 mg every 3 weeks), zimberelimab (240 mg every 3 weeks) until the tumor progressed or the side effects became intolerable.', 'interventionNames': ['Radiation: Stereotactic body radiotherapy (SBRT)', 'Drug: PD-1 blocking antibody']}] | Interventions:[{'type': 'RADIATION', 'name': 'Stereotactic body radiotherapy (SBRT)', 'description': 'All the patients first received SBRT with the dose of 25Gy up to 50Gy in five fractions.', 'armGroupLabels': ['SBRT+PD-1 blockers']}, {'type': 'DRUG', 'name': 'PD-1 blocking antibody', 'description': 'All the patients first received SBRT with the dose of 25Gy up to 50Gy in five fractions and then received the treatment of PD-1 blockers including pembrolizumab (200 mg every 3 weeks), carelizumab (200 mg every 3 weeks), tislelizumab (200 mg every 3 weeks), sintilimab (200 mg every 3 weeks), zimberelimab (240 mg every 3 weeks) until the tumor progressed or the side effects became intolerable.', 'armGroupLabels': ['SBRT+PD-1 blockers']}] | PrimaryOutcomes: [{'measure': 'progression-free survival (PFS)', 'description': 'PFS was defined as the time from SBRT to disease progression', 'timeFrame': '12 months'}] | SecondaryOutcomes: [{'measure': 'local progression-free survival (LPFS)', 'description': 'LPFS was defined as the time from SBRT to local progression.', 'timeFrame': '12 months'}, {'measure': 'Overall survival (OS)', 'description': 'OS was defined as the time from SBRT to death from any cause.', 'timeFrame': '18 months'}, {'measure': 'Adverse Events (AEs)', 'description': 'All kinds of side effects.', 'timeFrame': '18 months'}, {'measure': 'Pain relief rate (PRR）', 'description': 'The numeric rating scale (NRS) was used to evaluate the pain levels before and after treatment and the pain relief rate was calculated from the patients achieving pain The numeric rating scale (NRS) was used to evaluate the pain levels before and after treatment and the pain relief rate was calculated from the patients achieving pain The numeric rating scale (NRS) was used to evaluate the pain levels before and after treatment and the pain relief rate was calculated from the patients achieving pain relief after SBRT.', 'timeFrame': '18 months'}] |
Title: A Phase II Study of the Recombinant Human Monoclonal Anti-Vascular Endothelial Growth Factor Antibody (rhuMAB VEGF) Bevacizumab (NSC #704865, IND # 7,921) Administered in Times Sequential Combination With Cytosine Arabinoside (Ara-C) and Mitoxantrone for Adults With Refractory and Relapsed Acute Myelogenous Leukemias (AMLs) | Condition: Leukemia, Myelodysplastic Syndromes | Keywords: recurrent adult acute myeloid leukemia, relapsing chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, chronic myelomonocytic leukemia, secondary acute myeloid leukemia, previously treated myelodysplastic syndromes, childhood myelodysplastic syndromes | Summary: | Description: OBJECTIVES:
* Determine the clinical effectiveness of bevacizumab, cytarabine, and mitoxantrone in patients with poor-risk hematologic malignancies.
* Determine the toxic effects of this regimen in these patients.
* Determine whether this regimen can induce cell apoptosis in these patients.
* Determine the effects of bevacizumab on coagulation profiles in these patients.
OUTLINE: This is a multicenter study.
Patients receive cytarabine IV continuously over 72 hours on days 1-3, mitoxantrone IV over 30-60 minutes on day 4, and bevacizumab IV over 90 minutes on day 8 in the absence of disease progression or unacceptable toxicity. Patients achieving partial or complete remission may receive a second course of therapy beginning approximately 30 days after the completion of the first course.
Patients are followed until death.
PROJECTED ACCRUAL: A total of 12-45 patients will be accrued for this study within 1-3 years. | ArmGroups: N/A | Interventions:[{'type': 'BIOLOGICAL', 'name': 'bevacizumab'}, {'type': 'DRUG', 'name': 'cytarabine'}, {'type': 'DRUG', 'name': 'mitoxantrone hydrochloride'}] | PrimaryOutcomes: N/A | SecondaryOutcomes: N/A |
Title: Nivolumab in the Treatment of Patients With Non-small Cell Lung Cancer: The Australian Experience | Condition: Non-Small Cell Lung Cancer | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'Patients taking nivolumab', 'interventionNames': ['Other: Non-Interventional']}] | Interventions:[{'type': 'OTHER', 'name': 'Non-Interventional', 'description': 'Non-Interventional', 'armGroupLabels': ['Patients taking nivolumab']}] | PrimaryOutcomes: [{'measure': 'Time to treatment failure (TTF)', 'timeFrame': 'Approximately 27 months'}] | SecondaryOutcomes: [{'measure': 'Best overall response (BOR)', 'timeFrame': 'Approximately 27 months'}, {'measure': 'Progression free survival rate (PFSR)', 'timeFrame': 'Approximately 27 months'}, {'measure': 'Overall survival rate (OSR)', 'timeFrame': 'Approximately 27 months'}, {'measure': "Incidence of AE's", 'timeFrame': 'Approximately 27 months'}, {'measure': "Incidence of SAE's", 'timeFrame': 'Approximately 27 months'}, {'measure': 'Reasons for ceasing treatment', 'description': 'Any of the following: progressive disease, toxicity, patient wishes/preference, doctor decision, death', 'timeFrame': 'Approximately 27 months'}, {'measure': 'Incidence of patients with brain metastases', 'timeFrame': 'Approximately 27 months'}, {'measure': 'Incidence of re-treatment', 'timeFrame': 'Approximately 27 months'}] |
Title: GU-216: A Pilot Study of Circulating Tumor DNA Adaptive Risk Maintenance Approach for Bladder Cancer (CARMA) | Condition: Metastatic Urothelial Carcinoma | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'Maintenance Therapy 200mg Pembrolizumab', 'type': 'OTHER', 'description': 'Participants who have radiographical or ctDNA progression after 3-6 cycles of standard-of-care platinum-based chemotherapy will be offered 200mg Pembrolizumab every six weeks via IV infusion.', 'interventionNames': ['Drug: Pembrolizumab (200mg)']}, {'label': 'Maintenance Therapy 400mg Pembrolizumab', 'type': 'OTHER', 'description': 'Participants who have radiographical or ctDNA progression after 3-6 cycles of standard-of-care platinum-based chemotherapy will be offered 400mg Pembrolizumab every six weeks via IV infusion..', 'interventionNames': ['Drug: Pembrolizumab (400mg)']}, {'label': 'Active Surveillance', 'type': 'OTHER', 'description': 'Participants who are deemed ctDNA responders (reduction in ctDNA by 50% or more) on post-chemo testing will undergo active surveillance and continued serial ctDNA testing at regular intervals as defined by the study protocol. Patients will also undergo surveillance imaging as defined in the study protocol. At the time of first radiographic or ctDNA progression (to be assessed every 12 weeks in conjunction with radiographic assessment), the patient will be offered treatment with pembrolizumab.', 'interventionNames': ['Diagnostic Test: Monitoring']}] | Interventions:[{'type': 'DRUG', 'name': 'Pembrolizumab (200mg)', 'description': '200mg Pembrolizumab every six weeks via IV infusion.', 'armGroupLabels': ['Maintenance Therapy 200mg Pembrolizumab']}, {'type': 'DRUG', 'name': 'Pembrolizumab (400mg)', 'description': '400mg Pembrolizumab every six weeks via IV infusion.', 'armGroupLabels': ['Maintenance Therapy 400mg Pembrolizumab']}, {'type': 'DIAGNOSTIC_TEST', 'name': 'Monitoring', 'description': 'active surveillance and monitoring via continued serial ctDNA testing and radiographic assessments at regular intervals.', 'armGroupLabels': ['Active Surveillance']}] | PrimaryOutcomes: [{'measure': 'Proportion of patients who are progression-free by RECIST 1.1 and alive at six months from initiation of active surveillance.', 'timeFrame': '6 months'}] | SecondaryOutcomes: [{'measure': 'Overall survival from initial assignment to active surveillance or maintenance arms defined as time to death (or last known alive)', 'timeFrame': 'Up to participant death'}, {'measure': 'Progression-free survival, from initial assignment to maintenance arm defined by RECIST 1.1 or death from any cause.', 'timeFrame': '2 years'}] |
Title: Perfusion CT Imaging in Patients With Lung Malignancies Receiving Stereotactic Body Radiation Therapy (SBRT) | Condition: Lung Cancer | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'open label', 'type': 'OTHER', 'description': 'Perfusion CT Imaging', 'interventionNames': ['Device: Perfusion CT Imaging']}] | Interventions:[{'type': 'DEVICE', 'name': 'Perfusion CT Imaging', 'armGroupLabels': ['open label']}] | PrimaryOutcomes: [{'measure': 'Imaging of during and after SBRT treatment for lung malignancies with a combined perfusion and routine CT to assess therapy response of lung cancer and metastases.', 'timeFrame': '3-6 months'}] | SecondaryOutcomes: N/A |
Title: A Phase II Study of Thalidomide and Cyclophosphamide in Patients With Recurrent or Refractory Malignancies | Condition: Unspecified Childhood Solid Tumor, Protocol Specific | Keywords: unspecified childhood solid tumor, protocol specific | Summary: | Description: OBJECTIVES: I. Determine the efficacy and toxic effects of thalidomide and cyclophosphamide in patients with recurrent or refractory pediatric malignancies.
OUTLINE: Patients receive oral thalidomide 4 times daily. Cyclophosphamide is administered IV over 1 hour once every 4 weeks, beginning on the same day as thalidomide. Treatment continues in the absence of unacceptable toxicity or disease progression. Tumor response is assessed every 3 months.
PROJECTED ACCRUAL: A total of 45-80 patients will be accrued for this study within 2 years. | ArmGroups: N/A | Interventions:[{'type': 'DRUG', 'name': 'cyclophosphamide'}, {'type': 'DRUG', 'name': 'thalidomide'}] | PrimaryOutcomes: N/A | SecondaryOutcomes: N/A |
Title: Archer 1009:a Randomized, Double Blind Phase 3 Efficacy And Safety Study Of Pf-00299804 (Dacomitinib) Versus Erlotinib For The Treatment Of Advanced Non-small Cell Lung Cancer Following Progression After, Or Intolerance To, At Least One Prior Chemotherapy | Condition: Non-Small Cell Lung Cancer | Keywords: comparative study of PF-00299804 and Erlotinib, Double-Blind Phase 3 trial of TKI | Summary: | Description: N/A | ArmGroups: [{'label': 'A', 'type': 'EXPERIMENTAL', 'description': 'Blinded active PF-00299804 + blinded placebo comparator (erlotinib)', 'interventionNames': ['Drug: Dacomitinib (PF-00299804)', 'Drug: Placebo erlotinib']}, {'label': 'B', 'type': 'ACTIVE_COMPARATOR', 'description': 'Blinded active comparator (erlotinib) + blinded placebo PF-00299804', 'interventionNames': ['Drug: Active Comparator (erlotinib)', 'Drug: Placebo PF00299804']}] | Interventions:[{'type': 'DRUG', 'name': 'Dacomitinib (PF-00299804)', 'description': 'Dacomitinib (PF-00299804) is provided as 45 mg tablets, continuous oral daily dosing', 'armGroupLabels': ['A']}, {'type': 'DRUG', 'name': 'Active Comparator (erlotinib)', 'description': 'Active comparator (erlotinib) provided as 150 mg tablet, continuous oral daily dosing', 'armGroupLabels': ['B']}, {'type': 'DRUG', 'name': 'Placebo erlotinib', 'description': 'placebo erlotinib, provided as 150 mg tablet, continuous oral daily dosing.', 'armGroupLabels': ['A']}, {'type': 'DRUG', 'name': 'Placebo PF00299804', 'description': 'placebo PF-00299804, provide as 45 mg tablet, continuous oral daily dosing', 'armGroupLabels': ['B']}] | PrimaryOutcomes: [{'measure': 'Progression-Free Survival (PFS) Per Independent Radiologic Review.', 'description': 'PFS was defined as the time from randomization to the date of disease progression as by Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 per Independent Radiologic Review or death due to any cause, whichever occurred first. Objective progression was defined as a 20% increase in the sum of the diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions, or the appearance of any new unequivocal malignant lesions.', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy.'}, {'measure': 'Progression-Free Survival (PFS) Per Independent Radiologic Review in KRAS Wild-type (WT) Participants.', 'description': "PFS was defined as the time from randomization to the date of disease progression as by RECIST v1.1 per Independent Radiologic Review or death due to any cause, whichever occurred first. Objective progression was defined as a 20% increase in the sum of the diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions, or the appearance of any new unequivocal malignant lesions. Tumor tissue from participants' original diagnostic biopsies or recently obtained biopsies were analyzed to determine KRAS status.", 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy.'}] | SecondaryOutcomes: [{'measure': 'PFS Based on Investigator Review.', 'description': "PFS was defined as the time from randomization to the date of disease progression as by RECIST v1.1 per Investigator's Review or death due to any cause, whichever occurred first. Objective progression was defined as a 20% increase in the sum of the diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions, or the appearance of any new unequivocal malignant lesions.", 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy.'}, {'measure': 'PFS Based on Investigator Review in KRAS-WT Participants.', 'description': "PFS was defined as the time from randomization to the date of disease progression as by RECIST v1.1 per Investigator's Review or death due to any cause, whichever occurred first. Objective progression was defined as a 20% increase in the sum of the diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions, or the appearance of any new unequivocal malignant lesions. Tumor tissue from participants' original diagnostic biopsies or recently obtained biopsies were analyzed to determine KRAS status.", 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy.'}, {'measure': 'Overall Survival (OS).', 'description': 'OS was defined as the time from randomization to the date of death for any cause. In the absence of confirmation of death, survival time was censored at the last date the patient was known to be alive (ie, at their last known alive date from long term follow-up).', 'timeFrame': 'From date of randomization until the date of death from any cause or last date known to be alive, participants were followed up regardless of the reason for discontinuation from study treatment at intervals of no longer than every 2 months.'}, {'measure': 'OS in KRAS-WT Participants.', 'description': "OS was defined as the time from randomization to the date of death for any cause. In the absence of confirmation of death, survival time was censored at the last date the patient was known to be alive (ie, at their last known alive date from long term follow-up). Tumor tissue from participants' original diagnostic biopsies or recently obtained biopsies were analyzed to determine KRAS status.", 'timeFrame': 'From date of randomization until the date of death from any cause or last date known to be alive, participants were followed up regardless of the reason for discontinuation from study treatment at intervals of no longer than every 2 months.'}, {'measure': 'Best Overall Response (BOR) Per Independent Radiologic Review.', 'description': 'The BOR was the best response per RECIST (version 1.1) criteria as assessed by independent assessment recorded from randomization until disease progression. Per RECIST version 1.1: Complete Response (CR): disappearance of all pre-existing lesions except nodal disease, with all nodal lesions decreased to normal size (short axis\\<10 mm) and no appearance of new unequivocal malignant lesions; Partial Response (PR): \\>=30% decrease from baseline sum of diameters of all target lesions with no unequivocal progression of pre-existing non-target lesions or appearance of new unequivocal malignant lesions; Progressive Disease (PD): \\>=20% increase in the sum of diameters of target lesions above the smallest sum observed, with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions.', 'timeFrame': 'From date of randomization until progression or initiation of new anti-cancer therapy or death. Participants were followed up until progressive disease regardless of start of subsequent cancer therapy.'}, {'measure': 'BOR Per Investigator Review.', 'description': 'The BOR was the best response per RECIST (version 1.1) criteria as assessed by investigator assessment recorded from randomization until disease progression. Per RECIST version 1.1: CR: disappearance of all pre-existing lesions except nodal disease, with all nodal lesions decreased to normal size (short axis\\<10 mm) and no appearance of new unequivocal malignant lesions; PR: \\>=30% decrease from baseline sum of diameters of all target lesions with no unequivocal progression of pre-existing non-target lesions or appearance of new unequivocal malignant lesions; PD: \\>=20% increase in the sum of diameters of target lesions above the smallest sum observed, with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions.', 'timeFrame': 'From date of randomization until progression or initiation of new anti-cancer therapy or death. Participants were followed up until progressive disease regardless of start of subsequent cancer therapy.'}, {'measure': 'Duration of Response (DR) Based on Independent Radiologic Review.', 'description': 'DR was defined as the time from first documentation of response assessed by independent review (CR or PR whichever occurred first) to date of progression or death due to any cause, whichever occurs first. Per RECIST version 1.1: CR: disappearance of all pre-existing lesions except nodal disease, with all nodal lesions decreased to normal size (short axis\\<10 mm) and no appearance of new unequivocal malignant lesions; PR: \\>=30% decrease from baseline sum of diameters of all target lesions with no unequivocal progression of pre-existing non-target lesions or appearance of new unequivocal malignant lesions; PD: \\>=20% increase in the sum of diameters of target lesions above the smallest sum observed, with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions.', 'timeFrame': 'From date of randomization until progression or death due to any cause. Participants were followed up until progressive disease regardless of start of subsequent cancer therapy.'}, {'measure': 'DR Based on Investigator Review.', 'description': 'DR was defined as the time from first documentation of response assessed by investigator review (CR or PR whichever occurred first) to date of progression or death due to any cause, whichever occurs first. Per RECIST version 1.1: CR: disappearance of all pre-existing lesions except nodal disease, with all nodal lesions decreased to normal size (short axis\\<10 mm) and no appearance of new unequivocal malignant lesions; PR: \\>=30% decrease from baseline sum of diameters of all target lesions with no unequivocal progression of pre-existing non-target lesions or appearance of new unequivocal malignant lesions; PD: \\>=20% increase in the sum of diameters of target lesions above the smallest sum observed, with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions.', 'timeFrame': 'From date of randomization until progression or death due to any cause. Participants were followed up until progressive disease regardless of start of subsequent cancer therapy.'}, {'measure': 'Trough Concentrations (Ctrough) of Dacomitinib.', 'description': 'Mean Ctrough values of dacomitinib observed from Cycle 2 through 5, Day 1 for dose compliant participants.', 'timeFrame': 'Baseline up to Cycle 5 Day 1'}, {'measure': 'Trough Concentrations (Ctrough) of PF-05199265.', 'description': 'Mean Ctrough values of PF-05199265 observed from Cycle 2 through 5, Day 1 for dose compliant participants.', 'timeFrame': 'Baseline up to Cycle 5 Day 1'}, {'measure': 'Time to Deterioration (TTD) in Pain, Dyspnea, Fatigue or Cough Patient Reported Disease Symptoms.', 'description': "TTD defined as the time from first dose (baseline) to the first time a patient's score in pain, dyspnea, fatigue or cough from the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-LC13) increased by ≥10 points. A ≥10 point increase in score had to be maintained for ≥2 consecutive cycles for the symptom to be considered deteriorated. Participants were censored at the last time when they completed an assessment for pain, dyspnea, fatigue or cough if they had not deteriorated. A 10 point or higher change in the score is perceived by participants as clinically significant.", 'timeFrame': 'Data taken from Cycle 1 day 1 to the end of treatment or withdrawal.'}, {'measure': 'Mean and Difference in Mean in Functioning and Global Quality of Life (QOL) as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)', 'description': 'EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Scores ranged from 0-100 where a higher score indicated a better level of quality of life. Overall scores present the mean score for that scale from all time-point data.', 'timeFrame': 'Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores.'}, {'measure': 'Mean and Difference in Mean in QLQ-C30 Symptoms as Assessed by the EORTC-QLQ-C30.', 'description': 'EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Scores ranged from 0-100 where a higher score indicated a greater degree of symptoms/problems. Overall scores present the mean score for that scale from all time-point data.', 'timeFrame': 'Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores.'}, {'measure': 'Mean and Difference in Mean in Lung Cancer Symptom Scores as Assessed by the EORTC QLQ- LC13.', 'description': 'The QLQ-LC13 included questions specific to the disease associated symptoms (dyspnea, cough, haemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy, and alopecia), and analgesic use of lung cancer patients. Scores range from 0-100 and a higher score indicates greater degree of symptoms/problems. Overall scores present the mean score for that scale from all time-point data.', 'timeFrame': 'Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores.'}, {'measure': 'Mean and Difference in Mean of the EuroQoL-5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) Score', 'description': 'The EQ-5D is a validated and reliable self-report preference-based measure developed by the EuroQoL Group to assess health-related quality of life. It consists of the EQ-5D descriptive system and a visual analogue scale-the EQ VAS. The EQ-5D descriptive system measures a participants\' health state on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels, reflecting "no health problems," "moderate health problems," and "extreme health problems." The EQ VAS records the respondent\'s self-rated health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).', 'timeFrame': 'Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores.'}] |
Title: A Phase IB /II, Multicenter, Open-Label Study of Safety, Tolerability and Efficacy of SHR-A2102 for Injection With or Without Antitumor Therapy in Subjects With Advanced Solid Tumors | Condition: Advanced Solid Tumors | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'Treatment group A: SHR-A2102 + Adebrelimab injection', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: SHR-A2102 ; Adebrelimab injection']}, {'label': 'Treatment group B: SHR-A2102', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: SHR-A2102']}] | Interventions:[{'type': 'DRUG', 'name': 'SHR-A2102', 'description': 'SHR-A2102', 'armGroupLabels': ['Treatment group B: SHR-A2102']}, {'type': 'DRUG', 'name': 'SHR-A2102 ; Adebrelimab injection', 'description': 'SHR-A2102 + Adebrelimab injection', 'armGroupLabels': ['Treatment group A: SHR-A2102 + Adebrelimab injection']}] | PrimaryOutcomes: [{'measure': 'RP2D', 'timeFrame': 'through phase IB completion, an average of 1 years'}, {'measure': 'Incidence and severity of AE；', 'timeFrame': 'from Day1 to 90 days after last dose'}, {'measure': 'ORR', 'timeFrame': '18 months after the last subject was enrolled in the group'}] | SecondaryOutcomes: [{'measure': 'DCR(Investigator evaluation)', 'timeFrame': '18 months after the last subject was enrolled in the group'}, {'measure': 'DoR(Investigator evaluation)', 'timeFrame': '18 months after the last subject was enrolled in the group'}, {'measure': 'PFS(Investigator evaluation)', 'timeFrame': '18 months after the last subject was enrolled in the group'}, {'measure': 'OS(Investigator evaluation)', 'timeFrame': '18 months after the last subject was enrolled in the group'}, {'measure': 'SHR-A2102 and free toxin PK', 'timeFrame': 'through study completion, an average of 2 years'}, {'measure': 'SHR-1316 PK', 'timeFrame': 'through study completion, an average of 2 years'}, {'measure': 'SHR-A2102 Immunogenicity', 'timeFrame': 'through study completion, an average of 2 years'}, {'measure': 'SHR 1316 Immunogenicity', 'timeFrame': 'through study completion, an average of 2 years'}] |
Title: Evaluation of the Suitability of PD L 506 for Intraoperative Visualisation of Palpable and Nonpalpable Breast Cancer Tissue | Condition: Breast Tumour | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'PD L 506 2nd dose', 'type': 'ACTIVE_COMPARATOR', 'description': 'Different dosage', 'interventionNames': ['Drug: PD L 506']}, {'label': 'PD L 506', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: PD L 506']}] | Interventions:[{'type': 'DRUG', 'name': 'PD L 506', 'description': 'Two different doses will be compared', 'armGroupLabels': ['PD L 506', 'PD L 506 2nd dose']}] | PrimaryOutcomes: [{'measure': 'Fluorescence intensity in breast cancer tissue', 'timeFrame': '3 h after intake of study medication'}] | SecondaryOutcomes: [{'measure': 'Laboratory data and adverse events', 'timeFrame': '14 days'}] |
Title: A Randomized, Controlled, Double-blind, Multicenter Phase III Clinical Study of Envafolimab Plus Platinum-based Doublet Chemotherapy Versus Placebo Plus Platinum-based Doublet Chemotherapy in Patients With Non-small Cell Lung Cancer | Condition: Non-small Cell Lung Cancer | Keywords: Envafolimab | Summary: | Description: A total of approximately 390 participants are planned to be enrolled in this study. After being screened and qualified, the subjects will be randomly assigned to receive Envalfolimab or placebo plus platinum-based doublet chemotherapy in 1:1 ratio for a total of 3-4 cycles of neoadjuvant therapy (determined by the investigator), the feasibility of surgery is evaluated by the investigator within 4-6 weeks after the end of neoadjuvant therapy and surgery will be performed. Envafolimab (experimental group) or placebo (control group) will be administered after surgery. After completion of treatment, subjects will enter a follow-up phase, including safety follow-up, tumor disease follow-up, and survival follow-up.All randomized subjects in this study are required to receive tumor imaging evaluation as scheduled and get continuous safety assessment during the srceening and treatment period. | ArmGroups: [{'label': 'Envalfolimab plus platinum-based doublet chemotherapy', 'type': 'EXPERIMENTAL', 'description': 'Envalfolimab plus platinum-based doublet chemotherapy for a total of 3-4 cycles of neoadjuvant therapy (determined by the investigator), Envafolimab will be administered after surgery at 600 mg every 3 weeks(Q3W) for 16 cycles at most.', 'interventionNames': ['Drug: Envalfolimab subcutaneously injected+Platinum-based doublet chemotherapy intravenous injection']}, {'label': 'Placebo plus platinum-based doublet chemotherapy', 'type': 'ACTIVE_COMPARATOR', 'description': 'Placebo plus platinum-based doublet chemotherapy for a total of 3-4 cycles of neoadjuvant therapy (determined by the investigator), placebo will be administered after surgery every 3 weeks(Q3W) for 16 cycles at most.', 'interventionNames': ['Drug: placebo subcutaneously injected +Platinum-based doublet chemotherapy intravenous injection']}] | Interventions:[{'type': 'DRUG', 'name': 'Envalfolimab subcutaneously injected+Platinum-based doublet chemotherapy intravenous injection', 'description': 'The subjects receive Envafolimab/placebo treatment with a dosage of 600 mg/3 ml subcutaneously injected every 3 weeks.It will last about 3-4 cycles before surgery and 16 cycles after surgery.', 'armGroupLabels': ['Envalfolimab plus platinum-based doublet chemotherapy'], 'otherNames': ['Experimental']}, {'type': 'DRUG', 'name': 'placebo subcutaneously injected +Platinum-based doublet chemotherapy intravenous injection', 'description': "The subjects received platinum-based doublet chemotherapy on day 1 of every cycle. It's 3 weeks per cycle and lasts 3-4 cycles before surgery.", 'armGroupLabels': ['Placebo plus platinum-based doublet chemotherapy'], 'otherNames': ['Active Comparator']}] | PrimaryOutcomes: [{'measure': 'MPR by BIPR', '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 (evaluated by BIPR)', 'timeFrame': 'Up to 5 years'}, {'measure': 'EFS by BIRC', 'description': 'EFS is defined as the time from randomization until the occurrence of events leading to inoperable disease progression, post-operative disease progression (BIRC assessment based on RECIST 1.1) or recurrence/metastasis, or death from any cause.', 'timeFrame': 'Up to 5 years'}] | SecondaryOutcomes: [{'measure': '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, assessed by BIPR;', 'timeFrame': 'Up to 5 years'}, {'measure': 'DFS', 'description': 'DFS is defined as the time from post-surgery to radiographic disease progression, local or distant recurrence, or death from any cause, assessed by BIRC;', 'timeFrame': 'Up to 5 years'}, {'measure': 'OS', 'description': 'OS is defined as the time from randomization until death from any cause.;', 'timeFrame': 'Up to 5 years'}, {'measure': 'EFS', 'description': 'EFS is defined as the time from randomization until the occurrence of events leading to inoperable disease progression, post-operative disease progression or recurrence/metastasis, or death from any cause., assessed by investigator;', 'timeFrame': 'Up to 5 years'}, {'measure': 'Explore the quality of life for subjects by EORTC QLQ-C30', 'description': 'All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.\n\nThus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.', 'timeFrame': 'Up to 5 years'}, {'measure': 'Explore the quality of life for subjects by EORTC QLQ-LC13', 'description': 'All of the scales and single-item measures range in score from 0 to 100. A high score for the scales and single items represents a high level of symptomatology or problems.', 'timeFrame': 'Up to 5 years'}, {'measure': 'PD-L1, ctDNA', 'description': 'To explore the correlation between clinical efficacy and tumor tissue sample biomarkers (such as PD-L1 level, etc.) and blood sample biomarkers (such as ctDNA level, etc.)', 'timeFrame': 'Up to 5 years'}] |
Title: A Phase II Trial Evaluating the Activity of caBozantinib in Pre-treated pAtients With Metastatic COlorectal Cancer (mCRC). ABACO Trial. | Condition: Refractory Colorectal Adenocarcinoma | Keywords: crc | Summary: | Description: The prognosis of patients diagnosed with metastatic colorectal cancer (mCRC) remains poor despite significant progress made in the treatment efficacy and tolerability. The introduction of cytotoxic drugs (i.e. oxaliplatin, irinotecan, and trifluridine/tipiracil) and molecular targeted agents (i.e. bevacizumab, cetuximab, panitumumab, aflibercept, and regorafenib), has dramatically improved patients outcomes with an increase in median overall survival from 6 months with best supportive care only, to more than 30 months with new treatment strategies. The recent advances in genomic technologies have provided further insight into the profound complexity and molecular heterogeneity of colorectal cancer. According to the recent Consensus on CRC Molecular Subtypes (CMS) four biologically distinct subtypes have been identified.
CMS1 (14%) occurring more often in older age, female patients, is characterized by right-sided tumors, hypermutated, enriched for MSI and BRAF mutant and with immune pathway activation. CMS2 (37%) shows epithelial phenotype, left-sided location, chromosomal instability (CIN), microsatellites stable (MSS), TP53 mutation, WNT/MYC pathway activation, and Epidermal Growth Factor Receptor (EGFR) upregulation and is associated with better survival rates; CMS3(13%), also expressing epithelial phenotype, is highly heterogeneous in CIN/MSI status and KRAS and PIK3CA mutant; CMS4 (23%) is defined by mesenchymal phenotype, increased TGF-β and AXL signalling, younger age at diagnosis, invasive phenotype, NOTCH3/VEGFR2 overexpression, and worse survival outcomes. This knowledge cannot be immediately translated into clinical practice, since CMS is not yet used to stratify patients for anti-cancer treatment. However, a better understanding of the complex molecular landscape in CRC will contribute to new treatment strategies.
Cabozantinib is an oral, small-molecule inhibitor of tyrosine kinases, including MET, VEGF receptor 2 (VEGFR2), AXL and RET, currently approved for the treatment of patients with progressive, metastatic medullary thyroid cancer; treatment-naïve patients with renal cell carcinoma with intermediate or poor risk disease or previously treated with a vascular endothelial growth factor (VEGF)-inhibitor; hepatocellular carcinoma (HCC) previously treated with sorafenib.
Angiogenesis is a crucial mechanism in CRC development and progression Moreover, AXL and MET signalling pathways are implicated in CRC invasion and metastasis and are involved in drug resistance occurrence .
Cabozantinib has shown antitumor activity in preclinical CRC patient-derived tumor xenograft (PDTX) model leading to a decrease in the phosphorylation of Tie2, VEGFR2 (pro-angiogenic factors) and the MET, RET and AXL receptors (oncogenic pathways). | ArmGroups: [{'label': 'cabozantinib', 'type': 'EXPERIMENTAL', 'description': '60 mg once daily. Route: per os Cycle: 28 days', 'interventionNames': ['Drug: Cabozantinib']}] | Interventions:[{'type': 'DRUG', 'name': 'Cabozantinib', 'description': 'cabozantinib in patients with refractory mCRC', 'armGroupLabels': ['cabozantinib'], 'otherNames': ['Cabometyx']}] | PrimaryOutcomes: [{'measure': 'Progression free survival (PFS)', 'description': 'Progression Free Survival (PFS) rate at 16 weeks: the rate of patients who have not experienced disease progression or death for any cause at 16 weeks.', 'timeFrame': '16 weeks'}] | SecondaryOutcomes: [{'measure': 'Progression Free survival (PFS)', 'description': 'calculated from the start of the study treatment until disease progression or death for any cause.', 'timeFrame': 'from the start of the study treatment until disease progression or death for any cause, assessed up to 100 months'}, {'measure': 'Overall Survival (OS)', 'description': 'calculated from the start of the study treatment until death for any cause.', 'timeFrame': 'from the start of the study treatment until death for any cause, assessed up to 100 months'}, {'measure': 'Response Rate', 'description': 'rate of patients with complete response or partial response, as best response.', 'timeFrame': 'rate of patients with complete response or partial response, as best response, through study completion, an average of 1 year'}, {'measure': 'Disease Control Rate (DCR)', 'description': 'rate of patients with complete response, partial response and stable disease, as best response.', 'timeFrame': 'rate of patients with complete response, partial response and stable disease, as best response, during the course of the study, average time one year'}, {'measure': 'Safety as the description of adverse events', 'description': 'Adverse events graded according Criteria for Adverse Events (CTCAE) Version(v.) 5.0.', 'timeFrame': 'through study completion, an average of 1 year'}] |
Title: Clinical Protocol to Evaluate Glycans Analysis As a Diagnostic Test for Ovarian Cancer | Condition: Ovarian Cancer | Keywords: ovarian germ cell tumor, ovarian epithelial cancer | Summary: | Description: OBJECTIVES:
Primary
* Evaluate the accuracy of glycan analysis to distinguish between normal healthy control female subjects and those with ovarian epithelial cancer.
Secondary
* Compare the new assay to the standard CA 125 for diagnostic accuracy.
OUTLINE:
* Ovarian cancer patients: Blood samples are obtained periodically for up to 2 years. Patients undergoing surgery have blood samples drawn before and after surgery. Medical charts are reviewed periodically for up to 3 years.
* Healthy volunteers: One blood sample is obtained. Volunteers also complete a 1-page questionnaire.
PROJECTED ACCRUAL: A total of 300 healthy female participants and 400 patients will be accrued for this study. | ArmGroups: [{'label': 'Volunteers', 'description': 'Serum samples will be obtained from volunteers, but no tissue specimens. Volunteers will complete a questionnaire.'}, {'label': 'Patients with cancer', 'description': 'Ascites from patients with ovarian, peritoneal, and fallopian tube cancers for basic science studies'}] | Interventions:N/A | PrimaryOutcomes: [{'measure': 'Accuracy of glycan analysis', 'description': 'For healthy controls, a single sample will be obtained. For patients scheduled for surgery, two samples will be obtained: one preoperatively and one postoperatively. Ovarian cancer patients who agree to participate in the longitudinal study will have follow-up serum samples drawn periodically during chemotherapy treatments and then during surveillance visits, to correspond with routine blood testing for CA 125. They will be asked to participate for 2 years, with a maximum of 8 blood draws per year (to be coordinated with other venipunctures, if possible).', 'timeFrame': 'one time for healthy volunteers; up to 2 years for patients with cancer'}] | SecondaryOutcomes: [{'measure': 'Comparison of the new assay to the standard CA 125 assay', 'description': 'For healthy controls, a single sample will be obtained. For patients scheduled for surgery, two samples will be obtained: one preoperatively and one postoperatively. Ovarian cancer patients who agree to participate in the longitudinal study will have follow-up serum samples drawn periodically during chemotherapy treatments and then during surveillance visits, to correspond with routine blood testing for CA 125. They will be asked to participate for 2 years, with a maximum of 8 blood draws per year (to be coordinated with other venipunctures, if possible).', 'timeFrame': 'one time for healthy volunteers; up to 2 years for patients with cancer'}] |
Title: Weekly ModraDoc/r in Combination With Hormonal Treatment and High-dose Intensity-modulated Radiation Therapy in Patients With High-risk Early Stage Prostate Cancer | Condition: Prostatic Neoplasms | Keywords: High risk prostate cancer, >T2cN+M0 | Summary: | Description: Phase IA part This is an open-label, dose-escalating, non-randomized, single centre phase I study of ModraDoc006/r combined with ADT and radiotherapy in patients with high risk prostate cancer, as defined by node positive prostate cancer with all of the following primary tumor characteristics: stage ≥cT2c, Gleason score ≥ 4+3, any PSA level.
Phase IB part After determination of the MTD of ModraDoc006/r in the combined treatment with radiotherapy and hormonal therapy and good tolerability of the treatment without unexpected adverse events during the radiotherapy until 6 weeks after the end of radiotherapy, the study will be further conducted to the phase IB part. This part will explore the feasibility and tolerability of long term treatment with ModraDoc006/r. | ArmGroups: [{'label': 'N15DOP', 'type': 'EXPERIMENTAL', 'description': 'Chemoradiation with ModraDoc/r and radiotherapy of the prostate in dose escalation design, followed by maintenance treatment.', 'interventionNames': ['Drug: oral docetaxel (ModraDoc/r)', 'Drug: androgen deprivation therapy', 'Radiation: high-dose intensity-modulated radiation therapy']}] | Interventions:[{'type': 'DRUG', 'name': 'oral docetaxel (ModraDoc/r)', 'description': 'Weekly once- or twice daily ModraDoc/r', 'armGroupLabels': ['N15DOP'], 'otherNames': ['ModraDoc006/ritonavir']}, {'type': 'DRUG', 'name': 'androgen deprivation therapy', 'description': 'ADT according to the standard of care', 'armGroupLabels': ['N15DOP'], 'otherNames': ['hormonal therapy']}, {'type': 'RADIATION', 'name': 'high-dose intensity-modulated radiation therapy', 'description': '77 Gy in 35 fractions of 2.2 Gy, 5 fractions a week', 'armGroupLabels': ['N15DOP'], 'otherNames': ['radiotherapy']}] | PrimaryOutcomes: [{'measure': 'Maximal tolerated dose (MTD) of ModraDoc/r in the combination treatment', 'description': 'MTD of ModraDoc006/r (as ModraDoc006 10 mg tablets in combination with one tablet of 100 mg ritonavir) that can safely be administered in a bi-daily weekly schedule in combination with high-dose intensity modulated radiation therapy and androgen-deprivation therapy', 'timeFrame': '12 months'}] | SecondaryOutcomes: [{'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v.4.03 with treatment with ModraDoc006/r in combination with ADT and high dose radiotherapy', 'description': 'Number of participants with treatment-related adverse events as assessed by CTCAE', 'timeFrame': '12 months'}, {'measure': 'Number of patients that will have recurrence of prostate cancer after completion of the study treatment', 'description': 'Number of patients that will have recurrence of prostate cancer after completion of the study treatment', 'timeFrame': '10 years'}, {'measure': 'Peak Plasma Concentration (Cmax) of docetaxel in this regime.', 'description': 'Peak Plasma Concentration (Cmax) of docetaxel in this regime.', 'timeFrame': '12 months'}, {'measure': 'Area under the plasma concentration versus time curve (AUC) of docetaxel in this regime.', 'description': 'Area under the plasma concentration versus time curve (AUC) of docetaxel in this regime.', 'timeFrame': '12 months'}] |
Title: PHASE I PILOT STUDY OF SEQUENTIAL HIGH DOSE CYCLES OF CISPLATIN, CYCLOPHOSPHAMIDE, ETOPOSIDE AND IFOSFAMIDE, CARBOPLATIN AND TAXOL WITH AUTOLOGOUS STEM CELL SUPPORT | Condition: Cancer | Keywords: stage IV colon cancer, stage II breast cancer, stage IV breast cancer, stage IIIA breast cancer, recurrent breast cancer, stage IV gastric cancer, recurrent gastric cancer, localized osteosarcoma, metastatic osteosarcoma, stage IIIB breast cancer, recurrent pancreatic cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, stage IV anal cancer, recurrent anal cancer, stage IV esophageal cancer, recurrent esophageal cancer, stage III adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer, recurrent Wilms tumor and other childhood kidney tumors, advanced adult primary liver cancer, recurrent adult primary liver cancer, recurrent osteosarcoma, recurrent gallbladder cancer, recurrent extrahepatic bile duct cancer, recurrent small intestine cancer, stage II melanoma, stage III melanoma, stage IV melanoma, recurrent melanoma, metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor, recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor, stage IV adult soft tissue sarcoma, stage IV pancreatic cancer | Summary: | Description: OBJECTIVES:
* Evaluate the feasibility of administering 2 courses of high dose chemotherapy consisting of etoposide, cisplatin, and cyclophosphamide followed by ifosfamide, carboplatin, and paclitaxel (IC-T), each administered with filgrastim (G-CSF) and autologous stem cell support, to patients with advanced carcinomas.
* Describe the toxicity of these high dose chemotherapy regimens.
* Define the maximum tolerated dose of paclitaxel deliverable in this high dose regimen.
* Describe the pharmacokinetics of escalating doses of paclitaxel given as a 24-hour continuous infusion.
* Determine the disposition of carboplatin administered in the IC-T regimen.
OUTLINE: At least 4 weeks prior to chemotherapy, patients undergo stem cell collection following filgrastim (G-CSF) mobilization. Sufficient stem cells to support 2 courses of chemotherapy are required. Autologous bone marrow is collected as an adjuvant if stem cell harvest is inadequate.
Patients then receive high dose cisplatin, etoposide, and cyclophosphamide over 10 days, followed the next day by infusion of one fourth of the allotted stem cells, with the remaining allotment infused 2 days later. G-CSF is given for granulocyte support.
Beginning no sooner than 14 weeks from the start of the first course of chemotherapy, stable and responding patients receive high dose paclitaxel, carboplatin, and ifosfamide over 5 days, followed 2 days later with one-fourth of the allotted stem cells, with the remaining allotment infused the following day. G-CSF is given for granulocyte support. Groups of 3-6 patients are treated with escalating doses of paclitaxel until the maximum tolerated dose for this regimen is determined.
Patients are followed monthly for 1 year, every 3 months for 1 year, then as needed at the physician's discretion for at least 5 years.
PROJECTED ACCRUAL: Three to six patients will be entered at each dose of paclitaxel studied. | ArmGroups: [{'label': 'Sequential high dose chemotherapy', 'type': 'EXPERIMENTAL', 'interventionNames': ['Biological: filgrastim', 'Drug: carboplatin', 'Drug: cisplatin', 'Drug: cyclophosphamide', 'Drug: etoposide', 'Drug: ifosfamide', 'Drug: mesna', 'Drug: paclitaxel', 'Procedure: peripheral blood stem cell transplantation']}] | Interventions:[{'type': 'BIOLOGICAL', 'name': 'filgrastim', 'armGroupLabels': ['Sequential high dose chemotherapy']}, {'type': 'DRUG', 'name': 'carboplatin', 'armGroupLabels': ['Sequential high dose chemotherapy']}, {'type': 'DRUG', 'name': 'cisplatin', 'armGroupLabels': ['Sequential high dose chemotherapy']}, {'type': 'DRUG', 'name': 'cyclophosphamide', 'armGroupLabels': ['Sequential high dose chemotherapy']}, {'type': 'DRUG', 'name': 'etoposide', 'armGroupLabels': ['Sequential high dose chemotherapy']}, {'type': 'DRUG', 'name': 'ifosfamide', 'armGroupLabels': ['Sequential high dose chemotherapy']}, {'type': 'DRUG', 'name': 'mesna', 'armGroupLabels': ['Sequential high dose chemotherapy']}, {'type': 'DRUG', 'name': 'paclitaxel', 'armGroupLabels': ['Sequential high dose chemotherapy']}, {'type': 'PROCEDURE', 'name': 'peripheral blood stem cell transplantation', 'armGroupLabels': ['Sequential high dose chemotherapy']}] | PrimaryOutcomes: [{'measure': 'Feasibility of two cycles of high dose chemotherapy with stem cell reinfusion', 'timeFrame': '30 days from start of course II of treatment'}, {'measure': 'Toxicity of two cycles of high dose chemothearpy and stem cell reinfusion', 'description': 'Toxicity graded according to the NCI Common Toxicity Criteria and amended for subjects undergoing transplantation', 'timeFrame': '30 days from start of course II of treatment'}, {'measure': 'Maximum tolerated dose of two cycles of high dose chemothearpy and stem cell reinfusion', 'timeFrame': '30 days from start of course II of treatment'}] | SecondaryOutcomes: N/A |
Title: Health-promoting Lifestyle of Breast Cancer Patients and Family Members in a Chinese Genetic Counseling Clinic: A Cross-sectional Study | Condition: Breast Cancer, Genetic Testing | Keywords: Health-promoting lifestyle, breast cancer, genetic | Summary: | Description: Purpose: This study aimed to describe the health-promoting lifestyle of breast cancer patients and family members in a Chinese genetic counseling clinic, and to explore its various levels with different socio-economic variables.
Method: This was a cross-sectional study. The participants in this study originated from a genetic counseling clinic of a cancer center in Shanghai, China. 259 patients conformed to the inclusion and exclusion criteria were screened and contact from November 2019 to March 2022. Participants agreed to participate were sent a questionnaire web-link to be invited to finish this survey. Two questionnaires were included in the link, one referring to the socio-economic information, the other referring to the health-promoting lifestyle. Chinese Health-promoting lifestyle profile-Ⅱ(HPLP-Ⅱ) was used to evaluate the health-promoting lifestyle. | ArmGroups: [{'label': 'Breast cancer patients and their family members who have undertaken genetic testing', 'description': 'In this study, 259 participants were recruited from November 2019 to March 2022. All participants originated from a genetic counseling clinic of a cancer center in Shanghai, China. 259 participants were contact, and among them, 158 participants finally agreed to participate and completed the survey.', 'interventionNames': ['Genetic: genetic testing']}] | Interventions:[{'type': 'GENETIC', 'name': 'genetic testing', 'description': "Two questionnaires were included in the link, one referring to the demographic information, and another one involving the health-promoting lifestyle. In the demographic information, the genetic test results were not requested to be written, but the participants need to answer whether they understand the results. The HPLP-Ⅱ is an scale instrument used to evaluate a person's health-promoting lifestyle behaviors, which contains 52 items and has been translated into Chinese in 1997. It contains 6 subscales: self-actualization, health responsibility, physical activity, nutrition, interpersonal relationships and stress management.", 'armGroupLabels': ['Breast cancer patients and their family members who have undertaken genetic testing']}] | PrimaryOutcomes: [{'measure': 'Chinese Health-promoting lifestyle profile-Ⅱ', 'description': "HPLP-Ⅱ is an scale instrument used to evaluate a person's health-promoting lifestyle behaviors, which contains 52 items and has been translated into Chinese in 1997.It contains 6 subscales: self-actualization, health responsibility, physical activity, nutrition, interpersonal relationships and stress management. A Likert 4-scale is used to measure each item, and never to regularly signifies 1-4. The total score ranges from 52 to 208. Higher scores mean better health-promoting behaviors.", 'timeFrame': 'The primary outcome was measured during one month after the genetic test.'}] | SecondaryOutcomes: N/A |
Title: Endometrial Cancer in Black Women | Condition: Endometrial Cancer | Keywords: endometrial cancer, risk factors, questionnaire, 07-093 | Summary: | Description: OBJECTIVES:
* Establish and evaluate procedures for conducting a hospital-based case-control study of risk factors for endometrial cancer in black women.
OUTLINE: This is a multicenter study.
Participants complete questionnaires about lifestyle factors and their usual diet and measure their waist and hips. Saliva or buccal specimens are collected for future research.
PROJECTED ACCRUAL:
* A total of 30 cases and 30 controls will be accrued for this study. | ArmGroups: [{'label': 'case', 'description': 'Participants complete questionnaires about lifestyle factors and their usual diet and measure their waist and hips. Saliva or buccal specimens are collected for future research.', 'interventionNames': ['Other: questionnaire administration', 'Other: study of socioeconomic and demographic variables', 'Procedure: evaluation of cancer risk factors']}, {'label': 'control', 'description': 'Participants complete questionnaires about lifestyle factors and their usual diet and measure their waist and hips. Saliva or buccal specimens are collected for future research.', 'interventionNames': ['Other: questionnaire administration', 'Other: study of socioeconomic and demographic variables', 'Procedure: evaluation of cancer risk factors']}] | Interventions:[{'type': 'OTHER', 'name': 'questionnaire administration', 'armGroupLabels': ['case', 'control']}, {'type': 'OTHER', 'name': 'study of socioeconomic and demographic variables', 'armGroupLabels': ['case', 'control']}, {'type': 'PROCEDURE', 'name': 'evaluation of cancer risk factors', 'armGroupLabels': ['case', 'control']}] | PrimaryOutcomes: [{'measure': 'Number and percentage of potential cases and controls approached who are found to be eligible for the study and reasons for being ineligible (including language)', 'timeFrame': '2 years'}, {'measure': 'Number and percentage of cases and controls approached who sign informed consent', 'timeFrame': '2 years'}, {'measure': 'Number and percentage of cases and controls who complete each part of the study (main questionnaire, diet questionnaire, saliva/buccal specimen)', 'timeFrame': '2 years'}, {'measure': 'Proportion of questions with missing data', 'timeFrame': '2 years'}, {'measure': "Interviewer's evaluation of interview quality and respondent cooperation", 'timeFrame': '2 years'}, {'measure': 'Number and percentage of cases who are willing to have tumor specimens used for future research', 'timeFrame': '2 years'}, {'measure': 'Characteristics of cases and controls (demographics, main risk factors, and use of health care and screening)', 'timeFrame': '2 years'}, {'measure': "Proportion of participants who rate the study positively on each measure in the post-interview assessment and respondents' suggested changes to the study", 'timeFrame': '2 years'}] | SecondaryOutcomes: N/A |
Title: A Pragmatic Phase 2 Study of Focal Ablation (Focal Cryotherapy or High Intensity Frequency Ultrasound) in Men With Clinically Localized Prostate Cancer | Condition: Localized Prostate Carcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIB Prostate Cancer AJCC v8 | Keywords: | Summary: | Description: PRIMARY OBJECTIVE:
I. To determine the efficacy of focal therapy for treatment of prostate cancer.
SECONDARY OBJECTIVES:
I. Patient reported urinary, sexual function and quality of life (QOL) at 1 year.
II. To assess safety.
OUTLINE:
Patients undergo focal cryotherapy or high intensity focused ultrasound on study.
After completion of study treatment, patients are followed up at 7-14 days and periodically for up to 3 years. | ArmGroups: [{'label': 'Treatment (cryosurgery, high intensity focused ultrasound)', 'type': 'EXPERIMENTAL', 'description': 'Patients undergo focal cryotherapy or high intensity focused ultrasound on study.', 'interventionNames': ['Procedure: Cryosurgery', 'Procedure: High-Intensity Focused Ultrasound Ablation', 'Other: Survey Administration']}] | Interventions:[{'type': 'PROCEDURE', 'name': 'Cryosurgery', 'description': 'Undergo focal cryotherapy ablation', 'armGroupLabels': ['Treatment (cryosurgery, high intensity focused ultrasound)'], 'otherNames': ['Ablation, Cryo', 'Cryoablation', 'cryosurgical ablation']}, {'type': 'PROCEDURE', 'name': 'High-Intensity Focused Ultrasound Ablation', 'description': 'Undergo high intensity frequency ultrasound ablation', 'armGroupLabels': ['Treatment (cryosurgery, high intensity focused ultrasound)'], 'otherNames': ['Echopulse', 'Echotherapy', 'HIFU', 'High Intensity Focused Ultrasound', 'High Intensity Focused Ultrasound Therapy', 'High-intensity Focused Ultrasound', 'High-intensity Focused Ultrasound Therapy']}, {'type': 'OTHER', 'name': 'Survey Administration', 'description': 'Ancillary studies', 'armGroupLabels': ['Treatment (cryosurgery, high intensity focused ultrasound)']}] | PrimaryOutcomes: [{'measure': 'Pathologic outcome on surveillance prostate biopsy', 'description': 'Confidence intervals for the pathologic response rate will be calculated using the Wilson score method. Pathologic response rate will be analyzed by baseline clinical and molecular characteristics using univariable and multivariable logistic regression.', 'timeFrame': 'At year 1 and 3'}, {'measure': 'Proportion of participants who go onto whole gland salvage treatment', 'description': 'Will be estimated using the Kaplan-Meier method.', 'timeFrame': 'At 3 years'}, {'measure': 'Salvage whole gland treatment free survival', 'description': 'Will be analyzed by baseline clinical and molecular characteristics using univariable and multivariable Cox proportional hazards models.', 'timeFrame': 'At 3 years'}] | SecondaryOutcomes: [{'measure': 'Urinary function', 'description': 'Scores from Expanded Prostate Cancer Index Composite (EPIC-26) prostate cancer questionnaire will be used to assess urinary function.', 'timeFrame': 'At 1 year'}, {'measure': 'Sexual function', 'description': 'Scores from EPIC-26 prostate cancer questionnaire will be used to assess sexual function.', 'timeFrame': 'At 1 year'}, {'measure': 'Quality of life', 'description': 'Scores from EPIC-26 prostate cancer questionnaire will be used to assess quality of life.', 'timeFrame': 'At 1 year'}, {'measure': 'Adverse events', 'description': 'Number of participants experiencing treatment-related AEs, classified by severity and grade.', 'timeFrame': 'Up to end of treatment visit, approximately 7-14 days after treatment'}] |
Title: Biomarker Phase II Study Of Cabozantinib In Advanced Radioactive-Iodine Refractory Differentiated Thyroid Cancer. | Condition: Differentiated Thyroid Cancer | Keywords: Cancer, Thyroid, Cabozantinib | Summary: | Description: The trial will enroll competitively up to 41 subjects; male and female, ≥ 18 years, with ECOG PS 0-1 patients with advanced radioactive-iodine refractory differentiated thyroid cancer (DTC) who progressed to previous Tyrosine kinase inhibitors (TKIs), including but not limited to lenvatinib or sunitinib. Patients will have not received previously cabozantinib, selective small-molecule BRAF kinase inhibitors, immune checkpoint inhibitor therapy, or systemic chemotherapy regimens.
The design includes a screening phase in which patient eligibility is addressed, a treatment phase, and a follow-up phase.
Study treatment will begin as soon as possible after signing the informed consent and inclusion will be completed.
All patients will receive cabozantinib at a fixed dose of 60 mg once a day (QD). Patients will continue study treatment until PD (either clinical or radiological), or until unacceptable toxicity, the need for another systemic anticancer treatment, or other reasons for treatment discontinuation.
All patients will undergo periodic tumor assessments by CT or MRI scan every 12 weeks ± 14 days (3 months), and blood monitoring of tumor markers (i.e. thyroglobulin if applicable) every 12 weeks ± 3 days (2 months) from the start of study treatment until progression or patient withdrawal. Further CT/MRI scans could be performed upon suspicion of disease progression according to standard clinical practice and physician criteria. Safety will be assessed at every visit through continuous monitoring of signs and symptoms and periodic laboratory analysis.
The study includes the collection of two blood samples (baseline and after PD; 40 mL at each timepoint) for the determination of cf CHIP-seq (Chromatin immunoprecipitation-sequencing) and patient reported outcomes. | ArmGroups: [{'label': 'Cabozantinib, 60 mg', 'type': 'EXPERIMENTAL', 'description': 'Patients with advanced radioactive-iodine refractory DTC who progressed to previous TKIs (including but not limited to lenvatinib or sunitinib). Patients will have not received previously cabozantinib, selective small-molecule BRAF kinase inhibitors, immune checkpoint inhibitor therapy, or systemic chemotherapy regimens.', 'interventionNames': ['Drug: Cabozantinib']}] | Interventions:[{'type': 'DRUG', 'name': 'Cabozantinib', 'description': '* All enrolled patients will receive cabozantinib at a fixed dose of 60 mg once a day (QD). Patients will continue study treatment until PD (either clinical or radiological), or until unacceptable toxicity, the need for another systemic anticancer treatment, or other reasons for treatment discontinuation.\n* Patients will take the tablet(s) once daily at bed time except for Week 1 Day 1: the first dose of study treatment will be administered in the clinic so that each patient can be observed for initial tolerability. Subsequent doses will be self-administered at home. The tablets should be swallowed whole and not crushed and administered fasting for at least 2 hours before through 1 hour after. If a patient misses a dose, the missed dose should not be taken if it is less than 12 hours before the next dose.', 'armGroupLabels': ['Cabozantinib, 60 mg']}] | PrimaryOutcomes: [{'measure': 'Gene expression of molecular biomarkers characteristics of the pathology', 'description': 'Gene expression levels in the sample will be reported as media and interquartile range for each one of the biomarkers included in the determination. Determination of the expression of the molecular markers will perform applied chromatin immunoprecipitation of cell-free nucleosomes carrying active chromatin modifications followed by sequencing chromatin immunoprecipitation (cfChIP-seq) in blood samples. A blood sample of each patient will be collected for cfChIP-seq analysis in the baseline, before any dose of study treatment (week0)', 'timeFrame': 'Time point: At baseline, before any dose of study treatment'}, {'measure': 'Gene expression of molecular biomarkers characteristics of the pathology', 'description': 'Gene expression levels in the sample will be reported as media and interquartile range for each one of the biomarkers included in the determination. Determination of the expression of the molecular markers will perform applied chromatin immunoprecipitation of cell-free nucleosomes carrying active chromatin modifications followed by sequencing chromatin immunoprecipitation (cfChIP-seq) in blood samples. A blood sample of each patient will be collected and cfChIP-seq test will be performed as soon as the patient progresses according to RECIST 1.1 guidelines', 'timeFrame': 'Time point: Throughout the study period, approximately 2 years per patient'}] | SecondaryOutcomes: [{'measure': 'Objective response rate (ORR)', 'description': 'Objective response rate (ORR), primary endpoint for efficacy: Assessed by the investigator through imaging follow-up (CT scan/MRI) using RECIST 1.1. This will be considered as the percentage/proportion of patients with confirmed complete response (CR) or partial response (PR) as their overall best response throughout the study period. Objective responses will be assessed locally by the investigator according to RECIST, version 1.1, and indicating the change in size of tumors as compared with baseline, at the first dose of study treatment.', 'timeFrame': 'Throughout the study period, approximately 2 years per patient'}, {'measure': 'Disease control rate (DCR)', 'description': 'Percentage/proportion of patients with complete response (CR) or partial response (PR), according to ORR definition for the trial, or maintained stable disease (SD) as their overall best response, assessed by imaging follow-up (CT scan/MRI) and RECIST 1.1 criteria. Stable disease should be maintained for at least 4 months to be considered as a Chemical, Biological, or Radiological (CBR) event', 'timeFrame': 'Throughout the study period, approximately 2 years per patient'}, {'measure': 'Duration of response (DoR)', 'description': 'DoR is defined as the time from first confirmed response (CR or PR), according to ORR definition for the trial, to the date of the documented PD as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first. Those patients with response and without PD or death event will be censored on the date of their last tumor assessment.', 'timeFrame': 'Throughout the study period, approximately 2 years per patient'}, {'measure': 'Progression-free survival (PFS)', 'description': 'PFS is defined as time from first dosing date to the date of confirmed PD according to RECIST 1.1. Patients alive and free of events at the date of the analysis will be censored at their last known tumor assessment. Patients who start a new treatment line without progression will be censored on the date of first dose of the subsequent anticancer treatment.', 'timeFrame': 'Throughout the study period, approximately 2 years per patient'}, {'measure': 'Overall survival (OS)', 'description': 'Defined as the time elapsed from the first dose of study treatment until death from any cause. We will assess the median OS, estimated by Kaplan-Meier. Patients alive and free of events at the date of the analysis will be censored at their last known contact. Survival will be assessed by recording patient status at each visit according to Table 1. Long term follow up to be performed at least every 6 months.', 'timeFrame': 'Throughout the study period, approximately 2 years per patient'}, {'measure': 'Frequency of Adverse events (AEs) leading to treatment discontinuation.', 'description': 'Percentage of patients experiencing an adverse event leading to discontinuation of treatment', 'timeFrame': 'Throughout the study period, approximately 2 years per patient'}, {'measure': 'Health-related quality of life (HRQoL), assessed through the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) version 3.', 'description': "The EORTC QLQ-C30 questionnaire is a specific questionnaire validated for cancer that is composed of 30 questions or items. The questionnaire is structured in 5 functional scales (physical functioning, daily activities, emotional functioning, cognitive functioning and social functioning), 3 symptom scales (fatigue, pain and nausea, vomiting), 1 global health status scale, and 6 independent items (dyspnea, insomnia, anorexia, constipation, diarrhea and economic impact). Values between 1 and 4 (1: not at all, 2: a little, 3: quite, 4: a lot) are assigned according to the patient's responses to the item, only in items 29 and 30 are they evaluated with a score of 1 to 7 (1: dreadful, 7: excellent). The scores obtained are standardized and a score between 0 and 100 is obtained, which determines the level of impact of the cancer on the patient on each of the scales. A higher score indicating a better HRQoL.", 'timeFrame': 'Throughout the study period, approximately 2 years per patient'}] |
Title: SAABR: Single Arm Phase II Study of AR Targeted Therapy + Atezolizumab + GnRH Analog and Stereotactic Body Radiotherapy (SBRT) to the Prostate in Men with Newly Diagnosed Hormone-sensitive Metastatic Prostate Cancer | Condition: Metastatic Prostate Cancer | Keywords: Abiraterone Acetate, Atezolizumab, GnRH Analog, Radiation Therapy, Hormone sensitive prostate cancer, Stereotactic Body Radiotherapy, SBRT, Metastatic prostate cancer, 19-461, Memorial Sloan Kettering Cancer Center | Summary: | Description: N/A | ArmGroups: [{'label': 'Metastatic Prostate Cancer', 'type': 'EXPERIMENTAL', 'description': 'Participants will have untreated metastatic (M1a/b/c) hormone-sensitive prostate cancer documented by positive bone scan or metastatic lesion on CT or MRI; untreated is defined as having never received surgical, radiotherapeutic, or systemic therapy for their prostate cancer.Group 1 and 2. The first 20 patients enrolled will be in Group 1 and the remaining patients (and those who are already on a GnRH analog) will be assigned to Group 2. All study participants will receive treatment with atezolizumab, abiraterone acetate, prednisone, GnRH analog, and SBRT, at the same doses.', 'interventionNames': ['Drug: Atezolizumab', 'Drug: Abiraterone', 'Drug: Prednisone', 'Drug: GnRH analog', 'Radiation: Stereotactic Body Radiotherapy (SBRT)', 'Drug: Enzalutamide', 'Other: Follow up']}] | Interventions:[{'type': 'DRUG', 'name': 'Atezolizumab', 'description': 'Atezolizumab 1200 mg IV over 60 minutes every 3 weeks', 'armGroupLabels': ['Metastatic Prostate Cancer']}, {'type': 'DRUG', 'name': 'Abiraterone', 'description': 'Abiraterone 1000 mg daily', 'armGroupLabels': ['Metastatic Prostate Cancer']}, {'type': 'DRUG', 'name': 'Prednisone', 'description': 'Prednisone 5 mg daily', 'armGroupLabels': ['Metastatic Prostate Cancer']}, {'type': 'DRUG', 'name': 'GnRH analog', 'description': "Any GnRH analog that is commercially available, injectable, and long acting analog of the native LHRH peptide and is administered to subjects via intramuscular injection. For this study, any GnRH analog can be used and thee manufacturer's instructions for dose and frequency should be followed.", 'armGroupLabels': ['Metastatic Prostate Cancer']}, {'type': 'RADIATION', 'name': 'Stereotactic Body Radiotherapy (SBRT)', 'description': 'Intensity-modulated, image-guided, ultra-hypofractionated external beam radiotherapy (7.25-7.5 Gy x 5 to prostate and seminal vesicles QOD) will begin around 12 weeks (at Cycle 5 Day 1 (+/-5 days)', 'armGroupLabels': ['Metastatic Prostate Cancer']}, {'type': 'DRUG', 'name': 'Enzalutamide', 'description': '160 mg once daily', 'armGroupLabels': ['Metastatic Prostate Cancer']}, {'type': 'OTHER', 'name': 'Follow up', 'description': 'Subjects who discontinue study treatment for reasons other than progression will be followed every 6 months (+/- 4 weeks) until a documented progression event (i.e., PSA, radiographic, or clinical progression). After a documented progressionevent (whether on treatment or during follow up), subjects will continue to be followed every 6 months (+/- 4 weeks) for overall survival via chart review and/or telephone call.', 'armGroupLabels': ['Metastatic Prostate Cancer']}] | PrimaryOutcomes: [{'measure': 'Failure-free rate at 2 years', 'description': 'Failure is defined as: biochemical failure, radiographic progression defined by PCWG3, or death from any cause.', 'timeFrame': '2 years'}] | SecondaryOutcomes: N/A |
Title: A Phase I Clinical Trial Assessing the Safety and Feasibility of Administration of pNGVL4a-CRT/E7(Detox) DNA Vaccine Using the Intramuscular TriGridTM Delivery System in Combination With Cyclophosphamide in HPV-16 Associated Head and Neck Cancer Patients | Condition: Head and Neck Cancer | Keywords: HPV, Head and Neck Cancer, Vaccine, Immunotherapy, Cyclophosphamide, Sexually Transmitted Diseases, Viral | Summary: | Description: N/A | ArmGroups: [{'label': 'Cohort 1 - DNA Vaccine (Dose 0.5 mg/dose)', 'type': 'EXPERIMENTAL', 'description': 'pNGVL-4a-CRT/E7 (detox) DNA Vaccine (Dose 0.5 mg/dose) + Cyclophosphamide (200 mg/m2)', 'interventionNames': ['Biological: DNA Vaccine', 'Drug: Cyclophosphamide']}, {'label': 'Cohort 2 - DNA Vaccine (Dose 1.0 mg/dose)', 'type': 'EXPERIMENTAL', 'description': 'pNGVL-4a-CRT/E7 (detox) DNA Vaccine (Dose 1.0 mg/dose) + Cyclophosphamide (200 mg/m2)', 'interventionNames': ['Biological: DNA Vaccine', 'Drug: Cyclophosphamide']}, {'label': 'Cohort 3 - DNA Vaccine (Dose 2.0 mg/dose)', 'type': 'EXPERIMENTAL', 'description': 'pNGVL-4a-CRT/E7 (detox) DNA Vaccine (Dose 2.0 mg/dose) + Cyclophosphamide (200 mg/m2)', 'interventionNames': ['Biological: DNA Vaccine', 'Drug: Cyclophosphamide']}, {'label': 'Cohort 4 - DNA Vaccine (Dose 4.0 mg/dose)', 'type': 'EXPERIMENTAL', 'description': 'pNGVL-4a-CRT/E7 (detox) DNA Vaccine (Dose 4.0 mg/dose) + Cyclophosphamide (200 mg/m2)', 'interventionNames': ['Biological: DNA Vaccine', 'Drug: Cyclophosphamide']}] | Interventions:[{'type': 'BIOLOGICAL', 'name': 'DNA Vaccine', 'description': 'Patients will receive intramuscular needle injections of pNGVL4a-CRT/E7 (detox) DNA vaccine using the TDS-IM device on Day 1, 22, and 43 for a total of three vaccinations per patient. One day prior to each DNA vaccination, the patient will receive a single low dose of 200 mg/m2 of cyclophosphamide intravenously. The DNA vaccine will be administered in a dose-escalating manner.', 'armGroupLabels': ['Cohort 1 - DNA Vaccine (Dose 0.5 mg/dose)', 'Cohort 2 - DNA Vaccine (Dose 1.0 mg/dose)', 'Cohort 3 - DNA Vaccine (Dose 2.0 mg/dose)', 'Cohort 4 - DNA Vaccine (Dose 4.0 mg/dose)'], 'otherNames': ['pNGVL-4a-CRT/E7 (detox) DNA Vaccine']}, {'type': 'DRUG', 'name': 'Cyclophosphamide', 'description': 'A single low dose of 200 mg/m2 of cyclophosphamide (CTX) will be administered intravenously up to 24 hours (Day 0) prior to each DNA vaccination.', 'armGroupLabels': ['Cohort 1 - DNA Vaccine (Dose 0.5 mg/dose)', 'Cohort 2 - DNA Vaccine (Dose 1.0 mg/dose)', 'Cohort 3 - DNA Vaccine (Dose 2.0 mg/dose)', 'Cohort 4 - DNA Vaccine (Dose 4.0 mg/dose)'], 'otherNames': ['Cytoxan']}] | PrimaryOutcomes: [{'measure': 'Number of participants with adverse events after administration of pNGVL4a-CRT/E7 (detox) DNA vaccine using the intramuscular TriGridTM Delivery System (TDS-IM) in combination with cyclophosphamide', 'timeFrame': '5 years'}] | SecondaryOutcomes: [{'measure': 'Number of participants with measurable HPV-specific immune responses after vaccination', 'timeFrame': '5 years'}] |
Title: Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy - Prospective, Randomized, Two-armed Phase-II-study | Condition: Anal Cancer | Keywords: female patients, quality of life, vaginal dilator, vaginal fibrosis | Summary: | Description: The study is designed as a prospective, randomized, two-armed, single-center phase-II-trial. 60 patients will be included in the study. Patients fulfilling the inclusion criteria will be randomized into one of the two arms, which differ only in the diameter of a tampon used for vaginal dilatation during treatment. All patients will receive standard (chemo)radiotherapy with a total dose of 45-50,4 Gy (single dose 1,8-2 Gy) to the pelvic and inguinal (if required) lymphatic drainage with a boost to the anal canal up to 54-60 Gy (single doses 1.8-2.2 Gy). The primary objective is the assessment of the incidence and grade of vaginal fibrosis 12 months after (chemo)radiotherapy for anal cancer depending on the extent of intrafractional vaginal dilatation. Secondary endpoints are clinical symptoms and toxicity according to the Common Toxicity Criteria (CTC) version 5.0, assessment of clinical feasibility of daily use of a tampon for vaginal dilatation, assessment of the compliance for the use of a vaginal dilatator and quality of life assessed with the EORTC-QLQ30/-ANL27 questionnaires. | ArmGroups: [{'label': 'Tampon with extended vaginal dilatation', 'type': 'EXPERIMENTAL', 'description': 'Patients in arm A will use a special tampon with extended vaginal dilatation during radiotherapy', 'interventionNames': ['Device: special tampon with a diameter of 28mm']}, {'label': 'Commercially available tampon', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients in Arm B will use a normal commercially available tampon (diameter 12-13mm) during radiotherapy', 'interventionNames': ['Device: standard tampon with a diameter of 12-13mm']}] | Interventions:[{'type': 'DEVICE', 'name': 'special tampon with a diameter of 28mm', 'description': 'patients will use a special tampon with extended vaginal dilatation (diameter 28mm) during radiotherapy', 'armGroupLabels': ['Tampon with extended vaginal dilatation']}, {'type': 'DEVICE', 'name': 'standard tampon with a diameter of 12-13mm', 'description': 'patients in Arm B will use a normal commercially available tampon (diameter 12-13mm) during radiotherapy', 'armGroupLabels': ['Commercially available tampon']}] | PrimaryOutcomes: [{'measure': 'incidence and grade of vaginal fibrosis', 'description': 'during and after radiotherapy, clinical symptoms are assessed and graded', 'timeFrame': 'Up to 12 months after start of (chemo)radiotherapy'}] | SecondaryOutcomes: [{'measure': 'clinical symptoms and toxicity according to the CTC AE version 5.0. criteria', 'description': 'during and after radiotherapy, clinical symptoms are assessed and graded according to the CTC AE v5.0 criteria', 'timeFrame': 'weekly during radiotherapy, at each follow-up visit'}, {'measure': 'clinical feasibility of daily use of a special tampon', 'description': 'daily assessment of the clinical feasibility of daily use of a special tampon', 'timeFrame': 'continously during radiotherapy'}, {'measure': 'assessment of the compliance for the use of a vaginal dilatator', 'description': 'patients will be instructed to use a vaginal dilator 3 times a week, at each follow-up visit patients are asked about the frequency of vaginal dilator use', 'timeFrame': 'continously at every follow-up visit'}, {'measure': 'assessment of quality of life', 'description': 'EORTC-QLQ30/-ANL27 questionnaires are used to assess quality of life', 'timeFrame': 'baseline, 6-8 weeks after and 6/12 months after finishing radiotherapy'}] |
Title: A Phase I Trial of 61Cu-NODAGA-PSMA for Patients with Prostate Cancer | Condition: Prostate Adenocarcinoma | Keywords: PSMA, PET/CT, Phase 1 | Summary: | Description: This is a phase 1, non-randomized study. Subjects will undergo imaging with 100-300 MBq (2.7-8.1 mCi) of 61Cu-NODAGA-PSMA intravenously (IV), followed by PET/CT imaging 60 (+/- 10) minutes post radiotracer administration. This is a diagnostic imaging study. As the imaging agent will not have a treatment effect, efficacy evaluations that are standard in treatment protocols will not be performed. We expect to enroll 6-10 patients in the proposed study. The sample size is exploratory.
For the primary objective of safety, side effects will be monitored the day of and the day following radiotracer administration. As the PET radiotracer used in this trial is given at a low, imaging dose, serious adverse events are not expected. If a single serious adverse event is identified, then the protocol will be held until reviewed by the IRB.
For the secondary objective of dosimetry, dosimetry will be calculated from PET/CT images and radioactive counts in blood samples by an experience medical physicist.
For the secondary objective of effectiveness, the number of suspected PSMA-positive malignant lesions will be calculated in both the standard-of-care 18F-Piflufolastat PET/CT and the experimental 61Cu- PSMA PET/CT. Positive lesions will be considered to be the foci greater than local background that are not physiologic/benign by location. The percentage of patients with any suspected PSMApositive malignant lesions will be determined for each radiotracer. | ArmGroups: [{'label': 'Prostate Adenocarcinoma with PSMA-Positive Disease on a PSMA Targeted PET/CT', 'type': 'EXPERIMENTAL', 'description': 'TEST PRODUCT, DOSE, AND ROUTE OF ADMINISTRATION: Subjects will undergo imaging with 100-300 MBq (2.7-8.1 mCi) of 61Cu-NODAGA-PSMA intravenously (IV), followed by PET/CT imaging 60 (+/- 10) minutes post radiotracer administration.', 'interventionNames': ['Drug: Copper 61-PSMA PET/CT']}] | Interventions:[{'type': 'DRUG', 'name': 'Copper 61-PSMA PET/CT', 'description': 'TEST PRODUCT, DOSE, AND ROUTE OF ADMINISTRATION: Subjects will undergo imaging with 100-300 MBq (2.7-8.1 mCi) of 61Cu-NODAGA-PSMA intravenously (IV), followed by PET/CT imaging 60 (+/- 10) minutes post radiotracer administration.', 'armGroupLabels': ['Prostate Adenocarcinoma with PSMA-Positive Disease on a PSMA Targeted PET/CT']}] | PrimaryOutcomes: [{'measure': 'Incidence of Imaging Agent-Emergent Adverse Events [Safety and Tolerability]', 'description': 'For the primary objective of safety, side effects will be monitored the day of and the day following radiotracer administration.', 'timeFrame': 'Up to 24 hours after administration of radiotracer'}] | SecondaryOutcomes: [{'measure': 'Dosimetry', 'description': 'For the secondary objective of dosimetry, dosimetry will be calculated from PET/CT images and radioactive counts in blood samples by an experience medical physicist.', 'timeFrame': 'Up to 24 hours after administration of radiotracer'}, {'measure': 'Number of suspected PSMA-positive malignant lesions', 'description': 'For the secondary objective of effectiveness, the number of suspected PSMA-positive malignant lesions will be calculated in both the standard-of-care 18F-Piflufolastat PET/CT and the experimental 61Cu-PSMA PET/CT. Positive lesions will be considered to be the foci greater than local background that are not physiologic/benign by location. The percentage of patients with any suspected PSMA-positive malignant lesions will be determined for each radiotracer.', 'timeFrame': 'Up to 24 hours after administration of radiotracer'}] |
Title: A Phase II Study to Determine the Efficacy and Safety of Vvax001, a Therapeutic Semliki Forest Virus Based Cancer Vaccine, in Patients With HPV-16 Induced Grade 3 Cervical Intraepithelial Neoplasia | Condition: CIN3, Cervical Intraepithelial Neoplasia, Cervical Intraepithelial Neoplasia Grade 3, HPV 16 Infection | Keywords: | Summary: | Description: Human papillomavirus (HPV) infection is the most important cause of premalignant cervical disease. Current treatment for premalignant HPV-induced genital lesions primarily relies on surgery, which can be discomforting and carries a risk of complications like bleeding, cervical stenosis and/or incompetence which may lead to infertility and partus prematuris/immaturis. Above all, it does not necessarily eradicate the underlying HPV infection completely.
Therapeutic immunization is a very attractive alternative to the current treatment options for precancerous lesions and (invasive) cancer. The immune cells induced by cancer immunotherapy can target the tumor cells and kill them. When long-lasting immunity is induced the immunotherapy may prevent recurrence of the disease. Therefore, the approach taken in this study is to immunize with a replication-incompetent Semliki Forest Virus (SFV) vector encoding HPV-derived tumor antigens. Intramuscular immunization with these replication-incompetent SFV particles (Vvax001) is aimed at eliciting a therapeutic anti-tumor response.
A phase I study has been conducted in which vaccination with Vvax001 induced HPV16-E6,7-specific immune responses in women previously treated for cervical intraepithelial neoplasia (CIN) or cervical cancer (CC). Intramuscular immunization with Vvax001 was well tolerated, showing only mild to moderate local adverse reactions. Altogether, the data of this study justify testing of Vvax001 in CIN3 patients in the current phase II study.
In this open label phase II study patients with newly diagnosed HPV16 induced cervical intraepithelial neoplasia grade 3 (CIN3) will receive three bilateral intramuscular immunizations of Vvax001 (5x107 infectious particles \[IP\]) with an interval of 3 weeks between vaccinations at week 0, week 3 and week 6.
Patients will be monitored for regression of CIN3 lesions by colposcopy and digital imaging at week 9, week 17 and week 25. When complete regression of the CIN3 lesion is observed by colposcopy, a biopsy will be taken in week 25 to confirm regression and no LETZ will be performed. If complete regression has not occurred by 25 weeks, the standard-of-care LETZ will be performed. If progression of the CIN3 lesion is observed during the 25 week interval, a biopsy will be taken to confirm pathological progression. If pathological progression has occurred, patients will immediately undergo a LETZ. If no pathological progression has occurred, patients will continue to be monitored by colposcopy.
Patients with a complete regression will be followed-up by cytology at 3, 6 and 12 months after exit from the study. Hereafter, patients will be monitored through regular screening programs. | ArmGroups: [{'label': 'HPV16+ CIN3', 'type': 'EXPERIMENTAL', 'description': 'Patients with histological proven HPV16-positive cervical intraepithelial neoplasia grade 3.', 'interventionNames': ['Biological: Vvax001 therapeutic cancer vaccine']}] | Interventions:[{'type': 'BIOLOGICAL', 'name': 'Vvax001 therapeutic cancer vaccine', 'description': 'Patients will receive three immunizations, with an interval of 3 weeks between each immunization at weeks 0, 3 and 6. Each vaccination will be given as two injections; 1 injection in each leg. The injections will be administered intramuscularly in the upper legs, preferably in the m. vastus lateralis.', 'armGroupLabels': ['HPV16+ CIN3']}] | PrimaryOutcomes: [{'measure': 'Clinical efficacy of Vvax001', 'description': 'Clinical efficacy is determined by a pathological regression of the premalignant CIN3 lesion in pre- versus post-treatment tissue samples. A positive histologic regression is defined as a reduction from CIN3 to CIN1, or a reduction from CIN3 to no dysplasia.', 'timeFrame': 'At week 25 (19 weeks after the last immunization)'}] | SecondaryOutcomes: [{'measure': 'Immunogenicity of Vvax001', 'description': 'HPV-16 E6,7-specific T-cell immune responses in the peripheral blood will be measured by IFN-y ELISPOT', 'timeFrame': 'At weeks 7, 9, 17 and 25, respectively 1 week, 3 weeks, 11 weeks and 19 weeks after the last vaccination'}, {'measure': 'HPV 16 clearance', 'description': 'Standard HPV testing by molecular analysis will be performed on tissue collected during the last study visit.', 'timeFrame': 'Week 25 (19 weeks after the last immunization)'}, {'measure': 'Side effects/ adverse events', 'description': 'To monitor the side effects/ adverse events related to intramuscular administration of Vvax001. Toxicity will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.', 'timeFrame': 'up to 19 weeks after the last immunization'}] |
Title: Impact of an Intervention Combining Self-care and Hypnosis on the Well-being of Cancer Patients and Their Partners | Condition: Non-Metastatic Neoplasm | Keywords: Cancer, Fatigue, Hypnosis, Self-hypnosis, Self-care, Emotional distress, Cancer survivors | Summary: | Description: N/A | ArmGroups: [{'label': 'Experimental group : Hypnosis-based intervention', 'type': 'EXPERIMENTAL', 'description': 'Groupal intervention combining self-care techniques and self-hypnosis exercises', 'interventionNames': ['Behavioral: Self-hypnosis + Self-care']}, {'label': 'Control group : Usual care', 'type': 'NO_INTERVENTION', 'description': 'Control group receiving usual care but not the intervention'}] | Interventions:[{'type': 'BEHAVIORAL', 'name': 'Self-hypnosis + Self-care', 'description': 'Our groupal intervention is divided into 8 weekly 2-hour sessions in which one self-hypnosis exercise is proposed to participants. Self-care techniques are also discussed (knowing our own needs, self-respect, assertiveness, coping with ruminations...) and homework assignments are proposed to participants, in order to foster positive change.', 'armGroupLabels': ['Experimental group : Hypnosis-based intervention']}] | PrimaryOutcomes: [{'measure': 'Change in Cancer-Related Fatigue', 'description': 'A sense of tiredness or exhaustion linked with cancer and its treatments, that is not alleviated by sleep. It will be measured with the Multidimensional Fatigue Inventory (MFI-20) and the Insomnia Severity Index (ISI).', 'timeFrame': 'T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up)'}, {'measure': 'Change in emotional distress', 'description': 'Anxiety + Depression, measured with the Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': 'T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up)'}] | SecondaryOutcomes: [{'measure': 'Change in fear of recurrence', 'description': 'Fear that cancer could return. Measured with the Fear of Cancer Recurence Inventory', 'timeFrame': 'T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up)'}, {'measure': 'Change in emotion regulation', 'description': 'The way people deal with their emotions. Measured with one questionnaire (Cognitive Emotion Regulation Questionnaire) and a smartphone application asking participants about their daily emotion and how they deal with it. The application is used during 9 days at each measurement time.', 'timeFrame': 'T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up)'}, {'measure': 'Change in attentional bias towards threat', 'description': 'Attentional bias toward emotional information especially negative ones. It is linked with anxiety and will be measured by an computerized task.', 'timeFrame': 'T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up)'}, {'measure': 'Change in the quality of the conjugal relationship', 'description': "Communication about cancer and dyadic coping, measured with questionnaires (Couples' Illness Communication Scale ; Dyadic Coping Inventory). The two partners will complete these questionnaires.", 'timeFrame': 'T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up)'}, {'measure': "Change in partners' well-being", 'description': 'Anxiety and depression of the partners, measured with the HADS.', 'timeFrame': "- Couples' Illness Communication Scale (CICS) (Arden-Close et al., 2010) Dyadic Coping Inventory (DCI)"}] |
Title: Risk and Clinical Outcomes of Acute Myocardial Infarction in Patients With Cancer: A Nationwide Study | Condition: Acute Myocardial Infarction, Cancer | Keywords: Acute myocardial infarction, Cancer, Incidence, Prognosis | Summary: | Description: This study will be conducted using Korean National Health Insurance Service database. Patients who were diagnosed with cancer from 2002 to 2021 will be included in the study. Using the selected patients, current study will analyze the incidence and prognosis of acute myocardial infarction in cancer patients and the prognosis according to the treatment method for acute myocardial infarction will be compared. Primary outcome will be all-cause death. Secondary outcomes will be myocardial infarction, revascularization, hospitalization for heart failure, stroke, and clinically relevant bleeding. | ArmGroups: [{'label': 'Revascularized Group', 'description': 'Cancer patients with diagnosis of acute myocardial infarction that was treated with PCI or CABG', 'interventionNames': ['Procedure: Revascularization']}, {'label': 'Medical Group', 'description': 'Cancer patients with diagnosis of acute myocardial infarction that was treated with medical treatment only'}] | Interventions:[{'type': 'PROCEDURE', 'name': 'Revascularization', 'description': 'Performing PCI or CABG', 'armGroupLabels': ['Revascularized Group']}] | PrimaryOutcomes: [{'measure': 'All-cause death', 'description': 'All-cause death which was obtained from death certification collected by Statistics Korea at the Ministry of Strategy and Finance of South Korea', 'timeFrame': '2-years after diagnosis of acute myocardial infarction'}] | SecondaryOutcomes: [{'measure': 'Myocardial infarction', 'description': 'Myocardial infarction is defined as presence of the diagnostic codes (ICD-10 I21, I22) in the primary position during hospitalization', 'timeFrame': '2-years after diagnosis of acute myocardial infarction'}, {'measure': 'Revascularization', 'description': 'Percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)', 'timeFrame': '2-years after diagnosis of acute myocardial infarction'}, {'measure': 'Hospitalization for heart failure', 'description': 'Heart failure events requiring hospitalization defined as presence of the diagnostic codes (I110, I130, I132, I255, I420, I425-I429, I43, I50, I971) in the primary position during hospitalization', 'timeFrame': '2-years after diagnosis of acute myocardial infarction'}, {'measure': 'Stroke', 'description': 'Stroke is defined as ischemic stroke (ICD-10 I63, I64) or intracranial hemorrhage (ICD-10 I60-62), combined with the codes of diagnostic brain imaging.', 'timeFrame': '2-years after diagnosis of acute myocardial infarction'}, {'measure': 'Clinically relevant bleeding', 'description': 'Bleeding requiring hospitalization or transfusion', 'timeFrame': '2-years after diagnosis of acute myocardial infarction'}] |
Title: Phase I/II Study of Xeloda and Gleevec in Patients With Advanced Solid Tumors | Condition: Colon Cancer, Colorectal Cancer | Keywords: phase 1, phase I, phase one, colon cancer, colorectal cancer | Summary: | Description: N/A | ArmGroups: [{'label': 'A', 'type': 'EXPERIMENTAL', 'description': 'Xeloda plus gleevec', 'interventionNames': ['Drug: capecitabine, imatinib mesylate']}] | Interventions:[{'type': 'DRUG', 'name': 'capecitabine, imatinib mesylate', 'description': 'Capecitabine and imatinib mesylate will both be taken by mouth twice a day', 'armGroupLabels': ['A']}] | PrimaryOutcomes: [{'measure': 'To determine the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of Gleevec in combination with a fixed dose of Xeloda po bid daily in patients with colon cancer.', 'timeFrame': '4 weeks'}] | SecondaryOutcomes: [{'measure': 'To determine the time to progression, survival and response rate.', 'timeFrame': 'Until Patient goes off study'}, {'measure': 'To obtain preliminary data on molecular correlates to determine clinical efficacy', 'timeFrame': 'Until Patient Goes off study'}, {'measure': 'Toxicity.', 'timeFrame': '30 days after patient receives last drug dose'}] |
Title: Improving Fatigue: A Pilot Study of Acupuncture and Patient Education for Breast Cancer Survivors | Condition: Fatigue | Keywords: Cancer, Acupuncture | Summary: | Description: Patients will be randomly assigned to one of the two groups. Our hypothesis is that patients in the acupuncture/education group will experience greater relief of fatigue than those in the standard care group. | ArmGroups: [{'label': 'Acupuncture & educ', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients will receive a total of 8 acupuncture treatments. In each of the first four sessions, they will also receive patient education.', 'interventionNames': ['Procedure: Acupuncture and patient education']}, {'label': '2. Standard care', 'type': 'NO_INTERVENTION', 'description': 'Patients in the control arm will continue to receive standard care from their physician.'}] | Interventions:[{'type': 'PROCEDURE', 'name': 'Acupuncture and patient education', 'description': 'Acupuncture involves the insertion of extremely thin needles, much thinner than those used for drawing blood, into very specific acupuncture points. Patients will receive a total of 8 acupuncture treatments, each lasting 50 minutes. Patient education will be delivered to individuals over the course of approximately 50 minutes for each of the four sessions; topics will include acupressure, nutrition, exercise, stress management, and lifestyle advice.', 'armGroupLabels': ['Acupuncture & educ'], 'otherNames': ['Traditional Chinese Medicine, Integrative East-West Medicine']}] | PrimaryOutcomes: [{'measure': 'Fatigue as measured by the Brief Fatigue Inventory', 'timeFrame': 'prior to beginning of treatment and after treatment ends. Up to an average of 44 weeks.'}] | SecondaryOutcomes: [{'measure': 'Health-Related Quality of Life (HRQoL) as measured by the SF36', 'timeFrame': 'prior to beginning of treatment and after end of treatment. Up to an average of 44 weeks.'}, {'measure': 'Pain as measured by an analog scale', 'timeFrame': 'prior to beginning of treatment and after conclusion of treatment. Up to an average of 44 weeks.'}, {'measure': 'Cognitive complaints as measured by the FACT-COG', 'timeFrame': 'prior to the beginning of treatment and after end of treatment. Up to an average of 44 weeks.'}] |
Title: Immediate Tissue Expander and Lipofilling After Mastectomy for Breast Cancer Recurrence Following Lumpectomy and Irradiation: Retrospective Multicentric Clinical Trial | Condition: Breast Cancer | Keywords: Breast cancer, Radiotherapy, Implant-based breast reconstruction, Fat grafting, Adipose tissue transplant, Lipofilling, Hodgkin lymphoma, Expander | Summary: | Description: National Comprehensive Cancer Network guidelines recommend autologous reconstruction as the preferred breast reconstruction after mastectomy in previously irradiated patients because of higher complication rates and worse aesthetic outcomes as compared to immediate breast implant reconstruction. In fact, unacceptable rates of complications (60-70%) have been reported by first experiences. Instead, autologous reconstruction showed lower complication rates as compared to implant-based breast reconstruction (25.5% vs 50.9%). However, it may not be indicated in patients with previous surgery at the donor site or in case of other contraindications, requires longer surgical time and is at risk of donor-site morbidity and loss of sensation.
On the other hand, fat grafting improves softness of tissues and scars, releasing their rigidity and for these effects it has been studied for effectively promoting the regeneration of irradiated tissues, enlarging the envelope thickness for safety reasons, optimizing cosmetic outcomes and ultimately increasing patient comfort and quality of life.
Therefore, a surgical technique combining implant-based breast reconstruction after mastectomy and fat grafting may favor alloplastic reconstruction in selected patients.
The investigators enroll patients candidate to mastectomy and breast reconstruction who had received prior adjuvant radiation therapy after breast conserving surgery (BCS) or radiation therapy for the treatment of Hodgkin Lymphoma (HL).
Aims of the study are to investigate (i) the feasibility of implant-based breast reconstruction and fat grafting after mastectomy (simple mastectomy, nipple-sparing and skin-sparing mastectomy); (ii) the oncological safety of implant-based breast reconstruction and fat grafting. | ArmGroups: [{'label': 'Immediate tissue expander and fat grafting after mastectomy', 'type': 'EXPERIMENTAL', 'description': 'Patients underwent simple mastectomy, skin-sparing or nipple-sparing mastectomy and implant-based, two-stage breast reconstruction: contextual mastectomy and expander positioning were performed during first stage (stage I) while substitution of the expander with definitive implant occurred during second stage (stage II). Fat grafting with regenerative intent was performed during stage I or between stage I and II. Adipose tissue was harvested from the abdomen, flanks, trochanter regions, inner thigh and medial aspect of knees. Fat was injected in the subfascial plane of the pectoralis major muscle with blunt cannula in order to avoid thrombo-embolic risks. At least six months after stage I patients underwent expander substitution with definitive implant and contralateral mammoplasty when required. In case of complications that required removal of the implant, autologous reconstruction was performed.', 'interventionNames': ['Procedure: Immediate tissue expander and lipofilling after mastectomy']}] | Interventions:[{'type': 'PROCEDURE', 'name': 'Immediate tissue expander and lipofilling after mastectomy', 'description': 'Implant-based breast reconstruction and fat grafting after salvage or prophylactic mastectomy in patients previously exposed to radiation therapy on the breast as adjuvant treatment after breast conserving surgery (BCS) or on thoracic wall for Hodgkin Lymphoma (HL).', 'armGroupLabels': ['Immediate tissue expander and fat grafting after mastectomy']}] | PrimaryOutcomes: [{'measure': 'Complication rates after stage I and II', 'description': 'Identification of complication rates after stage I and II, measuring percentage of complications (pain and patient discomfort, partial necrosis of mastectomy flaps, nipple-areolar necrosis, delayed wound healing, capsular contracture, bleeding, expander or implant exposition, infection, expander rupture, re-operations, reconstruction failures) over the total number of surgical procedures of stage I and II.', 'timeFrame': '1 month, 6 months and 12 months'}, {'measure': "Patient's satisfaction", 'description': "Self-assessed patient reports for identification of patient's satisfaction, measuring percentage of patients that were satisfied with results overall.", 'timeFrame': '12 months'}, {'measure': 'Cosmetic outcomes', 'description': 'Clinical and photography-based assessments for cosmetic outcomes measurement graded by a plastic breast surgeon as excellent, very good, good, fair, or poor.', 'timeFrame': '1 month, 6 months and 12 months'}] | SecondaryOutcomes: [{'measure': 'Oncological safety of implant-based breast reconstruction and fat grafting.', 'description': 'Identification of rate of loco-regional and distant metastases.', 'timeFrame': '5 years'}] |
Title: A Randomized Study of Weekly Vinorelbine (Navelbine®) Alone or in Combination With Trastuzumab (Herceptin®) (NSC-688097) for Patients With HER-2-Positive Metastatic Breast Cancer Whose Tumors Have Progressed After Taxane + Trastuzumab Combination Therapy - Phase III | Condition: Breast Cancer | Keywords: stage IV breast cancer, recurrent breast cancer | Summary: | Description: OBJECTIVES:
* Compare progression-free survival (PFS) of women with HER2-positive progressive metastatic breast cancer treated with vinorelbine with or without trastuzumab (Herceptin®).
* Compare overall survival and time to treatment failure in patients treated with these regimens.
* Compare the toxicity of these regimens in these patients.
* Compare the response rate (complete and partial, confirmed and unconfirmed) in patients with measurable disease treated with these regimens.
* Correlate baseline circulating tumor cells (CTC) with PFS, overall survival, and disease progression status at 9 weeks in patients treated with these regimens.
* Correlate 4-week CTC with subsequent PFS and overall survival of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive trastuzumab (Herceptin®) IV over 90 minutes and vinorelbine IV over 10 minutes on day 1 of course 1. Patients receive trastuzumab IV over 30 minutes and vinorelbine IV over 10 minutes on days 1, 8, 15, and 22 in all subsequent courses. If trastuzumab is discontinued due to toxicity, patients may continue to receive vinorelbine alone.
* Arm II: Patients receive vinorelbine IV over 10 minutes on days 1, 8, 15, and 22.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years.
PROJECTED ACCRUAL: A total of 292 patients (146 per treatment arm) will be accrued for this study within 3 years. | ArmGroups: N/A | Interventions:[{'type': 'BIOLOGICAL', 'name': 'trastuzumab'}, {'type': 'DRUG', 'name': 'vinorelbine tartrate'}] | PrimaryOutcomes: N/A | SecondaryOutcomes: N/A |
Title: An Open, Multicenter, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacokinetics, and Antitumor Activity of GNC-038 Quad-specific Antibody Injection in Relapsed or Refractory Non-Hodgkin's Lymphoma, Relapsed or Refractory Acute Lymphoblastic Leukemia, and Refractory or Metastatic Solid Tumors | Condition: Non Hodgkin Lymphoma, Acute Lymphoblastic Leukemia | Keywords: | Summary: | Description: Phase Ia: To observe the safety and tolerability of GNC-038 in patients with relapsed or refractory non-Hodgkin lymphoma (R/R NHL)/relapsed or refractory acute lymphoblastic leukemia (R/R ALL), To determine the maximum tolerated dose (MTD) or maximum administration dose (MAD) and dose-limiting toxicity (DLT) of GNC-038 without MTD and recommend the dose for subsequent clinical studies. Phase Ib: To further observe the safety and tolerability of GNC-038 at the Phase Ia recommended dose to determine the Phase II recommended dose (RP2D). | ArmGroups: [{'label': 'Study treatment', 'type': 'EXPERIMENTAL', 'description': 'The patients received intravenous infusion of GNC-038 for 1 cycle. After the completion of 2 cycles of treatment, participants with no unbearable ae could proceed to the 3rd and 4th cycles of treatment. After four cycles of treatment, participants with clinical benefits could also receive four additional cycles of the same dose.', 'interventionNames': ['Drug: GNC-038']}] | Interventions:[{'type': 'DRUG', 'name': 'GNC-038', 'description': 'Administration by intravenous infusion.', 'armGroupLabels': ['Study treatment']}] | PrimaryOutcomes: [{'measure': 'Dose limiting toxicity (DLT)', 'description': 'The incidence and severity of adverse events (TEAE) during treatment were graded according to the National Cancer Institute Standard for Common Terminology for Adverse Events (NCI-CTCAE, v5.0).', 'timeFrame': 'Up to 14 days after the first dose'}, {'measure': 'Maximum tolerated dose (MTD) or maximum administrated dose (MAD)', 'description': 'In the dose increment stage, the highest dose whose estimated DLT rate is closest to the target DLT rate but does not exceed the upper bound of the equivalent interval of DLT rate is selected as MTD.', 'timeFrame': 'Up to 14 days after the first dose'}, {'measure': 'Treatment-Emergent Adverse Event (TEAE)', 'description': 'TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of GNC-038. The type, frequency and severity of TEAE will be evaluated during the treatment of GNC-038.', 'timeFrame': 'Up to approximately 24 months'}, {'measure': 'The recommended dose for future clinical study', 'description': 'The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of GNC-038.', 'timeFrame': 'Up to 14 days after the first dose of GNC-038'}] | SecondaryOutcomes: [{'measure': 'Adverse Events of special interest (AESI)', 'description': "AESI is an event of scientific and medical interest specific to the sponsor's product or research project.", 'timeFrame': 'Up to approximately 24 months'}, {'measure': 'Cmax: Maximum serum concentration of GNC-038', 'description': 'Maximum serum concentration (Cmax) of GNC-038 will be investigated.', 'timeFrame': 'Up to 14 days after the first dose of GNC-038'}, {'measure': 'Css: Concentration of GNC-038 at steady state plateau', 'description': 'Concentration of GNC-038 at steady state plateau will be investigated.', 'timeFrame': 'Up to 14 days after the first dose of GNC-038'}, {'measure': 'Tmax: Time to maximum serum concentration (Tmax) of GNC-038', 'description': 'Time to maximum serum concentration (Tmax) of GNC-038 will be investigated.', 'timeFrame': 'Up to 14 days after the first dose of GNC-038'}, {'measure': 'T1/2: Half-life of GNC-038', 'description': 'Half-life (T1/2) of GNC-038 will be investigated.', 'timeFrame': 'Up to 14 days after the first dose of GNC-038'}, {'measure': 'AUC0-inf: Area under the serum concentration-time curve from time 0 to infinity', 'description': 'Blood concentration - Area under time line.', 'timeFrame': 'Up to 14 days after the first dose of GNC-038'}, {'measure': 'AUC0-t: Area under the serum concentration-time curve from time 0 to the time of the last measurable concentration', 'description': 'Blood concentration - Area under time line.', 'timeFrame': 'Up to 14 days after the first dose of GNC-038'}, {'measure': 'CL: Clearance in the serum of GNC-038 per unit of time', 'description': 'To study the serum clearance rate of GNC-038 per unit time.', 'timeFrame': 'Up to 14 days after the first dose of GNC-038'}, {'measure': 'Incidence and titer of ADA (Anti-drug antibody)', 'description': 'Frequency and titer of anti-GNC-038 antibody (ADA) will be evaluated.', 'timeFrame': 'Up to approximately 24 months'}, {'measure': 'Incidence and titer of Nab (Neutralizing antibody)', 'description': 'Incidence and titer of Nab of GNC-038 will be evaluated.', 'timeFrame': 'Up to approximately 24 months'}, {'measure': 'ORR (Objective Response Rate )', 'description': 'ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.', 'timeFrame': 'Up to approximately 24 months'}, {'measure': 'DCR (Disease Control Rate)', 'description': 'The DCR is defined as the percentage of participants who has a CR, PR, or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \\[PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD\\]).', 'timeFrame': 'Up to approximately 24 months'}, {'measure': 'PFS (Progression-free Survival)', 'description': "The PFS is defined as the time from the participant's first dose of GNC-038 to the first date of either disease progression or death, whichever occurs first.", 'timeFrame': 'Up to approximately 24 months'}, {'measure': 'DOR (Duration of Response)', 'description': "The DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first.", 'timeFrame': 'Up to approximately 24 months'}] |
Title: Combination of Disitamab Vedotin and Anlotinib in the Treatment of HR-Negative, HER2-Low-Expressing Metastatic Breast Cancer: A Single-Arm, Multicenter, Phase II Clinical Study | Condition: Breast Cancer | Keywords: HER2 low expression, Breast Cancer, RC48, Disitamab Vedotin | Summary: | Description: N/A | ArmGroups: [{'label': 'RC48+Anlotinib', 'type': 'EXPERIMENTAL', 'description': 'Disitamab Vedotin : 2 mg/kg，ivgtt，d1-14/28day/cycle Anlotinib: 12mg once daily (taken before meals) orally, continuously for 2 weeks followed by a 1-week break. Each cycle consists of 21 days.', 'interventionNames': ['Drug: Disitamab Vedotin+Anlotinib']}] | Interventions:[{'type': 'DRUG', 'name': 'Disitamab Vedotin+Anlotinib', 'description': 'Disitamab Vedotin:2 mg/kg，ivgtt，d1-14/28day/cycle Anlotinib: 12mg once daily (taken before meals) orally, continuously for 2 weeks followed by a 1-week break. Each cycle consists of 21 days.', 'armGroupLabels': ['RC48+Anlotinib']}] | PrimaryOutcomes: [{'measure': 'Objective response rate (ORR)', 'description': 'The percentage of cases that have achieved complete or partial remission after drug treatment compared to the total evaluable cases.', 'timeFrame': '1year'}] | SecondaryOutcomes: [{'measure': 'Progression-Free Survival (PFS)', 'description': 'All adverse events (AEs) in this study will be encoded using MedDRA and classified according to the NCICTCAEv5.0 grading system.', 'timeFrame': '2years'}, {'measure': 'Overall Survival (OS)', 'description': "Defined as the time from the beginning of the patient's treatment to death from any cause.", 'timeFrame': '2years'}, {'measure': 'Disease Control Rate (DCR)', 'description': 'The proportion of patients who achieve complete remission (CR), partial remission (PR), or disease stability (SD) during or after treatment', 'timeFrame': '1year'}, {'measure': 'Duration of Response (DOR)', 'description': 'Defined as the date from which tumor remission was first recorded (evaluated according to the RECIST 1.1 standard) to the date when disease progression was first recorded (evaluated according to the RECIST 1.1 standard) or the date of death from any cause.', 'timeFrame': '1year'}, {'measure': 'AEs', 'description': 'All adverse events (AEs) in this study will be encoded using MedDRA and classified according to the NCICTCAEv5.0 grading system.', 'timeFrame': '2years'}] |
Title: A Phase II Pilot Study of yttriuM-90 in Combination With capEcitabine and aTezolizumab for oligomEtastatic cOlorectal Cancer With unResectable lIver MeTastasEs (METEORITE) | Condition: Colorectal Carcinoma Metastatic in the Liver | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'yttriuM-90 in combination with capEcitabine and aTezolizumab', 'type': 'EXPERIMENTAL', 'description': 'Atezolizumab 1,200 mg IV every 3 weeks for 5 doses Capecitabine 825 mg/m2 PO BID for 2 weeks beginning on the date of each Y-90 therapy administration Y-90 radioembolization one or both hemilivers based on distribution of disease', 'interventionNames': ['Combination Product: yttrium-90 radioembolization']}] | Interventions:[{'type': 'COMBINATION_PRODUCT', 'name': 'yttrium-90 radioembolization', 'description': 'yttrium-90 radioembolization in combination with capecitabine and atezolizumab for the treatment of unresectable colorectal cancer liver metastases in individuals who have been treated with two or more lines of systemic therapy.', 'armGroupLabels': ['yttriuM-90 in combination with capEcitabine and aTezolizumab'], 'otherNames': ['capecitabine and atezolizumab']}] | PrimaryOutcomes: [{'measure': 'To assess the preliminary efficacy with the combination of yttrium-90, capecitabine, and atezolizumab based on the intrahepatic disease control rate (iDCR) at 12 weeks', 'description': "Disease control rate is defined as the proportion of patients with complete response (CR), partial response (PR), or stable disease (SD) within the liver at first post-Y-90 follow-up imaging by NCI's response evaluation criteria in solid tumors (RECIST 1.1), which is a standard way to measure if the tumor is responding to treatment by measuring tumor lesions (cm).", 'timeFrame': '12 weeks'}] | SecondaryOutcomes: [{'measure': 'To evaluate the preliminary safety of the combination of yttrium-90, capecitabine, and atezolizumab', 'description': "Adverse events will be collected (side effects) per the National Cancer Institute's Common Terminology Criteria for Adverse Events CTCAE v5 (adverse events (side effects) are graded from 1-5).", 'timeFrame': 'Approximately 18 months'}, {'measure': 'To determine the extrahepatic disease control rate (eDCR) with the combination of yttrium-90, capecitabine, and atezolizumab', 'description': "assessment of extrahepatic disease control rate (eDCR), measurements from up to three of the target lesions identified outside the liver will be utilized to categorize non-liver response according to NCI's response evaluation criteria in solid tumors (RECIST 1.1), which is a standard way to measure if the tumor is responding to treatment by measuring lesions (cm).", 'timeFrame': 'Approximately 18 months'}, {'measure': 'To estimate the median overall response rate (ORR), progression free survival (PFS), and overall survival (OS) with the combination of yttrium-90, capecitabine, and atezolizumab', 'description': "CT imaging will be performed beginning on Day 90 (+7 days) or Day 132 (+7 days) depending on if the participant received one or two doses of Y-90, respectively. Subsequently, imaging is to be performed every 90 days (+14 days) until disease progression according to NCI's response evaluation criteria in solid tumors (RECIST) 1.1, which is a standard way to measure if the tumor is responding to treatment by measuring lesions (cm).", 'timeFrame': 'Approximately 18 months'}] |
Title: Prospective, Multicenter, Observational Study on Erbitux® (Cetuximab) in Patients With EGFR-expressing, KRAS Wild-type Metastatic Colorectal Cancer | Condition: Colorectal Neoplasm | Keywords: Colorectal cancer, Metastasis, Cetuximab, Erbitux, Epidermal growth factor receptor | Summary: | Description: Colorectal cancer is the fourth commonest form of cancer worldwide and remains a leading malignancy both in incidence and mortality. Erbitux is an immunoglobulin G1 monoclonal antibody that specifically blocks ligand binding to the EGFR with high affinity, thereby preventing downstream signal transduction and cellular responses. Erbitux enhances the effects of some common chemotherapy agents and radiotherapy and demonstrates minimal overlapping toxicities with these approaches. Erbitux in combination with other treatment modalities, has also shown efficacy in the treatment of a number of solid tumors, including mCRC, squamous cell carcinoma of the head and neck, and non-small cell lung cancer. Based on several studies conducted in the past, Erbitux has been approved for the treatment of subjects with EGFR-expressing, KRAS wild-type mCRC, as a single agent in subjects who have failed oxaliplatin-and irinotecan-based therapy and who are intolerant to irinotecan or in combination with chemotherapy. The most common Erbitux-related adverse events (AEs) are related to skin, infusion, and hypersensitivity reactions. Other side effects with Erbitux monotherapy include asthenia, dyspnoea, mucositis, nausea, pain, fever and headache.
OBJECTIVES
Primary objective:
* To obtain safety information on the use of Erbitux in subjects with EGFR-expressing, KRAS wild-type mCRC in terms of frequency and severity of AEs
Secondary objective:
* To gather clinical efficacy information of the treatment
The study will primarily collect safety data related to Erbitux treatment along with the clinical efficacy information from the start of treatment with Erbitux until progressive disease, Erbitux related intolerable toxicities, death, or withdrawal of Erbitux treatment whichever occurs first. All subjects will be enrolled in the order to visit the physician after making contract and each subject will be observed for a period of 4 months in average. Erbitux will be prescribed to mCRC subjects according to the approved national label as in routine clinical practice under the supervision of an investigator experienced in the use of antineoplastic medicinal products. Prior to the first infusion, subjects will receive pre-medication with an antihistamine and a corticosteroid. The initial dose of Erbitux is 400 mg/m2 body surface area and the subsequent weekly doses are 250 mg/m2 each administered intravenously (i.v.) via in-line filtration with an infusion pump, gravity drip, or a syringe pump. The recommended infusion period for the initial dose is 120 minutes and for the subsequent weekly doses is 60 minutes with the maximum infusion rate not exceeding 5 ml/min. The observational period of this study is defined as from the first infusion of Erbitux until 28 days after the last infusion of Erbitux in each subject, regardless the reason of discontinuation of Erbitux treatment. | ArmGroups: N/A | Interventions:[{'type': 'DRUG', 'name': 'Cetuximab', 'description': 'In subjects with mCRC, cetuximab will be used in combination with chemotherapy or as a single agent according to the approved national label as in routine clinical practice. The initial dose of Erbitux is 400 mg/m2 body surface area and the subsequent weekly doses are 250 mg/m2 each administered i.v. via in-line filtration with an infusion pump, gravity drip, or a syringe pump. The recommended infusion period for the initial dose is 120 minutes and for the subsequent weekly doses is 60 minutes with the maximum infusion rate not exceeding 5 ml/min.', 'otherNames': ['Erbitux']}] | PrimaryOutcomes: [{'measure': 'Safety and toxicity of Erbitux treatment', 'description': 'Frequency and severity of all AEs and serious adverse events; Laboratory information (haematology, clinical chemistry, EGFR test and KRAS test).', 'timeFrame': '120 minutes and for the subsequent weekly doses is 60 minutes. Before, during and at the end of Erbitux treatment period'}] | SecondaryOutcomes: [{'measure': 'Clinical efficacy of Erbitux treatment', 'description': 'The following data will be collected:\n\n* Best tumor response with Erbitux treatment\n* Time to progression of tumor with Erbitux treatment\n* Duration of response with Erbitux treatment', 'timeFrame': '120 minutes and for the subsequent weekly doses is 60 minutes From the start of treatment with Erbitux until progressive disease, Erbitux related intolerable toxicities, death, or withdrawal of Erbitux treatment whichever occurs first'}] |
Title: Randomized Phase II-Trial to Determine the Impact of Darbepoetin Alfa on the Frequency of RBC Transfusions in Patients With Metastatic "Poor Prognosis" Germ Cell Tumor Treated With High-Dose Chemotherapy (HD-VIP Regimen) | Condition: Dysgerminoma | Keywords: | Summary: | Description: N/A | ArmGroups: N/A | Interventions:[{'type': 'DRUG', 'name': 'Darbepoetin alfa'}] | PrimaryOutcomes: [{'measure': 'frequency of transfusions (reduction from 90% to 65%)'}] | SecondaryOutcomes: [{'measure': 'proportion of patients with no transfusions'}, {'measure': 'developing of hemoglobin levels'}, {'measure': 'objective remission rate'}, {'measure': 'progression-free- and overall-survival (pfs, os)'}, {'measure': 'quality of life'}] |
Title: Pilot Study of the Effectiveness of the JeffQuit Smoking Cessation Program | Condition: Current Smoker, Malignant Neoplasm | Keywords: | Summary: | Description: PRIMARY OBJECTIVES:
I. To assess the initial effectiveness of the JeffQuit program on smoking cessation in cancer patients.
II. To assess the quality of life improvements related to the JeffQuit smoking cessation program in cancer patients.
OUTLINE:
Patients undergo three, 1-hour group therapy sessions held by a JeffQuit practitioner over a 1-month period. Patients receive strategies for managing the psychological, habitual, and physiological components of smoking and help with developing a planned quit date. Patients are also provided with advice on how to switch to cigarette brands with less nicotine and then how to substitute the nicotine patch and gum for cigarettes. The JeffQuit counselor is available for additional individual support as needed.
After completion of study, patients are followed up at 6 months. | ArmGroups: [{'label': 'Supportive care (JeffQuit group therapy)', 'type': 'EXPERIMENTAL', 'description': 'Patients undergo three, 1-hour group therapy sessions held by a JeffQuit practitioner over a 1-month period. Patients receive strategies for managing the psychological, habitual, and physiological components of smoking and help with developing a planned quit date. Patients are also provided with advice on how to switch to cigarette brands with less nicotine and then how to substitute the nicotine patch and gum for cigarettes. The JeffQuit counselor is available for additional individual support as needed.', 'interventionNames': ['Other: Tobacco Cessation Counseling', 'Other: Support Group Therapy', 'Other: Quality-of-Life Assessment']}] | Interventions:[{'type': 'OTHER', 'name': 'Tobacco Cessation Counseling', 'description': 'Undergo JeffQuit group therapy', 'armGroupLabels': ['Supportive care (JeffQuit group therapy)'], 'otherNames': ['Tobacco Cessation Counseling, Tobacco Counseling']}, {'type': 'OTHER', 'name': 'Support Group Therapy', 'description': 'Undergo JeffQuit group therapy', 'armGroupLabels': ['Supportive care (JeffQuit group therapy)']}, {'type': 'OTHER', 'name': 'Quality-of-Life Assessment', 'description': 'Ancillary studies', 'armGroupLabels': ['Supportive care (JeffQuit group therapy)'], 'otherNames': ['Quality of Life Assessment, Quality-of-Life Assessment']}] | PrimaryOutcomes: [{'measure': 'Proportion of patients who are adherent to smoking abstinence', 'description': 'Calculated along with a 1-sided 95% exact confidence interval. An exact binomial test (with a one-sided alpha of 0.05) will also be used to test whether adherence is greater than 60%.', 'timeFrame': 'Up to 6 months after completion of intervention'}] | SecondaryOutcomes: [{'measure': 'Change in Patient Reported Outcomes Measurement Information System (PROMIS) quality of life scores', 'description': 'The scores for the Patient Reported Outcomes Measurement Information System (PROMIS) questionnaire will be evaluated for differences between the pre and post program states using analysis of variance using mixed models to allow for inclusion of all subjects with at least one measurement, with assessment of post-treatment to pre-treatment changes as the primary consideration. Longitudinal repeated measures using linear mixed models will be applied to assess the change from baseline as the outcome, and an exploratory analysis of potential clinical and demographic modifiers will be completed.', 'timeFrame': 'Baseline to up to 6 months after completion of intervention'}, {'measure': 'Change in Smoking Cessation Quality of Life (SCQoL) questionnaire scores', 'description': 'The scores for the Smoking Cessation Quality of Life (SCQoL) questionnaire will be evaluated for differences between the pre and post program states using analysis of variance using mixed models to allow for inclusion of all subjects with at least one measurement, with assessment of post-treatment to pre-treatment changes as the primary consideration. Longitudinal repeated measures using linear mixed models will be applied to assess the change from baseline as the outcome, and an exploratory analysis of potential clinical and demographic modifiers will be completed.', 'timeFrame': 'Baseline to up to 6 months after completion of intervention'}] |
Title: PROTOCOL FOR A PHASE I STUDY OF INTRATHECAL MONOCLONAL ANTIBODY FRAGMENT 131I Me1-14 F(ab')2 IN PATIENTS WITH NEOPLASMS METASTATIC TO THE LEPTOMENINGES | Condition: Metastatic Cancer | Keywords: leptomeningeal metastases | Summary: | Description: OBJECTIVES: I. Determine the toxicity and maximum tolerated dose of 131-iodine-labeled monoclonal antibody fragment Me1-14 F(ab')2 administered intrathecally in patients with neoplasms metastatic to the leptomeninges. II. Identify objective therapeutic responses to this treatment.
OUTLINE: Radioimmunotherapy. Iodine-131-Labeled Monoclonal Antibody Fragment Me1-14 F(ab')2, 131I-Me1-14 F(ab')2.
PROJECTED ACCRUAL: Three to 6 patients will be treated at each dose studied. | ArmGroups: N/A | Interventions:[{'type': 'BIOLOGICAL', 'name': "monoclonal antibody Me1-14 F(ab')2"}] | PrimaryOutcomes: N/A | SecondaryOutcomes: N/A |
Title: A Phase II, Single-center, Randomized Study of Vinorelbine Plus Apatinib Versus Vinorelbine as Second-Line or Third-Line Treatment in Patients With Advanced Triple-Negative Breast Cancer (NAN Trail) | Condition: Advanced Triple-Negative Breast Cancer | Keywords: | Summary: | Description: A Phase II, Single-center, Randomized Study of Vinorelbine Plus Apatinib Versus Vinorelbine as Second-Line or Third-Line Treatment in Patients With Advanced Triple-Negative Breast Cancer (NAN trail) | ArmGroups: [{'label': 'Vinorelbine Plus Apatinib', 'type': 'EXPERIMENTAL', 'description': 'Vinorelbine: 20 mg/m2, D6, D13, D20\n\nApatinib: 250 mg/d, D1-5, D8-12, D15-19. The starting dose will be 250mg/d in the first cycle, if tolerable, 500 mg/d will be administered from the cycle 2.', 'interventionNames': ['Drug: Vinorelbine', 'Drug: Apatinib']}, {'label': 'Vinorelbine', 'type': 'ACTIVE_COMPARATOR', 'description': 'Vinorelbine: 25 mg/m2, D1, D8, D15', 'interventionNames': ['Drug: Vinorelbine']}] | Interventions:[{'type': 'DRUG', 'name': 'Vinorelbine', 'description': 'Experimental: 20 mg/m2, D6, D13, D20 Active Comparator: 25 mg/m2, D1, D8, D15', 'armGroupLabels': ['Vinorelbine', 'Vinorelbine Plus Apatinib'], 'otherNames': ['NVB']}, {'type': 'DRUG', 'name': 'Apatinib', 'description': '250 mg/d, D1-5, D8-12, D15-19. The starting dose will be 250mg/d in the first cycle, if tolerable, 500 mg/d will be administered from the cycle 2.', 'armGroupLabels': ['Vinorelbine Plus Apatinib']}] | PrimaryOutcomes: [{'measure': 'PFS', 'description': 'Progression Free Survival', 'timeFrame': '6 weeks'}] | SecondaryOutcomes: [{'measure': 'OS', 'description': 'Overall Survival', '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 100 months'}, {'measure': 'ORR', 'description': 'Objective Response Rate', 'timeFrame': '6 weeks'}, {'measure': 'Safety: Number of Participants with Adverse Events', 'description': 'Number of Participants with Adverse Events as a Measure of Safety and Tolerability', 'timeFrame': '6 weeks'}] |
Title: MicroRNAs Methylation and Expression Profiling for Identification of Breast Cancer Patients at High Risk to Develop Distant Metastases | Condition: Breast Cancer Female, Metastases Breast | Keywords: microRNA, prognosis, risk prediction | Summary: | Description: The potential role of miRNAs will be studied as a predictor of metastases development. miRNAs expression and miRNAs promoter methylation will be evaluated in surgically removed specimens obtained from breast cancer patients at diagnosis. Relevant miRNAs will be first identified by analysing a retrospective breast cancer cohort including at least and subsequently validated on a prospective cohort. | ArmGroups: [{'label': 'Retrospective', 'description': 'Identification in a retrospective cohort of a miRNA panel associated with the development of distant metastases.The retrospective cohort consists of tumor and normal tissue obtained from breast cancer patients, stored at -80°C at the Laboratory of Oncology. Of these samples, 360 met the inclusion criteria.', 'interventionNames': ['Diagnostic Test: miRNA targeted analysis on breast cancer tissues', 'Diagnostic Test: miRNA profiling of breast cancer tissues']}, {'label': 'Prospective', 'description': 'The association between miRNA expression and the clinical course of the disease identified in the retrospective cohort, is being confirmed in an independent prospective cohort. Both normal and tumor tissues of the patients, as well as plasma collected before surgery and at each follow-up time point, is being analyzed. Based on the annual number of surgeries performed at the Breast Surgery Unit, we initially estimated that the prospective cohort would consist of about 500 patients recruited over three years. Since the project was extended for additional two years the actual number of subject recruited was 972. In addition plasma sample for 100 breast benign condition was also collected as controls.', 'interventionNames': ['Diagnostic Test: miRNA targeted analysis on breast cancer tissues', 'Diagnostic Test: miRNA targeted analysis on plasma samples']}] | Interventions:[{'type': 'DIAGNOSTIC_TEST', 'name': 'miRNA targeted analysis on breast cancer tissues', 'description': 'Total RNA is extracted from tissue sample and selected miRNA quantified by PCR based relative quantification method (QPCR) with a standard curve.', 'armGroupLabels': ['Prospective', 'Retrospective']}, {'type': 'DIAGNOSTIC_TEST', 'name': 'miRNA targeted analysis on plasma samples', 'description': 'miRNAs extracted from plasma samples are analysed by QPCR and/or ddPCR .', 'armGroupLabels': ['Prospective']}, {'type': 'DIAGNOSTIC_TEST', 'name': 'miRNA profiling of breast cancer tissues', 'description': 'Selected samples from the retrospective cohort are profiled for miRNA expression by using GeneChip® miRNA 4.0 Array.', 'armGroupLabels': ['Retrospective']}] | PrimaryOutcomes: [{'measure': 'Risk of metastases development', 'description': 'Identification of miRNAs associated with the risk to develop distant metastases.', 'timeFrame': 'evaluation 5 and 10 years after diagnosis'}] | SecondaryOutcomes: [{'measure': 'Overall Survival', 'description': 'Identification of miRNAs associated with the risk of cancer specific death', 'timeFrame': 'evaluation 5 and 10 years after diagnosis'}] |
Title: A Multicenter, Randomized, Double-blind, Parallel-controlled Phase 3 Study Evaluating the Efficacy and Safety of Recombinant Human Monoclonal Antibody Against Human Tumor Necrosis Factor-α (IBI303) Compared to Adalimumab in Patients With Active Ankylosing Spondylitis | Condition: AS | Keywords: ankylosing spondylitis, tumor necrosis factor-α inhibitors | Summary: | Description: Adults patients with active ankylosing spondylitis (AS) were randomized in a 1:1 ratio to receive treatment with adalimumab 40 mg every other week (eow) or IBI303, given subcutaneously (SC), in the 24-week double-blind (DB) phase. Randomized participants received one SC injection of the appropriate DB study medication (adalimumab 40 mg or IBI303) at Week 0 and then eow until Week 22. A follow-up visit occurred 70 days(Week 32) after the last dose of study drug to obtain information on any ongoing or new adverse events (AEs). | ArmGroups: [{'label': 'IBI303', 'type': 'EXPERIMENTAL', 'description': 'IBI303 40mg administered subcutaneously every other week, 12cycles', 'interventionNames': ['Drug: IBI303']}, {'label': 'Adalimumab', 'type': 'ACTIVE_COMPARATOR', 'description': 'Adalimumab 40mg administered subcutaneously every other week', 'interventionNames': ['Drug: Adalimumab']}] | Interventions:[{'type': 'DRUG', 'name': 'IBI303', 'description': '12 cycles. IBI303: 40 mg, iH', 'armGroupLabels': ['IBI303']}, {'type': 'DRUG', 'name': 'Adalimumab', 'description': '12 cycles. Adalimumab: 40mg, iH', 'armGroupLabels': ['Adalimumab']}] | PrimaryOutcomes: [{'measure': 'Number of participants meeting the Assessment of Spondyloarthritis International Society(ASAS) ASAS20 Response Criteria', 'timeFrame': 'Week 24'}] | SecondaryOutcomes: [{'measure': 'Number of participants meeting the ASAS20 Response', 'timeFrame': 'Week 2'}, {'measure': 'Number of participants meeting the ASAS20 Response', 'timeFrame': 'Week 4'}, {'measure': 'Number of participants meeting the ASAS20 Response', 'timeFrame': 'Week 8'}, {'measure': 'Number of participants meeting the ASAS20 Response', 'timeFrame': 'Week 12'}, {'measure': 'Number of participants meeting the ASAS20 Response', 'timeFrame': 'Week 16'}, {'measure': 'Number of participants meeting the ASAS20 Response', 'timeFrame': 'Week 20'}, {'measure': 'Number of participants meeting the ASAS40 Response Criteria', 'timeFrame': 'Week 24'}, {'measure': 'Number of Participants Meeting the ASAS5/6 Response Criteria', 'timeFrame': 'Week 24'}, {'measure': 'Number of Participants Meeting the ASAS Partial Remission', 'timeFrame': 'Week 24'}, {'measure': 'Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index(BASDAI), in Bath Ankylosing Spondylitis Functional Index(BASFI), in Bath Ankylosing Spondylitis Measure Index(BASMI)', 'timeFrame': 'Baseline and Week 24'}, {'measure': 'Number of participants meeting the ASAS40 Response Criteria', 'timeFrame': 'Week 2'}, {'measure': 'Number of participants meeting the ASAS40 Response Criteria', 'timeFrame': 'Week 4'}, {'measure': 'Number of participants meeting the ASAS40 Response Criteria', 'timeFrame': 'Week 8'}, {'measure': 'Number of participants meeting the ASAS40 Response Criteria', 'timeFrame': 'Week12'}, {'measure': 'Number of participants meeting the ASAS40 Response Criteria', 'timeFrame': 'Week16'}, {'measure': 'Number of participants meeting the ASAS40 Response Criteria', 'timeFrame': 'Week20'}, {'measure': 'Number of Participants Meeting the ASAS5/6 Response Criteria', 'timeFrame': 'Week 2'}, {'measure': 'Number of Participants Meeting the ASAS5/6 Response Criteria', 'timeFrame': 'Week 4'}, {'measure': 'Number of Participants Meeting the ASAS5/6 Response Criteria', 'timeFrame': 'Week 8'}, {'measure': 'Number of Participants Meeting the ASAS5/6 Response Criteria', 'timeFrame': 'Week 12'}, {'measure': 'Number of Participants Meeting the ASAS5/6 Response Criteria', 'timeFrame': 'Week 16'}, {'measure': 'Number of Participants Meeting the ASAS5/6 Response Criteria', 'timeFrame': 'Week 20'}, {'measure': 'Number of Participants Meeting the ASAS Partial Remission', 'timeFrame': 'Week 2'}, {'measure': 'Number of Participants Meeting the ASAS Partial Remission', 'timeFrame': 'Week 4'}, {'measure': 'Number of Participants Meeting the ASAS Partial Remission', 'timeFrame': 'Week 8'}, {'measure': 'Number of Participants Meeting the ASAS Partial Remission', 'timeFrame': 'Week 12'}, {'measure': 'Number of Participants Meeting the ASAS Partial Remission', 'timeFrame': 'Week 16'}, {'measure': 'Number of Participants Meeting the ASAS Partial Remission', 'timeFrame': 'Week 20'}, {'measure': 'Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index(BASDAI), in Bath Ankylosing Spondylitis Functional Index(BASFI), in Bath Ankylosing Spondylitis Messure Index(BASMI)', 'timeFrame': 'Baseline and Week 2'}, {'measure': 'Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index(BASDAI), in Bath Ankylosing Spondylitis Functional Index(BASFI), in Bath Ankylosing Spondylitis Messure Index(BASMI)', 'timeFrame': 'Baseline and Week 4'}, {'measure': 'Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index(BASDAI), in Bath Ankylosing Spondylitis Functional Index(BASFI), in Bath Ankylosing Spondylitis Messure Index(BASMI)', 'timeFrame': 'Baseline and Week 8'}, {'measure': 'Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index(BASDAI), in Bath Ankylosing Spondylitis Functional Index(BASFI), in Bath Ankylosing Spondylitis Messure Index(BASMI)', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index(BASDAI), in Bath Ankylosing Spondylitis Functional Index(BASFI), in Bath Ankylosing Spondylitis Messure Index(BASMI)', 'timeFrame': 'Baseline and Week 16'}, {'measure': 'Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index(BASDAI), in Bath Ankylosing Spondylitis Functional Index(BASFI), in Bath Ankylosing Spondylitis Messure Index(BASMI)', 'timeFrame': 'Baseline and Week 20'}, {'measure': 'Change from Baseline in Patient Global Assessment of Disease Activity', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Change from Baseline in Patient Global Assessment of Disease Activity', 'timeFrame': 'Baseline and Week 24'}, {'measure': 'Change from Baseline in Total Back Pain Score', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Change from Baseline in Total Back Pain Score', 'timeFrame': 'Baseline and Week 24'}, {'measure': 'Change From Baseline in Inflammation Score', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Change From Baseline in Inflammation Score', 'timeFrame': 'Baseline and Week 24'}, {'measure': 'Change from Baseline in Maastricht Ankylosing Spondylitis Enthesis Score(MASES)', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Change from Baseline in Maastricht Ankylosing Spondylitis Enthesis Score(MASES)', 'timeFrame': 'Baseline and Week 24'}, {'measure': 'Change from Baseline in ASDAS-CRP and ASDAS-ESR', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Change from Baseline in ASDAS-CRP and ASDAS-ESR', 'timeFrame': 'Baseline and Week 24'}, {'measure': 'Change from Baseline in EQ-5D/WPAI-SHP/HAQ-S QoL', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Change from Baseline in EQ-5D/WPAI-SHP/HAQ-S QoL', 'timeFrame': 'Baseline and Week 24'}] |
Title: Evalution of Safety, Tolerability and Pharmacokinetics of of HPPH in Ascending Dose for Cancer Patients in Phase I Clinical Trial | Condition: Esophageal Cancer | Keywords: PHHP, Esophageal cancer, Phase I study | Summary: | Description: The present study is phase I study to evaluate the safety, tolerability, and pharmacokinetics of multiple ascending injection doses of HPPH in Patients with Esophageal Cancer. Up to 30 patients are planned to be enrolled in 6 cohorts with each cohort consisting of 3-6 patients ( male and/or female patients). In each cohort, patients will receive HPPH and Lyophilized treatment. The dose escalation in Cohorts was from 2.5 to 3, 3.5, 4, 5, and 6mg/m2 of HPPH, respectively, administered intravenous drop infusion over 1 hour, once daily, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH. | ArmGroups: [{'label': 'HPPH 2.5 mg/m2', 'type': 'EXPERIMENTAL', 'description': 'HPPH 2.5 mg/m2, Freeze-dried powder injection, intravenous infusion once daily, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.', 'interventionNames': ['Drug: HPPH 2.5 mg/m2']}, {'label': 'HPPH 3 mg/m2', 'type': 'EXPERIMENTAL', 'description': 'HPPH 3 mg/m2, Freeze-dried powder injection, intravenous infusion once daily, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.', 'interventionNames': ['Drug: HPPH 3 mg/m2']}, {'label': 'HPPH 3.5 mg/m2', 'type': 'EXPERIMENTAL', 'description': 'HPPH 3.5 mg/m2, Freeze-dried powder injection, intravenous infusion once daily, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.', 'interventionNames': ['Drug: HPPH 3.5 mg/m2']}, {'label': 'HPPH 4 mg/m2', 'type': 'EXPERIMENTAL', 'description': 'HPPH 4 mg/m2, Freeze-dried powder injection, intravenous infusion once daily, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.', 'interventionNames': ['Drug: HPPH 4 mg/m2']}, {'label': 'HPPH 5 mg/m2', 'type': 'EXPERIMENTAL', 'description': 'HPPH 5 mg/m2, Freeze-dried powder injection, intravenous infusion once daily, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.', 'interventionNames': ['Drug: HPPH 5 mg/m2']}, {'label': 'HPPH 6 mg/m2', 'type': 'EXPERIMENTAL', 'description': 'HPPH 6 mg/m2, Freeze-dried powder injection, intravenous infusion once daily, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.', 'interventionNames': ['Drug: HPPH 6 mg/m2']}] | Interventions:[{'type': 'DRUG', 'name': 'HPPH 2.5 mg/m2', 'description': 'HPPH was administered as a single, 2.5 mg/m2, slow intravenous infusion over 1 hour , and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.', 'armGroupLabels': ['HPPH 2.5 mg/m2']}, {'type': 'DRUG', 'name': 'HPPH 3 mg/m2', 'description': 'HPPH was administered as a single, 3 mg/m2, slow intravenous infusion over 1 hour, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.', 'armGroupLabels': ['HPPH 3 mg/m2']}, {'type': 'DRUG', 'name': 'HPPH 3.5 mg/m2', 'description': 'HPPH was administered as a single, 3.5 mg/m2, slow intravenous infusion over 1 hour, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.', 'armGroupLabels': ['HPPH 3.5 mg/m2']}, {'type': 'DRUG', 'name': 'HPPH 4 mg/m2', 'description': 'HPPH was administered as a single, 4 mg/m2, slow intravenous infusion over 1 hour, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.', 'armGroupLabels': ['HPPH 4 mg/m2']}, {'type': 'DRUG', 'name': 'HPPH 5 mg/m2', 'description': 'HPPH was administered as a single, 5 mg/m2, slow intravenous infusion over 1 hour, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.', 'armGroupLabels': ['HPPH 5 mg/m2']}, {'type': 'DRUG', 'name': 'HPPH 6 mg/m2', 'description': 'HPPH was administered as a single, 6 mg/m2, slow intravenous infusion over 1 hour, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.', 'armGroupLabels': ['HPPH 6 mg/m2']}] | PrimaryOutcomes: [{'measure': 'The number of dose-limiting toxicity', 'description': 'Dose-limiting toxicity would be assesed by CTCAE4.0', 'timeFrame': 'Day 1 to Day 10'}] | SecondaryOutcomes: [{'measure': 'Maximum observed concentration (Cmax)', 'description': 'PK measurement expressed as Cmax for HPPH', 'timeFrame': 'Day 1 to Day 84'}, {'measure': 'Time to maximum concentration (tmax)', 'description': 'PK measurement expressed as Tmax for HPPH', 'timeFrame': 'Day 1 to Day 84'}, {'measure': 'Apparent terminal elimination phase half (t1/2)', 'description': 'PK measurement expressed as t1/2 for HPPH', 'timeFrame': 'Day 1 to Day 84'}, {'measure': 'Area under the concentration-time curve over the dosing interval (AUC0-t)', 'description': 'PK measurement expressed as AUC0-t for HPPH', 'timeFrame': 'Day 1 to Day 84'}, {'measure': 'Area under the concentration-time curve from zero extrapolated to infinity (AUC0-∞)', 'description': 'PK measurement expressed as AUC0-∞ for HPPH', 'timeFrame': 'Day 1 to Day 84'}] |
Title: Evaluation of the Gastrinoma in Patients With Zollinger-Ellison Syndrome | Condition: Zollinger Ellison Syndrome | Keywords: Zollinger-Ellison Syndrome, Natural History | Summary: | Description: This protocol concerns the approach to the localization and management of the tumor in patients with Zollinger-Ellison syndrome. It details the diagnostic imaging tests to be used to localize the tumor and the subsequent management of the tumor. | ArmGroups: [{'label': 'Patients', 'description': 'Patients will Zollinger-Ellison Syndrome'}] | Interventions:N/A | PrimaryOutcomes: [{'measure': 'To determine an approach to the localization and management of tumor in patients with ZES.', 'description': 'localization of tumor', 'timeFrame': 'Yearly'}] | SecondaryOutcomes: N/A |
Title: LCCC 1027: Expression Of P16INK4a As A Predictor Of Myelosuppression In Patients With Breast Cancer | Condition: Breast Cancer | Keywords: Breast, Cancer, Breast Cancer, New Diagnosis, Treatment, Chemotherapy, Blood, Blood Draw, Lab Draw, Gene, Gene Therapy, Geriatric, Oncology, Muss, UNC, North Carolina Cancer Hospital, Initial Treatment, CBC | Summary: | Description: N/A | ArmGroups: N/A | Interventions:N/A | PrimaryOutcomes: [{'measure': 'Determine if p16INK4a Expression at Baseline is Related to Nadir Neutrophil Counts in Women with Breast Cancer Receiving Chemotherapy', 'description': 'To measure and correlate baseline p16INK4a expression in subjects with stage I-IV breast cancer starting a new course of chemotherapy with a post cycle 1 chemotherapy absolute neutrophil count (ANC).', 'timeFrame': '24 months'}] | SecondaryOutcomes: [{'measure': 'Define the Association Between p16INK4a Expression and Physical Activity, Smoking and Alcohol Consumption in Women with Breast Cancer Receiving Chemotherapy', 'description': 'To explore the associations between p16INK4a expression at baseline and amount of vigorous physical activity, smoking habits, and weekly alcohol consumption.', 'timeFrame': '24 months'}, {'measure': 'Explore the Associations between p16INK4a Expression at Baseline and Other Chemotherapy-Related Toxicities including Nausea and Vomiting, Neuropathy, Fatigue and Other Grade 3 and 4 Toxicities', 'description': 'To explore the associations between p16INK4a expression at baseline and other chemotherapy-related toxicities, including the maximum toxicity experienced during that course of chemotherapy.', 'timeFrame': '24 Months'}, {'measure': 'Explore Associations between p16INK4a Expression at Baseline, Chemotherapy Regimen, and its Effect on Patient Function', 'description': 'To explore the associations between p16INK4a expression at baseline and type of chemotherapy received, co-morbidities, concomitant medications, and tumor characteristics.', 'timeFrame': '24 months'}] |
Title: Exploration of the Neuromuscular Mechanisms Associated With Sunitinib Related Fatigue | Condition: Fatigue, Recurrent Renal Cell Cancer, Stage IV Renal Cell Cancer | Keywords: | Summary: | Description: PRIMARY OBJECTIVES:
I. To determine the mechanisms associated with sunitinib related fatigue by recording EMG signals during a submaximal elbow contraction, twitch force and TMS prior to and at the end of 4 weeks of sunitinib in metastatic RCC patients.
OUTLINE:
Patients receive sunitinib malate orally (PO) daily for 4 weeks. Patients undergo neuromuscular testing at baseline and on day 28 and complete fatigue assessment at baseline and on days 14 and 28.
. | ArmGroups: [{'label': 'Supportive care (sunitinib malate, neuromuscular testing)', 'type': 'EXPERIMENTAL', 'description': 'Patients receive sunitinib malate PO daily for 4 weeks. Patients undergo neuromuscular testing at baseline and on day 28 and complete fatigue assessment at baseline and on days 14 and 28.', 'interventionNames': ['Procedure: transcranial magnetic stimulation', 'Procedure: electromyography', 'Other: survey administration', 'Drug: sunitinib malate']}] | Interventions:[{'type': 'PROCEDURE', 'name': 'transcranial magnetic stimulation', 'description': 'Undergo TMS', 'armGroupLabels': ['Supportive care (sunitinib malate, neuromuscular testing)'], 'otherNames': ['TMS']}, {'type': 'PROCEDURE', 'name': 'electromyography', 'description': 'Undergo EMG', 'armGroupLabels': ['Supportive care (sunitinib malate, neuromuscular testing)'], 'otherNames': ['EMG']}, {'type': 'OTHER', 'name': 'survey administration', 'description': 'Ancillary studies', 'armGroupLabels': ['Supportive care (sunitinib malate, neuromuscular testing)']}, {'type': 'DRUG', 'name': 'sunitinib malate', 'description': 'Given PO', 'armGroupLabels': ['Supportive care (sunitinib malate, neuromuscular testing)'], 'otherNames': ['SU11248', 'sunitinib', 'Sutent']}] | PrimaryOutcomes: [{'measure': 'Changes of Muscular (Peripheral) Fatigue Maximal Twitch Force (MTF)', 'description': 'The MTF will be elicited by supramaximal-intensity electrical stimulation of the muscle before and after the sustained contraction (SC). If the muscle is fatigued at the end of the SC, the MTF will be reduced because the ability of muscle to generate force declines with fatigue. If the sunitinib treatment results in minimal muscular fatigue, the MTF will not have as much reduction in the 2nd as that in the 1st session.', 'timeFrame': 'Baseline and 28 days'}, {'measure': 'Change in EMG Amplitude and Power Frequency', 'description': 'EMG amplitude will increase (for low-intensity SC) and mean power frequency (MPF) decrease with muscle fatigue. The EMG signals recorded during the SC, its amplitude and MPF will be analyzed to determine their changes at the end vs. beginning of the SC. If the sunitinib results in minimal muscular fatigue, the amount of EMG increase and MPF decrease will be reduced in the 2nd compared with those the 1st session.', 'timeFrame': 'Baseline and 28 days'}, {'measure': 'Changes in Motor Evoked Potential (MEP) by TMS', 'description': 'TMS illustrates the changes in corticospinal excitability occurring in association with fatigue. Central muscle evoked response (MEP) will be elicited using transcranial magnetic stimulation (TMS) using single stimulus pulses applied to the scalp overlying the primary motor cortex.', 'timeFrame': 'Baseline and 28 days'}] | SecondaryOutcomes: N/A |
Title: Prospective Comparison of Surgical Outcomes With Using Integrated Robotic Technology Versus Conventional Laparoscopy for Gastric Cancer Surgery | Condition: Gastric Cancer Patients Undergoing Minimally Invasive Gastrectomy | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'Integrated robotic surgery', 'type': 'EXPERIMENTAL', 'interventionNames': ['Procedure: Integrated robotic surgery']}, {'label': 'Conventional laparoscopic surgery', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Procedure: Conventional laparoscopic surgery']}] | Interventions:[{'type': 'PROCEDURE', 'name': 'Integrated robotic surgery', 'description': 'Robotic gastrectomy using Single-Site and Firefly technology will be performed. Specifically, two-port surgery using the Single-Site port and an independent trocar along the right flank (for harmonic scalpel) will be used, along with peritumoral injection of indocyanine green via endoscopy the day before surgery to completely visualize the entire lymphatic channel.', 'armGroupLabels': ['Integrated robotic surgery']}, {'type': 'PROCEDURE', 'name': 'Conventional laparoscopic surgery', 'description': 'conventional laparoscopic gastrectomy will be performed.', 'armGroupLabels': ['Conventional laparoscopic surgery']}] | PrimaryOutcomes: [{'measure': 'Number of retrieved LN', 'timeFrame': 'during the gastrectomy surgery'}] | SecondaryOutcomes: N/A |
Title: Phase 2 Trial of Fulvestrant and Binimetinib in Patients With Hormone Receptor-Positive Metastatic Breast Cancer With Inactivating or Inferred Inactivating NF1 Alterations: A ComboMATCH Treatment Trial | Condition: Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Negative Breast Carcinoma, Metastatic Hormone Receptor-Positive Breast Carcinoma | Keywords: | Summary: | Description: PRIMARY OBJECTIVES:
I. To determine whether the combination of fulvestrant and binimetinib improves progression-free survival (PFS) compared to treatment with fulvestrant alone in patients not previously treated with fulvestrant. (Cohort 1) II. To determine whether overall response rate (ORR) within 4 months in patients who have previously progressed on a fulvestrant-containing regimen is greater than 10%, as a historical comparison, when these patients receive combination fulvestrant and binimetinib therapy. (Cohort 2)
SECONDARY OBJECTIVES:
I. To estimate ORR at any time after the start of the treatment for Cohort 2 and separately for the two arms in Cohort 1.
II. To estimate PFS distribution in Cohort 2. III. To estimate clinical benefit rate separately for the two arms in Cohort 1 and Cohort 2.
IV. To determine the safety and toxicity profile in both cohorts. V. To estimate the overall survival (OS) in both cohorts. VI. Collect tissue and provide it to the ComboMATCH Registration Protocol to assess concordance between the diagnostic tumor mutation profile generated by the Designated Laboratories, the pre-treatment biopsy mutation profile, and the pre-treatment circulating tumor deoxyribonucleic acid (DNA) (ctDNA) mutation profile from plasma, as described in ComboMATCH Registration Protocol. For this treatment substudy, the outcome objective will be to report the proportion of cases providing sufficient tissue for that integrated scientific activity in the ComboMATCH Registration Protocol.
EXPLORATORY BIOMARKER OBJECTIVES:
I. To analyze the cell-free (cf)DNA at progression to determine the changes in cfDNA profile in order to understand blood-based mutation dynamics.
II. To analyze RNAseq at progression to determine potential pathways that are altered that may contribute to the sensitivity/resistance.
III. To discover/detect novel biomarkers using microscaled proteogenomics by analyzing the proteins and phosphor-proteins along with genomics to determine potential pathways that may correlate with the response to the combination treatment.
IV. To detect the loss of NF1, using immunohistochemistry staining to precisely measure the level of the NF1 protein.
V. To determine the variant allele frequency (VAF) of mutant NF1 measuring by using droplet digital polymerase chain reaction (ddPCR) for the targeted NF1 gene level.
OUTLINE: Patients who are fulvestrant naive are assigned to Cohort I, while patients who are fulvestrant resistant are assigned to Cohort II.
COHORT I: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive fulvestrant intramuscularly (IM) on day 1 and day 15 of cycle 1 and day 1 of subsequent cycles and binimetinib orally (PO) twice daily (BID) on days 15 to 28 of cycle 1 and day 1 through 28 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo a computed tomography (CT), magnetic resonance imaging (MRI), or bone scan, echocardiography (ECHO) or multi-gated acqusition scan (MUGA), and tumor biopsy, as well as possible blood sample collection during screening and on study.
ARM II: Patients receive fulvestrant IM on day 1 and day 15 of cycle 1 and day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who progress on fulvestrant alone may migrate to cohort II if they meet the migration eligibility criteria. Patients not willing to migrate to cohort II will have further therapy at the investigator's discretion. Patients undergo a CT, MRI, or bone scan and tumor biopsy, as well as ECHO or MUGA and possible blood sample collection during screening and on study.
COHORT II: Patients receive fulvestrant IM on day 1 of each cycle and binimetinib PO BID on days 15-28 of cycle 1 and day 1 through 28 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo a CT, MRI, or bone scan, ECHO or MUGA and tumor biopsy, as well as possible blood sample collection during screening and on study.
Upon completion of study treatment patients are followed up every 6 months for 5 years. | ArmGroups: [{'label': 'Cohort I (Arm I) (fulvestrant, binimetinib)', 'type': 'EXPERIMENTAL', 'description': 'Patients receive fulvestrant IM on day 1 and day 15 of cycle 1 and day 1 of subsequent cycles and binimetinib PO BID on days 15 to 28 of cycle 1 and day 1 through 28 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT, MRI, or bone scan, ECHO or MUGA, and tumor biopsy, as well as possible blood sample collection during screening and on study.', 'interventionNames': ['Drug: Binimetinib', 'Procedure: Biopsy', 'Procedure: Biospecimen Collection', 'Procedure: Bone Scan', 'Procedure: Computed Tomography', 'Procedure: Echocardiography', 'Drug: Fulvestrant', 'Procedure: Magnetic Resonance Imaging', 'Procedure: Multigated Acquisition Scan']}, {'label': 'Cohort I (Arm II)', 'type': 'ACTIVE_COMPARATOR', 'description': "Patients receive fulvestrant IM on day 1 and day 15 of cycle 1 and day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who progress on fulvestrant alone may migrate to cohort II if they meet the migration eligibility criteria. Patients not willing to migrate to cohort II will have further therapy at the investigator's discretion. Patients undergo a CT, MRI, or bone scan and tumor biopsy, as well as ECHO or MUGA and possible blood sample collection during screening and on study.", 'interventionNames': ['Procedure: Biopsy', 'Procedure: Biospecimen Collection', 'Procedure: Bone Scan', 'Procedure: Computed Tomography', 'Procedure: Echocardiography', 'Drug: Fulvestrant', 'Procedure: Magnetic Resonance Imaging', 'Procedure: Multigated Acquisition Scan']}, {'label': 'Cohort II (fulvestrant, binimetinib)', 'type': 'EXPERIMENTAL', 'description': 'Patients receive fulvestrant IM on day 1 of each cycle and binimetinib PO BID on days 15-28 of cycle 1 and day 1 through 28 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo a CT, MRI, or bone scan, ECHO or MUGA and tumor biopsy, as well as possible blood sample collection during screening and on study.', 'interventionNames': ['Drug: Binimetinib', 'Procedure: Biopsy', 'Procedure: Biospecimen Collection', 'Procedure: Bone Scan', 'Procedure: Computed Tomography', 'Procedure: Echocardiography', 'Drug: Fulvestrant', 'Procedure: Magnetic Resonance Imaging', 'Procedure: Multigated Acquisition Scan']}] | Interventions:[{'type': 'DRUG', 'name': 'Binimetinib', 'description': 'Given PO', 'armGroupLabels': ['Cohort I (Arm I) (fulvestrant, binimetinib)', 'Cohort II (fulvestrant, binimetinib)'], 'otherNames': ['ARRY 162', 'ARRY 438162', 'ARRY-162', 'ARRY-438162', 'ARRY162', 'ARRY438162', 'MEK 162', 'MEK-162', 'MEK162', 'Mektovi']}, {'type': 'PROCEDURE', 'name': 'Biopsy', 'description': 'Undergo tumor biopsy', 'armGroupLabels': ['Cohort I (Arm I) (fulvestrant, binimetinib)', 'Cohort I (Arm II)', 'Cohort II (fulvestrant, binimetinib)'], 'otherNames': ['BIOPSY_TYPE', 'Bx']}, {'type': 'PROCEDURE', 'name': 'Biospecimen Collection', 'description': 'Undergo blood sample collection', 'armGroupLabels': ['Cohort I (Arm I) (fulvestrant, binimetinib)', 'Cohort I (Arm II)', 'Cohort II (fulvestrant, binimetinib)'], 'otherNames': ['Biological Sample Collection', 'Biospecimen Collected', 'Specimen Collection']}, {'type': 'PROCEDURE', 'name': 'Bone Scan', 'description': 'Undergo bone scan', 'armGroupLabels': ['Cohort I (Arm I) (fulvestrant, binimetinib)', 'Cohort I (Arm II)', 'Cohort II (fulvestrant, binimetinib)'], 'otherNames': ['Bone Scintigraphy']}, {'type': 'PROCEDURE', 'name': 'Computed Tomography', 'description': 'Undergo CT scan', 'armGroupLabels': ['Cohort I (Arm I) (fulvestrant, binimetinib)', 'Cohort I (Arm II)', 'Cohort II (fulvestrant, binimetinib)'], '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': 'PROCEDURE', 'name': 'Echocardiography', 'description': 'Undergo ECHO', 'armGroupLabels': ['Cohort I (Arm I) (fulvestrant, binimetinib)', 'Cohort I (Arm II)', 'Cohort II (fulvestrant, binimetinib)'], 'otherNames': ['EC']}, {'type': 'DRUG', 'name': 'Fulvestrant', 'description': 'Given IM', 'armGroupLabels': ['Cohort I (Arm I) (fulvestrant, binimetinib)', 'Cohort I (Arm II)', 'Cohort II (fulvestrant, binimetinib)'], 'otherNames': ['Faslodex', 'Faslodex(ICI 182,780)', 'ICI 182,780', 'ICI 182780', 'ICI-182780', 'ICI182780', 'ZD 9238', 'ZD-9238', 'ZD9238']}, {'type': 'PROCEDURE', 'name': 'Magnetic Resonance Imaging', 'description': 'Undergo MRI', 'armGroupLabels': ['Cohort I (Arm I) (fulvestrant, binimetinib)', 'Cohort I (Arm II)', 'Cohort II (fulvestrant, binimetinib)'], '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': 'PROCEDURE', 'name': 'Multigated Acquisition Scan', 'description': 'Undergo MUGA', 'armGroupLabels': ['Cohort I (Arm I) (fulvestrant, binimetinib)', 'Cohort I (Arm II)', 'Cohort II (fulvestrant, binimetinib)'], 'otherNames': ['Blood Pool Scan', 'Equilibrium Radionuclide Angiography', 'Gated Blood Pool Imaging', 'Gated Heart Pool Scan', 'MUGA', 'MUGA Scan', 'Multi-Gated Acquisition Scan', 'Radionuclide Ventriculogram Scan', 'Radionuclide Ventriculography', 'RNV Scan', 'RNVG', 'SYMA Scanning', 'Synchronized Multigated Acquisition Scanning']}] | PrimaryOutcomes: [{'measure': 'Progression free survival (PFS) (Cohort I)', 'description': 'PFS of the two study arms will be compared by log-rank test (1-sided, alpha=0.1). Kaplan-Meier plot will be provided. Hazard ratio (HR) and the corresponding 95% confidence interval (CI) will be estimated by Cox proportional model using treatment as covariate.', 'timeFrame': 'The duration between randomization and progression or death from all cause, whichever happens first, assessed up to 5 years'}, {'measure': 'Objective response rate (ORR) (Cohort II)', 'description': 'ORR is the percentage of patients who reaches a complete or partial response (defined by Response Evaluation Criteria in Solid Tumors \\[RECIST\\] version\\[v\\]1.1) within 4 months of the start of the treatment. ORR will be calculated as the proportion of patients achieved partial response (PR) or complete response (CR) within 4 months after the initiation of the treatment. ORR will be reported with corresponding 95% exact CI. Patients who have withdrawn from the study before any efficacy follow up are considered non-evaluable for clinical response and will be replaced.', 'timeFrame': 'Within 4 months of the start of treatment'}] | SecondaryOutcomes: [{'measure': 'ORR for each study arm (Cohort I)', 'description': 'ORR is the percentage of patients who reach a complete or partial response (defined by RECIST v1.1) any time after the start of the treatment. ORR for each study arm will be calculated with corresponding 95% exact CI. Fisher exact test will be used to compare the ORR of the two study arms.', 'timeFrame': 'Any time after the start of the treatment, assessed up to 5 years'}, {'measure': 'ORR (Cohort II)', 'description': 'ORR is the percentage of patients who reach a complete or partial response (defined by RECIST v1.1) any time after the start of the treatment.', 'timeFrame': 'Any time after the start of the treatment, assessed up to 5 years'}, {'measure': 'Clinical benefit rate', 'description': 'Defined as proportion of patients who achieved a CR, PR, or stable disease defined by RECIST criteria any time after the start of the treatment. Clinical benefit rate will be analyzed for each arm of cohort I and cohort II as described for ORR. ORR for each study arm will be calculated with corresponding 95% exact CI. Fisher exact test will be used to compare the ORR of the two study arms.', 'timeFrame': 'Any time after the start of the treatment, assessed up to 5 years'}, {'measure': 'PFS (Cohort II)', 'description': "PFS for cohort II will be summarized using the Kaplan-Meier's method. Median PFS with corresponding 95% CI will be provided.", 'timeFrame': 'The duration between randomization and progression or death from all cause, whichever happens first, assessed up to 5 years'}, {'measure': 'Overall survival (OS)', 'description': "OS for cohort I will be analyzed as described for PFS in cohort I and OS for cohort II will be analyzed as described for PFS in cohort II. PFS of the two study arms will be compared by log-rank test (1-sided, alpha=0.1). Kaplan-Meir plot will be provided. HR and the corresponding 95% CI will be estimated by Cox proportional model using treatment as covariate. PFS for Cohort 2 will be summarized using the Kaplan-Meir's method. Median PFS with corresponding 95% CI will be provided.", 'timeFrame': 'The duration between randomization and death of all causes, assessed up to 5 years'}, {'measure': 'Incidence of adverse events', 'description': 'The grade of toxicity measurement will follow Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The distribution by treatment group of the highest grade of each CTCAEs experienced by each patient categorized will be tabulated. The tabulations will also be reviewed on a semi-annual basis by the Data Monitoring Committee. These tabulations will include summaries by system organ class and summaries by term under each system organ class.', 'timeFrame': 'Up to 5 years'}] |
Title: A Phase III, Multicenter, Randomized Controlled Study to Compare Safety and Efficacy of a Haploidentical HSCT and Adjunctive Treatment With ATIR101, a T-lymphocyte Enriched Leukocyte Preparation Depleted ex Vivo of Host Alloreactive T-cells, Versus a Haploidentical HSCT With Post-transplant Cyclophosphamide in Patients With a Hematologic Malignancy | Condition: Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome | Keywords: Haploidentical stem cell transplantation, Graft-versus-host disease, Immune reconstitution, Alloreactive T-cells, Photodynamic treatment, Hematologic malignancy, Transplant-related mortality, Overall survival, GRFS, GVHD | Summary: | Description: Study CR-AIR-009 is a Phase III randomized controlled multicenter open-label study comparing two parallel groups. After signing informed consent, a total of 250 patients will be randomized in a 1:1 fashion to receive either a T-cell depleted hematopoietic stem cell transplantation (HSCT; CD34 selection) from a related, haploidentical donor, followed by ATIR101 infusion, or a T-cell replete HSCT, followed by a high dose of post-transplant cyclophosphamide (PTCy).
Randomization will use minimization to balance treatment groups with respect to underlying disease (AML, ALL, or MDS), Disease Risk Index (DRI; intermediate risk, high risk, or very high risk) and center. A stochastic treatment allocation procedure will be used so that the treatment assignment is random for all patients entered in the study.
Patients randomized in the ATIR101 group will receive a single ATIR101 dose of 2×10E6 viable T-cells/kg between 28 and 32 days after the HSCT. Patients randomized in the PTCy group will receive cyclophosphamide 50 mg/kg/day at 3 and 4/5 days after the HSCT. All patients will be followed up for at least 24 months post HSCT. | ArmGroups: [{'label': 'ATIR101', 'type': 'EXPERIMENTAL', 'description': 'T-cell depleted HSCT from a related, haploidentical donor, followed by IV infusion with ATIR101 at a single dose of 2×10E6 viable T-cells/kg body weight between 28 and 32 days after the HSCT', 'interventionNames': ['Biological: ATIR101', 'Procedure: T-cell depleted HSCT from a related, haploidentical donor']}, {'label': 'PTCy', 'type': 'ACTIVE_COMPARATOR', 'description': 'T-cell replete HSCT from a related, haploidentical donor, followed by IV infusion of post-transplant cyclophosphamide (PTCy) 50 mg/kg/day at 3 and 4/5 days after the HSCT', 'interventionNames': ['Drug: Cyclophosphamide', 'Procedure: T-cell replete HSCT from a related, haploidentical donor']}] | Interventions:[{'type': 'BIOLOGICAL', 'name': 'ATIR101', 'description': 'ATIR101 is a T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells using photodynamic treatment; single dose of 2×10E6 viable T-cells/kg body weight between 28 and 32 days after the HSCT (intravenous infusion)', 'armGroupLabels': ['ATIR101']}, {'type': 'DRUG', 'name': 'Cyclophosphamide', 'description': 'High dose post-transplant cyclophosphamide 50 mg/kg/day at 3 and 4/5 days after the HSCT (powder for intravenous infusion)', 'armGroupLabels': ['PTCy']}, {'type': 'PROCEDURE', 'name': 'T-cell depleted HSCT from a related, haploidentical donor', 'description': 'T-cell depleted graft prepared from peripheral blood stem cells using the CD34+ cell selection method; infused after a total body irradiation (TBI) or non-TBI conditioning regimen', 'armGroupLabels': ['ATIR101']}, {'type': 'PROCEDURE', 'name': 'T-cell replete HSCT from a related, haploidentical donor', 'description': 'T-cell replete (full, non-manipulated) graft prepared from either bone marrow or peripheral blood stem cells; infused after a total body irradiation (TBI) or non-TBI conditioning regimen', 'armGroupLabels': ['PTCy']}] | PrimaryOutcomes: [{'measure': 'Graft-versus-host Disease-free, Relapse-free Survival (GRFS)', 'description': 'Defined as the time until acute GVHD grade III/IV, chronic GVHD requiring systemic treatment, relapse, or death, whichever occurs first. Kaplan-Meier estimates (percentage of participants) of GRFS were calculated at 24 months post HSCT.', 'timeFrame': '24 months post-HSCT'}] | SecondaryOutcomes: [{'measure': 'Overall Survival (OS)', 'description': 'OS is defined as the time from HSCT until death from any cause. Kaplan-Meier estimates (percentage of participants) of OS were calculated at 24 months post HSCT.', 'timeFrame': '24 months post-HSCT'}, {'measure': 'Progression-free Survival (PFS)', 'description': 'Defined as the time from HSCT until relapse, disease progression, or death, whichever occurs first. Kaplan-Meier estimates (percentage of participants) of PFS were calculated at 24 months post HSCT.', 'timeFrame': '24 months post-HSCT'}, {'measure': 'Relapse-related Mortality (RRM)', 'description': 'Time from randomization to death due to disease relapse or disease progression', 'timeFrame': 'Through study completion, at least two years post HSCT'}, {'measure': 'Transplant-related Mortality (TRM)', 'description': 'Defined as death due to causes other than disease relapse or progression, or other causes which are unrelated to the transplantation procedure (e.g. accident, suicide). Kaplan-Meier estimates (percentage of participants) of PFS were calculated at 24 months post HSCT.', 'timeFrame': '24 months post-HSCT'}] |
Title: Molecular Analysis Of Bladder Cancer | Condition: Bladder Cancer, Bladder Neoplasms | Keywords: Bladder Cancer, Cancer, bladder, Urinary Bladder Cancer | Summary: | Description: N/A | ArmGroups: N/A | Interventions:N/A | PrimaryOutcomes: N/A | SecondaryOutcomes: N/A |
Title: Efficacy of Lidocaine Versus Placebo in Palliative Care Patients With Opioid-refractory Cancer Pain With Neuropathic Component: a Multicenter, Prospective, Double-blind Randomized Placebo-controlled Study. | Condition: Cancer, Pain With Neuropathic Component | Keywords: cancer, pain | Summary: | Description: N/A | ArmGroups: [{'label': 'lidocaine', 'type': 'ACTIVE_COMPARATOR', 'description': 'Lidocaine. Initial dose IV will be 5 mg/kg per day during the first 24 hours the 8 mg/kg per day', 'interventionNames': ['Drug: Lidocaine']}, {'label': 'placebo', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Drug: Placebo']}] | Interventions:[{'type': 'DRUG', 'name': 'Lidocaine', 'armGroupLabels': ['lidocaine'], 'otherNames': ['Lidocaine. Initial dose IV will be 5 mg/kg per day during the first 24 hours the 8 mg/kg per day']}, {'type': 'DRUG', 'name': 'Placebo', 'armGroupLabels': ['placebo']}] | PrimaryOutcomes: [{'measure': 'Analgesic efficacy', 'description': 'Analgesic efficacy will be assessed from several endpoints. The primary endpoint will be defined as the change of pain level between baseline (T0) and 40 minutes (T1) after baseline. The pain level will be assessed using a self-administered numeric pain intensity scale (NPIS), ranged from 0 (no pain) to 10 (worst pain possible). A minimal 30% decrease of pain level between baseline and T1 will define the success, and other cases will define the failure of the treatment.', 'timeFrame': '40 minutes'}] | SecondaryOutcomes: [{'measure': 'intensity of the pain neuropathic', 'description': 'the intensity of the pain neuropathic component using the Neuropathic Pain Symptom Inventory (NPSI) at T4, T5, and T6 {Bouhassira, 2004 #9}; the NPSI is a 12-item self-administered questionnaire describing the intensity of the symptoms associated with pain neuropathic', 'timeFrame': '120 minutes'}] |
Title: Evaluating Immunological Parameters, Neurocognitive Changes, Activity Levels, and Driving Fitness in Hematological Malignancy Patients Undergoing Chimeric Antigen Receptor (CAR)-T Cell Therapy | Condition: Hematologic Neoplasms | Keywords: | Summary: | Description: Study specific aims are: (1A) Evaluate changes in serum inflammatory cytokine protein markers in patients receiving CAR T-cell therapy; (1B) Evaluate changes in electroencephalographic and radiologic markers of CAR-T-related toxicities in comparison to neurocognitive function following CAR T-cell therapy; (2A) Assess changes in activity levels using actigraphy/accelerometry to continuously monitor physical activity; and (2B) Assess changes in driving performance using a standardized on-road instrumented vehicle drive.
Patients (n=20) will be recruited into the study if they are diagnosed with relapsed or refractory DLBCL or ALL, and scheduled to undergo commercially-available CAR T-cell therapy.
The following measures will be completed during primary study visits: prior to apheresis (T0) and 8-weeks post CAR-T cell infusion (T6). (1) blood inflammatory proteins; (2) brain wave recordings (or EEG), brain imaging, and neurocognitive assessment; (3) free-living activity levels; and (4) driving performance and safety. EEG will assess neural activity patterns of brain dysfunction; brain imaging will look for brain abnormalities; neurocognitive assessments will evaluate changes in thinking, concentration, and memory. A research-grade activity monitor will be used to assess activity levels. Driving performance and safety will be evaluated using a driving simulator and an on-road vehicle designed to monitor behavior while drivers complete a driving course. Analyses will assess changes between study visits, as well as relationships between immunological, neurological, activity, and driving measures. | ArmGroups: [{'label': 'CAR-T patients', 'description': 'Relapsed or refractory Diffuse large B-cell lymphoma (DLBCL) or acute lymphoblastic leukemia (ALL) with intent to undergo commercially available CAR-T cell therapy'}] | Interventions:N/A | PrimaryOutcomes: [{'measure': 'Evaluate the relationship between immunologic markers of CRS and ICANS in hematologic malignancy patients undergoing CAR-T cell therapy', 'description': 'Change in serum inflammatory cytokine (IL-2, IL-4, IL-6, IL-10, TNF-alpha IFN-gamma, and IL-17A) concentrations from baseline', 'timeFrame': '6 weeks'}, {'measure': 'Evaluate the relationship between neurologic markers of CRS and ICANS in hematologic malignancy patients undergoing CAR-T cell therapy', 'description': 'Change in number of pathological EEG events from baseline', 'timeFrame': '6 weeks'}, {'measure': 'Activity level parameters- daily number of steps', 'description': 'Change in daily number of steps from baseline', 'timeFrame': '6 weeks'}, {'measure': 'On-Road Driving Performance', 'description': 'Change in number of driving safety errors from baseline', 'timeFrame': '6 weeks'}] | SecondaryOutcomes: N/A |
Title: A Phase Ib/II Study of Nivolumab Plus Chemotherapy in Patients With Advanced Cancer (NivoPlus) | Condition: Advanced Cancer, Pancreatic Cancer, Renal Cell Cancer, Non Small Cell Lung Cancer, Colorectal Carcinoma, Endometrial, Uterine | Keywords: | Summary: | Description: Determine the recommended phase 2 dose (RP2D) of chemotherapy in combination with nivolumab in subjects with advanced cancer. | ArmGroups: [{'label': 'Arm 1', 'type': 'EXPERIMENTAL', 'description': 'Temsirolimus 25 mg every 14 days + nivolumab', 'interventionNames': ['Drug: Temsirolimus', 'Drug: nivolumab']}, {'label': 'Arm 2', 'type': 'EXPERIMENTAL', 'description': 'Irinotecan 150 mg/m2 every 14 days + nivolumab', 'interventionNames': ['Drug: Irinotecan', 'Drug: nivolumab']}, {'label': 'Arm 3', 'type': 'EXPERIMENTAL', 'description': 'Irinotecan + capecitabine + nivolumab irinotecan 175 mg/m2 on day 1 every 14 days + capecitabine 1000 mg PO BID days 1-5 on, days 6-7 off, each 7 day period', 'interventionNames': ['Drug: Irinotecan + capecitabine', 'Drug: nivolumab']}] | Interventions:[{'type': 'DRUG', 'name': 'Temsirolimus', 'armGroupLabels': ['Arm 1'], 'otherNames': ['Torisel']}, {'type': 'DRUG', 'name': 'Irinotecan', 'armGroupLabels': ['Arm 2'], 'otherNames': ['Camptosar']}, {'type': 'DRUG', 'name': 'Irinotecan + capecitabine', 'armGroupLabels': ['Arm 3'], 'otherNames': ['Camptosar + Xeloda']}, {'type': 'DRUG', 'name': 'nivolumab', 'armGroupLabels': ['Arm 1', 'Arm 2', 'Arm 3'], 'otherNames': ['Opdivo']}] | PrimaryOutcomes: [{'measure': 'The recommended phase 2 dose (RP2D) of chemotherapy in combination with nivolumab in subjects with advanced cancer.', 'description': 'phase 2 dosing of nivolumab + chemotherapy', 'timeFrame': 'up to 4 weeks'}] | SecondaryOutcomes: [{'measure': 'Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03', 'description': 'Identify adverse Events', 'timeFrame': 'up to 12 months'}, {'measure': 'Response rate by irRC and response evaluation criteria in solid tumors (RECIST) 1.1 criteria1,2', 'description': 'Identify tumor response', 'timeFrame': '12 weeks'}, {'measure': 'The overall survival (OS) and progression-free survival (PFS)', 'description': 'Assess time until death after treatment', 'timeFrame': 'up to 12 months'}, {'measure': 'Quantify changes in amount of blood proteins and circulating tumor DNA in patients enrolled on this study', 'description': 'Assess tumor marker levels', 'timeFrame': 'up to 12 months'}] |
Title: Effect of Exercise Preconditioning in Ovarian Cancer on Treatment-Related Cardiotoxicity | Condition: Ovarian Cancer | Keywords: Cardiotoxicity, Ovarian Cancer, Exercise Training, Chemotherapy, Cardiovascular toxicity ovarian cancer chemotherapy | Summary: | Description: While survivorship for those diagnosed with epithelial ovarian cancer has continued to improve, the significant off target effects of adjuvant and neoadjuvant chemotherapy have become more prominent. These off-target effects include increased risk of cardiovascular disease, neuropathy, and decreased quality of life. Exercise initiated prior to chemotherapy induction and continued through treatment has promise in terms of preserving VO2peak and potentially mitigating the negative cardiovascular and neuropathic effects of chemotherapy. The goal of this study is to examine the effects of initiating exercise prior to any oncologic therapy and sustaining this exercise paradigm in newly diagnosed women with ovarian cancer who are undergoing initial surgery and chemotherapy. | ArmGroups: [{'label': 'Exercise', 'type': 'EXPERIMENTAL', 'description': 'Patients in the exercise group will perform interval training 3 days per week.', 'interventionNames': ['Behavioral: High intensity interval exercise']}, {'label': 'Attention Control', 'type': 'PLACEBO_COMPARATOR', 'description': 'Physical activity education and physical activity monitoring.', 'interventionNames': ['Behavioral: Attention control']}] | Interventions:[{'type': 'BEHAVIORAL', 'name': 'High intensity interval exercise', 'description': 'Patients in the exercise group will perform interval training (HIIT) 3 days per week, with each session consisting of four, 4-min intervals at 85-90% peak heart rate (PHR), separated by 3 min at 50% PHR. Each training session will begin with a 10-minute warm-up at 50% of PHR and end with a 5-min cool down at 50% PHR. Patients will undergo 2 initial training sessions at the exercise physiology core lab. All exercise will consist of stationary cycling to avoid discomfort associated with abdominal surgery as well as stress to the incision and help reduce fall risk. Study investigators will check in weekly with participants and remotely track exercise data and compliance via the Fitbit app.', 'armGroupLabels': ['Exercise']}, {'type': 'BEHAVIORAL', 'name': 'Attention control', 'description': 'Patients in the control group (physical activity education and physical activity monitoring) will receive counseling regarding the benefits of physical activity during chemotherapy treatment. During the intervention, participants will receive a weekly phone call to discuss their physical activity and remind them to engage in physical activity. Patients will be given a goal of working up to 30 minutes of exercise daily. Subjects will be urged to increase daily step counts by 250-500 steps/day. Physical activity will be objectively assessed and made available to the participant using a Fitbit.', 'armGroupLabels': ['Attention Control']}] | PrimaryOutcomes: [{'measure': 'VO2 Peak', 'description': 'Change in VO2peak (L/min) measured at pre-surgery, pre-chemotherapy, and post chemotherapy', 'timeFrame': '22 weeks'}] | SecondaryOutcomes: [{'measure': 'Global Longitudinal Strain', 'description': 'Global longitudinal strain (%) will be used to assess changes in cardiac contractile function and be measured by echocardiogram at pre-surgery, pre-chemotherapy, and post-chemotherapy', 'timeFrame': '22 weeks'}, {'measure': 'Ejection Fraction', 'description': 'Ejection fraction (%) will be used to assess changes in cardiac contractile function and be measured by echocardiogram at pre-surgery, pre-chemotherapy, and post-chemotherapy', 'timeFrame': '22 weeks'}, {'measure': 'Diastolic Function', 'description': "E' and A' (cm/s) will be used to calculate the E'/A' ratio to assess for diastolic dysfunction and be measured by echocardiogram at pre-surgery, pre-chemotherapy, and post-chemotherapy", 'timeFrame': '22 weeks'}, {'measure': 'Brachial Artery Endothelium-Dependent Flow-Mediated Dilation', 'description': 'Changes in endothelial function as measured by brachial artery endothelium-dependent flow-mediated dilation (%) at pre-surgery, pre-chemotherapy, and post-chemotherapy', 'timeFrame': '22 weeks'}, {'measure': 'Carotid-Femoral Pulse Wave Velocity', 'description': 'Changes in arterial stiffness as measured by carotid-femoral pulse wave velocity (m/s) at pre-surgery, pre-chemotherapy, and post-chemotherapy', 'timeFrame': '22 weeks'}, {'measure': 'Blood pressure', 'description': 'Changes in measures of central and brachial blood pressure (mmHg) at pre-surgery, pre-chemotherapy, and post-chemotherapy', 'timeFrame': '22 weeks'}, {'measure': 'Peripheral Neuropathy', 'description': 'A Neuropen will be used to assess for peripheral neuropathy via changes in perception to pressure prior to chemotherapy, at cycle 4, and after cycle 6.', 'timeFrame': '22 weeks'}, {'measure': 'Peripheral Neuropathy as assessed by the FACT-GOG-NTX Questionnaire', 'description': 'The functional assessment of cancer therapy/gynecologic oncology group- neurotoxicity (FACT-GOG-NTX) questionnaire is used to assess symptoms of peripheral neuropathy. This 38 item questionnaire utilizes the same questions as the FACT questionnaire with 11 questions specific to peripheral neuropathy. A 5 point Likert scale is used for each question and subscores are added together with high scores indicating better quality of life', 'timeFrame': '22 weeks'}, {'measure': 'Health Related Quality of Life as Measured by the FACT-O Questionnaire', 'description': 'The functional assessment of cancer therapy- ovarian cancer(FACT-O) questionnaire is used to assess health-related quality of life specific to cancer and includes a subscale for ovarian cancer. This 38 item questionnaire utilizes the same questions as the FACT questionnaire with 12 questions specific to ovarian cancer. A 5 point Likert scale is used for each question and subscores are added together with high scores indicating better quality of life', 'timeFrame': '22 weeks'}, {'measure': 'Quality of Life as Assessed by the Short Form Health Survey (SF-36)', 'description': 'The Short Form Health survey is a 36 item questionnaire that is used to measure general health and quality of life. Responses in each section are scored on a scale of 0-100 (with 100 indicating good health) and averaged together for each subscale score.', 'timeFrame': '22 weeks'}] |
Title: PBM-LEF Study: The Impact of PBM on Biomarkers of Radiation Lymphedema and Fibrosis in Head and Neck Cancer Patients: A Feasibility Study | Condition: Radiation Lymphedema, Radiation Fibrosis, Head and Neck Cancer | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'Active Treatment: PBM Therapy', 'type': 'EXPERIMENTAL', 'description': 'Participants who received bilateral neck RT will be treated with PBM to a total of 12 sites - 6 sites on each side of the neck and face along the 3 neck nodal levels (II, III, IV) of the sternocleidomastoid muscle (SCM), along the major salivary glands (parotid, and submandibular) and masseter\\].\n\nTreatment will occur at two timepoints:\n\n* At least 3 months and less than 18 months after RT completion of last dose to any site\n* Between 18 and 36 months after RT completion of last dose to any site', 'interventionNames': ['Device: Photobiomodulation (PBM) Therapy']}, {'label': 'Sham Treatment', 'type': 'SHAM_COMPARATOR', 'description': 'Participants who received bilateral neck RT will be treated with SHAM PBM to a total of 12 sites - 6 sites on each side of the neck and face along the 3 neck nodal levels (II, III, IV) of the sternocleidomastoid muscle (SCM), along the major salivary glands (parotid, and submandibular) and masseter\\].\n\nTreatment will occur at two timepoints:\n\n* At least 3 months and less than 18 months after RT completion of last dose to any site\n* Between 18 and 36 months after RT completion of last dose to any site', 'interventionNames': ['Device: Sham PBM']}] | Interventions:[{'type': 'DEVICE', 'name': 'Photobiomodulation (PBM) Therapy', 'description': 'PBM is a low-intensity form of light therapy and employs visible or near-infrared (NIR) light generated from a laser or Light Emitting Diode (LED).\n\nIn this study, PBM will be delivered using an LED device emitting 660 and 850nm with the purpose of research. The output power typically ranges from 5 to 200 mW with wavelengths ranging 600-1,000nm.', 'armGroupLabels': ['Active Treatment: PBM Therapy']}, {'type': 'DEVICE', 'name': 'Sham PBM', 'description': 'Sham PBM will be delivered using a matching shame device that emits no output power.', 'armGroupLabels': ['Sham Treatment']}] | PrimaryOutcomes: [{'measure': 'Soft tissue thickness (STT) at Nodal Level II - Right Side', 'description': 'STT will be measured via ultrasound.', 'timeFrame': 'Baseline, Week 2 Post-Treatment'}, {'measure': 'STT at Nodal Level II - Left Side', 'description': 'STT will be measured via ultrasound.', 'timeFrame': 'Baseline, Week 2 Post-Treatment'}, {'measure': 'STT at Nodal Level III - Right Side', 'description': 'STT will be measured via ultrasound.', 'timeFrame': 'Baseline, Week 2 Post-Treatment'}, {'measure': 'STT at Nodal Level III - Left Side', 'description': 'STT will be measured via ultrasound.', 'timeFrame': 'Baseline, Week 2 Post-Treatment'}, {'measure': 'STT at Nodal Level IV - Right Side', 'description': 'STT will be measured via ultrasound.', 'timeFrame': 'Baseline, Week 2 Post-Treatment'}, {'measure': 'STT at Nodal Level IV - Left Side', 'description': 'STT will be measured via ultrasound.', 'timeFrame': 'Baseline, Week 2 Post-Treatment'}] | SecondaryOutcomes: N/A |
Title: A Phase I Multicenter, Open Label, Clinical Trial of Immune Response, Safety and Tolerability of DNA Vector pPRA-PSM With Synthetic Peptides E-PRA and E-PSM in Subjects With Advance Solid Malignancies | Condition: Ovarian, Melanoma, Renal, Prostate, Colorectal, Endometrial Carcinoma, Cervical Carcinoma, Testicular Cancer, Thyroid Cancer, Small Cell Lung Carcinoma, Mesothelioma, Breast Carcinoma, Esophageal Carcinoma, Gastric Cancer, Pancreatic Carcinoma, Neuroendocrine Cancer, Liver Cancer, Gallbladder Cancer, Biliary Tract Cancer, Anal Carcinoma, Bone Sarcomas, Soft Tissue Sarcomas, Carcinoma of Unknown Origin, Primary | Keywords: Cancer Vaccine | Summary: | Description: The majority of tumors are ignored by the immune system and it was thought for a long time that tumor antigens did not exist. However, recently a number of tumor antigens have been described. These antigens reside on cancer cells and can be recognized by specific T-cells which can ultimately attack and destroy the tumor. | ArmGroups: [{'label': 'Low Dose Cohort', 'type': 'EXPERIMENTAL', 'interventionNames': ['Biological: PSMA/PRAME']}, {'label': 'High Dose Cohort', 'type': 'EXPERIMENTAL', 'interventionNames': ['Biological: PSMA/PRAME']}] | Interventions:[{'type': 'BIOLOGICAL', 'name': 'PSMA/PRAME', 'description': 'Low dose', 'armGroupLabels': ['Low Dose Cohort']}, {'type': 'BIOLOGICAL', 'name': 'PSMA/PRAME', 'description': 'high dose', 'armGroupLabels': ['High Dose Cohort']}] | PrimaryOutcomes: [{'measure': 'To determine the immunologic response to the treatment with MKC1106-PP regimen and 2) to determine the safety and adverse event profile of MKC1106-PP', 'timeFrame': 'Every 6 Weeks'}] | SecondaryOutcomes: [{'measure': 'to determine the blood plasmid levels by PCR analysis', 'timeFrame': 'Every 6 Weeks'}, {'measure': 'measure cytokine levels', 'timeFrame': 'Every 6 Weeks'}, {'measure': 'to describe any objective tumor responses to the treatment with MKC1106-PP', 'timeFrame': 'Every 6 Weeks'}] |
Title: Low Dose Total-Body Irradiation And Fludarabine Followed By HLA Matched Allogeneic Stem Cell Transplantation For Hematologic Malgnancies - A Multi-Center Study | Condition: Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases | Keywords: recurrent adult Hodgkin lymphoma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, chronic phase chronic myelogenous leukemia, accelerated phase chronic myelogenous leukemia, adult acute myeloid leukemia in remission, recurrent grade 3 follicular lymphoma, recurrent adult diffuse large cell lymphoma, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, recurrent mantle cell lymphoma, stage III mantle cell lymphoma, stage IV mantle cell lymphoma, refractory multiple myeloma, stage I mantle cell lymphoma, contiguous stage II mantle cell lymphoma, noncontiguous stage II mantle cell lymphoma, atypical chronic myeloid leukemia, myelodysplastic/myeloproliferative disease, unclassifiable, refractory chronic lymphocytic leukemia, adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with t(15;17)(q22;q12) | Summary: | Description: OBJECTIVES:
* Determine the response rate and duration of response in patients with low-risk hematologic malignancies treated with low-dose total-body irradiation (TBI) and fludarabine followed by HLA-matched allogeneic stem cell transplantation followed by a slow immunosuppression taper and donor leukocyte infusions (DLI).
* Determine the response rate and duration of response in patients with high-risk hematologic malignancies treated with low-dose TBI and fludarabine followed by HLA-matched allogeneic stem cell transplantation followed by a faster immunosuppression taper and DLI.
* Determine the incidence and extent of graft-versus-host disease, regimen-related toxicity, and engraftment in patients treated with these regimens.
* Assess the quality of life of patients treated with these regimens.
OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 groups (high-risk vs low-risk hematologic malignancy). The high-risk group includes acute myelogenous leukemia, myelodysplastic syndromes, accelerated phase chronic myelogenous leukemia (CML), second chronic phase CML, and non-Hodgkin's lymphoma. The low-risk group includes Hodgkin's lymphoma, first chronic phase CML, multiple myeloma, and chronic lymphocytic leukemia.
Patients receive fludarabine IV on days -4 to -2. Patients undergo total-body irradiation on day 0 followed by allogeneic stem cell transplantation. Patients also receive oral mycophenolate mofetil on days 0-28.
High-risk patients receive oral cyclosporine twice daily on days -2 to day 60. Patients with persistent disease, T-cell chimerism, and no graft-vs-host disease (GVHD) on day 90 receive up to 3 doses of donor leukocyte infusion (DLI) over the next 4 months.
Low-risk patients receive oral cyclosporine twice daily on days -2 to day 150. Patients with persistent disease, T-cell chimerism, and no GVHD on day 180 receive up to 3 doses of DLI over the next 4 months.
Quality of life is assessed at baseline and at 1, 3, 6, 9, 12, 18, and 24 months.
Patients are followed at 1, 3, 6, 9, and 12 months and then annually for 2 years.
PROJECTED ACCRUAL: A total of 120 patients (60 per group) will be accrued for this study. | ArmGroups: N/A | Interventions:[{'type': 'BIOLOGICAL', 'name': 'therapeutic allogeneic lymphocytes'}, {'type': 'DRUG', 'name': 'cyclosporine'}, {'type': 'DRUG', 'name': 'fludarabine phosphate'}, {'type': 'DRUG', 'name': 'mycophenolate mofetil'}, {'type': 'PROCEDURE', 'name': 'allogeneic bone marrow transplantation'}, {'type': 'PROCEDURE', 'name': 'peripheral blood stem cell transplantation'}, {'type': 'RADIATION', 'name': 'radiation therapy'}] | PrimaryOutcomes: N/A | SecondaryOutcomes: N/A |
Title: A Phase II Clinical Study of BBI503 in Adult Patients With Advanced Hepatobiliary Cancer | Condition: Hepatocellular Carcinoma, Cholangiocarcinoma | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'BBI503', 'type': 'EXPERIMENTAL', 'description': 'BBI503 will be administered orally, daily, in continuous 28-day cycles at a dose of 300 mg once daily', 'interventionNames': ['Drug: BBI503']}] | Interventions:[{'type': 'DRUG', 'name': 'BBI503', 'armGroupLabels': ['BBI503'], 'otherNames': ['Amcasertib', 'BBI-503', 'BB503']}] | PrimaryOutcomes: [{'measure': 'Disease Control Rate (DCR)', 'description': 'Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.', 'timeFrame': '8 weeks'}] | SecondaryOutcomes: [{'measure': 'Objective response rate (ORR)', 'description': 'Defined as the proportion of patients with a documented complete response and partial response (CR + PR) based on RECIST 1.1.', 'timeFrame': '8 weeks'}, {'measure': 'Progression free survival (PFS)', 'description': 'Defined as the time from enrollment to the first objective documentation of disease progression or death due to any cause.', 'timeFrame': '24 months'}, {'measure': 'Overall survival (OS)', 'description': 'Defined as the time from enrollment to death due to any cause.', 'timeFrame': '24 months'}, {'measure': 'Pharmacodynamics (biomarkers) of BBI503 when tumor biopsy is possible', 'timeFrame': 'baseline, 4 weeks'}, {'measure': 'Number of Patients with Adverse Events', 'description': 'All patients who have received at least one dose of BBI503 will be included in the safety analysis. The incidence of adverse events will be summarized by type of adverse event and severity.', 'timeFrame': '24 months'}] |
Title: A Randomized, Double-Blind, Phase III Clinical Trial of Neoadjuvant Chemotherapy With Atezolizumab or Placebo in Patients With Triple-Negative Breast Cancer Followed by Adjuvant Continuation of Atezolizumab or Placebo | Condition: Triple Negative Breast Cancer | Keywords: anti-PD-L1 antibody, TNBC | Summary: | Description: NSABP B-59/GBG 96-GeparDouze is a prospective, randomized, double-blind, Phase III clinical trial. This is a collaborative study being conducted by NSABP Foundation, Inc. in partnership with the German Breast Group (GBG), and supported by funding by Genentech, a Member of the Roche Group, and F. Hoffmann-La Roche, Ltd.
In this clinical trial of neoadjuvant and adjuvant administration of atezolizumab/placebo in patients with high risk triple-negative breast cancer, the potential incremental efficacy and safety of neoadjuvant administration of atezolizumab/placebo with a sequential regimen of weekly paclitaxel with every-3-week carboplatin followed immediately by neoadjuvant administration of atezolizumab/placebo with AC/EC will be evaluated. Patients will then undergo surgery. Following recovery from surgery, patients will initiate approximately 6 months of adjuvant therapy with atezolizumab/placebo and receive the same investigational agent they received pre-operatively. Administration of radiation therapy will be based on local standards at the discretion of patients and investigators, but if administered, atezolizumab/placebo will be administered concurrently. Adjuvant atezolizumab/placebo may be delayed until after completion of radiation therapy per investigator discretion. Patients with residual invasive cancer at the time of surgery may receive capecitabine concurrently with atezolizumab/placebo in the adjuvant setting per investigator discretion and local guidelines. Patients with germline BRCA1 or BRCA2 mutations with residual invasive cancer at the time of surgery may receive olaparib in the adjuvant setting per investigator discretion and local guidelines. Patients receiving olaparib must discontinue atezolizumab/placebo.
The primary aims of the study are 1) to determine value of atezolizumab in improving pathologic complete response in the breast and post-therapy lymph nodes evaluated histologically (pCR breast and nodes \[(ypT0/Tis ypN0)\]), and 2) to determine the value of atezolizumab in improving event-free survival (EFS). Secondary aims include: pathologic complete response in the breast (ypT0/Tis); pathologic complete response in the breast and lymph nodes (ypT0 ypN0); positive nodal status conversion rate; overall survival; recurrence-free interval: distant disease-free survival; brain metastases free survival; and toxicity. The stratification factors for the study are: 1) clinical size of the primary tumor (1.1-3.0 cm; \> 3.0 cm); 2) nodal status as determined by protocol-specified criteria (negative, positive); 3) AC/EC (every 2 weeks; every 3 weeks); and 4) Region (North America; Europe).
For patient eligibility, local testing on the diagnostic core must have determined the patient's tumor to be ER-negative, PgR-negative, and HER2-negative by current ASCO/CAP guidelines. Material from either the diagnostic core biopsy or the research biopsy must be sent for central testing for confirmation of ER, PgR, and HER2 to confirm eligibility. If local testing has determined a tumor to be HER2 equivocal or to have a borderline ER/PgR status (% IHC staining \< 10% for both), material may be submitted for central testing to determine eligibility.
In order to proactively identify and further assess any cardiac toxicity that may occur with the combination of anthracyclines and atezolizumab, this study includes a cardiac safety lead-in for the first 60 patients who initiate AC/EC. The safety lead-in will consist of assessment of ECG and serum troponin-T obtained just prior to administration of the first dose of AC/EC, following completion of the administration of the 1st and 3rd cycle of AC/EC prior to initiation of the atezolizumab/placebo. An additional assessment of LVEF with echocardiogram or MUGA scan will also be obtained prior to the 3rd dose of AC/EC. In order to provide an early assessment of cardiac safety, results of the troponin-T assessments, ECGs, LVEF assessment, and cardiac safety data will be evaluated by the Data Safety Monitoring Board (DSMB) when the last of the initial 20 patients who initiate AC/EC undergo their scheduled post-surgery LVEF assessment. When the last of the first 60 patients to initiate AC/EC undergo their scheduled post-surgery LVEF assessment, results of the troponin assessments, ECGs, LVEF assessments, and cardiac safety data from all 60 patients will be evaluated by the DSMB.
Research core biopsies of breast primary at baseline and 1-4 days prior to the second dose of atezolizumab/placebo are a study requirement for all patients. One to three representative blocks of residual primary tumor containing the maximum amount of tumor and node with the largest focus of metastasis is required from the definitive breast surgery if gross residual disease is greater than or equal to 1.0 cm. If gross residual disease is less than 1.0 cm, tissue should be submitted, if possible. Blood specimens will be collected on all patients at baseline for exploratory biomarker analysis and to support future correlative studies.
Accrual to NSABP B-59/GBG 96-GeparDouze began in December 2017 and was completed in May 2021 with a total of 1550 patients randomized. Based on actual accrual and the decision to eliminate pCR as a co-primary endpoint, we recalculated the power to detect a hazard ratio of 0.70 attributed to the addition of atezolizumab, assuming a lost-to-follow-up rate of 0.00083 per month, using the actual accrual pattern for the power calculation. With 1550 patients accrued in 42 months, an additional 22 months follow up will allow us to obtain 252 events under the assumptions stated above, which will provide 80% power to detect a HR of 0.7 between the atezolizumab and the placebo arm at an overall 2-sided alpha level of 0.05. | ArmGroups: [{'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'IV infusion once every 3 weeks for 4 doses (Cycle 1), once every 3 weeks for 4 doses (Cycle 2) and once every 3 weeks after surgery for 1 year after first dose', 'interventionNames': ['Drug: Placebo']}, {'label': 'Atezolizumab', 'type': 'EXPERIMENTAL', 'description': 'IV infusion, 1200mg, once every 3 weeks for 4 doses (Cycle 1), once every 3 weeks for 4 doses (Cycle 2) and once every 3 weeks after surgery for 1 year after first dose', 'interventionNames': ['Drug: Atezolizumab']}] | Interventions:[{'type': 'DRUG', 'name': 'Placebo', 'description': 'Following randomization, patients will receive Paclitaxel 80 mg/m2 IV weekly x 12 doses + Carboplatin AUC of 5 IV Day 1 every 3 weeks for 4 cycles + placebo IV Day 1 every 3 weeks for 4 doses.\n\nFollowed 2-3 weeks later by Doxorubicin (A) 60 mg/m2 IV + cyclophosphamide (C) 600 mg/m2 IV Day 1 every 2 or 3 weeks for 4 cycles OR Epirubicin (E) 90 mg/m2 IV + cyclophosphamide (C) 600 mg/m2 IV Day 1 every 2 or 3 weeks for 4 cycles.\n\n+ placebo IV Day 1 every 3 weeks for 3 to 4 doses depending on AC/EC schedule used.\n\nApproximately 3-4 weeks later: Surgery (Lumpectomy or mastectomy and axillary staging), followed by placebo IV Day 1 every 3 weeks after surgery until 1 year after the first dose.', 'armGroupLabels': ['Placebo']}, {'type': 'DRUG', 'name': 'Atezolizumab', 'description': 'Following randomization, patients will receive Paclitaxel 80 mg/m2 IV weekly x 12 doses + Carboplatin AUC of 5 IV Day 1 every 3 weeks for 4 cycles + Atezolizumab 1200 mg Day 1 every 3 weeks for 4 doses.\n\nFollowed 2-3 weeks later by Doxorubicin (A) 60 mg/m2 IV + cyclophosphamide (C) 600 mg/m2 IV Day 1 every 2 or 3 weeks for 4 cycles OR Epirubicin (E) 90 mg/m2 IV + cyclophosphamide (C) 600 mg/m2 IV Day 1 every 2 or 3 weeks for 4 cycles.\n\n+ Atezolizumab 1200 mg Day 1 every 3 weeks for 3 to 4 doses depending on AC/EC schedule used.\n\nApproximately 3-4 weeks later: Surgery (Lumpectomy or mastectomy and axillary staging), followed by Atezolizumab 1200 mg Day 1 every 3 weeks after surgery until 1 year after the first dose.', 'armGroupLabels': ['Atezolizumab']}] | PrimaryOutcomes: [{'measure': 'Event-free survival (EFS)', 'description': 'Time from randomization until event', 'timeFrame': 'From randomization until event, through study follow up to the time target number of events is obtained, up to 5 years'}] | SecondaryOutcomes: [{'measure': 'Overall survival (OS)', 'description': 'Time from randomization until death from any cause', 'timeFrame': 'From date of randomization through study follow-up, to the time the target number of events is obtained, up to 5 years'}, {'measure': 'Pathologic complete response in the breast and lymph nodes (ypT0/Tis ypN0)', 'description': 'Absence of any invasive component in the resected breast specimen and all resected lymph nodes', 'timeFrame': 'Following completion of neoadjuvant therapy (ypT0/Tis ypN0)'}, {'measure': 'Distant disease-free survival (DDFS)', 'description': 'Time from randomization until distant recurrence, death from breast cancer, death from other causes, and second primary invasive cancer (non-breast)', 'timeFrame': 'From date of randomization through study follow-up, to the time the target number of events is obtained, up to 5 years'}, {'measure': 'Disease-free survival (DFS)', 'description': 'Ipsilateral invasive breast tumor recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, ipsilateral or contralateral DCIS, second primary non-breast invasive cancer and death attributable to any cause including breast cancer, non-breast cancer, or unknown cause.', 'timeFrame': 'From the first breast surgical procedure to the first disease recurrence or death from any cause'}, {'measure': 'Frequency of Adverse Events', 'description': 'Frequency of adverse events graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)', 'timeFrame': 'From beginning of study therapy to 90 days after last dose of study therapy'}, {'measure': 'Frequency of immune Adverse Events of Special Interest', 'description': 'Frequency of immune adverse events of special interest according to the NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)', 'timeFrame': 'From beginning of study therapy to 90 days after last dose of study therapy'}, {'measure': 'Cardiac safety lead-in (Troponin-T)', 'description': 'Troponin-T levels in blood prior to initial dose of AC/EC following completion of carboplatin/paclitaxel co-administered with atezolizumab/placebo', 'timeFrame': 'prior to initial dose of AC/EC following completion of carboplatin/paclitaxel co-administered with atezolizumab/placebo, approximately 12 weeks'}, {'measure': 'Cardiac safety lead-in (Troponin-T)', 'description': 'Troponin-T levels in blood after administration of the 1st cycle of AC/EC prior to administration of atezolizumab/placebo', 'timeFrame': 'After administration of the 1st dose of AC/EC prior to administration of atezolizumab/placebo, approximately 1 hour after beginning the 1st dose of AC/EC'}, {'measure': 'Cardiac safety lead-in (Troponin-T)', 'description': 'Troponin-T levels in blood after administration of the 3rd cycle of AC/EC prior to administration of atezolizumab/placebo', 'timeFrame': 'After administration of the 3rd dose (Cycle 3; each cycle is 21 days) of AC/EC prior to administration of atezolizumab/placebo, approximately 1 hour after beginning the 3rd dose of AC/EC'}, {'measure': 'Cardiac safety lead-in (Left ventricular ejection fraction; LVEF)', 'description': 'LVEF levels measured at baseline prior to initiation of carboplatin/paclitaxel and atezolizumab/placebo', 'timeFrame': 'Prior to initiation of carboplatin/paclitaxel and atezolizumab/placebo, at baseline'}, {'measure': 'Cardiac safety lead-in (Left ventricular ejection fraction; LVEF)', 'description': 'LVEF levels measured before 3rd cycle of AC/EC', 'timeFrame': 'Prior to the 3rd cycle (each cycle is every 21 days) of AC/EC, approximately 6 weeks after initiation of AC/EC'}, {'measure': 'Cardiac safety lead-in (Left ventricular ejection fraction; LVEF)', 'description': 'LVEF levels measured after surgery', 'timeFrame': 'Four to 6 weeks after surgery'}] |
Title: Quality of Life in Younger Breast Cancer Survivors | Condition: Breast Cancer, Cancer Survivor, Cognitive/Functional Effects, Psychosocial Effects of Cancer and Its Treatment, Sexuality and Reproductive Issues, Spiritual Concerns | Keywords: cognitive/functional effects, spiritual concerns, sexuality and reproductive issues, psychosocial effects of cancer and its treatment, cancer survivor, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer | Summary: | Description: OBJECTIVES:
* Compare the quality of life (physical functioning, psychological functioning, social functioning, and spiritual functioning) of female breast cancer survivors who were age 45 or younger at the time of diagnosis with the quality of life of female breast cancer survivors who were age 55 to 70 at time of diagnosis (considering type of surgical treatment \[lumpectomy vs mastectomy\], hormonal treatments, and time since diagnosis as covariates) and age-matched (to the younger group) females with no history of breast cancer.
* Compare the quality of life (physical functioning, psychological functioning, social functioning, and spiritual functioning) of partners of breast cancer survivors who were age 45 or younger at time of diagnosis with the quality of life of partners of breast cancer survivors who were age 55 to 70 at diagnosis and partners of age-matched (to the younger group) females with no history of breast cancer.
* Test and compare quality of life models that identify the variables that mediate between antecedent variables of personal characteristics, diagnostic and treatment characteristics, and quality of life outcomes in order to determine where interventions to improve quality of life should be targeted.
* Explore the relationship of partner antecedent, mediating, and outcome variables as predictors or mediators of outcome variables for breast cancer survivors.
OUTLINE: This is a multicenter study.
Patients, spouse or partner of patients, age-matched acquaintances of patients, and partner of acquaintances complete questionnaires over 60-90 minutes about personal characteristics, self-efficacy, coping, social support, health care provider communication, physical, psychological, social, and spiritual functioning, and quality of life. After completing the study questionnaires, patients and age-matched acquaintances of patients are interviewed via telephone over 30 minutes for cognitive function assessment. A random subset of patients and spouses/partners of patients are interviewed via telephone over 45-60 minutes, using data-generating and open-ended questions, regarding physical functioning, sexual and reproductive issues, psychological issues, social impact, and methods used to deal with breast cancer survivor concerns.
Disease and treatment characteristics of patients are obtained from medical records.
PROJECTED ACCRUAL: A total of 2,697 patients, spouse or partner of patients, age-matched female acquaintances of patients, and partner of acquaintances will be accrued for this study. | ArmGroups: N/A | Interventions:[{'type': 'PROCEDURE', 'name': 'cognitive assessment'}, {'type': 'PROCEDURE', 'name': 'psychosocial assessment and care'}, {'type': 'PROCEDURE', 'name': 'quality-of-life assessment'}] | PrimaryOutcomes: [{'measure': 'Comparison of the quality of life'}, {'measure': 'Comparison of the quality of life of partners'}, {'measure': 'Comparison of quality of life models'}, {'measure': 'Correlation between partner antecedent, mediating, and outcome variables with patient outcome variables'}] | SecondaryOutcomes: N/A |
Title: An Open-label, Randomized Study to Assess the Relative Bioavailability (BA) and Bioequivalence (BE) of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer | Condition: Prostatic Neoplasms | Keywords: | Summary: | Description: Niraparib is an orally available, highly selective poly (adenosine diphosphate \[ADP\]-ribose) polymerase (PARP) inhibitor, with potent activity against PARP-1 and PARP-2 deoxyribonucleic acid (DNA)-repair polymerases. AA is a pro-drug of abiraterone which selectively inhibits the enzyme 17 alpha-hydroxylase/C17,20-lyase (CYP17), that is found in the testes and adrenals (leading to systemic inhibition of testosterone production), as well as in prostate tissues and tumors. The rationale of the study is to investigate the various strengths and formulations of niraparib and AA plus prednisone or prednisolone (P) in metastatic castration resistant prostate cancer (mCRPC) participants with and without homologous recombination repair (HRR) gene alterations. In participants with metastatic prostate cancer, DNA-repair anomalies are found in approximately 15 percent (%) to 20% of tumors. This study consists 4 periods: screening phase (up to 21 days); treatment phase (up to 22 days); extension and long-term extension phases (from day 23 until discontinuation); and post-treatment follow up phase (end of treatment \[EoT\] visit within 30 days after the last dose of study treatment). Total duration of study is up to 1.4 years. Efficacy, safety, pharmacokinetics (PK), and biomarkers will be assessed at specified time points during this study. Participants safety will be monitored throughout the study. | ArmGroups: [{'label': 'Treatment Sequence ABD', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive single doses of niraparib and abiraterone acetate (AA) using niraparib Formulation 1 as Treatment A in Treatment Period 1, followed by multiple doses of niraparib and AA using niraparib Formulation 2 as Treatment B in Treatment Period 2, followed by multiple doses of niraparib and AA using niraparib Formulation 4 as Treatment D in Treatment Period 3. From Period 2 onwards and during Extension and Long-term Extension Phases, all participants will continue to receive treatment with niraparib and AA-prednisone (AAP) or AAP alone.', 'interventionNames': ['Drug: Niraparib', 'Drug: Abiraterone Acetate (AA)', 'Drug: Prednisone']}, {'label': 'Treatment Sequence ADB', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive Treatment A in Treatment Period 1 followed by Treatment D in Treatment Period 2, followed by Treatment B in Treatment Period 3. From Period 2 onwards and during Extension and Long-term Extension Phases, all participants will continue to receive treatment with niraparib and AAP or AAP alone.', 'interventionNames': ['Drug: Niraparib', 'Drug: Abiraterone Acetate (AA)', 'Drug: Prednisone']}, {'label': 'Treatment Sequence CBD', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive single doses of niraparib and AA using niraparib Formulation 3 as Treatment C in Treatment Period 1, followed by Treatment B in Treatment Period 2, followed by Treatment D in Treatment Period 3. From Period 2 onwards and during Extension and Long-term Extension Phases, all participants will continue to receive treatment with niraparib and AAP or AAP alone.', 'interventionNames': ['Drug: Niraparib', 'Drug: Abiraterone Acetate (AA)', 'Drug: Prednisone']}, {'label': 'Treatment Sequence CDB', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive Treatment C in Treatment Period 1, followed by Treatment D in Treatment Period 2, followed by Treatment B in Treatment Period 3. From Period 2 onwards and during Extension and Long-term Extension Phases, all participants will continue to receive treatment with niraparib and AAP or AAP alone.', 'interventionNames': ['Drug: Niraparib', 'Drug: Abiraterone Acetate (AA)', 'Drug: Prednisone']}] | Interventions:[{'type': 'DRUG', 'name': 'Niraparib', 'description': 'Niraparib will be administered orally.', 'armGroupLabels': ['Treatment Sequence ABD', 'Treatment Sequence ADB', 'Treatment Sequence CBD', 'Treatment Sequence CDB']}, {'type': 'DRUG', 'name': 'Abiraterone Acetate (AA)', 'description': 'Abiraterone Acetate will be administered orally.', 'armGroupLabels': ['Treatment Sequence ABD', 'Treatment Sequence ADB', 'Treatment Sequence CBD', 'Treatment Sequence CDB']}, {'type': 'DRUG', 'name': 'Prednisone', 'description': 'Prednisone will be administered orally.', 'armGroupLabels': ['Treatment Sequence ABD', 'Treatment Sequence ADB', 'Treatment Sequence CBD', 'Treatment Sequence CDB']}] | PrimaryOutcomes: [{'measure': 'Maximum Observed Analyte Concentration at Steady State (Cmax,ss) of Niraparib and Abiraterone Acetate (AA) [Period 2 and Period 3]', 'description': 'Cmax,ss is defined as maximum observed analyte concentration at steady state.', 'timeFrame': 'Predose, up to 10 hour post dose'}, {'measure': 'Area Under the Plasma Concentration-time Curve from Time Zero to 24 Hours at Steady State (AUC [0-24h],ss) of Niraparib and AA (Period 2 and Period 3)', 'description': 'AUC (0-24h),ss is defined as area under the plasma concentration-time curve from time zero to 24 hours at steady state.', 'timeFrame': 'Predose, up to 24 hours post dose'}, {'measure': 'Ratio of Individual Cmax,ss Values Between Test and Reference Treatment (Period 2 and Period 3)', 'description': 'Ratio of individual Cmax,ss values between test and reference treatment will be assessed.', 'timeFrame': 'Predose, up to 10 hours post dose'}, {'measure': 'Ratio of individual AUC (0-24h),ss Values Between Test and Reference Treatment (Period 2 and Period 3)', 'description': 'Ratio of individual AUC (0-24h),ss values between test and reference treatment will be assessed.', 'timeFrame': 'Predose, up to 24 hours post dose'}] | SecondaryOutcomes: [{'measure': 'Maximum Observed Analyte Concentration at (Cmax) of Niraparib and AA (Period 1)', 'description': 'Cmax is defined as maximum observed analyte concentration.', 'timeFrame': 'Predose, up to 72 hours post dose'}, {'measure': 'Area Under the Plasma Concentration-time Curve from Time Zero to 72 Hours (AUC [0-72h]) of Niraparib and AA (Period 1)', 'description': 'AUC (0-72h) is defined as area under the plasma concentration-time curve from time zero to 72 hours post dosing.', 'timeFrame': 'Predose, up to 72 hours post dose'}, {'measure': 'Ratio of individual AUC (0-72h) Values Between Test and Reference Treatment (Period 1)', 'description': 'Ratio of individual AUC (0-72h) values between test and reference treatment will be assessed.', 'timeFrame': 'Predose, up to 72 hours post dose'}, {'measure': 'Serum Testosterone Level', 'description': 'Serum testosterone level will be assessed.', 'timeFrame': 'Predose on Day -7, Day 11, Day 12 and Day 23'}, {'measure': 'Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability', 'description': 'An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.', 'timeFrame': 'From study start until study completion (up to 3.1 years)'}, {'measure': 'Number of Participants with AEs by Severity', 'description': 'Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death.', 'timeFrame': 'From study start until study completion (up to 3.1 years)'}, {'measure': 'Number of Participants with Clinical Laboratory Abnormalities', 'description': 'Number of participants with clinical laboratory abnormalities including hematology, serum chemistry and urinalysis will be reported.', 'timeFrame': 'From study start until study completion (up to 3.1 years)'}] |
Title: Paclitaxel Poliglumex (CT-2103)/Carboplatin vs Paclitaxel/Carboplatin for the Treatment of Chemotherapy-Naïve Advanced Non-Small Cell Lung Cancer (NSCLC) in Women With Estradiol >30 pg/mL | Condition: Lung Cancer | Keywords: recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer | Summary: | Description: OBJECTIVES:
Primary
* Compare the overall survival of patients with chemotherapy-naïve stage IIIB or IV or recurrent non-small cell lung cancer treated with paclitaxel poliglumex and carboplatin vs paclitaxel and carboplatin.
Secondary
* Compare the progression-free survival of women treated with these regimens.
* Compare the disease control in women treated with these regimens.
* Compare the clinical benefit in women treated with these regimens.
* Compare the response rate in women treated with these regimens.
* Compare the quality of life of women treated with these regimens.
* Compare the safety and tolerability in women treated with these regimens.
OUTLINE: This is a multicenter study.
Patients are stratified according to age (≥ 60 vs \< 60 years old), geographical location (United States of America, Canada, or Australia vs the rest of the world), extent of disease (independent of brain metastases, i.e., brain metastases are not considered in determining extent of disease) (intrathoracic disease only vs extrathoracic disease), and ECOG performance status (0 or 1 vs 2). Patients will be randomized to 1 of 2 treatment arms.
* Arm I: Patients receive paclitaxel poliglumex IV over 10 minutes followed by carboplatin IV over 30 minutes on day 1.
* Arm II: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1.
In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, before each course, and at the completion of study treatment by the Pain Assessment Patient Questionnaire, the Pulmonary Symptom Index, and the Functional Assessment of Cancer Therapy- Lung Cancer Subscale (FACT-LCS) (only in countries in which a validated translation is currently available).
After completion of study therapy, patients are followed at least monthly. | ArmGroups: [{'label': 'Arm I', 'type': 'EXPERIMENTAL', 'description': 'Patients receive paclitaxel poliglumex IV over 10 minutes followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: carboplatin', 'Drug: paclitaxel poliglumex']}, {'label': 'Arm II', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: carboplatin', 'Drug: paclitaxel']}] | Interventions:[{'type': 'DRUG', 'name': 'carboplatin', 'description': 'Given IV', 'armGroupLabels': ['Arm I', 'Arm II']}, {'type': 'DRUG', 'name': 'paclitaxel', 'description': 'Given IV', 'armGroupLabels': ['Arm II']}, {'type': 'DRUG', 'name': 'paclitaxel poliglumex', 'description': 'Given IV', 'armGroupLabels': ['Arm I']}] | PrimaryOutcomes: [{'measure': 'Overall survival'}] | SecondaryOutcomes: [{'measure': 'Progression-free survival'}, {'measure': 'Disease control'}, {'measure': 'Clinical benefit as defined by use of opiates, growth factors, and transfusions,'}, {'measure': 'Response rate as assessed by complete response or partial response per RECIST criteria'}, {'measure': 'Quality of life as assessed by Fact-LCS Scores and Pulmonary Symptom Index (PSI) Scores and Pain Scores'}, {'measure': 'Safety as assessed by NCI CTCAE Version 3'}] |
Title: Surveillance of High-grade Non-muscle Invasive Bladder Tumours Using the Xpert Bladder Cancer Monitor | Condition: Non-muscle Invasive Bladder Cancer, Urinary Biomarker | Keywords: Flexible cystoscopy, Xpert Bladder Cancer Monitor | Summary: | Description: Epidemiology and treatment Bladder cancer is the 12th most diagnosed cancer worldwide with an incidence of approximately 550 000 new cases each year.1 A majority of the tumors are characterized as non-muscle invasive bladder cancer (NMIBC), meaning stage T1 according to the 2016 TNM-classification.2 Treatment of primary NMIBC is transurethral resection of the bladder (TUR-B) and treatment of recurring NMIBC is repeated TUR-B and often adjuvant instillation therapy with either Mitomycin C or Bacillus Calmette-Geerin (BCG) according to the histology of the tumor. NMIBC-tumors are graded into high grade (HG) and low grade (LG) according to the histological characteristics of their TUR-B specimen. Generally, intravesical Mitomycin C is recommended to treat LG tumors and intravesical BCG is recommended for treating HG tumors.3,4.
Follow-up schedules based on risk of recurrence. The histological grade, number of tumors, tumor size, T-stage, recurrence-rate and presence of carcinoma in situ (CIS) is used to estimate risk of recurrence according to the EORTC-scoring system. Based on the risk stratification, different follow-up schedules after initial TUR-B are planned. High risk tumors are followed-up with flexible cystoscopy and urinary cytology every four months until two recurrence-free years, whereas low and intermediate risk tumors are followed utilizing the 4-8-12 model where intervals between follow up are increased for patients without recurrence until 5 disease-free years.3 The evidence behind these follow-up schedules is not based on high level evidence and research but rather on tradition and 'clinical experience'.
Clinical challenge of current follow-up schedules The majority of patients with HG tumors will have recurrence despite treatment, especially within the two first years after diagnosis. Moreover, many patients will receive lifelong follow-up cystoscopy and urinary cytology tests. Follow-up schedules are costly due to many visits at the hospital for flexible cystoscopy, urinary cytology, and treatment. A micro-costing analysis performed by the Urological Research Unit at Aarhus University Hospital prior to initiation of the current study, has shown that the total expense in relation to flexible cystoscopy in the outpatient clinic is approximately 315 EUR per examination (Appendix 1). Equally important to frequency and cost of follow-up, every follow-up visit is associated with patient discomfort, pain, risk of infections, and strictures of the urethra.6 Each cystoscopy carries a 15% risk of complications. Nearly 1,500 cystoscopies are carried out in HG patients in Central Denmark Region each year, resulting in approximately 240 complications each year, with cystitis being the most common complication. Furthermore, flexible cystoscopy is not always reliable in terms of diagnosing recurrences and CIS.7-9
Urinary biomarkers A proposed alternative to flexible cystoscopy in the detection of recurrent NMBIC is non-invasive molecular urinary markers that detect mRNA, protein or DNA from selected genes relevant for bladder cancer in urine samples. Several studies have been prospectively validated and shown high sensitivity and specificity for urinary markers.10,11 Recently, the Xpert Bladder Cancer Monitor test was shown by Valenberg et al.12 to have a sensitivity of 83% and specificity of 76% for HG disease and similarly D'Elia et al.13 showed a specificity of 77% and sensitivity of 46% for a cohort of mainly LG patients. However, studies have until now focused mainly on detection of NMIBC in patients with incident tumors, which are most often larger and more easily diagnosed with urinary biomarkers than recurrences.14 To our knowledge, no studies have so far substituted cystoscopies for urinary biomarkers in a randomized controlled setting. Thus, the need for high level evidence regarding the use of urinary biomarkers for surveillance of NMIBC is still there. | ArmGroups: [{'label': 'Control', 'type': 'ACTIVE_COMPARATOR', 'description': 'Study subjects will cohere to current clinical guidelines for follow-up regimes of HG NMIBC with flexible cystoscopy and cytology every four months for a period of two years.', 'interventionNames': ['Diagnostic Test: Flexible cystoscopy (WL/NBI) and urinary cytology']}, {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Patients in the interventional arm will be followed at 4, 8, 16 and 20 months after inclusion with Xpert Bladder Cancer Monitor-test (and urinary cytology) instead of flexible cystoscopy.', 'interventionNames': ['Diagnostic Test: Xpert Bladder Cancer Monitor']}] | Interventions:[{'type': 'DIAGNOSTIC_TEST', 'name': 'Xpert Bladder Cancer Monitor', 'description': 'Xpert Bladder Cancer Monitor detects mRNA fragments from 5 genes frequently overexpressed in non-muscle invasive bladder cancer.', 'armGroupLabels': ['Intervention']}, {'type': 'DIAGNOSTIC_TEST', 'name': 'Flexible cystoscopy (WL/NBI) and urinary cytology', 'description': 'Adhering to current danish guidelines for follow-up of non-muscle invasive bladder cancer.', 'armGroupLabels': ['Control']}] | PrimaryOutcomes: [{'measure': 'Recurrence-free survival', 'description': 'Time from inclusion to detection of recurrence of bladder cancer.', 'timeFrame': '2 years follow-up per patient'}] | SecondaryOutcomes: N/A |
Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Trial of Tecemotide Versus Placebo in Subjects With Completed Concurrent Chemo-radiotherapy for Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) | Condition: Carcinoma, Non-Small-Cell Lung | Keywords: Carcinoma, Non-Small-Cell Lung, Tecemotide, Placebo, NSCLC, L-BLP25 | Summary: | Description: N/A | ArmGroups: [{'label': 'Tecemotide', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Tecemotide', 'Drug: Cyclophosphamide (CPA)']}, {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Drug: Placebo', 'Drug: Saline (sodium chloride)']}] | Interventions:[{'type': 'DRUG', 'name': 'Tecemotide', 'description': 'Tecemotide injection will be administered once weekly subcutaneously at a dose of 806 microgram up to Week 8 and from Week 14, every 6 weeks until end-of-trial, or until NSCLC progression.', 'armGroupLabels': ['Tecemotide']}, {'type': 'DRUG', 'name': 'Placebo', 'description': 'Matching placebo injection will be administered once weekly subcutaneously up to Week 8 and from Week 14, every 6 weeks until end-of-trial, or until NSCLC progression.', 'armGroupLabels': ['Placebo']}, {'type': 'DRUG', 'name': 'Cyclophosphamide (CPA)', 'description': 'CPA injection will be administered as a single intravenous infusion at a dose of 300 milligram per square meter (mg/m\\^2) (to a maximum of 600 mg) 3 days before the first injection of tecemotide.', 'armGroupLabels': ['Tecemotide']}, {'type': 'DRUG', 'name': 'Saline (sodium chloride)', 'description': 'Matching placebo (saline) injection will be administered as a single intravenous (0.9 percent \\[%\\] sodium chloride) infusion 3 days before the first injection of tecemotide-matching placebo.', 'armGroupLabels': ['Placebo']}] | PrimaryOutcomes: [{'measure': 'Overall Survival', 'description': 'Overall survival (OS) was defined as the time (in months) from randomization to death. Data has been presented in terms of number subjects who died and number of censored subjects.', 'timeFrame': 'Time from date of randomization until death, assessed maximum up to 16 months'}] | SecondaryOutcomes: [{'measure': 'Time to Symptom Progression (TTSP)', 'description': 'TTSP was measured from date of randomization to date of disease progression (defined based on RECIST v1.1), using the lung cancer symptom scale (LCSS), a validated questionnaire consisting of an observer scale and a subject scale used to specifically measure symptom changes relevant to quality of life (QoL) for individuals undergoing treatment for lung cancer. Subject scale was used as a tool to determine TTSP. It was a 9-item questionnaire used to document subject-reported outcomes for a variety of lung cancer associated symptoms. The average symptomatic burden index (ASBI) was used to determine differences in the treatment groups. ASBI was the mean of the 6 symptom scores derived from the LCSS questionnaire. Symptom progression was defined as an increase (worsening) of the ASBI score of 10% of the scale breadth (10 mm on a scale of 0-100 mm) from the baseline score on at least 2 consecutive assessments during the period when assessments are performed every 3 weeks and every 6 weeks.', 'timeFrame': 'Time from date of randomization until progressive disease (PD), assessed up to 16 months'}, {'measure': 'Progression Free Survival (PFS)', 'description': 'PFS was defined as the time from date of randomization until date of the first documentation of PD or death due to any cause in the absence of documented PD, whichever occurred first. PFS was assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). PD was defined as at least a 20% increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. Subjects without event were censored on the date of last tumor assessment.', 'timeFrame': 'Time from date of randomization until PD or death, assessed up to 16 months'}, {'measure': 'Time to Progression (TTP)', 'description': 'TTP was measured from the date of randomization to the date of tumor progression. Date of tumor progression was date of radiological diagnosis of PD, performed as per RECIST 1.1. PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum 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 1 or more new lesions is also considered progression. For participants alive without tumor progression at time of analysis, the time between date of randomization and date of last trial treatment was calculated and used as a censored observation in the analysis. Subjects dying from causes other than PD was censored at time of death.', 'timeFrame': 'Time from date of randomization until PD, assessed up to 16 months'}, {'measure': 'Number Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, National Cancer Institute-Common Toxicity Criteria (NCI-CTC)Grade 3/4 TEAEs, TEAEs Leading to Permanent Discontinuation, TEAEs Leading to Death, Injection Site Reactions (ISRs)', 'description': 'An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs occurred between the first dose of study drug and up to 42 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. Number of Subjects With TEAEs, Serious TEAEs, NCI-CTC Grade 3/4 TEAEs, TEAEs Leading to Permanent Discontinuation, TEAEs Leading to Death, and ISRs were reported.', 'timeFrame': 'Time from first dose up to 42 days after the last dose of the trial treatment: assessed maximum up to 16 months'}] |
Title: A Multicenter, Non-interventional Retrospective Study to Describe the Real-world Treatment Patterns and Associated Outcomes in Patients of China With HER2-positive Unresectable or Metastatic Breast Cancer | Condition: HER2-positive Breast Cancer | Keywords: HER2-positive Breast Cancer, Real-world study, Treatment patterns | Summary: | Description: The treatment landscape has changed dramatically with the lack of real-world evidence for usage and the efficacy of newly approved drugs in China. This multicenter, retrospective, non-interventional study will include patients newly diagnosed with HER2-positive unresectable or metastatic breast cancer, or first recurrent from early breast cancer.
The primary objective of this real-world study is to describe the treatment patterns of HER2-positive unresectable or metastatic breast cancer in China. Secondary objectives will include describing the demographic and clinicopathological characteristics of patients, efficacy of different treatment regimens, treatment options and efficacy of brain metastases, and safety and tolerability of different treatment regimens in patients with HER2-positive unresectable or metastatic breast cancer. | ArmGroups: N/A | Interventions:[{'type': 'OTHER', 'name': 'Electronic medical record and hospital information system or other available resources', 'description': 'This is a non-interventional study. No study medication will be provided to the participants.'}] | PrimaryOutcomes: [{'measure': 'Percentage of Participants Receiving Each Regimen in Each Treatment Line', 'timeFrame': 'Assessed over a 2 year, 8 month time period'}, {'measure': 'Treatment Sequence Since the Time of Diagnosis of HER2-positive Unresectable or Metastatic Breast Cancer', 'timeFrame': 'Assessed over a 2 year, 8 month time period'}, {'measure': 'Percentage of Participants Receiving Endocrine Therapy if Breast Cancer is Hormone Receptor Positive', 'timeFrame': 'Assessed over a 2 year, 8 month time period'}, {'measure': 'Percentage of Participants Receiving Local and Regional Treatment for Metastasis (Radiotherapy and/or Surgery) and Osteoprotective Therapy', 'timeFrame': 'Assessed over a 2 year, 8 month time period'}] | SecondaryOutcomes: [{'measure': 'Percentage of Participants With HER2-positive Unresectable or Metastatic Breast Cancer, Based on Demographic and Clinicopathological Characteristics', 'timeFrame': 'Assessed over a 2 year, 8 month time period'}, {'measure': 'Real-world Progression-free Survival (rwPFS) in Participants With HER2-positive Unresectable or Metastatic Breast Cancer', 'description': 'Real-world progression-free survival (rwPFS) is defined as the time from initiation of treatment to disease progression or death due to any cause.', 'timeFrame': 'Assessed over a 2 year, 8 month time period'}, {'measure': 'Time to Next Treatment (TTNT) in Participants With HER2-positive Unresectable or Metastatic Breast Cancer', 'description': 'Time to next treatment is defined as the time from initiation of a systemic therapy to the date of initiation of the first subsequent systemic therapy regimen or death.', 'timeFrame': 'Assessed over a 2 year, 8 month time period'}, {'measure': 'Duration of Treatment (DoT) in Participants With HER2-positive Unresectable or Metastatic Breast Cancer', 'description': 'Duration of treatment is defined as the length of time a patient is treated.', 'timeFrame': 'Assessed over a 2 year, 8 month time period'}, {'measure': 'Real-world Objective Response Rate (rwORR) in Participants With HER2-positive Unresectable or Metastatic Breast Cancer', 'description': 'Real-world objective response rate is defined as the percentage of participants who have a partial response or complete response to treatment within a certain period of time.', 'timeFrame': 'Assessed over a 2 year, 8 month time period'}, {'measure': 'Real-world Disease Control Rate (rwDCR) in Participants With HER2-positive Unresectable or Metastatic Breast Cancer', 'description': 'Real-world disease control rate is defined as the percentage of participants with advanced or metastatic cancer who have achieved complete response, partial response, and stable disease.', 'timeFrame': 'Assessed over a 2 year, 8 month time period'}, {'measure': 'Real-world Duration of Response (rwDoR) in Participants With HER2-positive Unresectable or Metastatic Breast Cancer', 'description': 'Real-world duration of response is defined as the time from randomization to disease progression or death in participants who achieve complete or partial response.', 'timeFrame': 'Assessed over a 2 year, 8 month time period'}, {'measure': 'Percentage of Participants With Brain Metastases Per Line of Treatment in Participants With HER2-positive Unresectable or Metastatic Breast Cancer', 'timeFrame': 'Assessed over a 2 year, 8 month time period'}, {'measure': 'Percentage of Participants With HER2-positive Unresectable or Metastatic Breast Cancer, Based on Clinical Characteristics of Brain Lesions', 'timeFrame': 'Assessed over a 2 year, 8 month time period'}, {'measure': 'Percentage of Participants Receiving Radiotherapy or Surgery in Participants With HER2-positive Unresectable or Metastatic Breast Cancer', 'timeFrame': 'Assessed over a 2 year, 8 month time period'}, {'measure': 'Treatment Pattern After Diagnosis of Brain Metastases in Participants With HER2-positive Unresectable or Metastatic Breast Cancer', 'timeFrame': 'Assessed over a 2 year, 8 month time period'}, {'measure': 'Real-world Progression-free Survival (rwPFS) After Diagnosis of Brain Metastases in Participants With HER2-positive Unresectable or Metastatic Breast Cancer', 'description': 'Real-world progression-free survival (rwPFS) is defined as the time from initiation of treatment to disease progression or death due to any cause.', 'timeFrame': 'Assessed over a 2 year, 8 month time period'}, {'measure': 'Time to Next Treatment (TTNT) After Diagnosis of Brain Metastases in Participants With HER2-positive Unresectable or Metastatic Breast Cancer', 'description': 'Time to next treatment is defined as the time from initiation of a systemic therapy to the date of initiation of the first subsequent systemic therapy regimen or death.', 'timeFrame': 'Assessed over a 2 year, 8 month time period'}, {'measure': 'Percentage of Participants With Adverse Events (AE) Leading to Treatment Discontinuation or Dose Modification', 'timeFrame': 'Assessed over a 2 year, 8 month time period'}] |
Title: A Phase I/II Trial to Evaluate the Safety and Tolerability of Alectinib and Bevacizumab in Patients With Advanced, ALK-Positive, Non-Small Cell Lung Cancer | Condition: Non-Small Cell Lung Cancer (NSCLC) | Keywords: Non-Small Cell Lung Cancer (NSCLC), Anaplastic lymphoma kinase, ALK, Brain metastases | Summary: | Description: This is a Phase I/II clinical trial.
* A Phase I clinical trial tests the safety of an investigational intervention and also tries to define the appropriate dose(s) of the investigational intervention to use for further studies.
* Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease.
* "Investigational" means that the intervention is being studied.
* In this research study, the investigators are investigating the combination of two study drugs: alectinib and bevacizumab. The FDA (the U.S. Food and Drug Administration) has not approved alectinib as a treatment for any disease.
It has been found that some people with NSCLC have a change (mutation) in a certain gene called the anaplastic lymphoma receptor tyrosine kinase (ALK) gene. This mutated gene helps cancer cells grow.
-- Alectinib belongs to a class of drugs designed to inhibit ALK. This drug has been used in other research studies. Information from those other research studies suggests that alectinib may be effective in killing cancer cells that have changes in ALK. Only participants with changes in the ALK gene will be allowed to participate in this study.
In this research study, Alectinib will be combined with Bevacizumab.
-- Bevacizumab (also called Avastin) works by slowing or stopping the growth of cells in cancer tumors by decreasing the blood supply of the tumors. If blood supply is decreased, oxygen and nutrients that are needed for tumor growth are decreased. The FDA has approved Bevacizumab as a treatment option for your disease
The purpose of this study is to test the safety of Alectinib and Bevacizumab. The investigators will also determine how effective this combination is in participants with advanced, ALK-positive NSCLC with a focus on participants with brain metastases. | ArmGroups: [{'label': 'Alectinib and Bevacizumab.', 'type': 'EXPERIMENTAL', 'description': 'Phase 1\n\n* Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation.\n* Alectinib, orally, twice a day, per cycle\n* Bevacizumab, iv, once per cycle\n\nPhase II In the phase II portion of this study, the investigators will evaluate the combination of alectinib plus bevacizumab in ALK-positive patients with untreated or progressive, asymptomatic brain metastases. Eligible participants will receive alectinib plus bevacizumab at the recommended phase II doses determined in the phase I portion of the study.', 'interventionNames': ['Drug: Alectinib', 'Drug: Bevacizumab']}] | Interventions:[{'type': 'DRUG', 'name': 'Alectinib', 'armGroupLabels': ['Alectinib and Bevacizumab.'], 'otherNames': ['Alecensa']}, {'type': 'DRUG', 'name': 'Bevacizumab', 'armGroupLabels': ['Alectinib and Bevacizumab.'], 'otherNames': ['Avastin']}] | PrimaryOutcomes: [{'measure': 'Recommended phase II dose of the combination of Alectinib and Bevacizumab', 'description': 'Phase I Primary Endpoint: To determine the recommended phase II dose of the combination of alectinib and bevacizumab.', 'timeFrame': '21 Days'}, {'measure': 'Number of participants treated with the combination of alectinib and bevacizumab with adverse events', 'description': 'Phase II Primary Endpoint: Safety and tolerability of alectinib and bevacizumab as assessed by Common Terminology Criteria for Adverse Events version 4.0', 'timeFrame': '2 years'}] | SecondaryOutcomes: [{'measure': 'Central nervous system objective response rate', 'description': 'Number of subjects with intracranial complete or partial responses', 'timeFrame': '2 years'}, {'measure': 'Central nervous system disease control rate', 'description': 'Number of subjects with intracranial complete responses, partial responses, or stable disease', 'timeFrame': '2 years'}, {'measure': 'Central nervous system progression-free survival', 'description': 'Time from initiation of alectinib/bevacizumab to central nervous system progression or death.', 'timeFrame': '2 years'}, {'measure': 'Overall objective response rate', 'description': 'Number of subjects with partial or complete responses', 'timeFrame': '2 years'}, {'measure': 'Overall disease control rate', 'description': 'Number of subjects with partial/complete responses or stable disease', 'timeFrame': '2 years'}, {'measure': 'Progression-free survival', 'description': 'Time from initiation of alectinib/bevacizumab to progression or death.', 'timeFrame': '2 years'}, {'measure': 'Quality of life: change from baseline to on-treatment, measured by the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30', 'description': 'Questionnaire', 'timeFrame': '2 years'}, {'measure': 'Quality of life: change from baseline and on-treatment, measured by the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-BN20', 'description': 'Questionnaire', 'timeFrame': '2 years'}, {'measure': 'Number of patients with an ALK resistance mutation', 'description': 'Determination of the number of patients who develop an ALK resistance mutation as a mechanism of resistance to alectinib and bevacizumab', 'timeFrame': '2 years'}] |
Title: A Phase 1b, Dose-Escalation Study of the Safety and Preliminary Efficacy of STI-1386 Oncolytic Virus in Patients With Relapsed or Refractory Solid Tumors | Condition: Cancer, Cancer of Pancreas, Sarcoma, Hepatic Metastasis, Solid Tumor | Keywords: Cancer, solid tumor, hepatic metastasis | Summary: | Description: This is a Phase 1b, dose-ascending study to assess the safety, tolerability and recommended phase 2 dose (RP2D) of STI-1386 in subjects with relapsed and refractory solid tumors (RRSTs). STI-1386 is a second generation oncolytic virus.
This is a two-stage study, the first stage uses a single ascending dose, followed by the multiple ascending dose stage. | ArmGroups: [{'label': 'STI-1386', 'type': 'EXPERIMENTAL', 'description': 'A dose-escalation standard 3+3 design will be utilized and a total of 3 dosing cohorts are planned, receiving up to 4 mL of 1 x 10\\^6 / 1 mL, 1 x 10\\^7 / 1 mL, or 1 x 10\\^8 / 1 mL.', 'interventionNames': ['Drug: STI-1386']}] | Interventions:[{'type': 'DRUG', 'name': 'STI-1386', 'description': 'Second generation oncolytic virus', 'armGroupLabels': ['STI-1386'], 'otherNames': ['Seprehvec']}] | PrimaryOutcomes: [{'measure': 'Incidence of adverse events (AEs)', 'description': 'Safety as assessed by incidence of AEs by type, frequency, severity, and causality using the Common Terminology Criteria for Adverse Events, Version 5 (CTCAEv5)', 'timeFrame': 'baseline through study completion at up to approximately 29 months'}, {'measure': 'Incidence of immune-related adverse events (IrAEs)', 'description': 'Safety as assessed by incidence of IrAEs by type, frequency, severity, and causality using the Common Terminology Criteria for Adverse Events, Version 5 (CTCAEv5)', 'timeFrame': 'baseline through study completion at up to approximately 29 months'}] | SecondaryOutcomes: [{'measure': 'Preliminary Efficacy of STI-1386', 'description': 'Assess the preliminary efficacy of STI-1386 using the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)', 'timeFrame': 'baseline through study completion at up to approximately 29 months'}, {'measure': 'Measuring Pharmacokinetic [PK] Profile', 'description': 'STI-1386 blood plasma concentrations will be measured', 'timeFrame': 'baseline through study completion at up to approximately 29 months'}, {'measure': 'Assess immunoglobulin levels', 'description': 'Assessment of serum immunoglobulin levels', 'timeFrame': 'baseline through study completion at up to approximately 29 months'}] |
Title: Testing Methods to Increase Lung Cancer Screening Among Quitline Callers | Condition: Population at Risk | Keywords: lung cancer, lung cancer screening | Summary: | Description: Aim 1: The 30-45 minute qualitative interviews will obtain: 1) feedback on the print adaptation of the Should I Screen website (the investigators will send it in advance of the interview), 2) recommendations for effective recruitment and retention procedures in Aim 2, 3) feedback on methods to increase the likelihood that participants will enroll and engage with the interventions (e.g., whether to present the study information immediately following initial contact with the quitline or later), 4) ideas to increase the likelihood that participants will contact their providers for an appointment to discuss lung screening, and 5) feedback on the Aim 2 measures regarding feasibility and acceptability.
Aim 2: H2.1. At 1- and 4-months post-randomization, the WEB arm will have significantly higher lung screening knowledge and intentions to undergo lung screening, compared to PRINT. H2.2 Moderators include, age, e-health literacy. For example, the investigators expect that younger participants will have significantly increased knowledge in the WEB (vs PRINT) arm, whereas intervention arm will have less of an impact among the older participants. H2.3 Mediators (e.g., prior lung screening, current primary care provider, lung cancer perceived risk) will positively affect knowledge and screening intentions. Aim 3. To evaluate reach (% of quitline users enrolled) and engagement (% who read the intervention materials) by study arm and subgroup (e.g., age, e-health literacy). The investigators will assess the feasibility for widespread implementation of both interventions | ArmGroups: [{'label': 'Web arm', 'type': 'ACTIVE_COMPARATOR', 'description': 'The Should I Screen educational website, developed by our consultant, Rafael Meza, PhD, is available at no cost, is written at an 8th grade reading level, requires 15 minutes to use, and undergoes regular updates (https://shouldiscreen.com). The goal is to increase lung screening awareness and to encourage a shared decision making visit with a provider. Sections of the website include the benefits (the reduced likelihood of dying from lung cancer) and harms (false alarms, overdiagnosis, more testing, and invasive procedures) of screening, causes of lung cancer, methods to reduce lung cancer risk, and the lung cancer risk calculator. Improvements in knowledge have been demonstrated with individuals eligible for screening.', 'interventionNames': ['Behavioral: Should I Screen website']}, {'label': 'Print Arm', 'type': 'ACTIVE_COMPARATOR', 'description': "The Should I Screen print-based education (included with this IRB protocol) will be developed in Aim 1 and compared to the Should I Screen website in Aim 2. It will also be at the 8th grade level and will require 15 minutes to read. Although it will contain the same topics as the website, there is one inherent difference - it is not possible to include the interactive risk calculator in the print version. The print-based version will list all of the risk criteria that are included in the algorithm so that participants can see which ones apply to them. However, the risk calculator requires the computer algorithm to calculate a person's 6-year risk of developing lung cancer.", 'interventionNames': ['Behavioral: Should I Screen print booklet']}] | Interventions:[{'type': 'BEHAVIORAL', 'name': 'Should I Screen website', 'description': 'The Should I Screen educational website, developed by our consultant, Rafael Meza, PhD, is available at no cost, is written at an 8th grade reading level, requires 15 minutes to use, and undergoes regular updates (https://shouldiscreen.com). The goal is to increase lung screening awareness and to encourage a shared decision making visit with a provider. Sections of the website include the benefits (the reduced likelihood of dying from lung cancer) and harms (false alarms, overdiagnosis, more testing, and invasive procedures) of screening, causes of lung cancer, methods to reduce lung cancer risk, and the lung cancer risk calculator. Improvements in knowledge have been demonstrated with individuals eligible for screening.', 'armGroupLabels': ['Web arm']}, {'type': 'BEHAVIORAL', 'name': 'Should I Screen print booklet', 'description': "The Should I Screen print-based education will be developed in Aim 1 and compared to the Should I Screen website in Aim 2. It will also be at the 8th grade level and will require 15 minutes to read. Although it will contain the same topics as the website, there is one inherent difference - it is not possible to include the interactive risk calculator in the print version. The print-based version will list all of the risk criteria that are included in the algorithm so that participants can see which ones apply to them. However, the risk calculator requires the computer algorithm to calculate a person's 6-year risk of developing lung cancer.", 'armGroupLabels': ['Print Arm']}] | PrimaryOutcomes: [{'measure': 'Reach of eligible quitline users', 'description': '% of eligible quitline users enrolled in the trial;', 'timeFrame': 'baseline assessment'}, {'measure': 'Intervention Engagement of eligible quitline users', 'description': 'WEB: electronic assessment of 1) logged on, 2) total time spent on website, 3) sections accessed; PRINT: self-reported time spent reading;', 'timeFrame': 'one month assessment'}, {'measure': 'Satisfaction with the intervention materials.', 'description': 'Assessment of satisfaction with length, format, and content of the materials', 'timeFrame': 'one month assessment'}, {'measure': 'Lung cancer screening knowledge', 'description': 'Assessment of lung cancer risk factors, screening eligibility, and pros/cons of screening', 'timeFrame': 'one month assessment'}, {'measure': 'Lung cancer screening knowledge', 'description': 'Assessment of lung cancer risk factors, screening eligibility, and pros/cons of screening', 'timeFrame': 'four month assessment'}, {'measure': 'Percentage of participants who intend to undergo lung cancer screening', 'description': 'Intent to undergo lung cancer screening', 'timeFrame': 'one month assessment'}, {'measure': 'Percentage of participants who intend to undergo lung cancer screening', 'description': 'Intent to undergo lung cancer screening', 'timeFrame': 'four month assessment'}] | SecondaryOutcomes: [{'measure': 'Percentage of participants with an appointment for a shared decision making visit', 'description': 'Shared decision making appt, lung screening referral, completed lung scan.', 'timeFrame': 'one month assessment'}, {'measure': 'Percentage of participants with an appointment for a shared decision making visit', 'description': 'Shared decision making appt, lung screening referral, completed lung scan.', 'timeFrame': 'four month assessment'}] |
Title: Little Cigar and Cigarillo Warnings to Reduce Tobacco-Related Cancers and Disease: Randomized Controlled Trial Among US Adults Who Use LCCs | Condition: Tobacco Use | Keywords: Cigar Warnings, Little Cigar Use, Cigar Use, Cigarillo Use | Summary: | Description: In this study, LCC warnings on packs will be electronically presented to participants over time to determine if newly developed LCC warnings increase quit intentions compared to FDA-proposed text-only warnings and a control condition (in which participants do not see LCC packs or warnings.) A daily diary methodology will be employed to present LCC warnings on packs to participants over time. Qualtrics will contact, screen, consent, and administer the survey. To enroll participants, Qualtrics will screen participants using the inclusion criteria and measures and invite eligible participants to enroll in the study. To collect at least 750 quality completes the investigators anticipate enrolling up to 3,000 people.
At the beginning of the baseline survey (day 0), participants will first consent to participate in the study and then complete a questionnaire about their tobacco use and behaviors (e.g., intentions and quit attempts) and other measures of interest. At the end of the baseline questionnaire, survey software will randomly assign participants to one of the 3 study conditions. The three study conditions are 1) Newly developed warnings with images (the six most effective warnings developed by the study team), 2) FDA-proposed text-only warnings, or 3) control condition in which participants will not receive an intervention (no warnings). Participants will be contacted via email each day (at approximately 6 am) to invite them to complete the survey for that day of the study protocol.
For subsequent days (days 1-6, 8-13, 15-20) participants will be contacted and asked to complete a daily survey which will assess their previous day use of LCCs, as well as cigarettes and e-cigarettes. During these daily surveys, participants assigned to condition 1 or 2 (i.e., the warning conditions) will view an image of a little cigar and cigarillo package with a warning according to the participant's condition. Participants within each warning condition will view a total of 6 different warnings over the course of 6 days each week, this will be repeated 3 times during the study, resulting in a total of 18 exposures. Participants will be required to view the warning for at least 5 seconds before answering questions.
On days 7 and 14 participants will be asked to complete a slightly longer survey with questions about their LCC behaviors including the number of LCCs used in the past week, the number of LCCs butted out because they wanted to smoke less, the number of LCCs forgone, other tobacco use, blunt use, and quit intentions and attempts.
For the post-test on day 21, participants will be asked to complete a longer questionnaire about their current tobacco use and behaviors including current LCC smoking behavior, LCC nicotine dependence, other tobacco product (OTP) use, LCC and OTP quit intentions, and LCC and O | ArmGroups: [{'label': 'Newly developed warnings with images', 'type': 'EXPERIMENTAL', 'description': 'Participants receive newly developed warnings intervention', 'interventionNames': ['Behavioral: Newly developed warnings with images at 30% size']}, {'label': 'FDA proposed text-only warnings', 'type': 'EXPERIMENTAL', 'description': 'Participants receive FDA proposed text only warning intervention', 'interventionNames': ['Behavioral: FDA proposed text-only warnings at 30% size']}, {'label': 'Control group, no intervention', 'type': 'NO_INTERVENTION', 'description': 'Participants do not receive an intervention'}] | Interventions:[{'type': 'BEHAVIORAL', 'name': 'Newly developed warnings with images at 30% size', 'description': 'On study days 1-6, 8-13 and 15-20, participants in this condition will view an image of a little cigar and cigarillo package with a warning developed by the study team that includes an image. The warnings will take up 30% of the package. Participants will view a total of 6 different warnings over the course of 6 days each week, this will be repeated 3 times during the study, resulting in a total of 18 exposures. Participants will be required to view the warning for at least 5 seconds.', 'armGroupLabels': ['Newly developed warnings with images']}, {'type': 'BEHAVIORAL', 'name': 'FDA proposed text-only warnings at 30% size', 'description': 'On study days 1-6, 8-13 and 15-20, participants in this condition will view an image of a little cigar and cigarillo package with a warning proposed by the FDA which is text only. The warnings will take up 30% of the package. Participants will view a total of 6 different warnings over the course of 6 days each week, this will be repeated 3 times during the study, resulting in a total of 18 exposures. Participants will be required to view the warning for at least 5 seconds.', 'armGroupLabels': ['FDA proposed text-only warnings']}] | PrimaryOutcomes: [{'measure': 'LCC quit intentions', 'description': 'Average quit intention score measured by survey. Quit intention measured with 3 questions, the final quit intention score is a mean of the response to the 3 questions, on a scale of 1 to 4, where 1 indicates low intention to quit, and 4 indicates a high intention to quit.', 'timeFrame': 'day 21 (post test)'}] | SecondaryOutcomes: [{'measure': 'Number of LCCs smoked in past day', 'description': 'Measured by survey', 'timeFrame': 'day 1'}, {'measure': 'Number of LCCs smoked in past day', 'description': 'Measured by survey', 'timeFrame': 'day 2'}, {'measure': 'Number of LCCs smoked in past day', 'description': 'Measured by survey', 'timeFrame': 'day 3'}, {'measure': 'Number of LCCs smoked in past day', 'description': 'Measured by survey', 'timeFrame': 'day 4'}, {'measure': 'Number of LCCs smoked in past day', 'description': 'Measured by survey', 'timeFrame': 'day 5'}, {'measure': 'Number of LCCs smoked in past day', 'description': 'Measured by survey', 'timeFrame': 'day 6'}, {'measure': 'Number of LCCs smoked in past day', 'description': 'Measured by survey', 'timeFrame': 'day 7'}, {'measure': 'Number of LCCs smoked in past day', 'description': 'Measured by survey', 'timeFrame': 'day 8'}, {'measure': 'Number of LCCs smoked in past day', 'description': 'Measured by survey', 'timeFrame': 'day 9'}, {'measure': 'Number of LCCs smoked in past day', 'description': 'Measured by survey', 'timeFrame': 'day 10'}, {'measure': 'Number of LCCs smoked in past day', 'description': 'Measured by survey', 'timeFrame': 'day 11'}, {'measure': 'Number of LCCs smoked in past day', 'description': 'Measured by survey', 'timeFrame': 'day 12'}, {'measure': 'Number of LCCs smoked in past day', 'description': 'Measured by survey', 'timeFrame': 'day 13'}, {'measure': 'Number of LCCs smoked in past day', 'description': 'Measured by survey', 'timeFrame': 'day 14'}, {'measure': 'Number of LCCs smoked in past day', 'description': 'Measured by survey', 'timeFrame': 'day 15'}, {'measure': 'Number of LCCs smoked in past day', 'description': 'Measured by survey', 'timeFrame': 'day 16'}, {'measure': 'Number of LCCs smoked in past day', 'description': 'Measured by survey', 'timeFrame': 'day 17'}, {'measure': 'Number of LCCs smoked in past day', 'description': 'Measured by survey', 'timeFrame': 'day 18'}, {'measure': 'Number of LCCs smoked in past day', 'description': 'Measured by survey', 'timeFrame': 'day 19'}, {'measure': 'Number of LCCs smoked in past day', 'description': 'Measured by survey', 'timeFrame': 'day 20'}, {'measure': 'Number of LCCs smoked in past day', 'description': 'Measured by survey', 'timeFrame': 'day 21 (post test)'}, {'measure': 'Number of days smoked LCCs in past week', 'description': 'Measured by survey', 'timeFrame': 'day 7'}, {'measure': 'Number of days smoked LCCs in past week', 'description': 'Measured by survey', 'timeFrame': 'day 14'}, {'measure': 'Number of days smoked LCCs in past week', 'description': 'Measured by survey', 'timeFrame': 'day 21 (post test)'}, {'measure': 'Number of LCCs smoked in the past week', 'description': 'Measured by survey', 'timeFrame': 'day 7'}, {'measure': 'Number of LCCs smoked in the past week', 'description': 'Measured by survey', 'timeFrame': 'day 14'}, {'measure': 'Number of LCCs smoked in the past week', 'description': 'Measured by survey', 'timeFrame': 'day 21 (post test)'}, {'measure': 'Number of LCCs butted out in the past week', 'description': 'Measured by survey', 'timeFrame': 'day 7'}, {'measure': 'Number of LCCs butted out in the past week', 'description': 'Measured by survey', 'timeFrame': 'day 14'}, {'measure': 'Number of LCCs butted out in the past week', 'description': 'Measured by survey', 'timeFrame': 'day 21 (post test)'}, {'measure': 'Number of LCCs forgone in the past week', 'description': 'Measured by survey', 'timeFrame': 'day 7'}, {'measure': 'Number of LCCs forgone in the past week', 'description': 'Measured by survey', 'timeFrame': 'day 14'}, {'measure': 'Number of LCCs forgone in the past week', 'description': 'Measured by survey', 'timeFrame': 'day 21 (post test)'}, {'measure': 'LCC quit attempts in past week', 'description': 'Measured by survey', 'timeFrame': 'day 7'}, {'measure': 'LCC quit attempts in past week', 'description': 'Measured by survey', 'timeFrame': 'day 14'}, {'measure': 'LCC quit attempts in past week', 'description': 'Measured by survey', 'timeFrame': 'day 21 (post test)'}, {'measure': 'LCC quit intentions', 'description': 'Average quit intention score measured by survey. Quit intention measured with 3 questions, the final quit intention score is a mean of the response to the 3 questions, on a scale of 1 to 4, where 1 indicates low intention to quit, and 4 indicates a high intention to quit.', 'timeFrame': 'day 7'}, {'measure': 'LCC quit intentions', 'description': 'Average quit intention score measured by survey. Quit intention measured with 3 questions, the final quit intention score is a mean of the response to the 3 questions, on a scale of 1 to 4, where 1 indicates low intention to quit, and 4 indicates a high intention to quit.', 'timeFrame': 'day 14'}, {'measure': 'Self reported learning', 'description': 'Measured by survey. Self-reported learning measured with one item on a 1 to 5 scale, where 1 indicates no learning, and 5 indicates a great deal of learning from the warnings in the study. Self reported learning is only measured in conditions 1 and 2, the conditions that receive warnings.', 'timeFrame': 'day 21 (post test)'}] |
Title: The Role of 68GA DOTATATE PET/CT In Breast Cancer Imaging; a Prospective Study Compared With 18F FDG PET/CT | Condition: Breast Cancer | Keywords: | Summary: | Description: This study is designed to explore and compare the uptake patterns of breast cancer lesions using two distinct PET/CT imaging modalities: 18F-FDG and 68Ga-DOTATATE. The primary goal is to assess the diagnostic and prognostic value of these imaging techniques in the context of breast cancer, with a particular focus on their ability to inform treatment strategies based on the biological characteristics and stage of the disease.
Breast cancer remains the most prevalent cancer among women globally, as highlighted by GLOBOCAN 2020 data. The disease's treatment involves a multifaceted approach, including surgery, chemotherapy, radiotherapy, targeted therapies, and endocrine therapy. The effectiveness of these treatments is significantly influenced by the tumor's biological attributes and its progression stage. In this light, the accurate pre-treatment staging of breast cancer is paramount, with 18F-FDG PET/CT playing an increasingly crucial role due to its high accuracy in detecting extra-axillary lymph node metastases and distant metastatic disease.
Somatostatin analogs, particularly 68Ga-DOTA-TATE, have emerged as potent tools for imaging and treating SSTR-positive neuroendocrine tumors, leveraging the high affinity of DOTA-TATE for SSTR2. This study extends the application of 68Ga-DOTATATE PET/CT to breast cancer, motivated by findings that SSTR2 is the most prevalent somatostatin receptor subtype in breast tumors. The differential expression of SSTR2, influenced by tumor differentiation and hormonal status, underlines the potential of 68Ga-DOTATATE PET/CT in providing additional insights into tumor biology.
The study will systematically compare the uptake of 18F-FDG and 68Ga-DOTATATE in breast cancer lesions, correlating these findings with histopathological subtypes and hormone receptor (ER and PR) as well as HER2 status. By doing so, it aims to elucidate the relevance of SSTR2 expression in the heterogeneity of breast cancer and its implications for targeting somatostatin receptors in diagnosis and therapy.
This research is expected to contribute significantly to the field of nuclear medicine and oncology by:
Providing comparative data on the diagnostic accuracy and prognostic value of 18F-FDG PET/CT and 68Ga-DOTATATE PET/CT in breast cancer staging.
Evaluating the expression of SSTR subtypes in breast cancer and their correlation with tumor histopathology and receptor status.
Assessing the potential of 68Ga-DOTATATE PET/CT as a complementary tool for the personalized management of breast cancer, particularly in cases with somatostatin receptor expression.
This study is guided by the latest advancements in molecular imaging and aims to refine breast cancer treatment protocols, offering a more tailored and effective approach to patient care. | ArmGroups: [{'label': 'Breast Cancer Patient', 'type': 'EXPERIMENTAL', 'interventionNames': ['Diagnostic Test: 18F FDG PET/CT', 'Diagnostic Test: 68Ga DOTATATE PET/CT']}] | Interventions:[{'type': 'DIAGNOSTIC_TEST', 'name': '18F FDG PET/CT', 'description': '18F-FDG PET/CT Imaging: Preparation: Participants will be instructed to fast for at least 6 hours before the procedure to ensure low insulin levels and high FDG uptake by cancer cells.\n\nRadiopharmaceutical Administration: Each participant will receive an intravenous injection of 18F-FDG, dosed at approximately 5.2 MBq/kg (0.14 mCi/kg) of body weight.\n\nImaging Protocol: After the injection, participants will rest in a quiet and dimly lit room for approximately 60 minutes to allow for optimal distribution and uptake of 18F-FDG by the tissues. Subsequently, they will be positioned on the PET/CT scanner bed, and imaging will be performed from the vertex to the proximal thighs. The scan will include a low-dose CT for attenuation correction followed by PET imaging, with the acquisition time adjusted based on the specific protocol (typically 2-3 minutes per bed position).', 'armGroupLabels': ['Breast Cancer Patient']}, {'type': 'DIAGNOSTIC_TEST', 'name': '68Ga DOTATATE PET/CT', 'description': '68Ga-DOTATATE PET/CT Imaging: Preparation: No specific fasting is required for 68Ga-DOTATATE PET/CT. However, participants may be advised to hydrate well before the procedure.\n\nRadiopharmaceutical Administration: Participants will receive an intravenous injection of 68Ga-DOTATATE, dosed at approximately 2.2 MBq/kg (0.06 mCi/kg) of body weight.\n\nImaging Protocol: Similar to the 18F-FDG protocol, after receiving 68Ga-DOTATATE, participants will wait for about 60 minutes to allow for sufficient uptake of the tracer. They will then undergo PET/CT scanning in a supine position, covering the same body regions as the FDG scan. A low-dose CT scan will be conducted first for attenuation correction, followed by the PET scan, with acquisition parameters tailored to the optimal detection of somatostatin receptor expression.', 'armGroupLabels': ['Breast Cancer Patient']}] | PrimaryOutcomes: [{'measure': 'Comparative Diagnostic Accuracy of 68Ga DOTATATE and 18F FDG PET/CT', 'description': 'The primary outcome of this study is to assess and compare the diagnostic accuracy of 18F-FDG PET/CT and 68Ga-DOTATATE PET/CT in detecting primary and metastatic breast cancer lesions. This will be evaluated through the identification of lesion uptake patterns, quantified by the maximum standardized uptake value (SUVmax), and the presence of extra-axillary lymph node and distant metastases as indicated by each imaging modality.', 'timeFrame': 'The diagnostic accuracy will be assessed immediately following the completion of both PET/CT scans, with each participant undergoing both scans within a one-week interval. The analysis of images and interpretation of results will occur after all particip'}] | SecondaryOutcomes: N/A |
Title: PROnostic Interest of 18F-FDG PET/CT in Patients With Metastatic Castration-resistant Prostate Cancer (mCPRC) Progressing on Chemotherapy, Treated With 177 Lu-PSMA (PROFLu)D7 (± 1 Day) | Condition: Prostate Cancer | Keywords: nuclear medicine, prostate cancer, PET scan | Summary: | Description: Prostate-specific membrane antigen (PSMA) is expressed in most metastatic castration-resistant prostate cancer (mCRPC) cells. In response to this finding, a vectorized internal radiotherapy (VIR) therapy was developed, lutetium 177-labeled PSMA, 177Lu-PSMA. Clinical trials have demonstrated its efficacy in men with metastatic castration-resistant prostate cancer . The number of patients treated in nuclear medicine departments has increased considerably in recent years, notably with the Food and Drug Administration's (FDA) and the European Medicines Agency's (EMA) approval of this treatment (177Lu-PSMA-617, Pluvicto®) in the setting of progressive mCRPC after at least one line of 2nd-generation hormone therapy and one line of taxane chemotherapy.
Patients eligible for treatment benefit from pre-therapy 68Ga-PSMA positron emission tomography (PET/CT) to assess PSMA expression by cancer cells, but 18FDG PET/CT, although mentioned in the EANM guidelines, is not routinely performed. For treatment follow-up of prostate cancer patients, the PCWG3 (prostate cancer working group 3) currently recommends conventional imaging (CT scan and bone scan) (4) and makes no mention of metabolic imaging, even though some lesions are not detectable with conventional imaging. In addition, one study reported that a high metabolic volume 18FDG PET/CT scan as part of the pre-therapy work-up for mCRPC prior to the introduction of 177Lu-PSMA or Cabazitaxel therapy was associated with a poorer response to treatment.
The aim of this retrospective study was to assess the prognostic value of parameters extracted from 18FDG PET/CT and 68Ga-PSMA PET in the initial work-up and follow-up of patients treated with 177Lu-PSMA in mCRPC. | ArmGroups: [{'label': 'Patients treated with 177Lu-PSMA for castration-resistant prostate cancer', 'description': 'Patients treated with 177Lu-PSMA for castration-resistant prostate cancer and who benefited from 68Ga-PSMA and 18FDG PET scans as part of the initial workup and treatment follow-up.', 'interventionNames': ['Device: PET scan of 18F-FDG']}] | Interventions:[{'type': 'DEVICE', 'name': 'PET scan of 18F-FDG', 'description': 'VEREOS PET scanner. Philips VEREOS digital PET-CT scanners are installed in the nuclear medicine department.', 'armGroupLabels': ['Patients treated with 177Lu-PSMA for castration-resistant prostate cancer']}] | PrimaryOutcomes: [{'measure': 'Diagnostic accuracy of 18FDG PET metabolic volume', 'description': 'Diagnostic accuracy of 18FDG PET metabolic volume in predicting 1-year overall survival.', 'timeFrame': '1 year'}] | SecondaryOutcomes: [{'measure': 'Diagnostic accuracy of 18FDG PET tumor parameter (SUVmax)', 'description': 'Diagnostic accuracy of 18FDG PET tumor parameter (SUVmax) in predicting 1-year overall survival.', 'timeFrame': '1 year'}, {'measure': 'Diagnostic accuracy of 18FDG PET tumor parameters (SUVmean)', 'description': 'Diagnostic accuracy of 18FDG PET tumor parameters (SUVmean), in predicting 1-year overall survival.', 'timeFrame': '1 year'}, {'measure': 'Diagnostic accuracy of 18FDG PET tumor parameters (FDG/PSMA mismatch)', 'description': 'Diagnostic accuracy of 18FDG PET tumor parameters (FDG/PSMA mismatch) in predicting 1-year overall survival.', 'timeFrame': '1 year'}] |
Title: Molecular Mechanisms of Senescence Predisposing to Cancer : Exploratory Analysis on Healthy Tissues Collected for Two Age Groups. | Condition: Sarcoma | Keywords: Mechanisms of Senescence, Senescence markers | Summary: | Description: * Information and obtaining informed consent.
* Collection of clinical data.
* Collection of two samples of healthy skin tissue, without disfigurement, during an intervention under general anesthesia for the treatment of a sarcoma.
* Freezing samples of healthy skin tissue in liquid nitrogen within 10 minutes after collection.
* Transfer of the samples to the laboratory of anatomopathology.
* Preparation of the healthy skin samples by the laboratory of anatomopathology.
* Transfer of the conditioned samples to the Institut de Biologie de Lille for analysis.
* Control of the aesthetic appearance during the postoperative consultation.
* Destruction of the samples at the end of analysis. | ArmGroups: [{'label': 'Collection of healthy skin tissue', 'type': 'EXPERIMENTAL', 'description': 'Collection of healthy skin tissue', 'interventionNames': ['Procedure: Collection of healthy skin tissue']}] | Interventions:[{'type': 'PROCEDURE', 'name': 'Collection of healthy skin tissue', 'description': 'Collection of two samples of healthy skin tissue, without disfigurement, during an intervention under general anesthesia for the treatment of a benign or malignant tumor.', 'armGroupLabels': ['Collection of healthy skin tissue']}] | PrimaryOutcomes: [{'measure': 'Expression of senescence markers in healthy skin tissues collected for the two age groups.', 'timeFrame': 'Baseline'}] | SecondaryOutcomes: [{'measure': 'Research of emerging cells in the skin tissue of the subjects of the two age groups via the expression of the Protease-Activated Receptor-1 (PAR-1).', 'timeFrame': 'Baseline'}, {'measure': 'Presence of different types of DNA damage (single and double strand breaks) in the keratinocytes and fibroblasts of the skin tissues of the two age groups.', 'timeFrame': 'Baseline'}, {'measure': 'Morbidity', 'description': 'Postoperative complications up to 30 days after surgery according to the Clavien-Dindo classification (2009), according to the NCI-CTCAE v4.0 beyond this deadline.', 'timeFrame': 'Baseline'}] |
Title: Pilot Feasibility Study of the Combination of a Personalized Therapeutic Anti-tumor Vaccine With Pembrolizumab and Standard of Care Chemotherapy in Squamous Non-Small Cell Lung Cancer and Extensive Stage Small Cell Lung Cancer | Condition: Non Small Cell Lung Cancer, NSCLC, Non-small Cell Lung Cancer, Small Cell Lung Extensive Stage | Keywords: | Summary: | Description: Please note that this study originally opened with ID# 201707041 but was withdrawn due to change in standard of care chemotherapy. This study was revised and submitted as an amendment to the same IND but our IRB required it to be submitted as a new study and it received a new ID#. | ArmGroups: [{'label': 'Cohort A: Stage IV squamous NSCLC', 'type': 'EXPERIMENTAL', 'description': "* 4 cycles of standard of care (SOC) platinum doublet chemotherapy (investigator's choice)\n* Pembrolizumab (200 mg every 3 weeks (Q3W) for 4 cycles while patient is receiving SOC chemo). Pembrolizumab may continue to be administered Q3W for a maximum of 35 total administrations\n* All patients will begin the NEO-PV-01 vaccination at Week 12, 3 weeks following the 4th cycle of pembrolizumab / chemotherapy. At Week 12 (Cycle 5), NEO-PV-01 vaccinations will be administered in a prime-boost schedule with 5 priming vaccinations over a 3 week period followed by booster vaccinations at 1 month and 2 months after the last priming vaccination\n* Up to 20 personalized vaccine peptides will be administered for each patient. Vaccine administration will occur on Days 1, 4, 8, 15 during Cycle 5 of pembrolizumab administration and Day 1 of Cycle 6 of pembrolizumab administration, on Day 8 during Cycle 7 of pembrolizumab administration, and on Day 15 during Cycle 8 of pembrolizumab administration", 'interventionNames': ['Drug: Pembrolizumab', 'Biological: NEO-PV-01 vaccine', 'Procedure: Biopsy', 'Drug: Poly ICLC', 'Procedure: Leukapheresis', 'Procedure: Peripheral blood samples']}, {'label': 'Cohort B: Extensive stage SCLC', 'type': 'EXPERIMENTAL', 'description': "* 4 cycles of standard of care (SOC) platinum doublet chemotherapy (investigator's choice)\n* Pembrolizumab (200 mg every 3 weeks (Q3W) for 4 cycles while patient is receiving SOC chemo). Pembrolizumab may continue to be administered Q3W for a maximum of 35 total administrations\n* All patients will begin the NEO-PV-01 vaccination at Week 12, 3 weeks following the 4th cycle of pembrolizumab / chemotherapy. At Week 12 (Cycle 5), NEO-PV-01 vaccinations will be administered in a prime-boost schedule with 5 priming vaccinations over a 3 week period followed by booster vaccinations at 1 month and 2 months after the last priming vaccination\n* Up to 20 personalized vaccine peptides will be administered for each patient. Vaccine administration will occur on Days 1, 4, 8, 15 during Cycle 5 of pembrolizumab administration and Day 1 of Cycle 6 of pembrolizumab administration, on Day 8 during Cycle 7 of pembrolizumab administration, and on Day 15 during Cycle 8 of pembrolizumab administration", 'interventionNames': ['Drug: Pembrolizumab', 'Biological: NEO-PV-01 vaccine', 'Procedure: Biopsy', 'Drug: Poly ICLC', 'Procedure: Leukapheresis', 'Procedure: Peripheral blood samples']}] | Interventions:[{'type': 'DRUG', 'name': 'Pembrolizumab', 'description': '-Pembrolizumab will be given intravenously over the course of 30 minutes', 'armGroupLabels': ['Cohort A: Stage IV squamous NSCLC', 'Cohort B: Extensive stage SCLC'], 'otherNames': ['Keytruda']}, {'type': 'BIOLOGICAL', 'name': 'NEO-PV-01 vaccine', 'description': '-Generation of the vaccine is expected to take approximately 12 weeks', 'armGroupLabels': ['Cohort A: Stage IV squamous NSCLC', 'Cohort B: Extensive stage SCLC'], 'otherNames': ['Personalized vaccine']}, {'type': 'PROCEDURE', 'name': 'Biopsy', 'description': '-Surgical or core needle biopsy of an accessible site for DNA and RNA sequencing, immunological analysis, and generation of NEO-PV-01 vaccine', 'armGroupLabels': ['Cohort A: Stage IV squamous NSCLC', 'Cohort B: Extensive stage SCLC']}, {'type': 'DRUG', 'name': 'Poly ICLC', 'description': '-NEO-PV-01 is combined with the adjuvant poly-ICLC prior to administration.', 'armGroupLabels': ['Cohort A: Stage IV squamous NSCLC', 'Cohort B: Extensive stage SCLC'], 'otherNames': ['Hiltonol']}, {'type': 'PROCEDURE', 'name': 'Leukapheresis', 'description': '-Peripheral blood mononuclear cells (PBMCs) for comprehensive immune system monitoring will be obtained from leukapheresis samples collected up to 7 days prior to initiation of NEO PV-01 vaccination and at 7 days (Week 20) following the first NEO-PV-01 booster vaccination.', 'armGroupLabels': ['Cohort A: Stage IV squamous NSCLC', 'Cohort B: Extensive stage SCLC']}, {'type': 'PROCEDURE', 'name': 'Peripheral blood samples', 'description': '-Blood samples (80 mL) for immune monitoring will be obtained prior to study treatment and at Weeks 6, 14, 16, 24, 36, 48, 63, 75, 87, and 99.', 'armGroupLabels': ['Cohort A: Stage IV squamous NSCLC', 'Cohort B: Extensive stage SCLC']}] | PrimaryOutcomes: [{'measure': 'Safety and feasibility of the combined regimen as measured by number of participants who experience a serious adverse event', 'description': '-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for all toxicity reporting.', 'timeFrame': '30 days following the completion of treatment (estimated to be 2 years and 16 weeks)'}] | SecondaryOutcomes: [{'measure': 'Objective response rate as measured by RECIST 1.1', 'description': '--Percentage of participants who experience a complete or partial response\n\n* Complete Response (CR): Disappearance of all target and non-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', 'timeFrame': 'Through completion of treatment (estimated to be 108 weeks)'}, {'measure': 'Progression-free survival (PFS) as measured by RECIST 1.1', 'description': '* PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.\n* Progressive disease: 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': 'Through completion of follow-up (estimated to be 7 years)'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Through completion of follow-up (estimated to be 7 years)'}, {'measure': 'Clinical benefit rate (CBR)', 'timeFrame': 'Through completion of treatment (estimated to be 108 weeks)'}, {'measure': 'Duration of response (DOR)', 'timeFrame': 'Through completion of treatment (estimated to be 108 weeks)'}, {'measure': 'Response conversion rate (RCR)', 'timeFrame': 'Through completion of treatment (estimated to be 108 weeks)'}, {'measure': 'Objective response rate (ORR) as measured per iRECIST', 'timeFrame': 'Through completion of treatment (estimated to be 108 weeks)'}, {'measure': 'Progression-free survival (PFS) as measured per iRECIST', 'description': '-PFS is defined as the duration of time from start of personalized vaccine treatment (\\~12 weeks after baseline) to time of progression or death, whichever occurs first.', 'timeFrame': 'Through completion of follow-up (estimated to be 7 years)'}] |
Title: A Phase I Study of the Intrathecal Administration of Resiniferatoxin for Treating Severe Refractory Pain Associated With Advanced Cancer | Condition: Intractable Pain, Palliative Care | Keywords: Vanilloid, Capsaicin, Cancer Pain, Nerve Block | Summary: | Description: Pain continues to be a major problem in patients with advanced cancer. Resiniferatoxin (RTX), a potent member of the family of drugs that includes capsaicin, selectively and irreversibly destroys the neurons (or their axons) transmitting chronic pain sensation. Intrathecal injection of RTX in several animal species has demonstrated a high level of safety, specificity, and efficacy in treating severe pain. This first-in-human, dose-escalation study is investigating the intrathecal administration of RTX in cancer patients with severe pain.
PRIMARY OBJECTIVE:
To investigate the safety and efficacy of RTX administered intrathecally in subjects with severe refractory pain associated with advanced cancer.
STUDY POPULATION:
Up to 45 subjects will be accrued. Eligible subjects will be greater than or equal to 18 years of age, have a clinical and histological diagnosis of advanced malignancy, and have severe pain due to malignancy that is at or below the level of the chest and not adequately relieved by other pain control therapies.
DESIGN:
This is a single site, non-randomized, open-label, dose-escalation study using a modified Fibonacci scheme. The starting dose of RTX was 13 micrograms given as a 2 mL injection via an intra-spinal catheter over approximately 30 seconds followed by a 1 mL flush. Six subjects were dosed at this level and 3 were dosed at the 26 microgram dose level at the same volume of injectate, flush and injection time. Under the study design, RTX doses were to be increased in progressively smaller percentage increments with each dose-escalation to occur in sequential groups of 3 subjects until 1 escalation above the effective dose in 100% of subjects (ED100), completion of the 100 microgram dose level, or establishment of the maximum tolerated dose (MTD), whichever occurs first. The total duration of study participation for any subject will be up to 7 months.
The amended RTX injection technique reduced the injection volume and increased the injection time to reduce the spread of RTX to above the T6 (sixth thoracic) vertebral level. The present technique is a 1 mL injection over 2 minutes (0.5 mL/minute) given via infusion pump, followed by flushing of the IT catheter with the minimum volume of sterile, preservative-free saline necessary to clear the internal volume of the catheter used for the injection. Three patients were treated at the new starting dose of 13 micrograms with the new injection technique. The next 3-patient cohort will receive a dose of 26 micrograms. The subsequent subject dose tier will receive a dose of 44 micrograms consistent with the protocol s dose-escalation algorithm. Administering this dose will require an infusion volume of 1.76 mL of the present 25 micrograms/mL RTX formulation.
OUTCOME MEASURES:
The primary study outcome is the ED100, the MTD, or the maximum dose administered, whichever is achieved first during dose-escalation. The primary pain variable for determining the ED100 is the daily worst pain intensity score averaged over a 4 to 7-day period during the 3 weeks before RTX dosing and during Days 8 through 14 after dosing. The numerical rating scale (NRS), administered verbally during a daily telephone interview, will be the primary pain assessment instrument. For a given subject, the treatment will be considered effective if the subject experiences a greater than or equal to 50% reduction in the mean daily worst pain score assessed by NRS (evaluated on Study Day 15). We may also consider RTX treatment to be successful if there is greater than or equal to 50% reduction in opiate intake, measured by morphine milligram equivalents (MME) per day, even if pain levels are unchanged after RTX treatment.
Secondary outcome measures will be other surveys of pain, including an assessment of worst daily pain by the visual analog scale, and assessments of function and quality of life.
Safety assessments will include hematology; serum clinical chemistry tests; cerebrospinal fluid examinations; physical, neurological, and eye examinations; reporting of adverse events; electrocardiograms; and findings on magnetic resonance imaging of the spine and brain. | ArmGroups: [{'label': 'Single Arm', 'type': 'EXPERIMENTAL', 'description': 'advanced cancer patients with pain', 'interventionNames': ['Drug: Intrathecal Resiniferatoxin']}] | Interventions:[{'type': 'DRUG', 'name': 'Intrathecal Resiniferatoxin', 'description': 'phase I, single-site, non-randomized, open-label, dose-escalation study to determine the safety and efficacy of IT RTX in subjects with severe refractory pain due to advanced malignancy', 'armGroupLabels': ['Single Arm']}] | PrimaryOutcomes: [{'measure': 'Investigate the safety and efficacy of RTX administered intrathecally in subjects with severe refractory pain associated with advanced cancer along with ED100, the MTD, or the maximum dose administered, whichever is achieved first during dose es...', 'description': 'Dose escalation decisions are based on both effectiveness (as assessed by mean worst pain on the NRS) and DLT. The dose escalation population will include all subjects who are dosed, complete the NRS, and have the DLT assessments from baseline through Day 15. Subjects who are not evaluable for dose escalation will be replaced.', 'timeFrame': 'Day 7, Day 15, Day 68, Day 188'}] | SecondaryOutcomes: [{'measure': 'Secondary outcome measures will be other surveys of pain, including an assessment of worst daily pain by the visual analog scale, and assessments of function and quality of life.', 'description': 'The secondary outcome variables will be summarized over time by dose cohort as appropriate for the outcome measure. Absolute and percentage change in the NRS and VAS pain scores between the pre- and post-RTX dosing assessments (baseline period and study Days 8 through 14, respectively) will also be summarized.', 'timeFrame': 'Day 7, Day 15, Day 68, Day 188'}] |
Title: Phase I Dose Escalation Study of Carboplatin, Pemetrexed and Exemestane in Post-menopausal Women With Metastatic Non-squamous NSCLC | Condition: Stage IV Non-small Cell Lung Cancer | Keywords: | Summary: | Description: PRIMARY OBJECTIVES:
I. Evaluate the safety and tolerability of escalating doses of exemestane when given with pemetrexed (pemetrexed disodium) and carboplatin in post-menopausal women with stage IV non-squamous, non-small cell lung cancer (NSCLC).
SECONDARY OBJECTIVES:
I. Determine the objective tumor response rate (defined by Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1) in patients treated with pemetrexed, carboplatin and exemestane.
II. Evaluate the pharmacokinetic profile of pemetrexed, carboplatin and exemestane.
III. Evaluate quality of life in patients treated with pemetrexed, carboplatin and exemestane.
IV. Analyze tumor tissue biomarkers for potential correlation with response.
OUTLINE: This is a dose-escalation study of exemestane.
Patients receive exemestane orally (PO) once daily (QD) on days 1-28 and pemetrexed disodium intravenously (IV) over 15 minutes and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, and then every 3 months thereafter. | ArmGroups: [{'label': 'Treatment (exemestane, pemetrexed disodium, and carboplatin)', 'type': 'EXPERIMENTAL', 'description': 'Patients receive exemestane PO QD on days 1-28 and pemetrexed disodium IV over 15 minutes and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: exemestane', 'Drug: pemetrexed disodium', 'Drug: carboplatin', 'Other: laboratory biomarker analysis', 'Other: pharmacological study', 'Other: questionnaire administration', 'Procedure: quality-of-life assessment']}] | Interventions:[{'type': 'DRUG', 'name': 'exemestane', 'description': 'Given PO', 'armGroupLabels': ['Treatment (exemestane, pemetrexed disodium, and carboplatin)'], 'otherNames': ['Aromasin', 'FCE-24304', 'PNU 155971']}, {'type': 'DRUG', 'name': 'pemetrexed disodium', 'description': 'Given IV', 'armGroupLabels': ['Treatment (exemestane, pemetrexed disodium, and carboplatin)'], 'otherNames': ['ALIMTA', 'LY231514', 'MTA']}, {'type': 'DRUG', 'name': 'carboplatin', 'description': 'Given IV', 'armGroupLabels': ['Treatment (exemestane, pemetrexed disodium, and carboplatin)'], 'otherNames': ['Carboplat', 'CBDCA', 'JM-8', 'Paraplat', 'Paraplatin']}, {'type': 'OTHER', 'name': 'laboratory biomarker analysis', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (exemestane, pemetrexed disodium, and carboplatin)']}, {'type': 'OTHER', 'name': 'pharmacological study', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (exemestane, pemetrexed disodium, and carboplatin)'], 'otherNames': ['pharmacological studies']}, {'type': 'OTHER', 'name': 'questionnaire administration', 'description': 'Ancillary studies', 'armGroupLabels': ['Treatment (exemestane, pemetrexed disodium, and carboplatin)']}, {'type': 'PROCEDURE', 'name': 'quality-of-life assessment', 'description': 'Ancillary studies', 'armGroupLabels': ['Treatment (exemestane, pemetrexed disodium, and carboplatin)'], 'otherNames': ['quality of life assessment']}] | PrimaryOutcomes: [{'measure': 'Tabulation, grading, and attribution of serious adverse events (SAEs) and adverse events (AEs) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0', 'timeFrame': 'Up to 3 years'}] | SecondaryOutcomes: [{'measure': 'Proportion achieving clinical response', 'description': "For categorical markers Fisher's exact test will be used. The log rank test will be used to examine association between categorical markers and time to disease progression. For quantitative markers one-way ANOVA will be used. Cox-proportional hazards regression models will be used to correlate quantitative markers with time to disease progression. Pearson correlations will be used between pairs of quantitative markers. If there is significant non-normality the Kendall correlation coefficients will be used. Mixed effects models will be used to quantify markers at multiple time points.", 'timeFrame': 'Up to 3 years'}, {'measure': 'Quality of life in patients treated with pemetrexed disodium, carboplatin and exemestane', 'description': 'Quality of life measures will be compared between response categories (ANOVA) and the effect of time on therapy will be assessed with mixed effects models.', 'timeFrame': 'Up to 3 years'}] |
Title: Phase I Dose-escalation Trial of CP-675,206 (Tremelimumab, Anti-CTLA-4 Monoclonal Antibody) for Patients With BCG-resistant Localized Transitional Cell Carcinoma of the Bladder | Condition: Bladder Cancer | Keywords: bladder cancer, BCG-resistant localized transitional cell of the bladder | Summary: | Description: N/A | ArmGroups: [{'label': '1', 'type': 'EXPERIMENTAL', 'description': 'BCG 81 mg intravesical weekly x 6 beginning on week 1, and weekly x 3 beginning at week 15 in combination with CP-675,206 I.V. week 3, week 1', 'interventionNames': ['Drug: BCG and CP-675,206']}] | Interventions:[{'type': 'DRUG', 'name': 'BCG and CP-675,206', 'description': 'Dose level -1: BCG 81 mg intravesical weekly x 6 beginning on week 1, and weekly x 3 beginning at week 15 CP-675,206 3 mg/kg I.V. week 3, week 15\n\nDose level 1: BCG 81 mg intravesical weekly x 6 beginning on week 1, and weekly x 3 beginning at week 15 CP-675,206 6 mg/kg I.V. week 3, week 15\n\nDose level 2: BCG 81 mg intravesical weekly x 6 beginning on week 1, and weekly x 3 beginning at week 15 CP-675,206 10 mg/kg IV week 3, week 15\n\nDose level 3: BCG 81 mg intravesical weekly x 6 beginning on week 1, and weekly x 3 beginning at week 15 CP-675,206 15 mg/kg IV week 3, week 15', 'armGroupLabels': ['1'], 'otherNames': ['Bacille Calmette-Guerin (BCG)', 'Tremelimumab']}] | PrimaryOutcomes: [{'measure': 'To determine the safety of CP-675,206 when delivered in combination with BCG in patients with BCG-resistant bladder carcinoma in situ', 'timeFrame': '24 months'}] | SecondaryOutcomes: [{'measure': 'To determine whether patients treated with CP-675,206 in combination with BCG develop cancer antigen-specific systemic immune responses', 'timeFrame': '24 months'}, {'measure': 'To determine whether patients treated with CP-675,206 in combination with BCG develop an increase in tumor-infiltrating lymphocytes', 'timeFrame': '24 months'}, {'measure': 'To determine whether patients treated with CP-675,206 in combination with BCG develop pathological and cytological complete responses', 'timeFrame': '24 months'}, {'measure': 'To determine the 1-year recurrence-free survival', 'timeFrame': '24 months'}, {'measure': 'To determine a recommended dose and schedule for phase II trial evaluation based on the maximum tolerated dose', 'timeFrame': '24 months'}] |
Title: A Randomized Phase 2 Trial of Durvalumab (MEDI4736) With or Without SBRT in Clinical Stage I, II, and IIIA Non-small Cell Lung Cancer (NSCLC) | Condition: Carcinoma, Non-Small-Cell Lung | Keywords: Lung neoplasms, Bronchial Neoplasms, Carcinoma, bronchogenic, Neoplasms, Neoplasms by site, Respiratory Tract Diseases, Respiratory Tract Neoplasms, Thoracic Neoplasms | Summary: | Description: This is a randomized open label phase II trial of preoperative anti-PD-L1 antibody durvalumab with or without concurrent non-ablative radiation followed by surgical resection and postoperative monthly maintenance durvalumab for twelve months, following standard of care postoperative therapy. | ArmGroups: [{'label': 'Arm 1 (Durvalumab monotherapy)', 'type': 'EXPERIMENTAL', 'description': 'Durvalumab (MEDI4736) 1.12 g administered pre-operatively every 3 weeks for 2 cycles followed by surgical resection. Durvalumab monotherapy 1.5 g will be given for 12 months post-operatively.', 'interventionNames': ['Drug: Durvalumab']}, {'label': 'Arm 2 (Durvalumab plus SBRT)', 'type': 'EXPERIMENTAL', 'description': 'Durvalumab (MEDI4736) 1.12 g administered pre-operatively every 3 weeks for 2 cycles plus radiotherapy delivered in 3 daily fractions starting concurrently with the first cycle of durvalumab (MEDI4736) followed by surgical resection. Durvalumab monotherapy 1.5 g will be given for 12 months post-operatively.', 'interventionNames': ['Drug: Durvalumab', 'Other: Durvalumab plus SBRT']}] | Interventions:[{'type': 'DRUG', 'name': 'Durvalumab', 'description': 'Intravenously', 'armGroupLabels': ['Arm 1 (Durvalumab monotherapy)', 'Arm 2 (Durvalumab plus SBRT)'], 'otherNames': ['MEDI4736']}, {'type': 'OTHER', 'name': 'Durvalumab plus SBRT', 'description': 'Intravenously plus radiotherapy', 'armGroupLabels': ['Arm 2 (Durvalumab plus SBRT)'], 'otherNames': ['MEDI4736']}] | PrimaryOutcomes: [{'measure': 'Number of Subjects With Major Pathological Response (MPR)', 'description': 'MPR is defined as ≤10% residual viable tumor in the resected specimen.', 'timeFrame': 'Durvalumab start date to surgical resection, up to 10 weeks'}] | SecondaryOutcomes: [{'measure': 'Kaplan-Meier Disease-Free Survival Proportion at 2 Years', 'description': 'Disease recurrence or death from any cause assessed using history, physical examination and CT scanning, histologically or cytologically confirmed whenever possible.', 'timeFrame': 'From date of Durvalumab start date until the date of first documented progression or date of death from any cause, whichever came first, assessed every 6 months for 2 years.'}, {'measure': 'Objective Clinical Response Rate', 'description': 'Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by PET/CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of diameters of target lesions; Progressive Disease (PD), \\>=20% increase in the sum of diameters of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.', 'timeFrame': 'Treatment day 1 up to weeks 6-7'}] |
Title: Sintilimab Combined With Low-dose Radiation Therapy for Neoadjuvant Treatment of Locally Advanced Deficient Mismatch Repair/Microsatellite Instability-high Gastric Cancer: a Prospective, Multi-center, Single-arm, Phase Ib/II Clinical Trial | Condition: Gastric Cancer | Keywords: gastric cancer, neoadjuvant therapy, sintilimab, LDRT | Summary: | Description: This is a prospective, multicenter, single-arm, phase Ib/II trial. In the phase Ib, 4 cases will be enrolled in each treatment group. In the phase II study, a total of 33 patients will be enrolled. Eligible patients will be registered and receive four cycles of sintilimab. Simultaneously, LDRT will be planned and administered. Radical D2 gastric cancer resection will be performed 4-6 weeks after the last administration of sintilimab. The primary endpoint of phase Ib is to determine the optimal radiation dose for phase II study. The primary endpoint of phase II is the pathological complete response (pCR) rate. Secondary endpoints include R0 resection rate, major pathological response (MPR), objective response rate (ORR), 3-year event-free survival (EFS) rate, 3-year overall survival (OS) rate and safety profile of the neoadjuvant regimen. | ArmGroups: [{'label': 'sintilimab+LDRT', 'type': 'EXPERIMENTAL', 'description': 'Laparoscopic exploration is required in all patients to detect occult peritoneal metastases.\n\nAll patients will start with one cycle of neoadjuvant therapy of sintilimab: 200 mg, iv drip, d1, q3w.\n\nThen, LDRT will be performed in the target area (including the primary gastric lesion and positive/suspected positive lymph nodes).\n\nAfter radiotherapy, patients will receive another three cycles of sintilimab. Radical D2 gastric cancer resection will be performed 4-6 weeks after the last administration of sintilimab.\n\nThe adjuvant therapy will start in 4-6 weeks after the surgery, and we recommend adjuvant treatment with sintilimab for up to 10 cycles.', 'interventionNames': ['Drug: sintiliman plus LDRT']}] | Interventions:[{'type': 'DRUG', 'name': 'sintiliman plus LDRT', 'description': 'All patients will start with one cycle of neoadjuvant therapy of sintilimab: sintilimab 200 mg, iv drip, d1, q3w.\n\nLDRT will be performed in the target area. After radiotherapy, patients will receive another three cycles of sintilimab.\n\nRadical D2 gastric cancer resection will be performed 4-6 weeks after the last administration of sintilimab.\n\nThe adjuvant therapy will start in 4-6 weeks after the surgery, and we recommend adjuvant treatment with sintilimab for up to 10 cycles.', 'armGroupLabels': ['sintilimab+LDRT']}] | PrimaryOutcomes: [{'measure': 'pCR rate', 'description': 'defined as the absence of viable tumor cells assessed by histological evaluation criteria after neoadjuvant therapy', 'timeFrame': '5 months after the last subject participating in'}] | SecondaryOutcomes: [{'measure': 'R0 resection rate', 'description': 'defined as the rate of the complete surgical removal of any residual cancer cells in the tumor bed', 'timeFrame': '5 months after the last subject participating in'}, {'measure': 'MPR rate', 'description': 'defined as tumor residual cells ≤10% in the surgical specimen', 'timeFrame': '5 months after the last subject participating in'}, {'measure': '3-year event-free survival (DFS)', 'description': 'defined as the proportion of patients without event 23 years after enrolment', 'timeFrame': 'every 3 month postoperation up to 36 months'}, {'measure': '2-year OS rate', 'description': 'defined as the proportion of patients survived 3 years after enrolment', 'timeFrame': 'every 3 month postoperation up to 36 months'}] |
Title: A Phase 1 First-in-Human, Multicenter, Open-Label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of ABBV-623 and ABBV-992 in Subjects With B-cell Malignancies | Condition: B-cell Lymphoma | Keywords: ABBV-623, ABBV-992, B-cell lymphoma, Cancer, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Mantle Cell Lymphoma (MCL), Marginal Zone Lymphoma (MZL), Waldenström's Macroglobulinemia (WM), Diffuse Large B-cell Lymphoma, Follicular Lymphoma | Summary: | Description: N/A | ArmGroups: [{'label': 'Monotherapy in Dose Escalation: ABBV-623', 'type': 'EXPERIMENTAL', 'description': 'Participants with Relapsed/Refractory (R/R) B-cell malignancies will receive escalating doses of ABBV-623.', 'interventionNames': ['Drug: ABBV-623']}, {'label': 'Monotherapy in Dose Escalation: ABBV-992', 'type': 'EXPERIMENTAL', 'description': 'Participants with R/R B-cell malignancies will receive escalating doses of ABBV-992.', 'interventionNames': ['Drug: ABBV-992']}, {'label': 'Combination in Dose Escalation', 'type': 'EXPERIMENTAL', 'description': 'Participants with R/R B-cell malignancies will receive escalating doses of ABBV-623 and ABBV-992.', 'interventionNames': ['Drug: ABBV-623', 'Drug: ABBV-992']}, {'label': 'Monotherapy in Dose Expansion: ABBV-623', 'type': 'EXPERIMENTAL', 'description': 'Participants with R/R B-cell malignancies will receive ABBV-623 at recommended Phase 2 dose (RP2D) determined in dose escalation phase.', 'interventionNames': ['Drug: ABBV-623']}, {'label': 'Monotherapy in Dose Expansion: ABBV-992', 'type': 'EXPERIMENTAL', 'description': 'Participants with R/R B-cell malignancies will receive ABBV-992 at recommended Phase 2 dose (RP2D) determined in dose escalation phase.', 'interventionNames': ['Drug: ABBV-992']}, {'label': 'Combination in Dose Expansion', 'type': 'EXPERIMENTAL', 'description': 'Participants with R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) will receive ABBV-623 and ABBV-992 at recommended Phase 2 dose (RP2D) determined in dose escalation phase.', 'interventionNames': ['Drug: ABBV-623', 'Drug: ABBV-992']}] | Interventions:[{'type': 'DRUG', 'name': 'ABBV-623', 'description': 'Oral Tablets', 'armGroupLabels': ['Combination in Dose Escalation', 'Combination in Dose Expansion', 'Monotherapy in Dose Escalation: ABBV-623', 'Monotherapy in Dose Expansion: ABBV-623']}, {'type': 'DRUG', 'name': 'ABBV-992', 'description': 'Oral Tablets', 'armGroupLabels': ['Combination in Dose Escalation', 'Combination in Dose Expansion', 'Monotherapy in Dose Escalation: ABBV-992', 'Monotherapy in Dose Expansion: ABBV-992']}] | PrimaryOutcomes: [{'measure': 'Percentage of Participants With Adverse Events (AEs)', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.', 'timeFrame': 'Up to approximately 25 months.'}, {'measure': 'Dose Escalation: Maximum Observed Plasma Concentration (Cmax) of ABBV-623', 'description': 'The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that ABBV-623 achieves in the blood after administration in a dosing interval.', 'timeFrame': 'Up to approximately 96 weeks'}, {'measure': 'Dose Escalation: Area Under the Plasma Concentration- Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration of ABBV-623', 'description': 'The area under the plasma concentration-time curve (AUC; measured in h\\*ng/mL/mg) is a method of measurement of the total exposure of ABBV-623 in blood plasma.', 'timeFrame': 'Up to approximately 96 weeks'}, {'measure': 'Dose Escalation: Maximum Observed Plasma Concentration (Cmax) of ABBV-992', 'description': 'The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that ABBV-992 achieves in the blood after administration in a dosing interval.', 'timeFrame': 'Up to approximately 96 weeks.'}, {'measure': 'Dose Escalation: Area Under the Plasma Concentration- Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration of ABBV-992', 'description': 'The area under the plasma concentration-time curve (AUC; measured in h\\*ng/mL/mg) is a method of measurement of the total exposure of ABBV-992 in blood plasma.', 'timeFrame': 'Up to approximately 96 weeks'}, {'measure': 'Combination Dose Expansion: Overall Response Rate (ORR) (PR or Better by IWCLL Criteria) in Participants With R/R CLL/SLL', 'description': 'ORR is the proportion of R/R CLL/SLL participants achieving a response of PR or better per IWCLL without the use of new anti-cancer therapy.', 'timeFrame': 'Up to approximately 2 years'}] | SecondaryOutcomes: [{'measure': 'Dose Escalation in Participants With R/R B-cell Malignancies: Percentage of Participants Achieving a Response of Partial Response (PR) or Better per Disease-Specific Response Criteria (e.g., IWCLL, Lugano, IWWM)', 'description': "Partial response (PR) as per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) , Lugano, International Workshop on Waldenström's Macroglobulinemia (IWWM) criteria in protocol.", 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Dose Escalation in Participants With R/R B-cell Malignancies: Duration of Response (DOR) for Participants With a Response of PR or Better', 'description': "Duration of Response (DOR) is defined as the time from the date of the participant's documented first response of PR or better to the date of documented disease progression or death due to the disease, whichever occurs first.", 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Dose Escalation in Participants With R/R B-cell Malignancies: Time to Response (TTR)', 'description': 'Time to response, defined as the length of time from the date of first dose of study drug to the date of first response of PR or better per disease-specific response criteria.', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Monotherapy Dose Expansion in Participants With R/R B-cell Malignancies: Achievement of a Response of PR or Better', 'description': "Partial response (PR) as per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) , Lugano, International Workshop on Waldenström's Macroglobulinemia (IWWM) criteria in protocol.", 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Monotherapy Dose Expansion in Participants With R/R B-cell Malignancies: Duration of Response (DOR) for Participants With a Response of PR or Better', 'description': "Duration of Response (DOR) is defined as the time from the date of the participant's documented first response of PR or better to the date of documented disease progression or death due to the disease, whichever occurs first.", 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Monotherapy Dose Expansion in Participants With R/R B-cell Malignancies: Time to Response (TTR)', 'description': 'Time to response, defined as the length of time from the date of first dose of study drug to the date of first response of PR or better per disease-specific response criteria.', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Combination Dose Expansion in Participants With CLL/SLL: Achievement of Bone Marrow Undetectable Minimal Residual Disease (uMRD)', 'description': 'Undetectable minimal residual disease (uMRD) is described as less than one myeloma cell per million bone marrow cells.', 'timeFrame': 'Up to approximately 6 months'}, {'measure': 'Combination Dose Expansion in Participants With CLL/SLL: Achievement of Bone Marrow Undetectable Minimal Residual Disease (uMRD)', 'description': 'Undetectable minimal residual disease (uMRD) is described as less than one myeloma cell per million bone marrow cells.', 'timeFrame': 'Up to approximately 1 Year'}, {'measure': 'Combination Dose Expansion in Participants With CLL/SLL: Percentage of Participants With Achievement of Peripheral Blood uMRD', 'description': 'Peripheral blood Undetectable minimal residual disease (uMRD) is described as less than one CLL cell per 10,000 leukocytes (or below 10\\^-4) or as specified in the protocol.', 'timeFrame': 'Up to approximately 96 weeks'}, {'measure': 'Combination Dose Expansion in Participants With CLL/SLL: Duration of Response for Participants With a Response of PR or Better', 'description': 'Duration of response is defined as the time from the initial objective response to disease progression or death, whichever occurs first.', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Combination Dose Expansion in Participants With CLL/SLL: Time to Response', 'description': 'Time to response is defined by the time between the date of the first drug intake and the date of the first assessment having documented the response.', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Combination Dose Expansion in Participants with CLL/SLL: Progression Free Survival', 'description': 'Progression free survival (PFS) is defined as the duration from start of the treatment to disease progression or death (regardless of cause of death), whichever comes first.', 'timeFrame': 'Approximately 2 years after study drug discontinuation'}, {'measure': 'Combination Dose Expansion in Participants With CLL/SLL: Overall Survival', 'description': 'Overall Survival is defined as the number of days from the date the participant was randomized to the date of death.', 'timeFrame': 'Approximately 2 years after study drug discontinuation'}] |
Title: A Randomized Control Trial (RCT) of Using Iodine-125 Brachytherapy Versus Intensity-modulated Radiation Therapy (IMRT) to Treat Inoperable Salivary Gland Cancer | Condition: Salivary Gland Cancer | Keywords: inoperable salivary gland cancer, brachytherapy, intensity-modulated radiation therapy | Summary: | Description: The target population are those patients with inoperable salivary gland derived primary or recurrent cancer, including local advanced primary salivary gland cancer which could not be resected completely; recurrent salivary gland cancer which could not be resected completely; T3/T4 tumor which could not tolerate surgery due to severe combined disease. The subjects would be divided into Iodine-125 radioactive seeds permanent interstitial implantation brachytherapy and intensity-modulated radiation therapy randomly. During the follow-up period, the efficacy and the safety index would be monitored. | ArmGroups: [{'label': 'brachytherapy', 'type': 'EXPERIMENTAL', 'description': 'Iodine-125 radioactive seeds permanent interstitial implantation brachytherapy', 'interventionNames': ['Radiation: brachytherapy']}, {'label': 'IMRT', 'type': 'ACTIVE_COMPARATOR', 'description': 'IMRT (intensity-modulated radiation therapy), 6 Millivolt (MV)-x fractionated irradiation, 1 time/day, 5 times a week, till the end. Add up to 33 times.', 'interventionNames': ['Radiation: IMRT']}] | Interventions:[{'type': 'RADIATION', 'name': 'brachytherapy', 'armGroupLabels': ['brachytherapy']}, {'type': 'RADIATION', 'name': 'IMRT', 'armGroupLabels': ['IMRT'], 'otherNames': ['intensity-modulated radiation therapy']}] | PrimaryOutcomes: [{'measure': 'local control rate', 'description': 'According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 standard, tumor progressing during the treatment and follow up period means local control failure, which include the sum of diameters of local and region target focus increases ≥20% or ≥5mm; new focus emerges at local or region area; metastases or secondary primary tumor would not be concluded.', 'timeFrame': '1 year'}] | SecondaryOutcomes: [{'measure': 'progression-free survival', 'description': 'progression-free survival is definite as the time of death of tumor progression event emerges from the patient was randomize. According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 standard, tumor progressing during the treatment and follow up period means local control failure, which include the sum of diameters of local and region target focus increases ≥20% or ≥5mm; new focus emerges at local or region area; metastases or secondary primary tumor would not be concluded. No respondent means the tumor advances at the first day.', 'timeFrame': '2 years'}, {'measure': 'overall survival', 'description': 'Refers to the result from a random start time to death of any cause. Records from the beginning of the random time to time of any cause of death. Shedding of subjects censored cases recorded censored time.', 'timeFrame': 'From date of randomization until the date of death from any cause, assessed up to 2 years'}] |
Title: Stool-based SDC2 DNA Methylation Test vs. Fecal Immunochemical Test on the Detection of Colorectal Advanced Adenomatous Polyps and Cancer in Chinese Population: A Multi-central Randomized Clinical Trial | Condition: Colorectal Cancer, Colorectal Adenomatous Polyp, Screening | Keywords: Colorectal cancer screening, SDC2 DNA Methylation, Fecal immunochemical test | Summary: | Description: A large cohort of participants will be asked to collect stool sample for either Stool-based SDC2 DNA Methylation Test or Fecal Immunochemical Test. Subjects who have positive results will undergo colonoscopy within 6 months.
Representative histopathology slides from tissue biopsied or excised during colonoscopy and those from subsequent definitive surgery may be retrieved in order to be evaluated by pathologists to confirm the diagnosis and staging. | ArmGroups: [{'label': 'Stool-based SDC2 DNA methylation test group', 'type': 'EXPERIMENTAL', 'description': 'Subjects will received the stool-based SDC2 DNA methylation test for the screening of colorectal advanced adenomatous polyps and cancer.', 'interventionNames': ['Diagnostic Test: Stool-based SDC2 DNA methylation test']}, {'label': 'Fecal immunochemical test group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Subjects will received the fecal immunochemical test for the screening of colorectal advanced adenomatous polyps and cancer.', 'interventionNames': ['Diagnostic Test: Fecal immunochemical test']}] | Interventions:[{'type': 'DIAGNOSTIC_TEST', 'name': 'Stool-based SDC2 DNA methylation test', 'description': 'Stool-based SDC2 DNA methylation test', 'armGroupLabels': ['Stool-based SDC2 DNA methylation test group']}, {'type': 'DIAGNOSTIC_TEST', 'name': 'Fecal immunochemical test', 'description': 'Fecal immunochemical test', 'armGroupLabels': ['Fecal immunochemical test group']}] | PrimaryOutcomes: [{'measure': 'The Detection Rate of Colorectal Polyps, Advanced Adenomatous Polyps and Cancer by Two Screening Methods', 'description': 'The stool-based SDC2 DNA methylation test CT values of 38 or less compared to beta-actin considered to be positive. Fecal immunochemical test values of more than 100 ng of hemoglobin per milliliter of buffer were considered as positive. An optical colonoscopy is used as diagnostic method. Lesions will be confirmed by histopathologic examination.', 'timeFrame': 'One year'}] | SecondaryOutcomes: N/A |
Title: Endoscopic Ultrasound-Guided Biliary Drainage (EUS-BD) Compared to Standard Transpapillary Biliary Drainage (ERCP-TP) for Palliation of Jaundice in Unresectable Cancer of the Head of the Pancreas (BILPAL TRIAL) | Condition: Pancreatic Cancer, Pancreatic Adenocarcinoma, Biliary Tract Neoplasms, Biliary Duct Obstruction, Unresectable Pancreatic Cancer, Periampullary Cancer, Periampullary Carcinoma Non-Resectable | Keywords: Endoscopy, Pancreatic Cancer, Bile duct, Periampullary, ERCP, Biliary drainage, Biliary obstruction, EUSBD, TEUS, EUS, Endoscopic Ultrasound | Summary: | Description: Obstructive jaundice is the most common symptom in patients with periampullary cancer and cancer of the pancreatic head. For patients with unresectable tumors, palliation of malignant obstructive is traditionally achieved using endoscopic retrograde cholangiopancreatography (ERCP) with transpapillary (TP) stent placement. Data show that ERCP is equivalent to surgery with regards to relief of jaundice. Self-expandable metal stents (SEMS) offer prolonged palliation compared to large-bore (10Fr) plastic stents. However, it is believed that gastric outlet obstruction occurs more commonly in patients who have received SEMS for palliation of MOJ. In addition, ERCP is associated with adverse events including pancreatitis, post-sphincterotomy bleeding, and perforation.
More recently endoscopic ultrasound (EUS)-guided biliary drainage has been described for biliary drainage in patients with malignant distal bile duct obstruction. Thus far it has been used as a rescue approach when traditional ERCP-guided transpapillary biliary drainage ERCP fails. TP failure can occur as a result of duodenal obstruction, failed cannulation, and failed wire access across the stricture.
Potential advantages of EUS-guided biliary drainage include avoidance of pancreatitis and post-sphincterotomy bleeding. Additionally, it may result in a lower frequency of gastric outlet obstruction since the stent does not encroach upon the tumor.
To compare the potential advantages of EUS-guided biliary drainage the investigators are conducting a multicenter, randomized trial comparing the EUS-guided drainage to traditional ERCP.
This EUS-BD vs. ERCP-TP-trial (BILPAL) is a randomized controlled multicenter trial that will provide evidence whether or not traditional ERCP biliary drainage is to be performed in patients with obstruction in bile duct due to unresectable pancreatic head or periampullary tumor.
This study will enroll 120 subjects; 60 subjects in each arm. Trial duration is about 1 year and involves 5-7 visits. | ArmGroups: [{'label': 'Endoscopic Ultrasound Guided Biliary Drainage', 'type': 'ACTIVE_COMPARATOR', 'description': 'Endoscopic Ultrasound Guided biliary drainage with stent placement. EUS via either stomach or duodenum.', 'interventionNames': ['Procedure: Endoscopic Ultrasound Guided Biliary Drainage']}, {'label': 'ERCP', 'type': 'PLACEBO_COMPARATOR', 'description': 'Endoscopic Retrograde Cholangiopancreatography with transpapillary biliary stent placement only.', 'interventionNames': ['Procedure: ERCP']}] | Interventions:[{'type': 'PROCEDURE', 'name': 'Endoscopic Ultrasound Guided Biliary Drainage', 'description': 'Endoscopic Ultrasound Guided biliary drainage with stent placement;', 'armGroupLabels': ['Endoscopic Ultrasound Guided Biliary Drainage'], 'otherNames': ['EUSBD']}, {'type': 'PROCEDURE', 'name': 'ERCP', 'description': 'Endoscopic Retrograde Cholangiopancreatography with transpapillary biliary stent placement', 'armGroupLabels': ['ERCP'], 'otherNames': ['ERCP-TP']}] | PrimaryOutcomes: [{'measure': 'Efficacy of Stent Patency', 'description': 'Efficacy is measure by the evaluation of biliary stent patency at month 6 post randomization', 'timeFrame': '6 months after randomization'}] | SecondaryOutcomes: [{'measure': 'Safety evaluation: Assessment of number and frequency of procedure related adverse events within 1 month of the procedure', 'description': 'Assessment of number and frequency of procedure related adverse events within 1 month of the procedure', 'timeFrame': 'Within 1 month of procedure'}, {'measure': 'Clinical Success', 'description': 'Resolution of jaundice due to obstruction in the bile duct', 'timeFrame': '1 month from procedure'}, {'measure': 'Technical Success', 'description': 'Technical success is defined as successful stent insertion providing biliary drainage with confirmation of appropriate radiographic positioning', 'timeFrame': '1 month from procedure'}, {'measure': 'Survival duration', 'description': 'Survival duration will be measured from time of diagnosis to death', 'timeFrame': '2 years from randomization'}, {'measure': 'Serum bilirubin decrease', 'description': 'Duration to achieving at least 30% decrease in serum bilirubin or normalization of serum bilirubin level (≤1.2 mg/dL)', 'timeFrame': '1 month from procedure'}, {'measure': 'Quality of Life', 'description': 'QOL will be measured via QLQ-C30 questionnaires completed by the subject at each follow up visit', 'timeFrame': '1 year from study enrollment'}] |
Title: Gender-related Characteristics of Bladder Cancer Treatment. Therapeutic Offer, Pathologic Features and Survival Outcomes of Patients Treated With Radical Cystectomy for Muscle-invasive Bladder Cancer | Condition: Bladder Cancer, Radical Cystectomy, Muscle-invasive Bladder Cancer | Keywords: | Summary: | Description: N/A | ArmGroups: N/A | Interventions:N/A | PrimaryOutcomes: [{'measure': 'gender-related discrepancies in the treatment offer for patients affected by MIBC from September 2016 to December 2020', 'timeFrame': '36 months'}] | SecondaryOutcomes: [{'measure': 'gender-related difference in the clinical and pathologic features of MIBC', 'timeFrame': '36 months'}, {'measure': 'gender-related difference in the survival outcomes', 'timeFrame': '36 months'}, {'measure': 'gender-related difference in the risk factors for development of BC', 'timeFrame': '36 months'}] |
Title: Randomized Chemoprevention Trial With 4-HPR (Fenretinide) in Superficial Bladder Cancer | Condition: Bladder Cancer | Keywords: stage 0 bladder cancer, stage I bladder cancer, transitional cell carcinoma of the bladder | Summary: | Description: OBJECTIVES:
* Determine the efficacy, mechanism of action, and toxicity of fenretinide in patients at risk of recurrent superficial bladder cancer after complete resection of initial tumor.
* Determine the treatment effects in modulating the expression of retinoid receptors, chromosomal abnormalities (numerical chromosomal abnormalities and DNA ploidy), apoptosis, and autocrine motility factor receptor (intermediate endpoint markers of recurrent disease) in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to lesion type (multifocal vs solitary). Patients are randomized to one of two treatment arms.
Patients receive either oral fenretinide or placebo on days 1-25. Courses repeat every 28 days for up to 1 year in the absence of disease progression, unacceptable toxicity, or development of a second primary cancer requiring therapy.
Patients are followed every 3 months for 15 months.
PROJECTED ACCRUAL: A total of 178 patients (89 per arm) will be accrued for this study. | ArmGroups: [{'label': 'Fenretinide', 'type': 'EXPERIMENTAL', 'description': 'Fenretinide (4-HPR) 200 mg orally every day for 12 months taken 25 out of every 28 days.', 'interventionNames': ['Drug: Fenretinide']}, {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo orally every day for 12 months, taken 25 out of every 28 days.', 'interventionNames': ['Other: Placebo']}] | Interventions:[{'type': 'DRUG', 'name': 'Fenretinide', 'description': '200 mg/day (two 100 mg capsules) for 25 days of 28 day cycle.', 'armGroupLabels': ['Fenretinide'], 'otherNames': ['4-HPR']}, {'type': 'OTHER', 'name': 'Placebo', 'description': 'Two placebo capsules for 25 days of 28 day cycle.', 'armGroupLabels': ['Placebo']}] | PrimaryOutcomes: [{'measure': 'Recurrence rate of transitional cell carcinoma (TCC)', 'description': 'Recurrence rates is defined as proportion of participants who recur within one year of surgery.', 'timeFrame': '1 year'}] | SecondaryOutcomes: N/A |
Title: A Phase II, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Neoadjuvant and Adjuvant Tiragolumab Plus Atezolizumab, With or Without Platinum-Based Chemotherapy, in Patients With Previously Untreated Locally Advanced Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer | Condition: Non-Small Cell Lung Cancer (NSCLC) | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'Cohort A (PD-L1 High)', 'type': 'EXPERIMENTAL', 'description': 'Participants with high programmed death-ligand 1 (PD-L1) expression level will be enrolled in Cohort A and receive neoadjuvant atezolizumab plus tiragolumab for 4 cycles, followed by surgical resection and either adjuvant atezolizumab plus tiragolumab for 16 cycles or adjuvant chemotherapy for 4 cycles at the discretion of the investigator.\n\nChemotherapy may include:\n\n* cisplatin/carboplatin + pemetrexed (for non-squamous only)\n* carboplatin + gemcitabine (for squamous only)\n* carboplatin + paclitaxel', 'interventionNames': ['Drug: Atezolizumab', 'Drug: Tiragolumab', 'Drug: Carboplatin', 'Drug: Cisplatin', 'Drug: Pemetrexed', 'Drug: Gemcitabine', 'Drug: Paclitaxel']}, {'label': 'Cohort B (PD-L1 All Comers)', 'type': 'EXPERIMENTAL', 'description': 'All comers, which are participants with any PD-L1 expression level, will be enrolled in Cohort B and receive neoadjuvant atezolizumab plus tiragolumab plus chemotherapy for 4 cycles, followed by surgical resection and adjuvant atezolizumab plus tiragolumab for 16 cycles.\n\nChemotherapy may include:\n\n* cisplatin/carboplatin + pemetrexed (for non-squamous only)\n* carboplatin + gemcitabine (for squamous only)\n* carboplatin + paclitaxel', 'interventionNames': ['Drug: Atezolizumab', 'Drug: Tiragolumab', 'Drug: Carboplatin', 'Drug: Cisplatin', 'Drug: Pemetrexed', 'Drug: Gemcitabine', 'Drug: Paclitaxel']}] | Interventions:[{'type': 'DRUG', 'name': 'Atezolizumab', 'description': 'Atezolizumab 1200 mg will be administered by intravenous (IV) infusion on Day 1 of each 21-day cycle.', 'armGroupLabels': ['Cohort A (PD-L1 High)', 'Cohort B (PD-L1 All Comers)'], 'otherNames': ['Tecentriq']}, {'type': 'DRUG', 'name': 'Tiragolumab', 'description': 'Tiragolumab 600 mg will be administered by IV infusion on Day 1 of each 21-day cycle.', 'armGroupLabels': ['Cohort A (PD-L1 High)', 'Cohort B (PD-L1 All Comers)'], 'otherNames': ['MTIG7192A']}, {'type': 'DRUG', 'name': 'Carboplatin', 'description': 'Carboplatin at initial target area under the concentration curve (AUC) of 5 or 6 mg/mL/min will be administered by IV infusion on Day 1 of each 21-day cycle.', 'armGroupLabels': ['Cohort A (PD-L1 High)', 'Cohort B (PD-L1 All Comers)']}, {'type': 'DRUG', 'name': 'Cisplatin', 'description': 'Cisplatin at 75 mg/m\\^2 will be administered by IV infusion on Day 1 of each 21-day cycle.', 'armGroupLabels': ['Cohort A (PD-L1 High)', 'Cohort B (PD-L1 All Comers)']}, {'type': 'DRUG', 'name': 'Pemetrexed', 'description': 'Pemetrexed at 500 mg/m\\^2 will be administered by IV infusion on Day 1 of each 21-day cycle.', 'armGroupLabels': ['Cohort A (PD-L1 High)', 'Cohort B (PD-L1 All Comers)']}, {'type': 'DRUG', 'name': 'Gemcitabine', 'description': 'Gemcitabine at 1000 or 1250 mg/m\\^2 will be administered by IV infusion on Days 1 and 8 of each 21-day cycle.', 'armGroupLabels': ['Cohort A (PD-L1 High)', 'Cohort B (PD-L1 All Comers)']}, {'type': 'DRUG', 'name': 'Paclitaxel', 'description': 'Paclitaxel at 175 or 200 mg/m\\^2 will be administered by IV infusion on Day 1 of each 21-day cycle.', 'armGroupLabels': ['Cohort A (PD-L1 High)', 'Cohort B (PD-L1 All Comers)']}] | PrimaryOutcomes: [{'measure': 'Number of Participants With Surgical Delays', 'timeFrame': 'Up to approximately 6 years'}, {'measure': 'Number of Participants With Operative and Post-operative Complications', 'timeFrame': 'Up to approximately 6 years'}, {'measure': 'Number of Participants With Surgical Cancellations Related to Study Treatment', 'timeFrame': 'Up to approximately 6 years'}, {'measure': 'Percentage of Participants With Adverse Events', 'timeFrame': 'Up to approximately 6 years'}, {'measure': 'Percentage of Participants Who Achieve Major Pathological Response (MPR)', 'timeFrame': 'At the time of surgery (approximately Weeks 17-20)'}] | SecondaryOutcomes: [{'measure': 'Percentage of Participants With Pathological Complete Response (pCR)', 'timeFrame': 'At the time of surgery (approximately Weeks 17-20)'}, {'measure': 'Event Free Survival (EFS)', 'timeFrame': 'From baseline to disease progression that precludes surgical resection, or local or distant disease recurrence after surgery, or death from any cause (up to approximately 6 years)'}, {'measure': 'Serum Concentrations of Atezolizumab', 'timeFrame': 'Day 1 of Cycle 1 (cycle=21 days): pre-dose and 30 minutes (min) post-dose; Day 1 of Cycles 2, 3, 4, 5, 8, 12, 16: pre-dose; at treatment discontinuation (TD) visit (up to approximately 9 months)'}, {'measure': 'Serum Concentrations of Tiragolumab', 'timeFrame': 'Day 1 of Cycle 1 (cycle=21 days): pre-dose and 30 min post-dose; Day 1 of Cycles 2, 3, 4, 5, 8, 12, 16: pre-dose; at TD visit (up to approximately 9 months)'}, {'measure': 'Percentage of Participants With Anti-drug Antibodies (ADAs) to Atezolizumab', 'timeFrame': 'Prior to the first infusion on Day 1 of Cycles 1, 2, 3, 4, 5, 8, 12 and 16 (cycle=21 days) and at TD visit (up to approximately 9 months)'}, {'measure': 'Percentage of Participants With ADAs to Tiragolumab', 'timeFrame': 'Prior to the first infusion on Day 1 of Cycles 1, 2, 3, 4, 5, 8, 12 and 16 (cycle=21 days) and at TD visit (up to approximately 9 months)'}] |
Title: Open-label Phase 1b Study of Ulixertinib and Cetuximab or Ulixertinib in Combination with Cetuximab and Encorafenib in Patients with Unresectable or Metastatic Colorectal Cancer Who Have Previously Received EGFR or BRAF-directed Therapy | Condition: Metastatic Colorectal Cancer | Keywords: | Summary: | Description: Primary Objective:
The primary objective is to establish the safety, maximally tolerated dose (MTD) and recommended phase 2 dose (RP2D) of small molecule inhibitor ulixertinib when combined with EGFR inhibitor cetuximab.
Primary Endpoints:
1. MTD based on number of dose-limiting toxicities (DLTs)
2. RP2D based on MTD
Secondary Objectives:
1. To evaluate the safety and efficacy of ulixertinib in combination with cetuximab +/- encorafenib
2. Safety profile per CTCAE v5.0, including term, incidence, severity, and duration of AEs
3. Overall response rate (ORR) and Duration of response (DOR), according to RECIST v1.1
4. Median progression free survival (PFS), according to RECIST v1.1 and median overall survival (OS)
Exploratory Objectives:
The exploratory objective is to evaluate the effects of ulixertinib plus cetuximab on pharmacodynamic markers.
Exploratory Endpoint(s):
1. Correlative studies will be performed using blood tissue specimens from participants to assess blood- and tissue-based biomarkers, gene alterations, immunologic markers and pharmacodynamic markers from study treatment.
2. To evaluate the effects of ulixertinib on pharmacodynamic markers: ctDNA tissue biopsies, and/or blood to assess biomarkers. Assays include, but are not limited to, Reverse Phase Protein Arrays (RPPA) to assess protein levels and Nanostring and/or RNA-exome to assess mRNA expression in tissue pre- and post-ulixertinib treatment. | ArmGroups: [{'label': 'BRAF Expansion Cohort', 'type': 'EXPERIMENTAL', 'description': '1 of these 2 doses will be selected as the recommended dose of ulixertinib that can be given in combination with cetuximab and encorafenib.', 'interventionNames': ['Drug: Cetuximab', 'Drug: Ulixertinib', 'Drug: Encorafenib']}, {'label': 'Cohort A', 'type': 'EXPERIMENTAL', 'description': '1 of these 2 doses will be selected as the recommended dose of ulixertinib that can be given in combination with cetuximab alone.', 'interventionNames': ['Drug: Cetuximab', 'Drug: Ulixertinib']}] | Interventions:[{'type': 'DRUG', 'name': 'Cetuximab', 'description': 'Given by IV (vein)', 'armGroupLabels': ['BRAF Expansion Cohort', 'Cohort A'], 'otherNames': ['ERBITUX']}, {'type': 'DRUG', 'name': 'Ulixertinib', 'description': 'Given by PO', 'armGroupLabels': ['BRAF Expansion Cohort', 'Cohort A'], 'otherNames': ['BVD-523']}, {'type': 'DRUG', 'name': 'Encorafenib', 'description': 'Given by PO', 'armGroupLabels': ['BRAF Expansion Cohort']}] | PrimaryOutcomes: [{'measure': 'Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0', 'timeFrame': 'through study completion; an average of 1 year'}] | SecondaryOutcomes: N/A |
Title: VITaL: A Randomised Controlled Trial Investigating Ventilation Imaging to Improve the Quality of Life for Patients With Lung Cancer Treated With Radiation Therapy | Condition: Lung Cancer | Keywords: Pneumonitis, Quality of Life, Curative treatment, Cancer, Healthy lung sparing | Summary: | Description: The planning and delivery of Radiation Therapy (RT) is a balance between delivering a curative dose to the tumour while sparing healthy organs, such as the lungs, from collateral damage such as pneumonitis. To minimise radiation-induced lung injury, our team has invented and pioneered ventilation imaging based on Computed Tomography (CT). This Australian-invented medical device, now an international field of research, uses CT scans routinely acquired for planning RT to compute a CT ventilation map showing high functioning and low functioning lung regions. This image is used as the basis for directing radiation away from the healthy, high functioning regions towards the low functioning regions, thereby aiming to reduce toxicity and improve the patient's quality of life. | ArmGroups: [{'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Lung sparing treatment plan', 'interventionNames': ['Device: Healthy lung sparing treatment plan']}, {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Standard treatment plan'}] | Interventions:[{'type': 'DEVICE', 'name': 'Healthy lung sparing treatment plan', 'description': 'CT Ventilation imaging will be used to create a healthy lung sparing treatment plan for patients who will receive radiation therapy treatment for their lung cancer.', 'armGroupLabels': ['Intervention']}] | PrimaryOutcomes: [{'measure': 'Patients receiving healthy lung sparing treatment (interventional arm) have better quality of life than patients receiving standard treatment (control arm).', 'description': 'Patients in the interventional healthy lung sparing arm will maintain their 3-month quality of life (measured via the Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire) more than patients receiving standard care by a clinically meaningful difference.', 'timeFrame': '3 months'}] | SecondaryOutcomes: [{'measure': 'Interventional arm patients will have reduced treatment lung side-effects.', 'description': 'Toxicities will be collected at each patient visit.', 'timeFrame': '2 years'}, {'measure': 'Interventional arm patients will have better lung function, as determined by the difference between pre and post treatment Forced Expiratory Volume (FEV1) scores, as healthy lung is spared.', 'description': 'Lung function tests (FEV-1) will be acquired at routine time points within the trial, including pre and post treatment.', 'timeFrame': '2 years'}, {'measure': 'In the interventional arm, a higher proportion of patients will receive immunotherapy', 'description': 'Adjuvant therapy will be described for all patients as part of routine follow up.', 'timeFrame': '2 years'}, {'measure': 'In the interventional arm, a higher proportion of patients will complete immunotherapy', 'description': 'Adjuvant therapy will be described for all patients as part of routine follow up.', 'timeFrame': '2 years'}, {'measure': 'Cost effectiveness will be demonstrated as measured via a health economics assessment', 'description': 'To be determined', 'timeFrame': '2 years'}] |
Title: Phase II, Open-Label Trial in Patients With Stage IV Malignant Melanoma Using Melaxin as a Cancer Vaccine in Conjunction With BCG | Condition: Melanoma | Keywords: Melanoma, Dendritic cells, Cell therapy, BCG vaccine | Summary: | Description: Chemotherapy and immunotherapy are the main therapies for metastatic melanoma with the hope of prolonging survival. The ideal immunotherapy would consist of the professional antigen-presenting cell, the dendritic cell, with the entire repertoire of tumor antigens inside. The best way to achieve this is by creating an autologous hybrid fusion cell of the dendritic cell and tumor cell. In this study, melanoma tumor tissue surgically removed from the patient will be disassociated into single cells, irradiated and fused to dendritic cells produced by culturing the patient's blood monocytes. Prior to the electrofusion procedure, the tumor cells are stained red and the dendritic cells are stained green. After fusion, the uniquely colored fused cells, or dendritomas, are separated from the unfused cells by use of a fluorescence activated cell sorter. This highly purified population is then divided into 4 doses containing 250,000 dendritomas each and frozen. Each dose is thawed, diluted to 1 milliliter (ml) with Sterile Saline for Injection containing 5 percent (%) human serum albumin and administered subcutaneously (SQ) over a lymph node bed to the patient once every 4 weeks. A separate injection of Bacillus Calmette-Guerin (BCG) is administered in the same area within 10 minutes of the dendritoma injection. The safety and efficacy of the therapy will be evaluated in 25 patients. | ArmGroups: [{'label': 'Melaxin and BCG', 'type': 'EXPERIMENTAL', 'description': 'Four 1 ml doses of 250,000 dendritomas SQ at 4 week intervals along with a separate SQ injection containing 1 million Colony Forming Units (CFU) of BCG. The dose of BCG will be decreased by 50% in subsequent dosing if there is injection site ulceration', 'interventionNames': ['Biological: Melaxin (autologous dendritoma vaccine) and BCG']}] | Interventions:[{'type': 'BIOLOGICAL', 'name': 'Melaxin (autologous dendritoma vaccine) and BCG', 'description': 'Four 1 ml doses of 250,000 dendritomas SQ at 4 week intervals along with a separate SQ injection containing 1 million CFU of BCG. The dose of BCG will be decreased by 50% in subsequent dosing if there is injection site ulceration.', 'armGroupLabels': ['Melaxin and BCG'], 'otherNames': ['Melaxin']}] | PrimaryOutcomes: [{'measure': 'Safety as Measured by Number of Participants With Unexpected Adverse Events or Unexpected Laboratory Results.', 'description': 'Expected adverse events included injection site reactions, fever, chills, and arthralgias as anticipated with vaccine therapy. No unexpected or uncommon adverse events occurred such as disseminated sepsis. Clinical laboratory results on all participants were within expected ranges, including an increase in the number of IFN gamma expressing T-cells.', 'timeFrame': 'From first vaccine to 18 months after the last injection'}] | SecondaryOutcomes: [{'measure': 'Tumor Response Measured by RECIST Criteria and Progression-free Survival.', 'description': 'CT scans for disease assessment occurred at three month intervals. If partial or complete responses were observed confirmation scans were performed within four weeks. Patients were followed for 18 months post study completion. All three participants recieved at least one vaccine, and all participants had progression of disease prior to the 18 month followup visit.', 'timeFrame': 'From first vaccine to 18 months after the last injection'}] |
Title: Efficacy and Safety of Supplement Adjuvant Capecitabine in Postoperative Hormone Receptor (HR)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative High-risk Breast Cancer Patients: a Multicenter, Single-arm Clinical Trial | Condition: Breast Cancer, Chemotherapy Effect | Keywords: breast cancer, HR positive HER2 negative, high-risk factors, capecitabine, adjuvant chemotherapy | Summary: | Description: N/A | ArmGroups: [{'label': 'capecitabine group', 'type': 'EXPERIMENTAL', 'description': 'All enrolled cases should be given standard chemotherapy, radiotherapy and endocrine therapy according to the Chinese Society of Clinical Oncology (CSCO) guidelines for the treatment of breast cancer, with the specific regimen decided by the doctor according to the condition. After the completion of standard chemotherapy, capecitabine 1250mg/m2 should be given orally twice a day for 2 weeks of the 3-week treatment course, and the total duration of treatment is 8 courses, which can be given simultaneously with radiotherapy and endocrine therapy. Premenopausal patients may use ovarian suppressants as needed.', 'interventionNames': ['Drug: Capecitabine']}] | Interventions:[{'type': 'DRUG', 'name': 'Capecitabine', 'description': 'capecitabine, 0.5g per pill, given 1250mg/m2 twice a day for 2 weeks of the 3-week treatment course. The total duration of treatment is 8 courses.', 'armGroupLabels': ['capecitabine group']}] | PrimaryOutcomes: [{'measure': 'disease free survival', 'description': 'defined as the time from randomization to recurrence in situ, metastasis, contralateral breast cancer, second primary cancer, and all-cause death.', 'timeFrame': '5 years'}] | SecondaryOutcomes: [{'measure': 'overall survival', 'description': 'defined as the time from randomizeation to all-cause death', 'timeFrame': '5 years'}, {'measure': 'invasive disease free survival', 'description': 'Defined as time from randomization to local or distant recurrence of invasive cancer', 'timeFrame': '5 years'}] |
Title: Phase III Randomized Trial Comparing Total Androgen Blockade Versus Total Androgen Blockade Plus Pelvic Irradiation in Clinical Stage T3-4, N0, M0 Adenocarcinoma of the Prostate | Condition: Prostate Cancer | Keywords: adenocarcinoma of the prostate, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer | Summary: | Description: OBJECTIVES:
* Compare the overall survival, disease specific survival, and time to progression in patients with locally advanced adenocarcinoma of the prostate treated with total androgen suppression with or without pelvic irradiation.
* Compare the symptomatic control as measured by the rates of surgical interventions needed for control of local disease (e.g., transurethral resections, stent insertions, nephrostomies, and colostomies) in patients treated with these regimens.
* Compare the quality of life of patients treated with these regimens.
* Compare the sensitivity of the EORTC-QLQ-C30+3 and a trial-specific checklist (PR17) with the FACT-P questionnaire in measuring changes in quality of life of patients treated with these regimens.
OUTLINE: This a randomized, multicenter study. Patients are stratified according to center, initial PSA level (less than 20 vs 20-50 vs greater than 50 ng/mL), method of node staging (clinical \[no CT scan\] vs radiological \[CT scan negative\] vs surgical), Gleason score (less than 8 vs 8-10), prior hormonal therapy (excluding orchiectomy) (yes vs no), and choice of hormonal therapy (bilateral orchiectomy with or without antiandrogen vs luteinizing hormone-releasing hormone \[LHRH\] with antiandrogen). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive antiandrogen therapy comprising oral flutamide every 8 hours, oral nilutamide every 8 hours for 1 month and then once daily, or oral bicalutamide once daily. Patients also choose to undergo bilateral orchiectomy or LHRH agonist therapy comprising goserelin subcutaneously (SC) every 4 weeks (short-acting formulation) or every 3 months (long-acting formulation), leuprolide intramuscularly every 4 weeks (short-acting formulation) or every 3 months (long-acting formulation), or buserelin SC every 8 weeks or every 12 weeks. Patients choosing orchiectomy may receive an antiandrogen for at least 6 weeks before surgery to counter any flare phenomenon and may continue the antiandrogen after surgery (at the physician's discretion).
* Arm II: Patients undergo total androgen ablation as in arm I. Patients with node-negative dissection undergo radiotherapy 5 days a week for 6.5-7 weeks. All other patients undergo radiotherapy 5 days a week for 5 weeks, followed by boost radiotherapy 5 days a week for 2-2.4 weeks.
Hormonal therapy on both arms continues in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, on the last day of radiotherapy, at 6 months, and then every 6 months thereafter.
Patients are followed at 1, 2, and 6 months and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 1,200 patients will be accrued for this study within 7.5 years. | ArmGroups: [{'label': 'Total Androgen Blockade', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Drug: bicalutamide', 'Drug: buserelin', 'Drug: flutamide', 'Drug: goserelin', 'Drug: leuprolide acetate', 'Drug: nilutamide', 'Procedure: orchiectomy']}, {'label': 'Total Androgen Blockade Vs TA Blockade Plus Pelvic Irradiation', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Drug: bicalutamide', 'Drug: buserelin', 'Drug: flutamide', 'Drug: goserelin', 'Drug: leuprolide acetate', 'Drug: nilutamide', 'Procedure: orchiectomy', 'Radiation: radiation therapy']}] | Interventions:[{'type': 'DRUG', 'name': 'bicalutamide', 'description': "Antiandrogen (optional with orchiectomy) Flutamide 250 mg po TID or Nilutamide 100 mg po TID x 1 mo; then 150 mg po QD or Bicalutamide 50 mg po QD PLUS (patient's choice) Bilateral orchiectomy or LHRH agonist Goserelin 3.6 mg SC (abd) q28d or 10.8 mg SC (abd) Q3mos or Leuprolide 7.5 mg IM q28d (Leuprorelin 3.75 mg) or 22.5 mg IM Q3mos (Leuprorelin 11.25 mg) or 30 mg IM Q4mos or Buserelin 6.3mg SC (abd) Q8wk or 9.45mg SC (abd) Q12wk", 'armGroupLabels': ['Total Androgen Blockade', 'Total Androgen Blockade Vs TA Blockade Plus Pelvic Irradiation']}, {'type': 'DRUG', 'name': 'buserelin', 'description': "Antiandrogen (optional with orchiectomy) Flutamide 250 mg po TID or Nilutamide 100 mg po TID x 1 mo; then 150 mg po QD or Bicalutamide 50 mg po QD PLUS (patient's choice) Bilateral orchiectomy or LHRH agonist Goserelin 3.6 mg SC (abd) q28d or 10.8 mg SC (abd) Q3mos or Leuprolide 7.5 mg IM q28d (Leuprorelin 3.75 mg) or 22.5 mg IM Q3mos (Leuprorelin 11.25 mg) or 30 mg IM Q4mos or Buserelin 6.3mg SC (abd) Q8wk or 9.45mg SC (abd) Q12wk", 'armGroupLabels': ['Total Androgen Blockade', 'Total Androgen Blockade Vs TA Blockade Plus Pelvic Irradiation']}, {'type': 'DRUG', 'name': 'flutamide', 'description': "Antiandrogen (optional with orchiectomy) Flutamide 250 mg po TID or Nilutamide 100 mg po TID x 1 mo; then 150 mg po QD or Bicalutamide 50 mg po QD PLUS (patient's choice) Bilateral orchiectomy or LHRH agonist Goserelin 3.6 mg SC (abd) q28d or 10.8 mg SC (abd) Q3mos or Leuprolide 7.5 mg IM q28d (Leuprorelin 3.75 mg) or 22.5 mg IM Q3mos (Leuprorelin 11.25 mg) or 30 mg IM Q4mos or Buserelin 6.3mg SC (abd) Q8wk or 9.45mg SC (abd) Q12wk", 'armGroupLabels': ['Total Androgen Blockade', 'Total Androgen Blockade Vs TA Blockade Plus Pelvic Irradiation']}, {'type': 'DRUG', 'name': 'goserelin', 'description': "Antiandrogen (optional with orchiectomy) Flutamide 250 mg po TID or Nilutamide 100 mg po TID x 1 mo; then 150 mg po QD or Bicalutamide 50 mg po QD PLUS (patient's choice) Bilateral orchiectomy or LHRH agonist Goserelin 3.6 mg SC (abd) q28d or 10.8 mg SC (abd) Q3mos or Leuprolide 7.5 mg IM q28d (Leuprorelin 3.75 mg) or 22.5 mg IM Q3mos (Leuprorelin 11.25 mg) or 30 mg IM Q4mos or Buserelin 6.3mg SC (abd) Q8wk or 9.45mg SC (abd) Q12wk", 'armGroupLabels': ['Total Androgen Blockade', 'Total Androgen Blockade Vs TA Blockade Plus Pelvic Irradiation']}, {'type': 'DRUG', 'name': 'leuprolide acetate', 'description': "Antiandrogen (optional with orchiectomy) Flutamide 250 mg po TID or Nilutamide 100 mg po TID x 1 mo; then 150 mg po QD or Bicalutamide 50 mg po QD PLUS (patient's choice) Bilateral orchiectomy or LHRH agonist Goserelin 3.6 mg SC (abd) q28d or 10.8 mg SC (abd) Q3mos or Leuprolide 7.5 mg IM q28d (Leuprorelin 3.75 mg) or 22.5 mg IM Q3mos (Leuprorelin 11.25 mg) or 30 mg IM Q4mos or Buserelin 6.3mg SC (abd) Q8wk or 9.45mg SC (abd) Q12wk", 'armGroupLabels': ['Total Androgen Blockade', 'Total Androgen Blockade Vs TA Blockade Plus Pelvic Irradiation']}, {'type': 'DRUG', 'name': 'nilutamide', 'description': "Antiandrogen (optional with orchiectomy) Flutamide 250 mg po TID or Nilutamide 100 mg po TID x 1 mo; then 150 mg po QD or Bicalutamide 50 mg po QD PLUS (patient's choice) Bilateral orchiectomy or LHRH agonist Goserelin 3.6 mg SC (abd) q28d or 10.8 mg SC (abd) Q3mos or Leuprolide 7.5 mg IM q28d (Leuprorelin 3.75 mg) or 22.5 mg IM Q3mos (Leuprorelin 11.25 mg) or 30 mg IM Q4mos or Buserelin 6.3mg SC (abd) Q8wk or 9.45mg SC (abd) Q12wk", 'armGroupLabels': ['Total Androgen Blockade', 'Total Androgen Blockade Vs TA Blockade Plus Pelvic Irradiation']}, {'type': 'PROCEDURE', 'name': 'orchiectomy', 'description': 'Optional orchiectomy', 'armGroupLabels': ['Total Androgen Blockade', 'Total Androgen Blockade Vs TA Blockade Plus Pelvic Irradiation']}, {'type': 'RADIATION', 'name': 'radiation therapy', 'description': 'Radical Radiation Therapy - (65-69 Gy; 35-37 treatments)', 'armGroupLabels': ['Total Androgen Blockade Vs TA Blockade Plus Pelvic Irradiation']}] | PrimaryOutcomes: [{'measure': 'Overall survival', 'timeFrame': '10 years'}] | SecondaryOutcomes: [{'measure': 'Disease specific survival', 'timeFrame': '10 years'}, {'measure': 'Time to disease progression', 'timeFrame': '10 years'}, {'measure': 'Symptomatic local control measured by surgical intervention rate', 'timeFrame': '10 years'}, {'measure': 'Quality of life assessed by EORTC-QLQ-C30 + 3 and a trial-specific checklist (PR17) or the FACT-P questionnaire', 'timeFrame': '10 years'}] |
Title: A Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-α) Inhibitor Therapy | Condition: Rheumatoid Arthritis | Keywords: moderate Rheumatoid Arthritis, severe Rheumatoid Arthritis, Olokizumab | Summary: | Description: The goal of this Phase III study was to assess the efficacy, safety and tolerability of OKZ in subjects with moderately to severely active RA who had responded inadequately to TNFi therapy. The primary endpoint of the trial was assessed at Week 12. Olokizumab was expected to reduce the disease activity and improve physical function. The study was expected to provide safety information in a large group of subjects over at least a 24 week period.
This was a randomized, double-blind, parallel-group, placebo-controlled, multicenter study. This study included a 4-week Screening Period, a double-blind Treatment Period from Week 0 to Week 24, and a Safety FollowUp Period from Week 24 to Week 44.
A total of 350 subjects were planned to be randomized.Subjects were assessed for eligibility to enter the study during a 4-week Screening Period. Eligible subjects were randomized at Visit 2 in a 2:2:1 ratio in one of 3 treatment groups (planned 140, 140, and 70 subjects per group, respectively) :
1. Olokizumab 64 mg q4w: SC injection of OKZ 64 mg q4w (alternating with SC injection of placebo OKZ q4w to maintain blinding) + MTX for 24 weeks,
2. Olokizumab 64 mg q2w: SC injection of OKZ 64 mg q2w + MTX for 24 weeks or
3. Placebo: SC injection of placebo q2w + MTX for 16 weeks.
Subjects who received placebo were re-randomized at Week 16 to receive 64 mg OKZ q4w + Methotrexate or 64 mg OKZ q2w +Methotrexate for 8 weeks.
Throughout the double-blind Treatment Period, all subjects were required to remain on a stable dose of background MTX with a stable route of administration. Concomitant treatment with folic acid was required for all subjects. The last dose of OKZ was administered at Week 20 for subjects receiving OKZ 64 mg q4w and at Week 22 for subjects receiving OKZ 64 mg q2w.
Following Visit 2 (randomization; Week 0), subjects returned to the study site at least every 2 weeks through Week 24 for response and safety assessments.
At Week 14, subjects who did not improve by at least 20% in both swollen and tender joint counts were classified as nonresponders and were administered sulfasalazine and/or hydroxychloroquine as rescue medication in addition to the assigned treatment.
After completion of the 24-week double-blind Treatment Period, subjects either rolled over into the long-term open-label extension (OLE) study or entered the Safety Follow-Up Period. During the Safety Follow-Up Period, subjects returned for visits +4, +8, and +22 weeks after the last dose of study treatment.
Subjects who discontinued randomized treatment prematurely were required to come for the End of Treatment (EoT) Visit 2 weeks after the last study treatment administration and then continue with the scheduled study visits.
Adverse events (AEs) were assessed throughout the study (starting when the subject signed the informed consent form) and evaluated using the Common Terminology Criteria for Adverse Events Version 4.0. There was ongoing monitoring of safety events, including laboratory findings, by the Sponsor or the Sponsor's designee. In addition, safety was assessed throughout the study by an independent Data Safety Monitoring Board and potential major adverse cardiac events were evaluated by an independent Cardiovascular Adjudication Committee.
The study was conducted at 123 sites across 11 countries globally (in US,EU, Russian Federation, Asia, Latin America) | ArmGroups: [{'label': 'Arm 1: Olokizumab q4w', 'type': 'EXPERIMENTAL', 'description': 'Olokizumab 64mg subcutaneous q4w + placebo + Methotrexate\n\nOlokizumab 64 mg subcutaneous q4w + placebo+ concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular) in order to maintain the blind, subjects randomized to receive OKZ q4w received placebo injections at the alternate q4w interval (e.g., Week 2, Week 6, etc.)', 'interventionNames': ['Drug: Olokizumab', 'Drug: Placebo']}, {'label': 'Arm 2: Olokizumab q2w', 'type': 'EXPERIMENTAL', 'description': 'Olokizumab 64mg subcutaneous q2w + Methotrexate\n\n64 mg Olokizumab administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular)', 'interventionNames': ['Drug: Olokizumab']}, {'label': 'Arm 3: Placebo q2w', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo q2w subcutaneous + Methotrexate\n\nPlacebo administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular)\n\nStarting at Week 16, all subjects in the placebo group were randomized in a blinded fashion to receive either OKZ 64 mg q2w or OKZ 64 mg q4w; equal numbers of subjects were planned to be assigned to each OKZ treatment group.', 'interventionNames': ['Drug: Placebo']}] | Interventions:[{'type': 'DRUG', 'name': 'Olokizumab', 'description': '160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial', 'armGroupLabels': ['Arm 1: Olokizumab q4w', 'Arm 2: Olokizumab q2w']}, {'type': 'DRUG', 'name': 'Placebo', 'description': 'sodium chloride 0.9% solution provided as either a 10 mL vial or ampoule, depending on market availability. Each placebo will be packed into a cardboard carton to contain 1 vial or ampoule', 'armGroupLabels': ['Arm 1: Olokizumab q4w', 'Arm 3: Placebo q2w']}] | PrimaryOutcomes: [{'measure': 'Percentage of Subjects Achieving American College of Rheumatology 20% (ACR20) Response', 'description': 'The difference between OKZ and placebo in the percentage of subjects achieving an ACR20 response and remaining on randomized treatment and in the study at Week 12. A responder is defined as any subject satisfying ACR20 criteria and remaining on randomized treatment and in the study at Week 12.\n\nAmerican College of Rheumatology 20 % response is a composite defined as a ≥ 20% improvement from baseline in the swollen joint counts assessed in 66 joints and in the tender joint count assessed in 68 joints; and a ≥20% improvement from baseline in at least 3 of the 5 remaining core set measures:\n\n* Patient Global Assessment of Disease Activity (VAS)\n* Patient Assessment of Pain (VAS)\n* HAQ-DI\n* Physician Global Assessment (VAS)\n* Level of acute phase reactant (CRP)', 'timeFrame': 'at Week 12'}] | SecondaryOutcomes: [{'measure': 'Percentage of Subjects Achieving Low Disease Activity', 'description': 'Defined as Disease Activity Score 28-joint count (DAS28) C-reactive protein (CRP) \\<3.2, and remaining on randomized treatment and in the study at Week 12', 'timeFrame': 'at Week 12'}, {'measure': 'Improvement of Physical Ability From Baseline to Week 12, as Measured by the Health Assessment Questionnaire Disability Index (HAQ-DI)', 'description': 'Change of physical ability from baseline (the last available assessment prior to the first dose of the study treatment) to week 12, as measured by HAQ-DI. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions.The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3 where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question. A decrease from baseline indicates improvement for HAQ-DI.The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered. The HAQ-DI total score ranges from 0 (the best outcome) to 3 (the worst outcome).', 'timeFrame': 'Baseline to Week 12'}, {'measure': 'Percentage of Subjects Achieving American College of Rheumatology 50% (ACR50) Response', 'description': 'Difference between OKZ and placebo in the percentage of subjects achieving an ACR50 response and remaining on randomized treatment and in the study at Week 12.\n\nAmerican College of Rheumatology 50% Response is a composite defined as ≥50%, improvement from baseline in the swollen joint counts assessed in 66 joints and in the tender joint count assessed in 68 joints; and a ≥50%, improvement from baseline in at least 3 of the 5 remaining core set measures:\n\n* Patient Global Assessment of Disease Activity (VAS)\n* Patient Assessment of Pain (VAS)\n* HAQ-DI\n* Physician Global Assessment (VAS)\n* Level of acute phase reactant (CRP)', 'timeFrame': 'at Week 12'}, {'measure': 'Percentage of Subjects With Clinical Disease Activity Index (CDAI) ≤ 2.8 (Remission)', 'description': 'Difference between OKZ and placebo in the percentage of subjects with Clinical Disease Activity Index (CDAI) ≤2.8 (remission) and remaining on randomized treatment and in the study at Week 12', 'timeFrame': 'at Week 12'}] |
Title: Phase 1 Multicenter, Open-Label, Dose Escalation Study and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of STP705 Administered Intratumorally in Cholangiocarcinoma, Hepatocellular Carcinoma or Liver Metastases in Subjects With Advanced/Metastatic or Surgically Unresectable Solid Tumors Who Are Refractory to Standard Therapy | Condition: Hepatocellular Carcinoma, Liver Metastases, Cholangiocarcinoma | Keywords: | Summary: | Description: This is an open label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of various doses of STP705 administered intratumorally in cholangiocarcinoma, hepatocellular carcinoma or liver metastasis.
The primary objective of this study is to determine the MTD or RP2D of STP705 and to establish the dose of STP705 recommended for future phase 2 studies when administered intratumorally.
A total of up to 30 patients will be enrolled in the dose escalation phase of the study. In addition, once the MTD or recommended phase 2 dose has been established, up to 20 additional patients maybe enrolled to confirm safety and explore anti-tumor activity.
Up to five dose levels will be explored (20,40,80,160,320 μg dose levels) and will depend on the number and intensity of observed toxicity. Intermediate doses maybe explored during escalation period.
It will follow an accelerated titration design, enrolling 1 patient per dose cohort and will expand to a standard 3+3 design after.
In the accelearted titration a Grade 2 SE triggers the transition to the 3+3 part of the study. The 3+3 part of the study will start at dose level 160μg.
Subjects will be evaluated for DLTs in the first cycle of treatment and graded aacording to NCI CTCAE v5. A cycle is 28 days. | ArmGroups: [{'label': 'Cohort 1: STP705 20 μg dose', 'type': 'EXPERIMENTAL', 'description': 'Intratumoral injection, administered as a single agent on Day 1,8 and 15 of a 28-day cycle. If the patient is deriving clinical benefit from the agent it may be continued and will be administered on Day 1 of each successive cycle.', 'interventionNames': ['Drug: STP705']}, {'label': 'Cohort 2: STP705 40 μg dose', 'type': 'EXPERIMENTAL', 'description': 'Intratumoral injection, administered as a single agent on Day 1,8 and 15 of a 28-day cycle. If the patient is deriving clinical benefit from the agent it may be continued and will be administered on Day 1 of each successive cycle.', 'interventionNames': ['Drug: STP705']}, {'label': 'Cohort 3: STP705 80 μg dose', 'type': 'EXPERIMENTAL', 'description': 'Intratumoral injection, administered as a single agent on Day 1,8 and 15 of a 28-day cycle. If the patient is deriving clinical benefit from the agent it may be continued and will be administered on Day 1 of each successive cycle.', 'interventionNames': ['Drug: STP705']}, {'label': 'Cohort 4: STP705 160 μg dose', 'type': 'EXPERIMENTAL', 'description': 'Intratumoral injection, administered as a single agent on Day 1,8 and 15 of a 28-day cycle. If the patient is deriving clinical benefit from the agent it may be continued and will be administered on Day 1 of each successive cycle.', 'interventionNames': ['Drug: STP705']}, {'label': 'Cohort 5: STP705 320 μg dose', 'type': 'EXPERIMENTAL', 'description': 'Intratumoral injection, administered as a single agent on Day 1,8 and 15 of a 28-day cycle. If the patient is deriving clinical benefit from the agent it may be continued and will be administered on Day 1 of each successive cycle.', 'interventionNames': ['Drug: STP705']}] | Interventions:[{'type': 'DRUG', 'name': 'STP705', 'description': 'Investigational Product', 'armGroupLabels': ['Cohort 1: STP705 20 μg dose', 'Cohort 2: STP705 40 μg dose', 'Cohort 3: STP705 80 μg dose', 'Cohort 4: STP705 160 μg dose', 'Cohort 5: STP705 320 μg dose'], 'otherNames': ['STP705 POWDER FOR INJECTION']}] | PrimaryOutcomes: [{'measure': 'Maximum Tolerated Dose (MTD)', 'description': 'Recommended starting dose \\& schedule', 'timeFrame': '28 day cycle'}, {'measure': 'Limited Dose Toxicity (LTD)', 'description': 'Recommended starting dose \\& dose escalation', 'timeFrame': '28 day cycle'}] | SecondaryOutcomes: N/A |
Title: A Phase I/II, Open-label, Multi-center, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of HMPL-453 in Patients With Advanced Solid Malignancies | Condition: Solid Tumor, Adult | Keywords: HMPL453, solid tumor, dose escalation | Summary: | Description: Dose-escalation stage (stage 1): Patients participating in the dose-escalation stage will take a single dose of HMPL-453 on Day 1 and will be followed for one week for safety observations. After one week of observation, if no safety issues occur, patients can continue multiple dosing of HMPL-453 QD and start on the DLT assessment cycles. Each cycle consists of 28-days. Patients are required to draw blood samples for PK and safety analysis at specific time points during the treatment.
The 3+3 design will be employed for the dose escalation and MTD ( maximum tolerated dose) determination. To limit the number of patients being exposed to potentially ineffective doses, one patient will be enrolled and dosed in the initial dose cohort. If there are no DLT or less than grade 2 toxicities of Common Terminology Criteria for Adverse Event ( CTC AE ) occur in the first treatment cycle, then the study will be escalated to the next dose cohort. Otherwise, the trial will revert to a standard 3+3 design.
Dose-Expansion Stage (Stage 2): This stage is to further evaluate the safety, tolerability, pharmacokinetics (PK) profile, and preliminary anti-tumor activity of HMPL-453 at the RP2D in approximately 60 patients with advanced solid tumor. Patients with FGFR ( Fibroblast Growth Factor Receptor) dysregulated advanced solid tumors, including but not limited to advanced urothelial bladder cancer, advanced cholangiocarcinoma (patients with cancers of the gallbladder or ampulla of Vater are not eligible) and others solid tumors are preferred to be enrolled.
Expansion stage will begin after dose-escalation stage is completed and the MTD/RP2D has been determined. Patients will receive HMPL-453 with 28-day treatment cycles until disease progression, death, intolerable toxicity, no longer benefiting from the study treatment per investigator's discretion, or withdrawal of consent, whichever comes first. | ArmGroups: [{'label': 'HMPL-453', 'type': 'EXPERIMENTAL', 'description': 'Two strengths of HMPL-453 tablets (25 mg and 100 mg based on the free base) will be used for clinical studies. The drug products are coated tablets, which are packaged in white induction sealed HDPE (high-density polyethylene) bottles. HMPL-453 will be administered to patients as oral tablet(s) on a daily basis, until disease progression, intolerable toxicity, or death. Dose levels are to be potentially tested in this study include 50, 100, 200, 300, 400, and 500 mg/day', 'interventionNames': ['Drug: HMPL-453']}] | Interventions:[{'type': 'DRUG', 'name': 'HMPL-453', 'description': 'oral administrative', 'armGroupLabels': ['HMPL-453']}] | PrimaryOutcomes: [{'measure': 'Incidence of DLTs by the NCI CTCAE v4.03', 'description': 'Incidence of DLTs by the NCI CTCAE v4.03', 'timeFrame': 'Cycle 1 (DLT assessment window 28 days)'}] | SecondaryOutcomes: [{'measure': 'Incidence of AEs and clinically significant laboratory abnormalities', 'description': 'incidence of any AEs associated to treatment', 'timeFrame': 'From first dose to 30 days after last dose of study treatment'}, {'measure': 'maximum plasma concentration (Cmax)', 'description': 'maximum plasma concentration (Cmax) of HMP 453', 'timeFrame': 'From first dose to day 56 of multiple dosing period'}, {'measure': 'time to reach maximum concentration (Tmax)', 'description': 'time to reach maximum concentration (Tmax) of HMP 453', 'timeFrame': 'From first dose to day 56 of multiple dosing period'}, {'measure': 'terminal half-life (t1/2)', 'description': 'terminal half-life (t1/2) of HMP-453', 'timeFrame': 'From first dose to day 56 of multiple dosing period'}, {'measure': 'area under the concentration-time curve (AUC0-t)', 'description': 'area under the concentration-time curve (AUC0-t) of HMP453', 'timeFrame': 'From first dose to day 56 of multiple dosing period'}, {'measure': 'apparent clearance (CL/F)', 'description': 'apparent clearance (CL/F) of HMP 453', 'timeFrame': 'From first dose to day 56 of multiple dosing period'}, {'measure': 'Serum phosphate level increases', 'description': 'to evaluate the fluctuate level of Serum phosphate level', 'timeFrame': 'From first dose to Day 21 of the last treatment cycle'}, {'measure': 'Objective response rate (ORR)', 'description': 'per RECIST', 'timeFrame': 'Every 8 weeks while being treated with HMPL-453 (expected average of 16 weeks)'}, {'measure': 'Duration of response (DoR)', 'description': 'from the date of response to progress or death', 'timeFrame': 'Every 8 weeks while being treated with HMPL-453 (expected average of 16 weeks)'}, {'measure': 'Disease Control Rate (DCR)', 'description': 'the response rate of PR (partial response) +CR(complete response) +SD （stable disease）', 'timeFrame': 'Every 8 weeks while being treated with HMPL-453 (expected average of 16 weeks)'}, {'measure': 'Change in tumor size', 'description': 'per RECIST to evaluate the change of target and non-target lesions', 'timeFrame': 'Every 8 weeks while being treated with HMPL-453 (expected average of 16 weeks)'}, {'measure': 'Progression free survival (PFS)', 'description': 'Per RECIST 1.1', 'timeFrame': 'Every 8 weeks while being treated with HMPL-453 (expected average of 16 weeks)'}] |
Title: Adjunctive Donepezil Therapy and Genetic Risk Factors of Cognitive Dysfunction in Brain Tumor Survivors | Condition: Brain Tumor, Brain Cancer, Cns Cancer, Cognitive Dysfunction | Keywords: Cognitive dysfunction | Summary: | Description: A significant proportion of brain tumor patients treated with radiation or chemotherapy who are in disease remission experience cognitive sequelae from their treatment. Cognitive dysfunction can be of sufficient severity to interfere with their ability to function at premorbid professional and social levels. There are, however, no approved pharmacological interventions for improving cognitive functions in cancer patients who display treatment-related cognitive deficits. Donepezil, an acetylcholinesterase inhibitor, has been shown to provide cognitive and functional benefits in patients with Alzheimer's disease, vascular dementia, and in patients with other neurological diseases without known cholinergic deficiency. The proposed pilot study will examine the efficacy of donepezil in improving cognitive functions in adult brain tumor patients treated with radiation and/or chemotherapy who have mild to moderate cognitive difficulties. Neuropsychological measures of executive, psychomotor speed, attention, and memory abilities will be administered prior to, during and following donepezil therapy. The proposed study will also test the hypothesis that the apolipoprotein E (APOE) e-4 allele correlates with the development of cognitive impairment after radiation or chemotherapy treatments. The proposed investigation is unprecedented and may provide preliminary information about (1) a pharmacological therapy that could improve cognitive functions in this population, and (2) a genetic risk factor that may increase vulnerability to radiation or chemotherapy-induced cognitive decline. | ArmGroups: [{'label': '1', 'type': 'EXPERIMENTAL', 'description': 'donepezil and questionaires', 'interventionNames': ['Other: donepezil and questionaires']}] | Interventions:[{'type': 'OTHER', 'name': 'donepezil and questionaires', 'description': 'Patients will undergo a brief cognitive evaluation prior to (baseline/Time 1), Cognitive Re-Evaluation (about 12 weeks after Time 1), Cognitive Re-Evaluation (about 12 weeks after Time 2) ,Cognitive Re-Evaluation (about 6 months after discontinuation of Donepezil). Then pt will be tx with donepezil, an acetylcholinesterase inhibitor. They will undergo a four-week dose titration (i.e., 5mg QD during weeks 1-4) to reach a final dose of 10mg QD of oral donepezil there after for a maximum of 24 weeks.', 'armGroupLabels': ['1']}] | PrimaryOutcomes: [{'measure': 'The primary goal of this study is to assess the efficacy of donepezil in improving executive abilities and psychomotor speed in adult brain tumor patients who have undergone cranial irradiation and/or chemotherapy.', 'timeFrame': 'conclusion of study'}] | SecondaryOutcomes: [{'measure': 'This study will also assess the efficacy of donepezil in improving other cognitive domains such as attention, memory, and general cognition in this population.', 'timeFrame': 'conclusion of study'}, {'measure': 'The study will also explore the possibility that the possession of the apolipoprotein E (APOE) є-4 allele is associated with the development of cognitive difficulties following cranial radiation and/or chemotherapy treatments.', 'timeFrame': 'conclusion of study'}] |
Title: Phase II Open Label Trial to Assess the Efficacy and the Impact on QTcF of Continuous Oral BIBW 2992 at a Daily Dose of 50mg in Patients With Relapsed or Refractory Solid Tumours Including Patients With Brain Metastases and Those With Glioblastoma Not Amenable to Other Therapy | Condition: Neoplasms | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'Monotherapy', 'type': 'EXPERIMENTAL', 'description': 'BIBW 2992 high dose, once daily, continuous, monotherapy', 'interventionNames': ['Drug: BIBW 2992']}] | Interventions:[{'type': 'DRUG', 'name': 'BIBW 2992', 'description': 'patients to receive continuous oral daily dosing of BIBW 2992', 'armGroupLabels': ['Monotherapy']}] | PrimaryOutcomes: [{'measure': 'Objective Response (OR)', 'description': 'OR is defined as complete response and partial response (PR) and was assessed according to the Macdonald criteria for glioblastomas and brain metastases and according to Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST) for solid tumours (excluding glioblastomas).', 'timeFrame': 'Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.'}, {'measure': 'Average Time-matched QT Corrected by the Fridericia Formula (QTcF) Change From Baseline to Day 14', 'description': 'Average time-matched QT corrected by the Fridericia formula (QTcF) change from baseline to day 14 over 1 to 24 hours following administration of afatinib.', 'timeFrame': 'The day before the first drug dose (baseline) and the day 14. Electrocardiograms (ECG) were performed at time point 0 and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 10 h, 24 h thereafter.'}] | SecondaryOutcomes: [{'measure': 'Progression-free Survival (PFS)', 'description': 'PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first. It was assessed according to the Macdonald criteria for glioblastomas and brain metastases and according to RECIST for solid tumours (excluding glioblastomas) as well as by the investigators assessment. Median time results from unstratified Kaplan-Meier estimates.', 'timeFrame': 'Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.'}, {'measure': 'Overall Survival (OS)', 'description': 'Overall survival (OS) is defined as time from start of treatment to death.', 'timeFrame': 'Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.'}, {'measure': 'Disease Control', 'description': 'Disease control was defined as CR, PR or stable disease (SD) and was assessed according to the Macdonald criteria for glioblastomas and brain metastases and according to RECIST for solid tumours (excluding glioblastomas).', 'timeFrame': 'Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.'}, {'measure': 'Duration of Disease Control (DC)', 'description': 'Duration of Disease control (DC). DC was defined as CR, PR or stable disease (SD) and was assessed according to the Macdonald criteria for glioblastomas and brain metastases and according to RECIST for solid tumours (excluding glioblastomas).', 'timeFrame': 'Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.'}, {'measure': 'Patients With Notable Findings in QTcF on Day 14', 'description': 'Notable findings are defined as a QTcF\\>500 ms or an increase in QTcF of \\>60ms.', 'timeFrame': 'Day 14'}, {'measure': 'Patients With Clinically Relevant Findings in ECG on Day 14', 'description': 'Patients with clinically relevant findings in Electrocardiogram data (ECG) on day 14.', 'timeFrame': 'Day 14'}, {'measure': 'Time-matched QTcF Changes From Baseline to Day 14 at Each Time-point', 'description': 'Individual QTcF measurements at each time-point. Response was defined as the change from baseline. Analysis adjusted for baseline using a mixed model.', 'timeFrame': 'Baseline and day 14 (at 1, 2, 3, 4, 5, 6, 7, 10, 24 hours post-dose )'}, {'measure': 'Average Time-matched QT Change From Baseline to Day 14', 'description': 'Average time-matched QT change from baseline to day 14 over 1 to 24 hours following administration of afatinib.', 'timeFrame': 'The day before the first drug dose (baseline) and the day 14. Electrocardiograms (ECG) were performed at time point 0 and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 10 h, 24 h thereafter.'}, {'measure': 'Patients With Notable Findings in QT on Day 14', 'description': 'Number of Patients with notable findings in QT on day 14. Notable findings are defined as a QT\\>500 ms.', 'timeFrame': 'Day 14'}, {'measure': 'Average Time-matched Heart Rate Change From Baseline to Day 14.', 'description': 'Average time-matched heart rate change from baseline to day 14.', 'timeFrame': 'The day before the first drug dose (baseline) and the day 14.'}, {'measure': 'Highest CTC Grade for Adverse Events', 'description': 'Highest Common Terminology Criteria (CTC) grade for adverse events', 'timeFrame': 'First administration of trial medication until 28 days after last administration of trial medication'}, {'measure': 'Area Under Curve 0-24 Hours (AUC0-24) on Day 1', 'description': 'AUC0-24 represents the area under the concentration curve of afatinib in plasma from 0 to 24 hours on Day 1.', 'timeFrame': '0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1'}, {'measure': 'Maximum Concentration (Cmax)', 'description': 'Cmax represents the maximum measured concentration of afatinib in plasma on Day 1.', 'timeFrame': '0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1'}, {'measure': 'Time From Dosing to the Maximum Concentration (Tmax)', 'description': 'tmax represents the time from dosing to the maximum concentration of afatinib in plasma on Day 1.', 'timeFrame': '0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1'}, {'measure': 'Area Under Curve of Afatinib Over a Uniform Dosing Interval Tau at Steady State (AUCtau,ss)', 'description': 'AUCtau,ss represents the area under the concentration curve of afatinib in plasma over a uniform dosing interval tau (24h) at steady state (Day14).', 'timeFrame': '0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 14'}, {'measure': 'Maximum Concentration of Afatinib in Plasma at Steady State (Cmax,ss)', 'description': 'Cmax,ss represents the maximum measured concentration of afatinib in plasma at steady state (Day 14).', 'timeFrame': '0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 14'}, {'measure': 'Time From Dosing to the Maximum Concentration of Afatinib in Plasma at Steady State (Tmax,ss)', 'description': 'tmax,ss represents the time from dosing to the maximum concentration of afatinib in plasma at steady state (Day 14).', 'timeFrame': '0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 14'}, {'measure': 'Accumulation Ratio of AUC Values (R_A,AUC)', 'description': 'R_A,AUC represents the accumulation ratio of AUC values after multiple dose administration over a uniform dosing interval t between days 1 and 14', 'timeFrame': '0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1 and 14'}, {'measure': 'Accumulation Ratio of AUC Values (R_A,Cmax)', 'description': 'R_A,Cmax represents the accumulation ratio of Cmax values after multiple dose administration over a uniform dosing interval t between days 1 and 14', 'timeFrame': '0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1 and 14'}, {'measure': 'Percentage Peak Trough Fluctuation (PTF)', 'description': 'PTF represents the percentage peak trough fluctuation. PTF is defined as difference between maximum and minimum concentration at steady state divided by the average concentration multiplied with 100 to report as percentage.', 'timeFrame': '0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 14'}] |
Title: Prospective, Longitudinal, Multinational Registry of Patients With Newly Diagnosed Peripheral T-Cell Lymphoma | Condition: Peripheral T-cell Lymphoma | Keywords: Non-Hodgkins Lymphoma, Non-Hodgkin's Lymphoma, Lymphoma | Summary: | Description: The COMPLETE registry is a prospective, longitudinal, multinational, observational study that will collect data on how patients with peripheral T-cell lymphoma (PTCL) are treated in academic and community practices. The registry will enroll newly-diagnosed patients with PTCL treated with a variety of regimens. The COMPLETE registry is designed to better understand PTCL patient characteristics, treatments, and outcomes to help design and understand future clinical trials. | ArmGroups: N/A | Interventions:N/A | PrimaryOutcomes: N/A | SecondaryOutcomes: N/A |
Title: Use of a Proliferation Saturation Index to Determine Personalized Radiotherapy Fractionation for Patients With HPV+ Oropharyngeal Cancers | Condition: Oropharyngeal Cancer | Keywords: HPV, Radiotherapy Fractionation, Proliferation Saturation Index, Larynx, Pharynx | Summary: | Description: Investigators hypothesize that using individual patient proliferation saturation index (PSI) to select radiotherapy fractionation (conventional fractionation or hyperfractionation) may improve the likelihood of a rapid response (defined as ≥ 32% reduction in volume at 4 weeks). | ArmGroups: [{'label': 'Radiotherapy Fractionation', 'type': 'EXPERIMENTAL', 'description': 'Investigators will use an individual patient proliferation saturation index (PSI) to select radiotherapy fractionation (conventional fractionation or hyperfractionation) to improve the likelihood of a rapid response (defined as ≥ 32% reduction in volume at 4 weeks).\n\nRadiotherapy fractionation: Standard fractionation at 2Gy once daily or Hyperfractionation at 1.2 Gy twice daily (≥ 6 hours apart)', 'interventionNames': ['Radiation: Radiotherapy fractionation']}] | Interventions:[{'type': 'RADIATION', 'name': 'Radiotherapy fractionation', 'description': 'Standard fractionation at 2Gy once daily or Hyperfractionation at 1.2 Gy twice daily (≥ 6 hours apart)', 'armGroupLabels': ['Radiotherapy Fractionation']}] | PrimaryOutcomes: [{'measure': 'Percentage of Response at Week 4 of Treatment', 'description': 'Fractionation of radiation will be individualized based on patient Proliferation Saturation Index (PSI). Objective is to increase the rate of response of ≥ 32% at 4 weeks to 63% of patients, above the expected 49%. Result is reported as percentage of participants who met the criteria for ≥ 32% reduction in tumor volume by week 4.', 'timeFrame': 'At 4 weeks of treatment'}] | SecondaryOutcomes: [{'measure': 'Rate of Complete Response at 2-3 Months', 'description': 'Rate of complete response by Computed Tomography (CT) at 2 months or Positron Emission Topography (PET)/CT at 3 months following completion of therapy', 'timeFrame': '2-3 months post treatment'}] |
Title: Pelvic Nodes Ultra-Hypo Fractionated Versus Conventionally Fractionated IMRT With HDR Brachytherapy Boost in Prostate Cancer: A Collaborative Multi-institutional Non-inferiority Phase 3 Trial. (PCS-XI) | Condition: Prostate Cancer, Node; Prostate, Radiotherapy Side Effect | Keywords: ultra hypo fractionation, brachytherapy | Summary: | Description: Prostate cancer is the most common non-skin cancer in North American men. In 2020, an estimated 23 300 Canadian men will be diagnosed with prostate cancer of which, 4200 will die. Fortunately, with an early screening, most will have a localized disease at diagnosis. Despite this, high risk disease affects a growing portion of the population and this according to age (29.3%, 39.1%, 60.4%, et 90.6% respectively at 55-59, 65-69, 75-79, \& 85-89 years of age). Gleason score 8 to 10 tumors follow the same pattern (16.5%, 23.4%, 37.2%, and 59.9% at respective ages). Those patients are at risk for harboring lymph nodes metastasis.
Multiple therapeutic options, with similar biochemical disease-free survival (bDFS) are available: surgery +/- salvage radiotherapy +/- androgen deprivation therapy (ADT) or radiotherapy (RT) +/- HDR-BT +/- ADT. For men with high-risk disease, the combined approach of RT + HDR-BT + ADT might even offer higher cancer specific survival (CSS) rates when compared to surgery.
HDR-BT allows for the delivery of a very high (ablative) dose of radiation while giving a lower dose to the nearby organs at risk (OARs). Recently published literature showed that pelvic RT plus HDR-BT significantly increased bDFS (84 vs 77%).
Pelvic RT is generally given on a daily basis (5 days/week) over a period of 4-5 weeks, with 1,8-2,15Gy per fraction. This requires a substantial time investment from patients undergoing treatment. Many studies have shown that prostate cancer offers a radiation cell kill ratio (α/β) of 0.9-1.5 Gy. Furthermore, the most commonly used α/β value for prostate cancer is 1,5 Gy (range 0,8 - 2,2). This low α/β ratio offers a more efficient cell kill with hypo-fractionated doses, offering a better tumor control with a lower cumulative dose, given in a shorter time span. Recently, a multicentric randomized phase III study has shown similar late toxicity and oncologic control outcomes between UHF (\>/= 5 Gy/fraction) and conventionally fractionated RT. However, until now, no phase III study has compared combined UHF pelvic RT to standard fractionation combined with an HDR-BT in this population.
The proposed experimental fractionation scheme for whole pelvic RT in this study will be 5Gy administered every other day over 2 weeks (UHF). It will be compared to standard pelvic RT (1.8-2.15Gy/working day) given over 4 to 5 weeks. Both will be combined with a single 15 Gy fraction of HDR-BT and ADT (goserelin). The UHF treatment modality significantly reduces the overall treatment time, freeing machine-time and allowing more patients to be treated. Given its low α/β ratio, prostate cancer is readily amenable to UHF fractionation. The bio-equivalent dose calculations were done based on published litterature. Neo-adjuvant and adjuvant ADT (goserelin) will be administered for a duration according to NCCN guidelines.
In these COVID-19 pandemic times, a reduction in the number of patients' visits to the clinic is highly desirable in order to limit the risk of virus transmission. UHF would also lower the socio-economic burden incurred by the patients and their families. It also increases the therapeutic efficiency reducing costs for both, patients and health services. The proposed study aims to demonstrate the non-inferiority of UHF treatment compared to standard of care. If this hypothesis is confirmed, all future patients could benefit from it.
In order to improve the quality of life of men diagnosed with prostate cancer this study aim to demonstrate that combined UHF pelvic RT plus HDR-BT (+ ADT according to NCCN guidelines) is safe and non-inferior to standard fractionation regimens in regard to toxicities and tumor control for prostate cancer patients with risk of nodal involvement. Therefore, 500 men will be recruited, in order to confirm the hypothesis. | ArmGroups: [{'label': 'ultra hypo fractionation radiation therapy (UHF)', 'type': 'EXPERIMENTAL', 'description': '5 radiation treatments (5 Gy per fraction) to the prostate, seminal vesicle and pelvic nodes given every other day over 2 weeks for a total of 25 Gy.', 'interventionNames': ['Radiation: Report and compare changes in a non-inferiority analysis of the International Prostate Symptom Score (I-PSS)', 'Radiation: Report and compare changes in a non-inferiority analysis of the expanded prostate cancer index composite" (EPIC-26):', 'Radiation: Report and compare changes in a non-inferiority analysis of the Sexual Health Inventory for Men (SHIM)', 'Radiation: Report and compare changes in a non-inferiority analysis of the toxicities reported according to the Common Terminology Criteria for Adverse Events (CTCAE)', 'Radiation: Report and compare the biochemical disease free survival (bDFS)', 'Radiation: Report and compare the disease free survival (DFS)', 'Radiation: Report and compare the metastase free survival (MFS)', 'Radiation: Report and compare the overall survival (OS)']}, {'label': 'standard of care fractionation (SOC)', 'type': 'ACTIVE_COMPARATOR', 'description': '20-25 radiation treatments (range: 1,8 to 2,15 Gy per fraction) to the prostate, seminal vesicle and pelvic nodes given in 20-25 working day treatments over 4-5 weeks for a total of 43 Gy to 46 Gy.', 'interventionNames': ['Radiation: Report and compare changes in a non-inferiority analysis of the International Prostate Symptom Score (I-PSS)', 'Radiation: Report and compare changes in a non-inferiority analysis of the expanded prostate cancer index composite" (EPIC-26):', 'Radiation: Report and compare changes in a non-inferiority analysis of the Sexual Health Inventory for Men (SHIM)', 'Radiation: Report and compare changes in a non-inferiority analysis of the toxicities reported according to the Common Terminology Criteria for Adverse Events (CTCAE)', 'Radiation: Report and compare the biochemical disease free survival (bDFS)', 'Radiation: Report and compare the disease free survival (DFS)', 'Radiation: Report and compare the metastase free survival (MFS)', 'Radiation: Report and compare the overall survival (OS)']}] | Interventions:[{'type': 'RADIATION', 'name': 'Report and compare changes in a non-inferiority analysis of the International Prostate Symptom Score (I-PSS)', 'description': 'Assess early and late genito-urinary (GU) toxicities induced assessed via the International Prostate Symptom Score (I-PSS) in the experimental UHF group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group).', 'armGroupLabels': ['standard of care fractionation (SOC)', 'ultra hypo fractionation radiation therapy (UHF)']}, {'type': 'RADIATION', 'name': 'Report and compare changes in a non-inferiority analysis of the expanded prostate cancer index composite" (EPIC-26):', 'description': 'Assess early and late genito-urinary (GU) and gastro-intestinal (GI) toxicities induced and quality of life assessed via expanded prostate cancer index composite (EPIC-26) in the experimental UHF group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group).', 'armGroupLabels': ['standard of care fractionation (SOC)', 'ultra hypo fractionation radiation therapy (UHF)']}, {'type': 'RADIATION', 'name': 'Report and compare changes in a non-inferiority analysis of the Sexual Health Inventory for Men (SHIM)', 'description': 'Assess early and late sexual health in the experimental UHF group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group).', 'armGroupLabels': ['standard of care fractionation (SOC)', 'ultra hypo fractionation radiation therapy (UHF)']}, {'type': 'RADIATION', 'name': 'Report and compare changes in a non-inferiority analysis of the toxicities reported according to the Common Terminology Criteria for Adverse Events (CTCAE)', 'description': 'Assess early and late toxicities reported according to the Common Terminology Criteria for Adverse Events (CTCAE) in the experimental UHF group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group).', 'armGroupLabels': ['standard of care fractionation (SOC)', 'ultra hypo fractionation radiation therapy (UHF)']}, {'type': 'RADIATION', 'name': 'Report and compare the biochemical disease free survival (bDFS)', 'description': 'Assess the 5 and 10 years biochemical disease-free survival (bDFS) in the UHF group and compare them for non-inferiority to those of the control group.', 'armGroupLabels': ['standard of care fractionation (SOC)', 'ultra hypo fractionation radiation therapy (UHF)']}, {'type': 'RADIATION', 'name': 'Report and compare the disease free survival (DFS)', 'description': 'Assess the 5 and 10 years disease-free survival (DFS) in the UHF group and compare them for non-inferiority to those of the control group.', 'armGroupLabels': ['standard of care fractionation (SOC)', 'ultra hypo fractionation radiation therapy (UHF)']}, {'type': 'RADIATION', 'name': 'Report and compare the metastase free survival (MFS)', 'description': 'Assess the 5 and 10 years metastasis-free survival (MFS) in the UHF group and compare them for non-inferiority to those of the control group.', 'armGroupLabels': ['standard of care fractionation (SOC)', 'ultra hypo fractionation radiation therapy (UHF)']}, {'type': 'RADIATION', 'name': 'Report and compare the overall survival (OS)', 'description': 'Assess the 5 and 10 years overall survival (OS) in the UHF group and compare them for non-inferiority to those of the control group.', 'armGroupLabels': ['standard of care fractionation (SOC)', 'ultra hypo fractionation radiation therapy (UHF)']}] | PrimaryOutcomes: [{'measure': 'Non-inferiority analysis of early change in genito-urinary (GU) toxicities induced.', 'description': 'Assess early genito-urinary (GU) toxicities induced opposed to baseline assessed via the International Prostate Symptom Score (I-PSS) in the experimental UH group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group).', 'timeFrame': 'Every 3 months for 1 year.'}, {'measure': 'Non-inferiority analysis of early change in reported Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire.', 'description': 'Assess early health-related quality of life opposed to baseline assessed via the Expanded Prostate Cancer Index Composite (EPIC-26) in the experimental UH group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group) every 3 months for 1 year.', 'timeFrame': 'Every 3 months for 1 year.'}, {'measure': 'Non-inferiority analysis of late change in genito-urinary (GU) toxicities induced.', 'description': 'Assess late genito-urinary (GU) toxicities induced opposed to baseline evaluated by the International Prostate Symptom Score (I-PSS) in the experimental UH group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group).', 'timeFrame': 'Every 6 months up to 36 months, then annually up to 10 years.'}, {'measure': 'Non-inferiority analysis of late change in reported Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire.', 'description': 'Assess late health-related quality of life opposed to baseline assessed via the Expanded Prostate Cancer Index Composite (EPIC-26) in the experimental UH group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group) every 6 months up to 36 months, then annually.', 'timeFrame': 'Every 6 months up to 36 months, then annually up to 10 years.'}, {'measure': 'Non-inferiority analysis of early change in sexual health.', 'description': 'Assess early quality of life opposed to baseline assessed via the Sexual Health Inventory for Men (SHIM) in the experimental UH group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group) every 3 months for 1 year.', 'timeFrame': 'Every 3 months for 1 year.'}, {'measure': 'Non-inferiority analysis of late change in sexual health.', 'description': 'Assess early sexual health status opposed to baseline assessed via the Sexual Health Inventory for Men (SHIM) in the experimental UH group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group) every 6 months up to 36 months, then annually.', 'timeFrame': 'Every 6 months up to 36 months, then annually up to 10 years.'}, {'measure': 'Non-inferiority analysis of early change in toxicities reporte via the Common Terminology Criteria for Adverse Events (CTCAE).', 'description': 'Assess early reported toxicities opposed to baseline assessed via the Common Terminology Criteria for Adverse Events (CTCAE) in the experimental UH group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group) every 3 months for 1 year, every 6 months up to 36 months, then annually.', 'timeFrame': 'Every 3 months for 1 year.'}, {'measure': 'Non-inferiority analysis of late change in toxicities reporte via the Common Terminology Criteria for Adverse Events (CTCAE).', 'description': 'Assess early reported toxicities opposed to baseline assessed via the Common Terminology Criteria for Adverse Events (CTCAE) in the experimental UH group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group) every 3 months for 1 year, every 6 months up to 36 months, then annually.', 'timeFrame': 'Every 6 months up to 36 months, then annually up to 10 years.'}] | SecondaryOutcomes: [{'measure': 'Non-inferiority analysis of 5 years biochemical Disease Free Survival.', 'description': 'Assess the 5 years the biochemical disease-free survival (bDFS) in the UH group and compare them for non-inferiority to those of the control group.', 'timeFrame': '5 years (median)'}, {'measure': 'Non-inferiority analysis of 5 years Disease Free Survival.', 'description': 'Assess the 5 years the disease-free survival (DFS) in the UH group and compare them for non-inferiority to those of the control group.', 'timeFrame': '5 years (median)'}, {'measure': 'Non-inferiority analysis of 5 years Metastasis Free Survival.', 'description': 'Assess the 5 years the Metastasis Free Survival (MFS) in the UH group and compare them for non-inferiority to those of the control group.', 'timeFrame': '5 years (median)'}, {'measure': 'Non-inferiority analysis of 5 years Overall Survival.', 'description': 'Assess the 5 years the Overall Survival (OS) in the UH group and compare them for non-inferiority to those of the control group.', 'timeFrame': '5 years (median)'}, {'measure': 'Non-inferiority analysis of 10 years biochemical Disease Free Survival.', 'description': 'Assess the 10 years the biochemical disease-free survival (bDFS) in the UH group and compare them for non-inferiority to those of the control group.', 'timeFrame': '10 years (median)'}, {'measure': 'Non-inferiority analysis of 10 years Disease Free Survival.', 'description': 'Assess the 10 years the disease-free survival (DFS) in the UH group and compare them for non-inferiority to those of the control group.', 'timeFrame': '10 years (median)'}, {'measure': 'Non-inferiority analysis of 10 years Metastasis Free Survival.', 'description': 'Assess the 10 years the Metastasis Free Survival (MFS) in the UH group and compare them for non-inferiority to those of the control group.', 'timeFrame': '10 years (median)'}, {'measure': 'Non-inferiority analysis of 10 years Overall Survival.', 'description': 'Assess the 10 years the Overall Survival (OS) in the UH group and compare them for non-inferiority to those of the control group.', 'timeFrame': '10 years (median)'}] |
Title: Predictive Value of Geriatric Oncology Screening and Geriatric Assessment in Older Patients With Solid Cancers (PROGNOSIS-RCT) | Condition: Frailty, Cancer, Age | Keywords: Frailty, Aged, Neoplasms, Cancer Patients, Geriatric Screening, Geriatric 8, Geriatric Assessment, Randomized Clinical Trial | Summary: | Description: This study aims to examine the effects of Comprehensive Geriatric Assessment and interventions on prognosis in the older frail cancer patient in a Randomized Clinical Trial design.
Patients screened frail with the Geriatric 8 screening tool, aged 70 or more, and found eligible for oncologic treatment, will be included. We plan to enrol a total of 322 cancer patients for 12 months. Participants will be allocated randomly to either interventional or control group.
Participants in the interventional group will be offered a Comprehensive Geriatric Assessment and intervention at the start-up of cancer treatment. The Comprehensive Geriatric Assessment will be an add on to standardized cancer treatment offered at the Oncologic Outpatient Clinic at Odense University Hospital.
Comprehensive Geriatric Assessment will be performed by a team consisting of a doctor, nurse and physiotherapist. If needed, referral to a dietician or an occupational therapist for further evaluation will be made. The health issues are assessed using validated tests based on a Danish version of the Geriatric Core Dataset (G-CODE). Follow-up on Comprehensive Geriatric Assessment is scheduled for one month after initial evaluation.
The randomized groups will be compared with respect to primary and secondary endpoints. | ArmGroups: [{'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Comprehensive Geriatric Assessment and follow-up as add on to standard oncologic care', 'interventionNames': ['Other: Comprehensive Geriatric Assessment and follow-up']}, {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'standard oncologic care according to national guidelines'}] | Interventions:[{'type': 'OTHER', 'name': 'Comprehensive Geriatric Assessment and follow-up', 'description': 'All patients will receive standardized oncological treatment according to national guidelines. For patients randomized to the intervention arm, a full Comprehensive Geriatric Assessment (CGA) and corresponding interventions on identified health issues will be performed alongside oncologic treatment. The domains are assessed using validated tests based on a Danish version of the Geriatric Core Dataset (G-CODE). The domains are cognition, mood, comorbidity, functional status, physical status, polypharmacy, nutrition, fall risc and social support. The CGA will be performed by the PhD-student (geriatric resident) or a geriatrician together with geriatric nurses at the Department of Geriatric Medicine, OUH. Nutritional status and interventions are assessed by a dietician. A physical therapist will evaluate the physical performance as part of the CGA.\n\nFollow-up on initial treatment plan is scheduled to one month after baseline CGA.', 'armGroupLabels': ['Intervention']}] | PrimaryOutcomes: [{'measure': 'physical function for patients receiving palliative oncologic treatment', 'description': 'measured by 30 seconds Chair Stand Test, number of repetitions in a 30 seconds time period.', 'timeFrame': '3 months'}, {'measure': 'unplanned hospital admissions for patients receiving adjuvant oncologic treatment', 'description': 'number of unplanned hospitalisations including admissions to Oncologic Department, Emergency Department and Medical Departments. Data will be retrieved trough review of electronic medical records.', 'timeFrame': '6 months'}] | SecondaryOutcomes: [{'measure': 'Physical functional for patients receiving curative oncologic treatment', 'description': 'measured by 30 seconds Chair Stand Test, number of repetitions in a 30 seconds time period.', 'timeFrame': '3 months'}, {'measure': 'Physical functional for patients receiving curative oncologic treatment', 'description': 'measured by 30 seconds Chair Stand Test, number of repetitions in a 30 seconds time period.', 'timeFrame': '6 months'}, {'measure': 'Physical functional for patients receiving palliative oncologic treatment', 'description': 'measured by 30 seconds Chair Stand Test, number of repetitions in a 30 seconds time period.', 'timeFrame': '6 months'}, {'measure': 'number of unplanned hospital admissions for patients receiving palliative oncologic treatment', 'description': 'Number of unplanned hospitalisations including admissions to Oncologic Department, Emergency Department and Medical Departments. Data will be retrieved trough review of electronic medical records.', 'timeFrame': '6 months'}, {'measure': 'Health-related Quality of life', 'description': 'Measured by EORTC-QLQ-C30', 'timeFrame': '12 months'}, {'measure': 'Health-related Quality of life', 'description': 'Measured by EORTC-QLQ-ELD14', 'timeFrame': '12 months follow-up'}, {'measure': 'Elderly Functional Index Score (ELFI-score)', 'description': 'Self reported functioning score. It is a composite score derived from the three scales "physical functioning", "Role functioning" and Social Functioning", from the quality of life questionnaire EORTC-QLQ-C30 and the scale "Mobility" from the quality of life questionnaire EORTC-QLQ-ELD-14. The range is (12-48), with a higher score being a better outcome.', 'timeFrame': '6 months'}, {'measure': 'Number of patients who experience oncologic treatment toxicity', 'description': 'Treatment toxicity grade 3+ evaluated with Common Terminology Criteria for Adverse Events', 'timeFrame': '6 months'}, {'measure': 'Number of patients with adherence to initial oncologic treatment plan', 'description': 'Registration of dose reductions, discontinuations and delays of intended cancer treatment.', 'timeFrame': '6 months'}, {'measure': 'Degree of Polypharmacy (PP)', 'description': 'Degree of polypharmacy. Polypharmacy is defined as daily use of more than 5 prescription drugs.', 'timeFrame': '3 months'}, {'measure': 'Number of potential Inappropriate Medications (PIM)', 'description': 'Using the Screening Tool for Older Persons Prescriptions (STOPP) criteria. Number of PIM will be registered for each patient', 'timeFrame': '3 months'}, {'measure': 'Number of Potential Drug Interactions (PDI)', 'description': "Using Stockley's Drug Interaction Database. Number of PDI will be registered for each patient", 'timeFrame': '3 months'}, {'measure': 'Overall survival', 'description': 'Measured from Geriatric 8 screening to time of death', 'timeFrame': '12 months'}, {'measure': 'Cancer specific survival', 'description': 'Measured from Geriatric 8 screening to time of death in patients with residual cancer', 'timeFrame': '12 months'}] |
Title: Stereotactic Body Radiation Therapy and Short-Term Androgen Ablation for Intermediate-Risk, Localized, Adenocarcinoma of the Prostate | Condition: Adenocarcinoma of the Prostate | Keywords: | Summary: | Description: This will be a Phase I/II study evaluating the effectiveness and toxicity of a combined regimen of 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions) with androgen deprivation therapy (ADT) for 4 months total. | ArmGroups: [{'label': 'Radiation with Androgen Deprivation Therapy (ADT)', 'type': 'EXPERIMENTAL', 'description': 'This will be a Phase I/II study evaluating the effectiveness and toxicity of a combined regimen of 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions) with androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT (stereotactic body radiation therapy). This choice of daily dose is based on the prior published experience showing safety and efficacy of hypofractionated regimens.', 'interventionNames': ['Radiation: Radiation Therapy', 'Drug: Androgen Deprivation Therapy (ADT)']}] | Interventions:[{'type': 'RADIATION', 'name': 'Radiation Therapy', 'description': '7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions)', 'armGroupLabels': ['Radiation with Androgen Deprivation Therapy (ADT)']}, {'type': 'DRUG', 'name': 'Androgen Deprivation Therapy (ADT)', 'description': 'Androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT.', 'armGroupLabels': ['Radiation with Androgen Deprivation Therapy (ADT)']}] | PrimaryOutcomes: [{'measure': 'Biochemical failure free-rate', 'description': 'To assess 5-year biochemical failure free rate (BFFR) associated with image-guided radiation therapy in doses of 7.25 Gy every other day to a total dose of 36.25 Gy (5 fractions) along with 4 months of androgen deprivation therapy (ADT) neoadjuvantly and concurrently.', 'timeFrame': '1, 2, 3, 6 12, 18. 24, 30, 36 mont, 4 year and 5 year follow-up points after treatment has been completed'}] | SecondaryOutcomes: [{'measure': 'Various Control Rate Assessments', 'description': 'Assess biochemical, clinical, and pathologic control rates associated with the combined hypofractionated dose regimen and ADT.', 'timeFrame': '1 year'}, {'measure': 'Dose Volume/ Imaging Data Assessments', 'description': 'Collect dose/volume and imaging data to allow normal tissue complication probability modeling and targeting assessment for patients treated with hypofractionated radiation therapy.', 'timeFrame': '1 year'}, {'measure': 'Biomarker Studies', 'description': 'Collect whole blood to perform correlative studies for serum cytokine profiling and future biomarker studies.', 'timeFrame': '1 year'}, {'measure': 'Gastrointestinal (GI) and Genitourinary (GU toxicity) assessment', 'description': '1) Assess the incidence of grade 3 or greater GU (genitourinary) and GI (gastrointestinal) toxicity with image-guided radiation therapy in doses of 7.25 Gy every other day to a total dose of 36.25 Gy (5 fractions) along with 4 months of androgen deprivation therapy (ADT) neoadjuvantly and concurrently.', 'timeFrame': '1 year'}] |
Title: Helicobacter Pylori Eradication to Prevent Gastric Cancer in a High-Risk Population of China: A Randomized Controlled Trial | Condition: Helicobacter Infections, Stomach Neoplasms | Keywords: Helicobacter Infections, Helicobacter pylori, Drug Therapy, Precancerous Conditions, Stomach Neoplasms, Incidence | Summary: | Description: N/A | ArmGroups: [{'label': 'OAC triple therapy', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: OAC triple therapy']}, {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Drug: Placebo']}] | Interventions:[{'type': 'DRUG', 'name': 'OAC triple therapy', 'description': 'Omeprazole, 20mg, amoxicillin, 1000mg, and clarithromycin, 500mg, all twice a day for 2 weeks.', 'armGroupLabels': ['OAC triple therapy']}, {'type': 'DRUG', 'name': 'Placebo', 'description': 'Omeprazole placebo, amoxicillin placebo, and clarithromycin placebo, all twice a day for 2 weeks.', 'armGroupLabels': ['Placebo']}] | PrimaryOutcomes: [{'measure': 'Gastric cancer incidence', 'description': 'The incidence of gastric cancer in the two groups', 'timeFrame': '10 years'}] | SecondaryOutcomes: [{'measure': 'Histopathological changes', 'description': 'The histopathological changes of atrophic gastritis or intestinal metaplasia in the two groups', 'timeFrame': '10 years'}] |
Title: A Phase 1 Study to Determine Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of SCO-120 in Hormone Receptor Positive, HER-2 Negative Advanced Breast Cancer Patients | Condition: HER2-negative Breast Cancer, Advanced Breast Cancer, Hormone Receptor-positive Breast Cancer | Keywords: | Summary: | Description: Part 1 \& 2: Approximately 51 subjects will be enrolled Part 3: Approximately 90 subjects will be enrolled | ArmGroups: [{'label': 'SCO-120', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Part 1', 'Drug: Part 2', 'Drug: Part 3']}] | Interventions:[{'type': 'DRUG', 'name': 'Part 1', 'description': 'Dose escalation cohort', 'armGroupLabels': ['SCO-120']}, {'type': 'DRUG', 'name': 'Part 2', 'description': 'Pharmacodyanamic (PD) dose exploration cohorts', 'armGroupLabels': ['SCO-120']}, {'type': 'DRUG', 'name': 'Part 3', 'description': 'Dose expansion at dose(s) ≤ maximum tolerated dose (MTD) cohort', 'armGroupLabels': ['SCO-120']}] | PrimaryOutcomes: [{'measure': 'Incidence of dose limiting toxicities at each dose levels (Part 1 only)', 'timeFrame': '28 Days/End of Cycle 1'}, {'measure': 'Incidence and severity of adverse events with each dose level', 'description': 'The intensity of adverse events will be graded as per CTCAE, Version 5.0 and categorized as serious adverse events or non-serious adverse events.', 'timeFrame': 'upto 30 days of last dose'}] | SecondaryOutcomes: [{'measure': 'evaluation of Cmax (Part 1 and Part 2)', 'description': 'Pharmacokinetic analysis will be performed using non-compartmental analysis. The actual elapsed time from dose will be used in the final pharmacokinetic parameter calculations', 'timeFrame': 'Through Cycle 1 and Cycle 2 (Each cycle of 28 Days)'}, {'measure': 'evaluation of tmax (Part 1 and Part 2)', 'description': 'Pharmacokinetic analysis will be performed using non-compartmental analysis. The actual elapsed time from dose will be used in the final pharmacokinetic parameter calculations', 'timeFrame': 'Through Cycle 1 and Cycle 2 (Each cycle of 28 Days)'}, {'measure': 'evaluation of AUC (Part 1 and Part 2)', 'description': 'Pharmacokinetic analysis will be performed using non-compartmental analysis. The actual elapsed time from dose will be used in the final pharmacokinetic parameter calculations', 'timeFrame': 'Through Cycle 1 and Cycle 2 (Each cycle of 28 Days)'}, {'measure': 'tumour response', 'timeFrame': "Every 8 weeks, for 'Time point Response (Partial Response[PR], Stable Disease[SD], Disease progression [DP] or Complete Response [CR]), Through study completion, an average of 1 year."}] |
Title: The Effects of T4 Mono Replacement Versus T4/T3 Combination Replacement on Psychological Distress After Total Thyroidectomy in Thyroid Cancer Patients; Prospective, Randomized, Double Blind, T4 Comparative Clinical Study | Condition: Thyroid Cancer, Distress, Depression, Anxiety, Fatigue | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'T4/T3 combination replacement', 'type': 'ACTIVE_COMPARATOR', 'description': 'Comthyroid', 'interventionNames': ['Drug: Comthyroid']}, {'label': 'T4 mono replacement', 'type': 'ACTIVE_COMPARATOR', 'description': 'Synthroid', 'interventionNames': ['Drug: Synthroid']}] | Interventions:[{'type': 'DRUG', 'name': 'Comthyroid', 'description': 'T4/T3 combination replacement', 'armGroupLabels': ['T4/T3 combination replacement']}, {'type': 'DRUG', 'name': 'Synthroid', 'description': 'T4 mono replacement', 'armGroupLabels': ['T4 mono replacement']}] | PrimaryOutcomes: [{'measure': 'Psychological distress (depression or anxiety) assessed with HADS', 'description': 'Change from baseline HADS total score at 24 weeks', 'timeFrame': 'baseline, 24 weeks'}, {'measure': 'Fatigue assessed with MDASI-F', 'description': 'Change from baseline MDASI-F score at 24 weeks', 'timeFrame': 'baseline, 24 weeks'}] | SecondaryOutcomes: [{'measure': 'Depression assessed with BDI', 'description': 'Change from baseline BDI total score at 24 weeks', 'timeFrame': 'baseline, 4, 12, 24 weeks'}, {'measure': 'Anxiety assessed with BAI', 'description': 'Change from baseline BAI total score at 24 weeks', 'timeFrame': 'baseline, 4, 12, 24 weeks'}, {'measure': 'Fatigue assessed with BFI', 'description': 'Change from baseline BFI total score at 24 weeks', 'timeFrame': 'baseline, 4, 12, 24 weeks'}, {'measure': 'Response rate using BDI', 'description': 'improvement of depression sx. ≥ 50%', 'timeFrame': 'baseline, 4, 12, 24 weeks'}, {'measure': 'Response rate using BAI', 'description': 'improvement of anxiety sx. ≥ 50%', 'timeFrame': 'baseline, 4, 12, 24 weeks'}, {'measure': 'Response rate using BFI', 'description': 'improvement of fatigue sx. ≥ 50%', 'timeFrame': 'baseline, 4, 12, 24 weeks'}, {'measure': 'Remisssion rate using BDI', 'timeFrame': 'baseline, 4, 12, 24 weeks'}, {'measure': 'Remission rate using BAI', 'timeFrame': 'baseline, 4, 12, 24 weeks'}, {'measure': 'Remission rate using BFI', 'timeFrame': 'baseline, 4, 12, 24 weeks'}] |
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