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Title: Impact of the COVID-19 Infectious Epidemic on the Management of Oncology and Onco-hematology Patients and on the Psychological Consequences for Patients and Caregivers | Condition: COVID-19, Cancer | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'Patients', 'interventionNames': ['Other: Questionnaire']}, {'label': 'Caregivers', 'interventionNames': ['Other: Questionnaire']}] | Interventions:[{'type': 'OTHER', 'name': 'Questionnaire', 'description': 'delivery of questionnaires on perceived stress, post-traumatic stress, sleep disorders, quality of life, cognitive complaint', 'armGroupLabels': ['Caregivers', 'Patients']}] | PrimaryOutcomes: [{'measure': 'To assess the impact of the COVID-19 pandemic on the modifications of treatments administered in hospital (day units) to patients with cancer or malignant hemopathy', 'description': 'Proportion of patients with modification of the treatments administered', 'timeFrame': 'up to 6 months'}, {'measure': 'To assess the impact of the COVID-19 pandemic on the change in the rate of treatment administration in hospital (day units) to patients with cancer or malignant hemopathy', 'description': 'Proportion of patients with change in the rate of treatment administration', 'timeFrame': 'up to 6 months'}, {'measure': 'To assess the impact of the COVID-19 pandemic on the number of cures administeredin hospital (day units) to patients with cancer or malignant hemopathy', 'description': 'Proportion of patients with change in the number of cures administered', 'timeFrame': 'up to 6 months'}, {'measure': 'To assess the impact of the COVID-19 pandemic on change of modality of administration in hospital (day units) to patients with cancer or malignant hemopathy', 'description': 'Proportion of patients with change of modality of administration (home administration to replace day hospital administration, teleconsultation uses)', 'timeFrame': 'up to 6 months'}] | SecondaryOutcomes: [{'measure': 'Evaluate the perceived stress on cancer patients treated in unit day of hospital', 'description': 'Score of questionnaires of Perceived Stress Scale \\[0-40 points\\]', 'timeFrame': 'up to 12 months'}, {'measure': 'Evaluate the post-traumatic stress on cancer patients treated in unit day of hospital', 'description': 'Score of questionnaires of Impact of Event Scale-Revised \\[0-88 points\\]', 'timeFrame': 'up to 12 months'}, {'measure': 'Evaluate the sleep disorders on cancer patients treated in unit day of hospital', 'description': 'Score of questionnaires of sleep disorders (ISI scale, 0-28 points)', 'timeFrame': 'up to 12 months'}, {'measure': 'Evaluate the quality of life on cancer patients treated in unit day of hospital', 'description': 'Score of questionnaires of quality of life (FACT-G scale)', 'timeFrame': 'up to 12 months'}, {'measure': 'Evaluate the cognitive complaints on cancer patients treated in unit day of hospital', 'description': 'Score of questionnaires of cognitive complaints (Fact-Cog scales; 0-148 points)', 'timeFrame': 'up to 12 months'}, {'measure': 'Evaluate the perceived stress on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness)', 'description': 'Score of questionnaires of Perceived Stress Scale \\[0-40 points\\]', 'timeFrame': 'up to 12 months'}, {'measure': 'Evaluate the post-traumatic stress on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness)', 'description': 'Score of questionnaires of Impact of Event Scale-Revised \\[0-88 points\\]', 'timeFrame': 'up to 12 months'}, {'measure': 'Evaluate the burnout on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness)', 'description': 'Score of questionnaires of burnout ((Maslach Burn Out Inventory scale, 0-132 points)', 'timeFrame': 'up to 12 months'}, {'measure': 'Evaluate the feeling of personal effectiveness on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness)', 'description': 'Score of questionnaires of feeling of personal effectiveness (0-30 points)', 'timeFrame': 'up to 12 months'}] |
Title: A Phase I, Open-Label, Multi-Center Dose Escalation Study to Evaluate Safety, Pharmacokinetics and Preliminary Efficacy of HL-085 in Patients With Advanced Solid Tumors | Condition: Solid Tumor, Adult | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'Dose Escalation', 'type': 'EXPERIMENTAL', 'description': 'There are 3 cohorts for the dose escalation study. Six subjects each cohort will receive oral administration of HL-085 capsules at three daily dose levels (12 mg, 18 mg and 24 mg). Three subjects of each cohort will receive TID and 3 subjects will receive BID dose regimen. Dose escalation can occur after 6 patients have completed 28 days of treatment and no or 1 DLT is identified.', 'interventionNames': ['Drug: HL-085']}] | Interventions:[{'type': 'DRUG', 'name': 'HL-085', 'description': 'HL-085 is a MEK inhibitor with potential indication for cancers. It will be given twice or three times daily continuously in the study until disease progression; or the risks outweigh the benefits, if the subject continues study treatment; or subjects with poor compliance; or subjects need to receive or have already started alternative antitumor drugs; or Subjects who need to receive or have already started alternative any other concomitant medication and/or treatment, which would significantly impact their safety; or interruption of IP administration for more than 14 days due to IP-related AEs.', 'armGroupLabels': ['Dose Escalation']}] | PrimaryOutcomes: [{'measure': 'Characterize the safety profile of the study drug at 3 dose levels in terms of number of treatment emergent events assessed by CTCAE v5.0., abnormal clinical laboratory and electrocardiograms findings (i.e. QT and QTc intervals).', 'timeFrame': '7 months (6 months treatment + 1 month follow-up)'}, {'measure': 'Cmax: the maximum plasma concentration of HL-085 or metabolite(s);', 'timeFrame': '1 month (Cycle 1 Day 1-31)'}, {'measure': 'Tmax: the time of Cmax;', 'timeFrame': '1 month (Cycle 1 Day 1-31)'}, {'measure': 'Area under the curve at steady state: a measure of the exposure to HL-085 or metabolite(s) at steady state.', 'timeFrame': '1 month (Cycle 1 Day 1-31)'}] | SecondaryOutcomes: [{'measure': 'Evaluate the efficacy of the study drug in terms of overall response rate, progression-free survival. ORR is the proportion of patients with a best overall response of complete response (CR) or partial response (PR), as assessed per RECIST v1.1.', 'timeFrame': '7 months (6 months treatment + 1 month follow-up)'}] |
Title: Frequency, Clinical Phenotype and Genetic Analysis of Heritable Kidney Cancer Syndromes | Condition: Renal Tumor Histology, Kidney Cancer, Renal Cell Carcinoma, Familial Renal Cancer, HLRCC, VHL Syndrome, BAP1 Tumor Predisposition Syndrome, FLCN Gene Mutation, ALK Gene Mutation, FH Gene Mutation, Birt-Hogg-Dube Syndrome, MET Gene Mutation, Cutaneous Leiomyoma, Cutaneous Leiomyomata With Uterine Leiomyomata | Keywords: | Summary: | Description: Background:
• The genetic etiology of heritable kidney cancer syndromes remains to be determined.
Objectives:
* Define the risk of developing renal cance in heritable kidney cancer syndromes
* Define the types and characteristics (including patterns of growth) of heritable kidney cancer syndromes.
* Determine genotype/phenotype correlations.
* To characterize the natural and clinical histories of heritable kidney cancer syndromes.
* To determine the genetic etiology of heritable kidney cancer syndromes.
Design:
* These rare families will be recruited to genetically confirm diagnosis, determine size and location of renal tumors, size at presentation, growth rate and metastatic potential of renal tumors.
* Genetic testing will be offered to gain appreciation of the effect of mutations on the relative activity of various germline and somatic mutations.
* To determine if there is a relationship between mutation and disease manifestations and phenotype. | ArmGroups: [{'label': 'Patient with heritable kidney cancer syndrome', 'description': 'Patients with known or suspected heritable kidney cancer syndromes, including VHL and HLRCC Disease.', 'interventionNames': ['Genetic: Gene test']}, {'label': 'Family members of heritable kidney cancer syndrome', 'description': 'Family members (related by blood) of patients who have or are suspected of having heritable kidney cancer syndromes, including VHL and HLRCC Disease.', 'interventionNames': ['Genetic: Gene test']}, {'label': 'Not proven genetic etiology', 'description': 'Patients and biologic family members with a heritable kidney cancer syndrome of suspected, but not proven genetic etiology.', 'interventionNames': ['Genetic: Gene test']}] | Interventions:[{'type': 'GENETIC', 'name': 'Gene test', 'description': 'Next generation sequencing of blood, urine and/or benign and malignant tissue of patients and family members with known or suspected heritable kidney cancer syndromes, including VHL and HLRCC Disease.', 'armGroupLabels': ['Family members of heritable kidney cancer syndrome', 'Not proven genetic etiology', 'Patient with heritable kidney cancer syndrome']}] | PrimaryOutcomes: [{'measure': 'Clinical phenotypes of patients of heritable kidney cancer syndromes', 'description': 'Chart review of disease outcome', 'timeFrame': '5 years'}, {'measure': 'Genotypes of patients of heritable kidney cancer syndromes', 'description': 'Genotyping for genetic variants that could modify the risk of cancer in subjects.', 'timeFrame': '5 years'}] | SecondaryOutcomes: [{'measure': 'Clinical phenotypes of family members of the patients', 'description': 'Questionnaire and chart review of the clinical phenotype', 'timeFrame': '5 years'}, {'measure': 'Prevalence of germline variants in the unselected general population of renal cancer patients', 'description': 'Frequency of germline pathogenic/likely pathogenic variants in renal cancer', 'timeFrame': '5 years'}] |
Title: Incorporating Veterans Preferences Into Lung Cancer Screening Decisions | Condition: Lung Cancer Screening | Keywords: lung cancer, decision support, implementation | Summary: | Description: Lung cancer is the leading cause of cancer deaths in the United States. Recent clinical trials provide evidence that screening with low dose CT scans will decrease lung cancer and all-cause mortality among older heavy smokers. Clinical guidelines have been issued with the USPSTF recommending annual screening from age 55 to 80 for those with 30 pack years or more of smoking or who quit less than 15 years ago. Evidence clearly delineates both the benefits (mortality reduction) and harms (false positives, follow-up testing, risk of invasive testing, and risk of overdiagnosis) of lung cancer screening. Preliminary data from an HSR\&D pilot grant finds that some Veterans are highly reluctant to enter the care pathway associated with lung cancer screening due to its potential harms. Additional preliminary data using Best Worst Scaling in older smokers demonstrate groups of patients who place greater importance on harms than benefit when considering lung cancer screening. Preference assessment methods can help Veterans to weigh benefits and harms, consider the clinical pathway they are entering, anticipate future health states, and communicate these values to their health care providers. Although basic educational tools to inform lung cancer decision-making have been developed, there is a lack of validated preference assessment tools that can be integrated into the clinical setting. Building upon preference assessment methods developed and validated in an HSR\&D pilot grant (PI-Schapira) and using a trans-disciplinary approach, this team is positioned to advance the science and practice of decision support for lung cancer screening in the Veteran population. The objectives of this study are to 1) elicit patient and provider stakeholder input to inform the development of a lung cancer screening decision tool, 2) develop a web based Lung Cancer Screening Decision Tool (LCSDecTool) that incorporates patient and provider input, and 3) evaluate the impact of the LCSDecTool compared to usual care on the decision process, clinical outcomes, and quality of life. The study will be conducted in 3 phases. In phase 1, mixed methods will be used to assess usability of preference assessment methods and perceived usefulness of a web based lung cancer screening decision support tool among patient and provider stakeholders. In phase 2, an interactive web based decision support program will be developed that incorporates preference assessment methods. In phase 3, a pilot RCT will be conduced to evaluate the efficacy of the web based decision support program. Outcomes evaluated will include decision quality as indicated by knowledge, decisional conflict, and decision regret; screening behavior, clinical outcomes as indicated by anxiety, and quality of life. The study was conducted across three VA sites; West Haven-VA in Connecticut, Corporal Michael J. Crescenz VA in Philadelphia, Pennsylvania, and the Zablocki VA in Milwaukee, WI. Results of this study will provide tools that can be used to integrate lung cancer screening into clinical practice at VA Medical Centers in a patient centered approach. Lung cancer screening is fundamentally different from existing screening paradigms in several respects; eligibility is defined by a behavior (smoking), a high rate of false positive findings is expected, and the target population is older with higher comorbidity than the target population for cervical, breast, or colorectal screening. Given these unique aspects of lung cancer screening, there is a critical need to develop and test tools for preference assessment and informed decision making that are applicable for the VA setting. The current proposal provides a mechanism to accomplish these goals. The Principal Investigator is working closely with the US Department of Veterans Affairs National Center for Health Promotion and Disease Prevention to integrate the tools and paradigm developed to primary care in the VA Medical Care System. The work builds directly upon a recently completed HSR\&D pilot support in the area of lung cancer and shared decision making. | ArmGroups: [{'label': 'Intervention Group', 'type': 'EXPERIMENTAL', 'description': 'Participants in this arm will use the lung cancer screening decision aid (LCSDecTool)', 'interventionNames': ['Behavioral: Lung Cancer Screening Decision Tool']}, {'label': 'Control Group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Content that provides general information on disease prevention and health promotion unrelated to lung cancer. The information will be delivered on the same modality and take a similar amount of time to administer.', 'interventionNames': ['Behavioral: Control Intervention']}] | Interventions:[{'type': 'BEHAVIORAL', 'name': 'Lung Cancer Screening Decision Tool', 'description': 'This will be a lung cancer screening decision support tool that is web based and provides patients with information about the potential benefits and harms associated with lung cancer screening and helps them to consider their personal values when making a decision about whether to initiate or continue with lung cancer screening.', 'armGroupLabels': ['Intervention Group'], 'otherNames': ['LCSDecTool']}, {'type': 'BEHAVIORAL', 'name': 'Control Intervention', 'description': 'This will be a health message regarding prevention and healthy behavior that is not related to lung cancer screening but delivered in a similar modality and taking approximately the same amount of time as the LCSDecTool.', 'armGroupLabels': ['Control Group'], 'otherNames': ['Control']}] | PrimaryOutcomes: [{'measure': 'Decisional Conflict', 'description': 'The Decisional Conflict Scale is a 16-item scale with a value that ranges 0 (low decisional conflict) to 100 (high decisional conflict. The scale includes five subscales in the domains of uncertainty ( 3 items), Informed (3 items), Value Clarity (3 items), Support ( 3 items), and Effective DM (4 items).\n\nEach item is scored from a 0 (strongly agree), 1 (agree), 2 (neither agree nor disagree), 3) (disagree) or 4 (strongly disagree). The total sore for the 16 items is calculated by a) summing scores, b) dividing by 16, c) multiplying by 25. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict).\n\nFor each subscale the scores are obtained by a) summing scores, b) dividing by the number of items in the subscale, c) multiplying by 25. Scores are interpreted as range from 0(low decisional conflict) to 100 (high decisional conflict) in the respective domains.', 'timeFrame': '1 month following the intervention'}] | SecondaryOutcomes: [{'measure': 'Decision Regret', 'description': 'Decision regret as measured by a 5-item Decision Regret scale that is patient reported. This score range is from 0 (low decisional regret) to 100 (high decisional regret).', 'timeFrame': '1 month following intervention'}, {'measure': 'Lung Cancer Knowledge', 'description': 'Knowledge was measured with the 12-Item Brief Measures of Smokers Knowledge of Lung Cancer Screening Scale. The scores on this scale range from 0 (low level of knowledge) to 12 (high level of knowledge). Higher scores indicate a better outcome. Each correct response to an item is added to create the final score.', 'timeFrame': 'Immediately Post Intervention, within 24 hours of intervention following the intervention'}, {'measure': 'Lung Cancer Screening Knowledge', 'description': 'Knowledge was measured with the 12-Item Brief Measures of Smokers Knowledge of Lung Cancer Screening Scale. The scores on this scale range from 0 (low level of knowledge) to 12 (high level of knowledge). Higher scores indicate a higher amount of knowledge. Higher scores are a better outcome. 1 point is given to each correct item. The points are added to provide the total score.', 'timeFrame': '1 month post intervention'}, {'measure': 'Lung Cancer Screening Knowledge', 'description': 'Knowledge was measured with the 12-Item Brief Measures of Smokers Knowledge of Lung Cancer Screening Scale. The scores on this scale range from 0 (low level of knowledge) to 12 (high level of knowledge).', 'timeFrame': '3 months post intervention'}, {'measure': 'Anxiety', 'description': 'State anxiety was measured on the State Trait Anxiety Index Scale using the State subscale. This measure included 20 items with a total score ranging from 20 (low anxiety) to 80 (high anxiety).', 'timeFrame': '1 month following intervention'}, {'measure': 'Lung Cancer Screening Uptake', 'description': 'Documentation of receiving a lung cancer screening test by 6 months following the intervention. This was obtained by chart review.', 'timeFrame': '6 months after the intervention'}, {'measure': 'Lung Cancer Screening Uptake Within 9 Months', 'description': 'A documented lung cancer screening test completed within 9 months of the intervention obtained by chart review', 'timeFrame': '9 months'}, {'measure': 'Lung Cancer Worry', 'description': 'Lung cancer worry as measured by a 7 item scale with a range of scores from 3 (low worry) to 13 (high worry).', 'timeFrame': '1 month after the intervention'}, {'measure': 'Decisional Conflict', 'description': 'Measured by the Decisional Conflict Scale a 16-item scale with scores from 0(low decisional conflict) to 100 (high decisional conflict).', 'timeFrame': 'Immediately post-intervention-the same day as the intervention following the intervention.'}, {'measure': 'Decisional Conflict', 'description': 'Decisional conflict as measured by the 16 item decisional conflict scale scored from 0 (low decisional conflict) to 100 (high decisional conflict)', 'timeFrame': '3 months post-intervention'}, {'measure': 'Decisional Regret', 'description': 'Decisional regret was measured on the Decisional Regret scale. This is a 5 time scale with scores ranging from 0 (low decisional regret) to 100 (high decisional regret).', 'timeFrame': '3 months post-intervention'}, {'measure': 'Decisional Regret', 'description': 'Decisional regret was measured on a 5 point decisional regret scale with scores ranging from 0 (low regret) to 100 (high regret).', 'timeFrame': 'Immediately post-intervention-the same day as the intervention following the intervention'}, {'measure': 'Anxiety', 'description': 'Trait anxiety was measured using the State Trait Anxiety Index. This is a 20 item measure with scores ranging from 20 (low anxiety) to 80 (high anxiety).', 'timeFrame': 'Immediately post-intervention-the same day as the intervention following the intervention'}, {'measure': 'Anxiety', 'description': 'Anxiety was measured using the Trait items on the State Trait Anxiety Index with scores ranging from 20 (low anxiety) to 80 (high anxiety).', 'timeFrame': '3 months post intervention'}, {'measure': 'Lung Cancer Worry', 'description': 'Lung cancer worry was measured on a 3 point scale with scores ranging from 3 (low worry) to 13 (high worry)', 'timeFrame': 'immediately post-intervention-the same day as the intervention following the intervention.'}, {'measure': 'Lung Cancer Worry', 'description': 'Lung Cancer Worry was measured on a 3 item scale with scores ranging from 3(low worry) to 13 (high worry)', 'timeFrame': '3 months post-intervention'}] |
Title: Assessment of Nipple Sparing Mastectomy as a Treatment Option for Breast Cancer | Condition: Breast Cancer | Keywords: breast cancer, mastectomy, breast reconstruction | Summary: | Description: N/A | ArmGroups: N/A | Interventions:[{'type': 'PROCEDURE', 'name': 'nipple sparing mastectomy', 'description': 'The investigators categorized the incisions into radial, inframammary, and periareolar incisions with planned reconstruction types; direct to implant (DTI), transversus rectus abdominis myocutaneous (TRAM) flap, latissimus dorsi myocutaneous (LD) flap, or LD with implant.'}] | PrimaryOutcomes: [{'measure': 'patients complications after nipple sparing mastectomy', 'description': 'Complete general examination, local examination of the skin, nipple and areola were done to determine whether the patients suffered from any complaints', 'timeFrame': '2017-2019'}] | SecondaryOutcomes: [{'measure': 'Aesthetic results assessed by Tzafetta et al scoring system', 'timeFrame': '2017-2019'}] |
Title: An Individualised 8-week Remote Exercise Intervention to Improve QoL, Cardiometabolic Risk and Physical Activity Level in Men With Prostate Cancer Undergoing ADT Treatment. | Condition: Prostate Cancer | Keywords: Prostate cancer, Exercise, Online, Quality of Life | Summary: | Description: N/A | ArmGroups: [{'label': 'Exercise', 'type': 'EXPERIMENTAL', 'description': 'Exercise arm', 'interventionNames': ['Behavioral: Exercise']}] | Interventions:[{'type': 'BEHAVIORAL', 'name': 'Exercise', 'description': '8 week exercise intervention, 3x/wk', 'armGroupLabels': ['Exercise']}] | PrimaryOutcomes: [{'measure': 'Functional Assessment of Cancer Therapy-Prostate', 'description': 'Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire. Twenty-seven questions about physical, social/family, emotional and functional well-being are graded from 0-4 (0 = not at all; 4 = very much), yielding a total between 0 and 108.', 'timeFrame': 't= 0, 4, 8, 16 & 30 weeks'}, {'measure': 'Functional Assessment of Cancer Therapy', 'description': 'Functional Assessment of Cancer Therapy fatigue (FACIT-f) questionnaire. The FACIT-Fatigue is a validated questionnaire that was originally developed for the precise evaluation of fatigue levels in cancer patients with anemia. It consists of 13 questions using a 5 point scale (0=not at all; 1 = a little bit, 2 = somewhat, 3 = quite a bit and 4 = very much). It has been used frequently in the clinical trial setting (please see appendix 1). Responses to each question are added with equal weight to obtain a total score. The range of possible scores is 0-52, with 0 corresponding to the highest level of fatigue and 52 corresponding to the lowest level of fatigue.', 'timeFrame': 't= 0, 4, 8, 16 & 30 weeks'}] | SecondaryOutcomes: [{'measure': 'Leisure time physical activity', 'description': 'Godin Leisure Time Exercise Questionnaire. This is a 3 question self-report questionnaire - indirect measure of physical activity', 'timeFrame': 't= 0, 4, 8, 16 & 30 weeks'}, {'measure': 'Physical activity', 'description': 'The Dukes Activity Status Index. The Duke Activity Status Index (DASI) is a 12-item questionnaire that utilized self-reported physical work capacity to estimate peak metabolic equivalents (METs).', 'timeFrame': 't= 0, 4, 8, 16 & 30 weeks'}, {'measure': 'Cardiovascular risk', 'description': 'Qrisk3. Estimation of cardiovascular risk based on demographical and physiological parameters', 'timeFrame': 't= 0, 4, 8 weeks'}, {'measure': 'Exercise adherence', 'description': 'Session adherence. The number of sessions attended, and % of scheduled sessions performed. Every exercise session either completed or not completed over the 8 week intervention period', 'timeFrame': 'weekly for 8 weeks'}, {'measure': 'Health status', 'description': 'eq-5d-5l. It comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels: no problems, slight problems, some problems, severe problems and unable to do. Each level of answer consists of each level of score ranges from 1 to 5. Each participant will have a health status consisting of 5 digits. Using the set of weights from Vietnamese population provided from the EuroGroup, we can convert each EQ-5D health state into a single summary index value. The index value ranges from 0 to 1, higher scores meaning better health quality.', 'timeFrame': 't= 0, 4, 8, 16 & 30 weeks'}] |
Title: The Efficacy and Drug Resistance Molecular Biology of Apatinib Combined With EGFR-TK1 Treated for Advanced Slow-progressed Non-Small Cell Lung Cancer (NSCLC) | Condition: Non Small Cell Lung Cancer | Keywords: Apatinib, Non Small Cell Lung Cancer, EGFR TKI, slowly progress | Summary: | Description: Epidermal growth factor receptor Tyrosine kinase inhibitor (EGFR TKI) have been approved to treat NSCLC harboring EGFR mutation as first-line therapy. However, a large proportion of patients would become acquired resistant of EGFR-TKI after about one year although initially sensitivity. Previous studies demonstrated that the anti-angiogenesis combined with EGFR-TKI in slow-progressed EGFR mutation-positive non-small cell lung cancer achieved good efficacy and disease control rates, prolonged the progression free survival. The present study is aim to expand the number of samples to monitor resistance-related genes and tumor cells. Furthermore, to investigate the mechanism of anti-angiogenesis combine with EGFR-TKI and provide the theory for the use and promotion of clinically protocols. In this study, the primary objective is the objective response rates and the secondary goal are disease control rates, overall survival, progression free survival and drug safety. | ArmGroups: [{'label': 'Apatinib combined with EGFR-TKI', 'type': 'EXPERIMENTAL', 'description': 'Apatinib 250 millgram（mg/day（d））combined with EGFR-TKI', 'interventionNames': ['Drug: Apatinib（250mg/d） combined with EGFR-TKI']}] | Interventions:[{'type': 'DRUG', 'name': 'Apatinib（250mg/d） combined with EGFR-TKI', 'description': 'Patients with advanced non-small cell lung cancer (NSCLC) who had treated with EGFR-TKI and progressed slowly because of resistance are underwent with apatinib mesylate and continuous EGFR-TKI.', 'armGroupLabels': ['Apatinib combined with EGFR-TKI']}] | PrimaryOutcomes: [{'measure': 'Objective response rates (ORR)', 'description': 'Objective response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response according to Response Evaluation Criteria in Solid Tumors 1.1（RECIST1.1）', 'timeFrame': 'two years'}] | SecondaryOutcomes: [{'measure': 'Disease control rate (DCR)', 'description': 'Disease Control Rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease according to radiological assessments.', 'timeFrame': 'two years'}, {'measure': 'Overall survival (OS)', 'description': 'Time from randomization to death for any cause.', 'timeFrame': 'two years'}, {'measure': 'Progression free survival (PFS)', 'description': 'PFS defined as date of randomization until the date of objectively determined progression defined by Response Evaluation Criteria in Solid Tumors criteria or death from any cause, whichever is first.', 'timeFrame': 'two years'}, {'measure': 'Drug safety: Number of participants with treatment-related adverse events', 'description': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0', 'timeFrame': 'two years'}] |
Title: Multi-Center, Randomized Trial of Photodynamic Therapy Versus Argon Plasma Coagulation for Lung Cancer With Endobronchial Obstruction | Condition: Non Small Cell Lung Cancer | Keywords: non small cell lung cancer, photodynamic therapy, argon plasma coagulation, endobronchial obstruction | Summary: | Description: This is a multi-center, randomized study that will compare the efficacy of photodynamic therapy (PDT) and argon plasma coagulation (APC) in the treatment of airway obstruction caused by non small cell lung cancer. Participants will be randomized in a 1:1 ratio to receive treatment with one of these two treatment modalities. | ArmGroups: [{'label': 'Photodynamic Therapy', 'type': 'EXPERIMENTAL', 'description': 'Photodynamic therapy (PDT) uses activation of a photosensitizer by light of a specific wavelength to generate reactive oxygen species and singlet oxygen that causes direct cell damage and death, apoptosis, tumor vasculature damage and thrombosis, and inflammation leading to an immunological response.Following randomization, subjects will undergo treatment with either PDT or APC. Subjects will then have six additional study visits at 30, 45, 60, 90, and 180 days after their last PDT or APC treatment', 'interventionNames': ['Procedure: Photodynamic Therapy']}, {'label': 'Argon Plasma Coagulation', 'type': 'EXPERIMENTAL', 'description': 'Argon plasma coagulation (APC) is a noncontact form of electrocautery. Following randomization, subjects will undergo treatment with either DPT or APC. Subjects will then have six additional study visits at 30, 45, 60, 90, and 180 days after their last PDT or APC treatment.', 'interventionNames': ['Procedure: Argon Plasma Coagulation']}] | Interventions:[{'type': 'PROCEDURE', 'name': 'Photodynamic Therapy', 'description': 'Participants on this arm will be treated with photodynamic therapy. PDT is a two-stage process. The first stage of PDT is the intravenous injection of porfimer sodium (Photofrin) administered as a single slow intravenous injection over 3 to 5 minutes. The second stage involves the application of laser light to the tumor by bronchoscopy.', 'armGroupLabels': ['Photodynamic Therapy']}, {'type': 'PROCEDURE', 'name': 'Argon Plasma Coagulation', 'description': 'Participants on this arm will be treated with argon plasma coagulation. A flexible probe housing a wire delivers high-frequency, high-voltage electric current to a monopolar tungsten electrode present at the tip of the probe. Argon gas flows through the probe, and is charged or ionized to produce "plasma" as it flows around the tungsten electrode. Electric current flows through the plasma to the nearest tissue, and heat is produced as it passes through the tissue. Increased resistance created by coagulated tissue impairs the flow of electric current, and keeps the ablation depth to 1 to 2 mm.', 'armGroupLabels': ['Argon Plasma Coagulation']}] | PrimaryOutcomes: [{'measure': 'Treatment time until failure', 'description': 'Measure the time until treatment failure. Treatment failure is defined in this study as the occurrence of any of the following: failure to improve airway patency, airway-re-obstruction, need for additional airway intervention, and/or worsening symptoms at 90 days after the last PDT or APC treatment .', 'timeFrame': '90 days'}] | SecondaryOutcomes: [{'measure': 'Change in mean score of quality of life using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire and Lung Cancer Module (EORTC QLQ-LC13) at 30, 90 and 180 days after the last PDT or APC', 'description': 'QLQ-LC13 incorporates one multi-item scale to assess dyspnoea, and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and haemoptysis. 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': '30 days through 180 days'}, {'measure': 'Need for additional bronchoscopic therapies for either endobronchial obstruction at the treated site or for recurrent obstruction with no additional therapies offered at 30, 90, and 180 days following the last PDT or APC treatment', 'description': 'This will be assessed as Yes/No at each of the time points as to whether additional bronchoscopic therapies are needed, in the opinion of the treating investigator', 'timeFrame': '30 days through 180 days'}, {'measure': 'Median survival time', 'description': 'The median survival time for each treatment cohort will be estimated in days after the last PDT or APC treatment using a Kaplan-Meier survival curve', 'timeFrame': '6 months'}, {'measure': 'Percent reduction in airway obstruction as measured by bronchoscopy at 30 and 90 days after the last PDT or APC treatment', 'description': 'Percent reduction in airway obstruction will be calculated with the formula: \\[(baseline obstruction percentage - residual obstruction percentage)/baseline obstruction percentage x 100%\\].', 'timeFrame': '30 days through 90 days'}, {'measure': 'Resolution of atelectasis, if present, at 30, 45, 60, 75, 90, and 180 days after the last PDT or APC treatment', 'description': 'This will be assessed by examining subject chest x-rays and/or chest CT scans at each of these time points for the presence or absence of atelectasis.', 'timeFrame': '30 days through 180 days'}, {'measure': 'Resolution of post-obstructive pneumonia, if present, at 30, 45, 60, 75, 90, and 180 days after the last PDT or APC treatment', 'description': 'This will be assessed by examining subject chest x-rays and/or chest CT scan for the presence or absence of post-obstructive pneumonia, as well as the physical examination of subjects for post-obstructive pneumonia symptoms (such as fever, pleuritic chest pain, and productive cough) at each of these time points.', 'timeFrame': '30 days through 180 days'}, {'measure': 'Change in dyspnea (as measured by the transitional dyspnea index (TDI), using the score obtained from the Baseline Dyspnea Index (BDI) as the baseline comparator) at 30, 60, 90, and 180 days after the last PDT or APC treatment', 'description': 'The Baseline Dyspnea Index measures the severity of dyspnea at baseline using the sum of the scores for three items that assess functional impairment and magnitude of effort required for daily activities. Total possible score ranges from 0 to 12. A lower total score indicates more severe dyspnea. The Transitional Dyspnea Index evaluates change in dyspnea as compared to the score obtained by the Baseline Dyspnea Index using a scale of -9 to +9. A negative score (-1 to -9) indicates worsening dyspnea as compared to baseline, a positive score (+1 to +9) indicates improvement in dyspnea as compared to baseline, and a score of 0 indicates no change in dyspnea as compared to baseline.', 'timeFrame': '30 days through 180 days'}, {'measure': 'Change in hemoptysis, if present, at 30, 45, 60, 75, 90, and 180 days after the last PDT or APC treatment using categorical measures (worsened, unchanged, improved, resolved)', 'timeFrame': '30 days through 180 days'}, {'measure': 'Change in cough, if present, at 30, 45, 60, 75, 90, and 180 days after the last PDT or APC treatment using categorical measures (worsened, unchanged, improved, resolved)', 'timeFrame': '30 days through 180 days'}, {'measure': 'Change in Karnofsky performance status, if present, at 30, 60, 90, and 180 days after the last PDT or APC treatment using categorical measures (worsened, unchanged, improved, resolved).', 'timeFrame': '30 days through 180 days'}, {'measure': 'Proportion of patients experiencing treatment failure at 90 days', 'description': 'Treatment failure is defined as failure to improve airway patency, airway re-obstruction, need for additional airway intervention and/or worsening symptoms.', 'timeFrame': '90 days'}] |
Title: A Phase II Study of Carboplatin, Etoposide, and Exisulind in Patients With Extensive Small Cell Lung Cancer | Condition: Lung Cancer | Keywords: extensive stage small cell lung cancer | Summary: | Description: OBJECTIVES:
* Determine the percentage of patients with extensive stage small cell lung cancer who live more than 12 months after treatment with carboplatin, etoposide, and exisulind.
* Determine the response rate of patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive carboplatin IV over 30 minutes on day 1 and etoposide IV over 30-60 minutes on days 1-3. Patients also receive oral exisulind twice daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year and then every 4 months for 2 years. | ArmGroups: [{'label': 'carboplatin + etoposide + exisulind', 'type': 'EXPERIMENTAL', 'description': 'Patients receive carboplatin IV over 30 minutes on day 1 and etoposide IV over 30-60 minutes on days 1-3. Patients also receive oral exisulind twice daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed every 2 months for 1 year and then every 4 months for 2 years.', 'interventionNames': ['Drug: carboplatin', 'Drug: etoposide', 'Drug: exisulind']}] | Interventions:[{'type': 'DRUG', 'name': 'carboplatin', 'armGroupLabels': ['carboplatin + etoposide + exisulind']}, {'type': 'DRUG', 'name': 'etoposide', 'armGroupLabels': ['carboplatin + etoposide + exisulind']}, {'type': 'DRUG', 'name': 'exisulind', 'armGroupLabels': ['carboplatin + etoposide + exisulind']}] | PrimaryOutcomes: [{'measure': 'percentage of patients with extensive stage small cell lung cancer who live more than 12 months after treatment', 'timeFrame': 'Up to 3 years'}] | SecondaryOutcomes: [{'measure': 'response rate', 'timeFrame': 'Up to 3 years'}] |
Title: Can Patients With Multiple Breast Cancers in the Same Breast Avoid Mastectomy by Having Multiple Lumpectomies to Achieve Equivalent Rates of Local Breast Cancer Recurrence? A Randomised Controlled Feasibility Study. | Condition: Breast Cancer, Unilateral | Keywords: Breast Cancer, Mastectomy, Therapeutic Mammoplasty, Multiple Ipsilateral Breast Cancers | Summary: | Description: The investigators will run a small study to evaluate whether a sufficient number of eligible patients can be identified and are willing to accept randomisation of the interventions in question. Recruitment and compliance rates of which will inform the feasibility and design of a larger trial. This will comprise a multi-centre randomised controlled trial in women with Multiple Ipsilateral Breast cancer (MIBC) requiring surgery. Participants will receive either Therapeutic Mammoplasty (TM) following excision of each cancer focus or mastectomy (+/- reconstruction). Patients will be randomised (1:1) into either intervention or control group.Therapeutic mammoplasty is an operation to remove breast cancer(s) whilst also significantly reducing the size of the breast. Therapeutic mammoplasty can be used to remove more than one cancer in the breast using separate lumpectomies. Both skin and breast tissue are removed, leaving scars similar to those seen after a standard breast reduction. Each patient is followed up for 12 months post treatment with a total of 50 patients recruited. Timings of the follow-up visits are aligned with standard of care practice for this patient population with quality of life questionnaires and clinical photographs completed before and after surgery. Twenty women will also be invited to an optional semi-structured interview at twelve months. | ArmGroups: [{'label': 'Mastectomy +/- reconstruction', 'type': 'ACTIVE_COMPARATOR', 'description': 'Either a simple mastectomy or skin sparing mastectomy technique will be used. Women in this arm will be offered either immediate or delayed breast reconstruction according to standard practice. Reconstructions will be followed by chemotherapy and/or endocrine therapy as determined by local clinicians . Chest wall and/or regional nodal radiotherapy will be prescribed according to local centre policy.', 'interventionNames': ['Procedure: Mastectomy']}, {'label': 'Therapeutic Mammoplasty', 'type': 'ACTIVE_COMPARATOR', 'description': 'Therapeutic Mammoplasty (TM) comprises well-established surgical techniques involving volume displacement using breast reduction techniques, or volume replacement to maximize the volume of tissue that can be excised resulting in effective local control whilst maximizing cosmetic outcomes. This group will either have one "disease site" lumpectomy in the case of multifocal tumours or distant "disease site" lumpectomies in multicentric cancers.', 'interventionNames': ['Procedure: Therapeutic Mammoplasty']}] | Interventions:[{'type': 'PROCEDURE', 'name': 'Mastectomy', 'description': 'Removal of the whole breast.', 'armGroupLabels': ['Mastectomy +/- reconstruction']}, {'type': 'PROCEDURE', 'name': 'Therapeutic Mammoplasty', 'description': 'Excision via lumpectomy of multifocal or multicentric cancers with breast volume displacement techniques to maximise cosmetic outcomes.', 'armGroupLabels': ['Therapeutic Mammoplasty']}] | PrimaryOutcomes: [{'measure': 'Number of women screened', 'description': 'Numbers of women with more than one cancer in the same breast (MIBC) screened for the trial', 'timeFrame': '36 Months'}, {'measure': 'Number of women eligible for the trial', 'description': 'Numbers of eligible women based on trial criteria and suitable for therapeutic mammoplasty', 'timeFrame': '36 Months'}, {'measure': 'Consent rate', 'description': 'The proportion of women eligible for the trial who provide written informed consent', 'timeFrame': '36 Months'}, {'measure': 'Compliance with trial procedures', 'description': 'Rate of compliance with allocated treatment and reason for deviation', 'timeFrame': '36 Months'}] | SecondaryOutcomes: [{'measure': 'Reasons why patients accept or decline randomisation', 'description': 'Tabulation of reasons why patients accept or decline randomisation (assessed from patient-completed Qualitative Study questionnaire)', 'timeFrame': '36 Months'}, {'measure': 'Qualitative research (clinical staff)', 'description': 'Tabulation of views of clinical staff following qualitative interviews', 'timeFrame': '36 Months'}, {'measure': 'Qualitative research (patients)', 'description': 'Tabulation of views of participating patients following qualitative interviews', 'timeFrame': '36 Months'}] |
Title: A Single-Blind Randomized Trial of Image-Guided Functional Lung Avoidance Thoracic Radiotherapy for Locally Advanced Non-Small Cell and Small Cell Lung Cancer | Condition: Small Cell Lung Cancer, Limited Stage, Stage III Non-small Cell Lung Cancer | Keywords: Lung Cancer, Radiotherapy, Biomarkers, Radiation Lung Injury, Quality of Life | Summary: | Description: N/A | ArmGroups: [{'label': 'Functional Lung Avoidance-TRT', 'type': 'EXPERIMENTAL', 'description': 'Functional Lung Avoidance Thoracic Radiotherapy\n\nThe avoidance thoracic radiotherapy treatment plan will be designed to optimize such that radiation dose to functional lung identified by four-dimensional (4D) CT ventilation imaging is as low as reasonably achievable', 'interventionNames': ['Radiation: Functional Lung Avoidance Thoracic Radiotherapy']}, {'label': 'Standard-TRT', 'type': 'ACTIVE_COMPARATOR', 'description': 'Standard Thoracic Radiotherapy\n\nThe standard thoracic radiotherapy treatment plan will be designed without reference to the functional lung 4D CT ventilation imaging', 'interventionNames': ['Radiation: Standard Thoracic Radiotherapy']}] | Interventions:[{'type': 'RADIATION', 'name': 'Functional Lung Avoidance Thoracic Radiotherapy', 'description': '* Chemoradiation for non-small cell lung cancer: 60 Gy in 30 once-daily fractions (Dose reduction to 54 Gy in 30 once-daily fractions is allowed)\n* Radiation alone for non-small cell lung cancer: 60 Gy in 25 once-daily fractions (Dose reduction to 55 Gy in 25 once-daily fractions is allowed)\n* Chemoradiation for small-cell lung cancer: 45 Gy in 30 twice-daily fractions', 'armGroupLabels': ['Functional Lung Avoidance-TRT']}, {'type': 'RADIATION', 'name': 'Standard Thoracic Radiotherapy', 'description': '* Chemoradiation for non-small cell lung cancer: 60 Gy in 30 once-daily fractions (Dose reduction to 54 Gy in 30 once-daily fractions is allowed)\n* Radiation alone for non-small cell lung cancer: 60 Gy in 25 once-daily fractions (Dose reduction to 55 Gy in 25 once-daily fractions is allowed)\n* Chemoradiation for small-cell lung cancer: 45 Gy in 30 twice-daily fractions', 'armGroupLabels': ['Standard-TRT']}] | PrimaryOutcomes: [{'measure': 'The pulmonary quality of life at 3 months post-radiotherapy', 'description': 'Functional Assessment of Cancer Therapy-Lung Cancer Subscale (FACT-LCS)', 'timeFrame': 'Change from Baseline Functional Assessment of Cancer Therapy-Lung Cancer Subscale at 3 months'}] | SecondaryOutcomes: [{'measure': 'Changes of pulmonary function test post-radiotherapy', 'description': 'Screening spirometry, diffusion capacity of lung for carbon monoxide', 'timeFrame': 'At baseline, 3, 6, 12 months, and annually until year 5 post-radiotherapy'}, {'measure': 'Patient reported outcome (Quality of Life questionnaire by Functional Assessment of Cancer Therapy)', 'description': 'Functional Assessment of Cancer Therapy-Lung', 'timeFrame': 'At baseline, 1, 2, 3, 4, 6, 9 12 months post-radiotherapy'}, {'measure': 'Patient reported outcome (Quality of Life questionnaire by EORTC Core)', 'description': 'EORTC Quality of Life-Core 30 questionnaire module', 'timeFrame': 'At baseline, 1, 2, 3, 4, 6, 9 12 months post-radiotherapy'}, {'measure': 'Patient reported outcome (Quality of Life questionnaire by EORTC Lung cancer)', 'description': 'EORTC Quality of Life questionnaire -Lung cancer 13', 'timeFrame': 'At baseline, 1, 2, 3, 4, 6, 9 12 months post-radiotherapy'}, {'measure': 'Acute toxicity', 'description': 'Common Toxicity Criteria for Adverse Events version 4', 'timeFrame': 'From date of radiotherapy until 90 days after radiotherapy starts'}, {'measure': 'Late toxicity', 'description': 'Common Toxicity Criteria for Adverse Events version 4', 'timeFrame': '90 days after radiotherapy starts until the date of death from any cause, up to 60 months'}, {'measure': 'Progression free survival', 'description': 'Number of participant without disease progression', 'timeFrame': 'From date of enrollment until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 60 months'}, {'measure': 'Overall survival', 'description': 'Number of participant alive', 'timeFrame': 'From date of enrollment until the date of death from any cause, assessed up to 60 months'}] |
Title: Observational Study on the Efficacy and Safety of Huaier Granules Compared With Platinum Containing Dual Drug Combination Chemotherapy in Adjuvant Therapy for Resectable Stage II-IIIA Non-small Cell Lung Cancer After Radical Surgery | Condition: Non-small Cell Lung Cancer | Keywords: Huaier granule, Non-small Cell Lung Cancer, Efficacy, Safety | Summary: | Description: This study is a small sample observational study, mainly exploring whether the 3-year DFS of the Huaier group is not inferior to the control group receiving standard platinum dual drug chemotherapy. Therefore, this study will conduct a small sample exploratory analysis. It is expected to include 240 non-small cell lung cancer patients who have been diagnosed with stage Ⅱ-ⅢA and are eligible for surgery at selected research centers from April 2023 to July 2025. Among them, 120 patients in the Huaier Granule group refused to undergo adjuvant chemotherapy due to reasons such as intolerance or disagreement, and agreed to receive Huaier Granule monotherapy as an adjuvant treatment; There are 120 patients in the control group, all of whom plan to receive standard chemotherapy as an adjuvant treatment plan (including platinum based dual-drug combination chemotherapy). | ArmGroups: [{'label': 'Huaier Granule', 'description': 'The subjects voluntarily gave up postoperative adjuvant therapy, including chemotherapy, targeted therapy, immunotherapy, and radiation therapy, and agreed to take Huaier granules.', 'interventionNames': ['Drug: Huaier granule']}, {'label': 'Control', 'description': 'The subjects received standard platinum dual-drug chemotherapy.', 'interventionNames': ['Other: Control']}] | Interventions:[{'type': 'DRUG', 'name': 'Huaier granule', 'description': 'The subjects voluntarily gave up postoperative adjuvant therapy, including chemotherapy, targeted therapy, immunotherapy, and radiation therapy, and agreed to take Huaier granules.The subjects took Huaier granules orally, one bag (10g) per time, three times a day. Until the end of the study, intolerable toxicity, withdrawal from the study for any reason or death, or when the researcher determines that there is no further benefit, whichever occurs first. Please refer to the drug manual for specific usage. It is recommended that patients start taking Huaier granules 1-2 weeks after surgery.', 'armGroupLabels': ['Huaier Granule'], 'otherNames': ['Z20000109（NMPA Approval Number）']}, {'type': 'OTHER', 'name': 'Control', 'description': 'The subjects received standard platinum dual drug chemotherapy.The subjects were treated with carboplatin injection (300mg/m2, intravenous injection, first day) combined with pemetrexed disodium (pathological type: adenocarcinoma, intravenous injection, 500mg/m2) or albumin bound paclitaxel (pathological type: squamous cell carcinoma, 260mg/m2, intravenous injection, first day) every three weeks, with a maximum of four cycles.', 'armGroupLabels': ['Control']}] | PrimaryOutcomes: [{'measure': '3-year disease-free survival (DFS) rate', 'description': 'The proportion of participants who did not experience disease recurrence or death within 3 years after undergoing lung cancer radical surgery.', 'timeFrame': 'start of treatment until 3-year follow-up'}] | SecondaryOutcomes: [{'measure': '1-year or 2-year DFS rate', 'description': 'The proportion of participants who did not experience disease recurrence or death within 1 or 2 years after undergoing lung cancer radical surgery', 'timeFrame': 'start of treatment until 1-year or 2-year follow-up'}, {'measure': '1-year, 2-year or 3-year overall survival (OS) rate', 'description': 'The proportion of subjects who survived within 1 year, 2 years or 3 years after undergoing radical lung cancer surgery among all subjects.', 'timeFrame': 'start of treatment until 1-year, 2-year or 3-year follow-up'}, {'measure': '1-year, 2-year or 3-year local recurrence free survival (LRFS) rates', 'description': 'The proportion of subjects who did not experience local recurrence of lung cancer within 1 year, 2 years or 3 years after undergoing radical lung cancer surgery.', 'timeFrame': 'start of treatment until 1-year, 2-year or 3-year follow-up'}, {'measure': '1-year, 2-year or 3-year distant metastasis free survival (DMFS) rates', 'description': 'The proportion of subjects who did not experience distant metastasis within 1 year, 2 years, or 3 years after undergoing lung cancer radical surgery', 'timeFrame': 'start of treatment until 1-year, 2-year or 3-year follow-up'}, {'measure': 'Quality of Life Score (SF-36 Scale)', 'description': 'The Health Survey Short Form\\[(SF-36 Scale (Chinese Version) \\]developed by the US Medical Bureau research team was used for evaluation. The scale has 36 items and aims to evaluate the health and functional status of multiple age groups, different diseases, and control populations.Note that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.', 'timeFrame': 'start of treatment until 3-year follow-up'}, {'measure': 'The incidence and severity of adverse events (AE) and severe adverse events (SAE)', 'description': 'The definitions and severity grading of AE and SAE can refer to the corresponding descriptions in the definition and evaluation section of AE. The incidence rate is defined as the proportion of subjects who have experienced AE and SAE to the corresponding total population.', 'timeFrame': 'start of treatment until 3-year follow-up'}] |
Title: Survival prEdiction in bLadder Cancer Patients Treated by nEoadjuvant Chemotherapy Before cysTectomy | Condition: Bladder Cancer, Genomic Instability | Keywords: Neoadjuvent chemotherapy, Molecular subtype, Bladder cancer, Genomic instability, Artificial intelligence | Summary: | Description: The project is based on three prospective cohorts of patients with MIBC: the VESPER trial (n=296), the St-Louis Hospital cohort (n=99), and the COBLAnCE cohort (n=312). Using WES and RNAseq, the investigators will determine genomic instability, DDR gene mutation and molecular subtypes. After digitization of tumour slides, the investigators will train and test predictive models based on deep learning approaches to predict outcome after neoadjuvant chemotherapy, either by estimating molecular subtypes and genetic features from pathological images, or by directly defining a prognostic signature. The statistical analyses will assess the performance of the models combining genomic instability, DNA Damage Response mutations and/or molecular subtyping to predict outcome after neoadjuvant chemotherapy and compare them with the models based on WSI deep learning approaches. These results will help to design new therapeutic strategies. | ArmGroups: [{'label': 'Patients enrolled in VESPER study', 'description': 'Tumors from patient having muscle invasive bladder cancer who benefit from neoadjuvant chemotherapy with cisplatine included in VESPER cohort', 'interventionNames': ['Combination Product: neoadjuvant chemotherapy with cisplatine']}, {'label': 'Patients from St Louis cohort not enrolled in VESPER study', 'description': 'Tumors from patient having muscle invasive bladder cancer who benefit from neoadjuvant chemotherapy with cisplatine included in Saint-Louis cohort', 'interventionNames': ['Combination Product: neoadjuvant chemotherapy with cisplatine']}, {'label': 'Patients from COBLAnCE cohort not enrolled in VESPER study', 'description': 'Tumors from patient having muscle invasive bladder cancer who benefit from neoadjuvant chemotherapy with cisplatine included in COBLAnCE cohort', 'interventionNames': ['Combination Product: neoadjuvant chemotherapy with cisplatine']}] | Interventions:[{'type': 'COMBINATION_PRODUCT', 'name': 'neoadjuvant chemotherapy with cisplatine', 'description': 'Blood from patient having muscle invasive bladder cancer who benefit from neoadjuvant chemotherapy with cisplatine', 'armGroupLabels': ['Patients enrolled in VESPER study', 'Patients from COBLAnCE cohort not enrolled in VESPER study', 'Patients from St Louis cohort not enrolled in VESPER study']}] | PrimaryOutcomes: [{'measure': 'Progression-free survival', 'description': 'The time from enrollment to progression or death', 'timeFrame': '3 years'}] | SecondaryOutcomes: [{'measure': 'Overall survival', 'description': 'The time from enrollment to death', 'timeFrame': '5 years'}] |
Title: A Study of Patient Preference Between Cabazitaxel and Docetaxel in First-line Chemotherapy for Metastatic Castrate-resistant Prostate Cancer | Condition: Metastatic Castration-resistant Prostate Cancer | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'Do/Ca', 'type': 'OTHER', 'description': 'Arm Do/Ca : Taxotere 75mg/m2/3w x 4 cycles, followed by Jevtana 25mg/m2/3w x 4 cycles', 'interventionNames': ['Drug: Taxotere', 'Drug: Jevtana']}, {'label': 'Ca/Do', 'type': 'OTHER', 'description': 'Arm Ca/Do : Jevtana 25mg/m2/3w x 4 cycles, followed by Taxotere 75mg/m2/3w x 4 cycles', 'interventionNames': ['Drug: Taxotere', 'Drug: Jevtana']}] | Interventions:[{'type': 'DRUG', 'name': 'Taxotere', 'armGroupLabels': ['Ca/Do', 'Do/Ca']}, {'type': 'DRUG', 'name': 'Jevtana', 'armGroupLabels': ['Ca/Do', 'Do/Ca']}] | PrimaryOutcomes: [{'measure': 'Patient preference', 'description': 'Patient preference (Taxotere versus Jevtana) assessed by a single question after completion of the second period of chemotherapy.\n\nPrimary outcome measure will be assessed in the intent-to-treat population as defined by all patients having completed the first 4 cycles without progression and having received at least 1 cycle of the second treatment period. Patients having progressed during the first period will discontinue the trial.', 'timeFrame': 'Assessed up 21 weeks after randomization'}] | SecondaryOutcomes: N/A |
Title: Diagnostic Study of Patent Blue V Dye to Identify Sentinel Lymph Nodes in Patients With Stage I or IIA Breast Cancer | Condition: Breast Cancer | Keywords: stage I breast cancer, stage II breast cancer | Summary: | Description: OBJECTIVES: I. Determine whether the concept of a sentinel lymph node within the axillary nodal basin is valid in staging breast cancer. II. Determine the sensitivity of combined methods of identification of sentinel lymph nodes by patent blue V dye and gamma probe detection in these women.
OUTLINE: Patients receive patent blue V dye injection peritumorally prior to surgery. Preoperative lymphoscintigraphy is performed using technetium Tc 99 sulfur rhenium colloid injected around the tumor associated with intraoperative gamma probe detection. Nonpalpable tumors receive a localized injection using stereotactic injection techniques. Patients then undergo standard axillary (level I and II) lymph node dissection.
PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study within 1 year. | ArmGroups: N/A | Interventions:[{'type': 'DRUG', 'name': 'patent blue V dye'}, {'type': 'PROCEDURE', 'name': 'lymphangiography'}, {'type': 'PROCEDURE', 'name': 'radionuclide imaging'}, {'type': 'PROCEDURE', 'name': 'sentinel lymph node biopsy'}, {'type': 'RADIATION', 'name': 'technetium Tc 99m sulfur colloid'}] | PrimaryOutcomes: N/A | SecondaryOutcomes: N/A |
Title: Comparative Effectiveness of HIPEC Following Interval Debulking Surgery in Patients With Advanced-stage Ovarian Cancer Undergoing Neoadjuvant Chemotherapy: Multicenter, Prospective, Cohort Study | Condition: Ovarian Cancer | Keywords: HIPEC, Interval debulking surgery | Summary: | Description: GOG 172 trial showed a dramatic improvement of overall survival in patients with stage III disease treated with intraperitoneal cisplatin and paclitaxel compared with those with intravenous administration. Currently, prospective cohort study showed a survival benefit of intraperitoneal chemotherapy compared with intravenous chemotherapy. Despite this improvement, intraperitoneal chemotherapy is not widely used as standard therapy owing to the high rate of adverse effects and inconvenience of administering therapy intraperitoneally. Hyperthermic intraperitoneal chemotherapy (HIPEC) is a multi-modal approach with combined intraperitoneal chemotherapy and hyperthermia. It maintains the theoretical benefit of intraperitoneal chemotherapy and reduces most of the adverse events from catheter-related problems with delivery of the chemotherapeutic agent at the end of surgery. In addition, hyperthermia increases the penetration of chemotherapy at the peritoneal surface and chemo-sensitivity. In this trial, we aim to evaluate the efficacy and safety of HIPEC procedures performed after interval debulking surgery in patients with advanced ovarian cancer. | ArmGroups: [{'label': 'NAC-IDS-HIPEC', 'type': 'EXPERIMENTAL', 'description': "Under the clinicians' decision, HIPEC procedures will be performed at the time of IDS.", 'interventionNames': ['Procedure: HIPEC']}, {'label': 'NAC-IDS', 'type': 'NO_INTERVENTION', 'description': "Under the clinicians' decision, HIPEC procedures will not be performed at the time of IDS."}] | Interventions:[{'type': 'PROCEDURE', 'name': 'HIPEC', 'description': 'HIPEC(paclitaxel 175mg/m2, 90min; open or closed technique) after IDS . IDS is recommended within 4 weeks after the 3rd NAC cycle. HIPEC procedure is allowed only in case of residual disease less than 5mm.', 'armGroupLabels': ['NAC-IDS-HIPEC']}] | PrimaryOutcomes: [{'measure': 'Progression free survival', 'description': 'From the study enrollment to the disease progression', 'timeFrame': 'up to 5 years'}] | SecondaryOutcomes: [{'measure': 'Response rate', 'description': 'rate of patients with partial or complete response (RECIST criteria version 1.1 ) after primary treatment', 'timeFrame': 'up to 1 years'}, {'measure': 'Overall survival', 'description': 'From study enrollment to the patients death', 'timeFrame': 'up to 5 years'}, {'measure': 'Adverse drug reaction', 'description': 'Incidence of grade 3 or 4 drug adverse reaction (NCI CTCAE version 4.03)', 'timeFrame': 'up to 1 years'}] |
Title: Pamiparib and Low Dose Temozolomide In Patients With Platinum Sensitive Biliary Tract Cancer | Condition: Platinum-Sensitive Biliary Tract Cancer | Keywords: Pamiparib, Biliary Tract Cancer, Temozolomide | Summary: | Description: N/A | ArmGroups: [{'label': 'CisGem/GemOx', 'type': 'ACTIVE_COMPARATOR', 'description': 'Cisplatin/Gemcitabine (3-week cycle):\n\n* Cisplatin IV 25 mg/m² d1 and day8\n* Gemcitabine 1000 mg/m² d1 and d8\n\nThis treatment regimen will be given until documented disease progression, unacceptable toxicity, or patient refusal, for a maximum of 2 years.\n\nIn case of unacceptable toxicity the CisGem regimen can also be switched to a GemOx regimen (4-week cycle):\n\n* Oxaliplatin IV 100 mg/m² d1 and day15\n* Gemcitabine 1000 mg/m² d1 and d15', 'interventionNames': ['Drug: Cisplatin', 'Drug: Gemcitabine', 'Drug: Oxaliplatin']}, {'label': 'PamTMZ', 'type': 'EXPERIMENTAL', 'description': 'Pamiparib + temozolomide (4-week cycle):\n\nPamiparib 60 mg PO twice a day d1-d28 Temozolomide 60 mg PO daily d1-d7\n\nThis treatment regimen will be given until documented disease progression, unacceptable toxicity, or patient refusal, for a maximum of 2 years.', 'interventionNames': ['Drug: Pamiparib', 'Drug: Temozolomide']}] | Interventions:[{'type': 'DRUG', 'name': 'Cisplatin', 'description': 'Cisplatin IV 25 mg/m² on d1 and d8 - always combined with Gemcitabine; maximum treatment 2 years', 'armGroupLabels': ['CisGem/GemOx']}, {'type': 'DRUG', 'name': 'Gemcitabine', 'description': 'Gemcitabine IV 1000 mg/m² on d1 and d8 if in combination with Cisplatin; Gemcitabine IV 1000 mg/m² on d1 and d15 if in combination with Oxaliplatin; maximum treatment 2 years', 'armGroupLabels': ['CisGem/GemOx']}, {'type': 'DRUG', 'name': 'Oxaliplatin', 'description': 'Oxaliplatin IV 100 mg/m² on d1 and d15 - always combined with Gemcitabine; maximum treatment 2 years', 'armGroupLabels': ['CisGem/GemOx']}, {'type': 'DRUG', 'name': 'Pamiparib', 'description': 'Pamiparib 60 mg PO twice a day from d1 to day28 in a 4-week cycle - always combined with Temozolomide; until progression or maximum treatment 2 years', 'armGroupLabels': ['PamTMZ']}, {'type': 'DRUG', 'name': 'Temozolomide', 'description': 'Temozolomide 60 mg PO once a day from d1 to d7 in a 4-week cycle - always combined with Pamiparib; until progression or maximum treatment 2 years', 'armGroupLabels': ['PamTMZ']}] | PrimaryOutcomes: [{'measure': 'Progression-free survival (PFS)', 'description': 'Progression-free survival according to RECIST v1.1 from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months', 'timeFrame': '36 months from randomization'}] | SecondaryOutcomes: [{'measure': 'Incidence of adverse events (safety and toxicity)', 'description': 'Assessment of adverse events according to CTCAE v5.0 - From date of randomization until the date of end of treatment visit or date of death from any cause, whichever came first, assessed up to 25 months', 'timeFrame': '25 months from randomization'}, {'measure': 'PFS as per central review', 'description': 'PFS as per central review assessment from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months', 'timeFrame': '36 months from randomization'}, {'measure': 'overall survival (OS)', 'description': 'Overall survival from date of randomization until the date of end of treatment visit or date of death from any cause, whichever came first, assessed up to 36 months', 'timeFrame': '36 months from randomization'}, {'measure': 'Best overall response', 'description': 'Best overall response according to RECIST v1.1 from date of randomization until the date of end of treatment visit or date of death from any cause, whichever came first, assessed up to 36 months', 'timeFrame': '36 months from randomization'}, {'measure': 'Global Health Status/Quality of Life/physical functioning', 'description': 'Global Health Status/Quality of Life/physical functioning assessed with EORTC QLQ-30 questionnaire from date of randomization until 6 months thereafter or until date of death from any cause, whichever came first.\n\nThis instrument is composed of multi-item and single-item scales. These include five functional scales (physical, role, emotional, social, and cognitive), three symptom (fatigue, nausea and vomiting and pain) and a global health status/QoL scale and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties).\n\nThe scales range from 0 to 100 with the worst score being 0 for functioning scales and 100 for symptom scales.', 'timeFrame': '6 months from randomization'}, {'measure': 'Jaundice scale', 'description': 'Jaundice scale assessed with EORTC QLQ-BIL21 questionnaire from date of randomization until 6 months thereafter or until date of death from any cause, whichever came first.\n\nThe Cholangiocarcinoma and Gallbladder Cancer Module (QLQ-BIL21) is a supplementary questionnaire module to be employed in conjunction with the QLQ-C30. The QLQ-BIL21 incorporates five multi-item scales to assess eating, jaundice, tiredness, pain and anxiety. In addition, three single items assess treatment side-effects, drainage bags/tubes and weight loss.\n\nThe scales range from 0 to 100.', 'timeFrame': '6 months from randomization'}] |
Title: Pilot Study of Non-Myeloablative, HLA-Matched Allogeneic Stem Cell Transplantation for Pediatric Hematopoietic Malignancies | Condition: Hodgkin Lymphoma, Lymphocytic Leukemia, Mixed Cell Leukemia, Myelodysplastic Syndrome, Non Hodgkin's Lymphoma, CML, ALL, AML, Lymphoma | Keywords: Leukemia, Myelodysplastic Syndrome, Bone Marrow Transplant, Pediatric Oncology, Lymphoma, Efficacy, Safety, Childhood Cancer | Summary: | Description: Background:
* Allogeneic blood and marrow stem cell transplantation (BMT) plays an important role in the curative treatment of a number of pediatric malignancies. Unfortunately, the success of conventional allogeneic BMT is limited in part by the multiple toxicities associated with myeloablative preparative regimens.
* Non-myeloablative pre-transplant regimens are associated with less toxic side effects than standard BMT. Recently, a novel immunosuppressive, non-myeloablative pre-transplant chemotherapy regimen has been shown to facilitate complete donor engraftment in an adult trial at the NCI.
Objectives:
The primary objective of this protocol is to evaluate the efficacy and safety of this treatment approach in pediatric patients with hematopoietic malignancies
Eligibility:
Inclusion Criteria
Age: Patient must be greater than or equal to 5 years and less than 22 years of age.
Diagnosis:
* Hodgkin s and Non-Hodgkin s Lymphoma: Refractory disease or relapse after salvage regimen.
* Acute Myelogenous Leukemia: History of bone marrow relapse in remission (CR) #2 or greater.
* Acute Lymphocytic Leukemia: History of bone marrow relapse in CR #2 or greater (CR#1 with Philadelphia chromosome positive or prior induction failure).
* Acute Hybrid Leukemia including mixed lineage, biphenotypic and undifferentiated: History of bone marrow relapse in CR #2 or greater (CR#1 with Philadelphia chromosome positive or prior induction failure).
* Myelodysplastic Syndrome: RAEB or RAEB-t with less than 10% blasts in marrow and blood.
* Chronic Myelogenous Leukemia: Chronic phase or accelerated phase with less than 10% blasts in marrow and blood.
* Juvenile Myelomonocytic Leukemia: less than 10% blasts in marrow and blood.
Prior Therapy: Chemotherapy to achieve above criteria allowed. Prior BMT allowed as long as at least day 100+ post-prior BMT, no evidence of GVHD, and no detectable residual donor chimerism.
Donor: First degree related donors, who are HLA matched (single HLA-A or B locus mismatch allowed), weight greater than or equal to 15 kilograms, and who meet standard donation criteria will be considered. The same donor from a prior BMT is allowed.
ECOG Performance Status: 0, 1, or 2. and life expectancy: greater than 3 months.
Liver Function: Serum direct bilirubin less than 2.0 mg/dL and serum ALT and AST values less than or equal to 2.5x upper limit of normal. (Values above these levels may be accepted if due to malignancy.)
Renal Function: Age adjusted normal serum creatinine or Cr clearance greater than or equal to 60 mL/min/1.73 m(2).
Pulmonary Function: DLCO greater than or equal to 50%.
Cardiac Function: LVEF greater than or equal to 45% by MUGA or LVSF greater than or equal to 28% by ECHO
Exclusion Criteria
* Active CNS malignancy: Tumor mass on CT or leptomeningeal disease. (Patients with a history of CNS involvement and no current evidence of CNS disease are allowed.)
* HIV infection, active hepatitis B or C infection: HbSAg or HCV seropositive and elevated liver transaminases.
* Fanconi Anemia.
* Lactating or pregnant females.
Design:
Pilot Study
* Initial evaluation: Patient and donor will be screened for eligibility. G-CSF primed bone marrow derived stem cells will be collected from the donor.
* Induction/Consolidation chemotherapy: 1 to 3 cycles will be given every 22 days depending on disease response, CD4 count, and toxicities.
* Lymphoma: fludarabine, etoposide, doxorubicin, vincristine, cyclophohamide, prednisone, and filgrastim (EPOCH-fludarabine).
* Leukemia and MDS: Fludarabine, cytarabine, and filgrastim (FLAG).
* Transplantation: Fludarabine and cyclophosphamide will be administered over 4 days followed by bone marrow transplant. Patients will remain hospitalized until bone marrow recovery. Patients will be monitored closely at the NIH for at least 100 days post-BMT.
* Post-transplant CNS prophylaxis for ALL: Standard post-transplant CNS prophylaxis will be employed with intrathecal methotrexate to decrease the risk of CNS relapse for all patients with ALL.
* Total number of recipient and donors to be accrued is 56. | ArmGroups: [{'label': '1', 'type': 'EXPERIMENTAL', 'description': 'Transplant with Induction Therapy', 'interventionNames': ['Procedure: Stem cell transplantation']}] | Interventions:[{'type': 'PROCEDURE', 'name': 'Stem cell transplantation', 'description': '\\>3 x 106/kg CD34+ stem cells by IV infusion', 'armGroupLabels': ['1']}] | PrimaryOutcomes: [{'measure': 'To determine the efficacy and safety of this chemotherapy regimen in facilitating donor engraftment after allogeneic bone marrow transplantation (BMT).'}, {'measure': 'Safety/Efficacy', 'timeFrame': '5 years'}] | SecondaryOutcomes: [{'measure': 'Toxicity of regimen', 'timeFrame': '5 years'}, {'measure': 'To determine the toxicity of this non-myelablative allogeneic BMT regimen.'}, {'measure': 'fludarabine-based induction reducing T-cells', 'timeFrame': '5 years'}, {'measure': 'immune suppression', 'timeFrame': '5 years'}, {'measure': 'IL-7 levels', 'timeFrame': '5 years'}, {'measure': 'cytokine profiles', 'timeFrame': '5 years'}, {'measure': 'response rates and DFS', 'timeFrame': '5 years'}, {'measure': 'incidence and severity of GVHD', 'timeFrame': '5 years'}, {'measure': 'response rates, DFS rates, and incidence and severity ofGVHD following withdrawal of immunosuppression and donorlymphocyte infusions (DLI) for patients who developprogressive disease after day +28 post-transplant', 'timeFrame': '5 years'}] |
Title: A Phase I Open Label Trial of Continuous Dosing With BIBW 2992 Combined With Paclitaxel and BIBW 2992 Combined With Paclitaxel and Bevacizumab, BIBW 2992 Combined With Carboplatin and BIBW 2992 Combined With Paclitaxel and Carboplatin in Patients With Advanced Solid Tumours | Condition: Neoplasms | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'Part A', 'type': 'EXPERIMENTAL', 'description': 'BIBW2992 + Paclitaxel', 'interventionNames': ['Drug: BIBW 2992', 'Drug: Paclitaxel']}, {'label': 'Part B', 'type': 'EXPERIMENTAL', 'description': 'BIBW2992 + Paclitaxel + Bevacizumab', 'interventionNames': ['Drug: Paclitaxel', 'Drug: BIBW2992', 'Drug: Bevacizumab']}, {'label': 'Part C', 'type': 'EXPERIMENTAL', 'description': 'BIBW2992 + Carboplatin', 'interventionNames': ['Drug: Carboplatin', 'Drug: BIBW 2992']}, {'label': 'Part D', 'type': 'EXPERIMENTAL', 'description': 'BIBW2992 +Paclitaxel + Carboplatin', 'interventionNames': ['Drug: Carboplatin', 'Drug: Paclitaxel', 'Drug: BIBW 2992']}] | Interventions:[{'type': 'DRUG', 'name': 'Paclitaxel', 'description': 'Part A and B:80mg/m2 given on Day 1, 8 and 15 of 28 Day cycle.', 'armGroupLabels': ['Part B']}, {'type': 'DRUG', 'name': 'Carboplatin', 'description': 'AUC6 given on day 1 of 21 day cycle', 'armGroupLabels': ['Part D']}, {'type': 'DRUG', 'name': 'BIBW 2992', 'description': 'Escalating dose cohorts', 'armGroupLabels': ['Part A']}, {'type': 'DRUG', 'name': 'Paclitaxel', 'description': 'Part A and B:80mg/m2 given on Day 1, 8 and 15 of 28 Day cycle.', 'armGroupLabels': ['Part A']}, {'type': 'DRUG', 'name': 'BIBW2992', 'description': 'MTD dose of part A', 'armGroupLabels': ['Part B']}, {'type': 'DRUG', 'name': 'Paclitaxel', 'description': '175mg/m2 given on Day 1 of 21 Day cycle', 'armGroupLabels': ['Part D']}, {'type': 'DRUG', 'name': 'Carboplatin', 'description': 'AUC6 given on day 1 of 21 day cycle', 'armGroupLabels': ['Part C']}, {'type': 'DRUG', 'name': 'Bevacizumab', 'description': 'Escalating dose Cohorts - 5mg / kg, 7.5mg / kg and 10mg / kg given Day 1 and Day 15 of a 28 days cycle', 'armGroupLabels': ['Part B']}, {'type': 'DRUG', 'name': 'BIBW 2992', 'description': 'Escalating dose cohorts', 'armGroupLabels': ['Part D']}, {'type': 'DRUG', 'name': 'BIBW 2992', 'description': 'Escalating dose cohorts', 'armGroupLabels': ['Part C']}] | PrimaryOutcomes: [{'measure': 'Number of Participants With Dose Limiting Toxicities (DLTs) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD)', 'description': 'Dose limiting toxicity (DLT) was defined as an Adverse Event (AE) or laboratory abnormality considered as related to study treatment.', 'timeFrame': 'Cycle 1: 21 days (part C and D) or 28 days (part A and B)'}, {'measure': 'Maximum Tolerated Dose (MTD)', 'description': 'The MTD of afatinib in selected combination treatments was defined as the highest dose at which no more than 1 out of 6 patients experienced DLTs during the first treatment cycle, i.e. the highest dose with a DLT incidence ≤17%. The MTD was determined separately for Afatinib in combination with Paclitaxel (part A), Afatinib in combination with Paclitaxel and Bevacizumab (part B), Afatinib and Carboplatin (part C), and Afatinib in combination with Paclitaxel and Carboplatin (part D).\n\nIn part C, dose escalation was not continued beyond the dose level A40C6, due to safety and pharmacokinetic considerations and upon mutual agreement between the investigators and the sponsor. Formally, no MTD was determined, however a recommended phase II dose was determined and is presented here.\n\n0=not maximum tolerated dose, 1=is maximum tolerated dose\n\nNote, the depicted order of treatment groups is driven by dose level, not by the actual dosing steps.', 'timeFrame': 'Cycle 1: 21 days (part C and D) or 28 days (part A and B)'}] | SecondaryOutcomes: [{'measure': 'Incidence and Intensity of AEs According to the Maximum Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Grade', 'description': 'Incidence and Intensity of AEs (Adverse Events) graded according to the maximum CTCAE (Common Toxicity Criteria for Adverse Events) grade based on the number of patients with AEs with CTCAE Grade 1-5.', 'timeFrame': 'From first drug administration until the end of treatment cycle 1; 21 days (part C and D) or 28 days (part A and B)'}, {'measure': 'Part A: AUCt,ss: Area Under the Concentration-Time Curve of Afatinib in Plasma at Steady State on Day 15', 'description': 'Area under the concentration-time curve of Afatinib in plasma at steady state.', 'timeFrame': 'Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 and 24:00.'}, {'measure': 'Part A: Afatinib Cmax,ss on Day 15', 'description': 'Maximum measured concentration of Afatinib in plasma at steady state.', 'timeFrame': 'Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 and 24:00.'}, {'measure': 'Part A: AUC0-24: Area Under the Concentration-Time Curve of Paclitaxel in Plasma Over the Time Interval From Zero Extrapolated to 24 Hours on Day 1 and Day 15', 'description': 'AUC0-24: Area under the concentration-time curve of Paclitaxel in plasma over the time interval from zero extrapolated to 24 hours.', 'timeFrame': 'Day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00. Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00.'}, {'measure': 'Part A: Paclitaxel Cmax on Day 1 and Day 15', 'description': 'Maximum measured concentration of Paclitaxel in plasma.', 'timeFrame': 'Day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00. Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00.'}, {'measure': 'Part B: AUCt,ss: Area Under the Concentration-Time Curve of Afatinib in Plasma at Steady State on Day 15', 'description': 'Area under the concentration-time curve of Afatinib in plasma at steady state.', 'timeFrame': 'Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00. There were no analyzable patients for Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab.'}, {'measure': 'Part B: Afatinib Cmax,ss on Day 15', 'description': 'Maximum measured concentration of Afatinib in plasma at steady state.', 'timeFrame': 'Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 and 24:00.'}, {'measure': 'Part B: Area Under the Concentration-Time Curve of Paclitaxel in Plasma Over the Time Interval From 0 Extrapolated Upto 24 Hours on Day 1 and Day 15', 'description': 'AUC0-24: Area under the concentration-time curve of Paclitaxel in plasma over the time interval from zero extrapolated to 24 hours.', 'timeFrame': 'Day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00. Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00.'}, {'measure': 'Part B: Paclitaxel Cmax on Day 1 and Day 15', 'description': 'Maximum measured concentration of Paclitaxel in plasma.', 'timeFrame': 'Day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00. Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00.'}, {'measure': 'Part B: Bevacizumab Plasma Concentration', 'description': 'Bevacizumab plasma concentration after infusion of Bevacizumab 5mg/kg after end of 1st and 2nd infusion in Cycle 1.', 'timeFrame': 'Day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00. Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00.'}, {'measure': 'Part C: AUCt,ss: Area Under the Concentration-Time Curve of Afatinib in Plasma at Steady State in Cycle 2', 'description': 'AUCt,ss: Area under the concentration-time curve of Afatinib in plasma at steady state.', 'timeFrame': 'Cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00 and 24:00.'}, {'measure': 'Part C: Afatinib Cmax,ss in Cycle 2', 'description': 'Maximum measured concentration of Afatinib in plasma at steady state.', 'timeFrame': 'Cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00 and 24:00.'}, {'measure': 'Part C: Area Under the Concentration-Time Curve of Carboplatin in Plasma Over the Time Interval From 0 Extrapolated Upto 24 Hours in Cycle 1 and Cycle 2', 'description': 'AUC0-24: Area under the concentration-time curve of Carboplatin in plasma over the time interval from zero extrapolated to 24 hours.', 'timeFrame': 'Cycle 1, day 1 and cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 24:00.'}, {'measure': 'Part C: Carboplatin Cmax in Cycle 1 and Cycle 2', 'description': 'Maximum measured concentration of Carboplatin in plasma.', 'timeFrame': 'Cycle 1, day 1 and cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 24:00'}, {'measure': 'Part D: AUCt,ss: Area Under the Concentration-Time Curve of Afatinib in Plasma at Steady State.', 'description': 'AUCt,ss: Area under the concentration-time curve of Afatinib at steady state.', 'timeFrame': 'Cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00 and 24:00.'}, {'measure': 'Part D: Afatinib Cmax,ss', 'description': 'Maximum measured concentration of Afatinib in plasma at steady state.', 'timeFrame': 'Cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00 and 24:00.'}, {'measure': 'Part D: Area Under the Concentration-Time Curve of Paclitaxel in Plasma Over the Time Interval From 0 Extrapolated Upto 23 Hours in Cycle 1 and Cycle 2', 'description': 'AUC0-23: Area under the concentration-time curve of Paclitaxel in plasma over the time interval from zero extrapolated to 23 hours.', 'timeFrame': 'Cycle 1, day 1 and cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00 and 23:00.'}, {'measure': 'Part D: Paclitaxel Cmax in Cycle 1 and 2', 'description': 'Maximum measured concentration of Paclitaxel in plasma.', 'timeFrame': 'Cycle 1, day 1 and cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00 and 24:00'}, {'measure': 'Part D: Area Under the Concentration-Time Curve of Carboplatin in Plasma Over the Time Interval From 0 Extrapolated Upto 24 Hours in Cycle 1 and Cycle 2', 'description': 'AUC0-24: Area under the concentration-time curve of Carboplatin in plasma over the time interval from zero extrapolated to 24 hours.', 'timeFrame': 'Cycle 1, day 1 and cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00 and 24:00'}, {'measure': 'Part D: Carboplatin Cmax in Cycle 1 and 2', 'description': 'Maximum measured concentration of Carboplatin in plasma.', 'timeFrame': 'Cycle 1, day 1 and cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00 and 24:00.'}, {'measure': 'Objective Tumour Response (Unconfirmed)', 'description': 'Number of subjects with objective tumour response (unconfirmed).\n\nObjective Response (OR) was defined as Complete Response (CR) or Partial Response (PR).', 'timeFrame': 'From first drug administration until the last trial drug administration, up to 1156 days.'}, {'measure': 'Objective Tumour Response (Confirmed)', 'description': 'Number of subjects with confirmed objective tumour response.\n\nObjective Response (OR) was defined as Complete Response (CR) or Partial Response (PR). Objective response was to be confirmed by a second tumour assessment at least 4 weeks after the assessment of CR or PR.', 'timeFrame': 'From first drug administration until the last trial drug administration, up to 1156 days.'}] |
Title: Phase I, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of Icotinib Combined With Gemcitabine as First-line Treatment in Locally Advanced, Unresectable or Metastatic Pancreatic Cancer | Condition: Pancreatic Cancer | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'icotinib plus gemcitabine', 'type': 'EXPERIMENTAL', 'description': 'Three dose of icotinib are designed to be evaluated, 125 mg three times per day, 250 mg three times per day, and 375 mg three times per day. Dose escalations are based on predefined dose escalation decision rules. The Maximum Administered Dose (MAD) was reached at the dose level when at least 30% patients developed a dose limited toxicity.\n\nGemcitabine: 1000 mg/m2 on Days 1, 8, and 15 of a 28 day cycle by IV administration every 4 weeks.', 'interventionNames': ['Drug: icotinib', 'Drug: Gemcitabine']}] | Interventions:[{'type': 'DRUG', 'name': 'icotinib', 'description': 'Three dose levels of icotinib are designed to be evaluated, 125 mg three times per day, 250 mg three times per day, and 375 mg three times per day. Dose escalations are based on predefined dose escalation decision rules. The Maximum Administered Dose (MAD) was reached at the dose level when at least 30% patients developed a dose limited toxicity.', 'armGroupLabels': ['icotinib plus gemcitabine'], 'otherNames': ['Commana']}, {'type': 'DRUG', 'name': 'Gemcitabine', 'description': 'Gemcitabine: 1000 mg/m2 on Days 1, 8, and 15 of a 28 day cycle by IV administration every 4 weeks.', 'armGroupLabels': ['icotinib plus gemcitabine'], 'otherNames': ['Gemzar']}] | PrimaryOutcomes: [{'measure': 'The number of patients who suffer adverse events', 'timeFrame': '24 months'}] | SecondaryOutcomes: [{'measure': 'Tumor response assessed by RECIST 1.1', 'timeFrame': '3 months'}, {'measure': 'Progression-free survival', 'timeFrame': '4 months'}] |
Title: Functional Recovery and Oncologic Efficacy of Robotic Versus Laparoscopy NOSE for Patients With Stage I III Left Sided Colon Cancer: A Randomized Controlled Trial | Condition: Colorectal Cancer | Keywords: Colorectal cancer, Natural orifice specimen extraction, Laparoscopic surgery, Robotic surgery | Summary: | Description: Over the past three decades, laparoscopic surgery has evolved incessantly, especially in the field of colorectal surgery. It has been widely accepted by surgeons and patients in light of the better peri-operative outcomes and analogical long-term effectiveness, compared with open surgery for colorectal cancers. However, current conventional laparoscopic colorectal surgery requires an additional abdominal incision for specimen retrieval and sometimes for intestinal reconstruction, which increases the risk of various postoperative complications, including pain, surgical site infection, incisional hernia, and injury to the epigastric artery and abdominal cutaneous nerves, and, consequently, can delay postoperative chemotherapy.
To mitigate these unfavorable outcomes, natural orifice specimen extraction (NOSE) via the anus, stomach, or vagina, was introduced. One randomized trial reported better short-term surgical outcomes, including reduced pain and lower analgesia requirements for laparoscopic NOSE colectomy, compared with conventional laparoscopic colectomy. Transanal specimen extraction has been utilized after laparoscopic colon or rectal cancer surgery and has been found to be feasible, safe, and oncologically sound in selected cases. Several multiport laparoscopic platforms are currently available to complete all NOSE procedures and reestablish intestinal continuity with a single stapled anastomosis, which has been shown to improve short-term results compared with conventional laparoscopic colectomy. However, concerns remain regarding the long-term oncologic safety (tumor cell spillage with local recurrence and long-term survival) when NOSE is used for colorectal malignancy.
A barrier to wider adoption of NOSE is technical difficulty. The mini-laparotomy, in some cases, is used to perform a majority of the operation, as in hand-assisted laparoscopy. Adoption of NOSE by surgeons who typically perform colectomies in this fashion would be faced with a steeper learning curve than surgeons who use the mini-laparotomy solely as a specimen extraction site. On that note, intracorporeal anastomosis is a prerequisite skill for those adopting NOSE. Removal of more proximal specimens, as in a right colectomy, requires the presence of a skilled endoscopist who can snare and pull the specimen endoluminally through the length of the distal gastrointestinal tract. Specimen extraction via the vagina requires a posterior colpotomy, an operative maneuver that is not typically performed by general or colorectal surgeons. Furthermore, these technical challenges are amplified by a lack of standardization of the technique.
The demands for these technical skills are more important in removing right-sided colon pathology, as compared to left-sided pathology. There are inherent anatomic factors that make NOSE for right-sided colon pathology more difficult. Right colectomy specimens extracted through the lower gastrointestinal tract via distal colotomy must travel the length of the remaining transverse, descending, and sigmoid colon, through the rectum and out of the anus using an endoscope. While this was demonstrated to be feasible in 2010 by Eshuis et al, it is inherently difficult due to the anatomically narrow and torturous sigmoid colon. In that series, extraction via colotomy failed in 2 of 10 patients due to the bulk of the specimen. This technique is still performed in some centers, though limitations related to the size of the specimen are stricter than for left-sided colon lesions. This approach has little practicality due to its significant technical challenges, hence its limited use.
Bacterial contamination is always a concern during the NOSE procedure. Most researchers strongly suggest that mechanical bowel preparation, intraoperative transanal lavage with povidone iodine solution, transluminal wound protector, and prophylactic antibiotics are applied to reduce the bacterial load. Recently, a study showed that the risk of bacterial contamination with NOSE was not significantly higher than that in conventional laparoscopic surgery. In some studies, patients who had NOSE did not experience significant postoperative morbidity or laboratory data changes, such as leukocytosis, CRP level elevation, rectal wound-related complications or leakage, than the conventional group.
Tumor size is considered before applying the NOSE procedure. Many authors limit indications to tumors smaller than 3 - 6.5 cm. Some authors have stated that obese patients are not suitable for transrectal specimen extraction and set the BMI cutoff at \> 28-35 kg/m2. Most researchers considered patients with a bulky mesocolon, a narrow pelvis, and previous pelvic surgery with severe adhesions were not eligible for NOSE.
It is generally accepted that laparoscopic NOSE can achieve oncological and surgical safety comparable to that of conventional laparoscopic surgery for patients with sigmoid and rectal cancer. Remarkably, Laparoscopic NOSE patients were associated with a shorter hospital stay, shorter time to first flatus or defecation, less postoperative pain, and fewer surgical site infections and total perioperative complications. In general, the operative time in laparoscopic NOSE was longer than that in conventional laparoscopic surgery. The long-term oncological efficacy of laparoscopic NOSE seems to be equivalent to that of conventional laparoscopic surgery. Furthermore, specimen retrieval through alternative routes to avoid an abdominal incision is beneficial for the prevention of incisional hernia.
Currently, robotic surgical approaches are becoming more popular for treating colorectal cancer. Robotic techniques can overcome some technical limitations of laparoscopic surgery, including an unstable camera view and straight laparoscopic instruments. Robotic surgery is advantageous because it provides surgeon-control of the camera, high-definition three-dimensional vision, excellent ergonomics, decreased physiological tremor, more freedom of angles of instruments, and the ability to simultaneously control the camera and two additional instruments that facilitate traction and countertraction, all of which enable to facilitate the procedures, even in difficult settings.
The unique advantages of the surgical robot make colorectal surgery operations more precise and intelligent, providing more options for minimizing operative stress during colorectal surgery. The proximity between the sigmoid colon and rectum to the anal location provides a favorable predisposition for transanal specimen retrieval without significantly increasing the difficulty of the surgical operation. However, to date, only very few studies compared robotic NOSE versus laparoscopic NOSE for the surgery of colorectal cancer. Actually, our preliminary data has shown the safety and feasibility of robotic NOSE, as compared with laparoscopic NOSE for the surgery of colorectal cancer.
Even to date, laparoscopic NOSE procedure for colorectal cancer is still not popular due to the technique difficulty associated with an intra-corporeal anastomosis for NOSE and the oncologic concern of tumor spillage at the staple line during tumor retrieval process. In this respect, the introduction of robotic system can overcome the technical difficulties.
In this project, the investigator aims to provide the level 1 evidence for the comparison of robotic versus laparoscopic NOSE for the surgery of stage I-III colorectal cancer. the investigator hypothesize that, with the increased maneuverability of the current robotic system, robotic surgery will be a good option for patients with stage I-III colorectal cancer requiring a NOSE procedure. | ArmGroups: [{'label': 'Laparoscopic surgery', 'type': 'EXPERIMENTAL', 'description': 'The patients in this group will undergo laparoscopic surgery.', 'interventionNames': ['Procedure: Colectomy with NOSE procedure']}, {'label': 'Robotic surgery', 'type': 'ACTIVE_COMPARATOR', 'description': 'The patients in this group will undergo robotic surgery.', 'interventionNames': ['Procedure: Colectomy with NOSE procedure']}] | Interventions:[{'type': 'PROCEDURE', 'name': 'Colectomy with NOSE procedure', 'description': 'The specimen will be extract from the anus.', 'armGroupLabels': ['Laparoscopic surgery', 'Robotic surgery']}] | PrimaryOutcomes: [{'measure': 'The surgical efficiency of both NOSE procedures', 'description': 'The operation time defined as the incision of wound and application of the surgical dressing', 'timeFrame': 'Intraoperative hours with an average of 5 hours'}] | SecondaryOutcomes: [{'measure': 'Overall disease-free survival', 'description': 'The duration between surgery and death', 'timeFrame': '5 years'}, {'measure': 'Overall recurrence-free survival', 'description': 'The duration between surgery and recurrence', 'timeFrame': '5 years'}, {'measure': 'Incontinence', 'description': 'Evaluated by questionnaire', 'timeFrame': '6 months'}, {'measure': 'Time to return work', 'description': 'Disability', 'timeFrame': '1 year'}, {'measure': 'Total fee and equipment fee', 'description': 'Total Cost', 'timeFrame': '3 months'}, {'measure': 'Blood loss', 'description': 'measured by the amount Mof blood in suction bottle and the number of blood soaked gauzes', 'timeFrame': 'Intraoperative hours with an average of 5 years'}, {'measure': 'Conversion rate', 'description': 'Conversion from robotic surgery to laparoscopic surgery or open surgery', 'timeFrame': 'Intraoperative hours with an average of 5 years'}, {'measure': 'Complications', 'description': 'Any complication during or after surgery grading by Calvien -Dindo classification', 'timeFrame': '30 days'}, {'measure': 'Wound size', 'description': 'Total length of the wounds', 'timeFrame': 'Intraoperative hours with an average of 5 years'}, {'measure': 'Serum C reactive protein (CRP)', 'description': 'CRP could be an indicator of the severity of surgical stress.', 'timeFrame': 'Throughout the admission with an average of 7 days'}, {'measure': 'Erythrocyte sedimentation rate (ESR)', 'description': 'ESR could be an indicator of the severity of surgical stress.', 'timeFrame': 'Throughout the admission with an average of 7 days'}, {'measure': 'Blood lymphocyte counts', 'description': 'Blood lymphocyte counts could be an indicator of the severity of surgical stress.', 'timeFrame': 'Throughout the admission with an average of 7 days'}, {'measure': 'CD4+ to CD8+ ratio', 'description': 'CD4 to CD8 ratio could be an indicator of the severity of surgical stress.', 'timeFrame': 'ESR could be an indicator of the severity of surgical stress.'}] |
Title: A Phase 2 Open-label Study of Zelavespib (PU-H71) in Subjects With Accelerated Phase Myeloproliferative Neoplasm (AP MPN) or Blast Phase Myeloproliferative Neoplasm | Condition: Accelerated Phase MPN, Blast Phase MPN | Keywords: myeloproliferative neoplasm | Summary: | Description: Oral zelavespib 1501050 mg will be administered once daily (QD), in the morning ≥ 1 hour before eating breakfast, for each day of a 21-day cycle, for 6 cycles. Subjects who derive clinical benefit may continue treatment until disease progression, unacceptable toxicity, death, or study termination.
In Stage 1, up to 2317 subjects will be enrolled and will complete 6 cycles of treatment. If fewer than 2 subjects achieve \<CR?/PR?/CBR?/PBR?\> in Stage 1, the trial will be stopped for futility. If 2 or more subjects achieve \<CR?/PR?/CBR?/PBR?\>a response , an additional 33 subjects will be enrolled, enrollment will begin in Stage 2 for a total of 56 subjects. . If fewer than 2 subjects achieve a response in Stage 1, the trial will be stopped for futility.
In Cycle 1, subjects will attend 3 clinic visits (Day 1, Day 8, and Day 15) and will be contacted by phone by the site at approximately Day 4 . In subsequent cycles, subjects will attend a clinic visit on Day 1 onlyand will be contacted by phone on Days 8 and 15 so the site staff can inquire about changes in concomitant medications and potential AEs. On days of clinic visits, subjects will arrive at the clinic without eating anything in the morning or taking the study drug. Predose biological samples will be collected for safety laboratory tests and other clinical assessments, and subjects will undergo physical examinations and ECGs. Subjects will receive the study drug at the clinic and at least 1 hour after dosing, breakfast will be provided. On some clinic days, subjects may be required to remain in the clinic for up to 8 hours for additional ECGs and collection of samples for PK testing.
Each subject will participate in the study for approximately 6.5 months , which includes a 28-day screening period, 6 cycles of treatment, and a final follow-up visit 30 days after the final dose of study treatment. | ArmGroups: [{'label': 'Oral zelavespib 100 mg', 'type': 'OTHER', 'description': 'Oral zelavespib 100 mg will be administered once daily', 'interventionNames': ['Drug: zelavespib']}] | Interventions:[{'type': 'DRUG', 'name': 'zelavespib', 'description': 'Oral zelavespib 100 mg will be administered once daily', 'armGroupLabels': ['Oral zelavespib 100 mg']}] | PrimaryOutcomes: [{'measure': 'Determine the MTD and safety of PU-H71 in subjects with AP-MPN and BP-MPN', 'description': 'Assess the safety profile by measuring Incidence and severity of adverse events (AEs), changes in physical examinations, electrocardiograms (ECGs), vital signs, and clinical laboratory evaluations', 'timeFrame': 'up to 6 months'}] | SecondaryOutcomes: N/A |
Title: A Prospective Study Assessing Whether Immunoscore Colon Test Impacts the Choice of Adjuvant Chemotherapy, in a Multidisciplinary Meeting, for Treating Non-metastatic Colon Cancer Patients After Curative-intent Surgery | Condition: Colonic Neoplasms | Keywords: Immunoscore Adjuvant Prospective Colon | Summary: | Description: On previous studies, Immunoscore Colon test identified subgroups of stage II and III colon cancer patients whose Chemotherapy could be adjusted.
The study hypothesis is that Immunoscore Colon Test will modify the therapeutic decision in MM.
With Alpha and Beta at 5% and p0=10% modification rate, the participating investigators need to include 280 participants, 140 in each cohort (stage II and stage III).
Participants will have tumor samples from their curative surgery tested with Immunoscore Colon. When the patients are evaluated in MM, a first therapeutic decision will be taken before disclosing the test result. ICT result will then be communicated and a second decision will be taken. | ArmGroups: [{'label': 'Single arm', 'type': 'OTHER', 'description': 'All participants are included in the same arm. Immunoscore Colon Test is applied on a tumor sample and the result is kept secret. In the Multidisciplinary Meeting evaluating the adjuvant therapy of the participant, a first therapeutic decision is taken, then Immunoscore result will be disclosed and the Multidisciplinary Meeting will take a second decision.', 'interventionNames': ['Diagnostic Test: Immunoscore Colon Test']}] | Interventions:[{'type': 'DIAGNOSTIC_TEST', 'name': 'Immunoscore Colon Test', 'description': 'Immunoscore Colon is a CE-marked in-vitro diagnostic test, allowing the quantification of CD3 and CD8 positive cells in formalin-fixed paraffin-embedded (FFPE) tissue samples of primary colon cancer. The test uses immunohistochemistry, digital pathology techniques and a dedicated software.', 'armGroupLabels': ['Single arm']}] | PrimaryOutcomes: [{'measure': 'Modification rate of adjuvant therapeutic strategy', 'description': 'Modifications of adjuvant therapy, type and/or duration', 'timeFrame': 'At the multidisciplinary meeting, up to 6 weeks after the cancer surgery'}] | SecondaryOutcomes: N/A |
Title: Effects of Aerobic Exercise on Skeletal Muscle Remodeling in Colorectal Cancer | Condition: Colonic Neoplasms, Rectal Neoplasms | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'Attention control', 'type': 'SHAM_COMPARATOR', 'description': 'Static stretching', 'interventionNames': ['Behavioral: Progressive stretching']}, {'label': 'Aerobic exercise', 'type': 'EXPERIMENTAL', 'description': 'Aerobic exercise at a dose of 225 minutes per week', 'interventionNames': ['Behavioral: Aerobic exercise']}] | Interventions:[{'type': 'BEHAVIORAL', 'name': 'Aerobic exercise', 'description': 'Moderate- to vigorous-intensity aerobic exercise', 'armGroupLabels': ['Aerobic exercise']}, {'type': 'BEHAVIORAL', 'name': 'Progressive stretching', 'description': 'Statistic stretching of eight major muscle groups', 'armGroupLabels': ['Attention control']}] | PrimaryOutcomes: [{'measure': 'Whole-Body Intermuscular Adipose Tissue', 'description': 'Mean (kg) whole-body intermuscular adipose tissue quantified using magnetic resonance imaging.', 'timeFrame': 'up to Week 12'}] | SecondaryOutcomes: N/A |
Title: Efficacy and Safety of Erlotinib (Tarceva® ) Therapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) , Subtype Adenocarcinoma, Who Have Good Performance Status (PS 0-1) - ELEMENT | Condition: Non-Squamous Non-Small Cell Lung Cancer | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'Erlotinib 150 mg', 'description': 'Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years.', 'interventionNames': ['Drug: Erlotinib 150 mg']}] | Interventions:[{'type': 'DRUG', 'name': 'Erlotinib 150 mg', 'armGroupLabels': ['Erlotinib 150 mg']}] | PrimaryOutcomes: [{'measure': 'Progression-Free Survival (PFS)', 'description': 'PFS was defined as the time from initial dose of erlotinib to progression or death from any cause.', 'timeFrame': 'Approximately 3 years'}] | SecondaryOutcomes: [{'measure': 'Percentage of Participants With Overall Response', 'description': 'Overall response was defined, based on response evaluation criteria in solid tumours (RECIST) v 1.1, as complete response (CR) plus partial response (PR). CR: complete disappearance of all target lesions; PR: at least 30% decrease in the sum of the longest diameter of all target lesions taking as reference the baseline sum of all target lesions.', 'timeFrame': 'Approximately 3 years'}, {'measure': 'Proportions of Participants With Adverse Events (AEs), Serious AEs, and AEs of Special Interest (AESIs)', 'description': 'An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant, according to national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) criteria version 4.0. An AESI was defined as interstitial pulmonary disease.', 'timeFrame': 'Baseline up to 3 years'}] |
Title: A Phase I Investigation of the Intravenous Administration of AGS-1C4D4 in Patients With Advanced Hormone Refractory Prostate Cancer | Condition: Prostate Cancer | Keywords: HRPC, Advanced hormone refractory prostate cancer | Summary: | Description: Cohorts of 1-6 patients will be administered AGS-1C404 in sequentially rising dose levels. Dose escalation will continue until the MTD of AGS-1C4D4 is established or the maximum planned dose is reached. | ArmGroups: [{'label': '1.AGS-1C4D4', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: AGS-1C4D4']}] | Interventions:[{'type': 'DRUG', 'name': 'AGS-1C4D4', 'description': 'IV', 'armGroupLabels': ['1.AGS-1C4D4']}] | PrimaryOutcomes: [{'measure': 'Safety, tolerability and side effects of AGS-1C4D4 in adult patients with advanced HRPC.', 'timeFrame': '3 Months'}] | SecondaryOutcomes: [{'measure': 'The pharmacokinetic profile of AGS-1C4D4 in adult patients with advanced HRPC.', 'timeFrame': '3 Months'}] |
Title: Overcoming Literacy Barriers in Colorectal Cancer Screening | Condition: Colorectal Cancer, Health Literacy | Keywords: Colorectal cancer, Screening, Health literacy, Patient education, Computer assisted instruction | Summary: | Description: Results will be stratified by low/marginal and adequate literacy as determined by the Rapid Estimate of Adult Literacy in Medicine instrument. | ArmGroups: [{'label': 'Intervention group', 'type': 'EXPERIMENTAL', 'interventionNames': ['Behavioral: CHOICE decision aid']}, {'label': 'Placebo group', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Behavioral: YourMeds patient education program']}] | Interventions:[{'type': 'BEHAVIORAL', 'name': 'CHOICE decision aid', 'description': 'computer-based patient decision aid about colorectal cancer screening delivered immediately before a healthcare provider visit', 'armGroupLabels': ['Intervention group'], 'otherNames': ['CHOICE']}, {'type': 'BEHAVIORAL', 'name': 'YourMeds patient education program', 'description': 'computer-based patient education program about prescription drug safety seen immediately before a healthcare provider visit', 'armGroupLabels': ['Placebo group'], 'otherNames': ['YourMeds']}] | PrimaryOutcomes: [{'measure': 'Receipt of colorectal cancer screening', 'timeFrame': '24 weeks'}] | SecondaryOutcomes: [{'measure': "Change in participants' readiness to be screened (Stage of Change)", 'timeFrame': 'Day 1'}, {'measure': 'Self-reported intent to discuss colorectal cancer screening with healthcare provider', 'timeFrame': 'Day 1'}, {'measure': 'Provider ordering a colorectal cancer screening test', 'timeFrame': 'Day 1'}, {'measure': 'Participant completion of computer program without assistance', 'timeFrame': 'Day 1'}, {'measure': 'Participant acceptance of computer program', 'timeFrame': 'Day 1'}, {'measure': 'Number of polyps and cancers found by screening tests performed', 'timeFrame': '24 weeks'}] |
Title: Phase I Trial of Photodynamic Therapy With HPPH (2-1[Hexyloxyethyl]-2-devinylpyropheophorbide-a) for Treatment of Dysplasia, Carcinoma in Situ and T1 Carcinoma of the Larynx | Condition: Head and Neck Cancer | Keywords: recurrent squamous cell carcinoma of the larynx, stage I squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage 0 laryngeal cancer | Summary: | Description: OBJECTIVES:
Primary
* To determine the maximum tolerated dose of laser light therapy using a fixed dose of HPPH in patients with dysplasia, squamous cell carcinoma in situ, or T1 squamous cell carcinoma of the larynx.
Secondary
* To determine response in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of laser light therapy.
Patients undergo photodynamic therapy comprising HPPH IV over 1 hour on day 1 and laser light therapy to the tumor on day 2. Approximately 8 weeks later, patients with a partial response, no response, or a geographical miss may receive a second course of treatment.
After completion of study treatment, patients are followed at 1 week, 1 month, 3 months, and then periodically thereafter. | ArmGroups: [{'label': 'Treatment PDT', 'type': 'EXPERIMENTAL', 'description': 'Patients undergo PDT comprising HPPH IV over 1 hour on day 1 followed by laser light to the tumor on day 2. At least 6 weeks later, patients achieving partial response, no response, or a geographical miss may undergo a second course of treatment.', 'interventionNames': ['Drug: HPPH', 'Procedure: laser therapy']}] | Interventions:[{'type': 'DRUG', 'name': 'HPPH', 'description': 'Given IV', 'armGroupLabels': ['Treatment PDT']}, {'type': 'PROCEDURE', 'name': 'laser therapy', 'description': 'Escalating light doses with 665 nm light', 'armGroupLabels': ['Treatment PDT']}] | PrimaryOutcomes: [{'measure': 'Toxicity', 'timeFrame': '6 weeks'}, {'measure': 'Tumor response', 'timeFrame': '3 months'}] | SecondaryOutcomes: N/A |
Title: An Exploratory Study to Evaluate the Distribution of [111In]ABY-025 Uptake for SPECT Imaging in Subjects With Metastatic Breast Cancer | Condition: Breast Cancer | Keywords: Breast cancer, Diagnostics, HER2, Imaging, Metastases, SPECT, Imaging of metastases | Summary: | Description: N/A | ArmGroups: N/A | Interventions:[{'type': 'DRUG', 'name': '111-In-ABY-025', 'description': 'Intravenous injection of the agent'}] | PrimaryOutcomes: [{'measure': 'Imaging of metastases', 'description': 'Imaging of breast cancer metastases using 111-In-ABY015 for SPECT', 'timeFrame': 'One year'}] | SecondaryOutcomes: [{'measure': 'Can the new molecule be used for imaging in extended studies', 'timeFrame': 'October 2010 - June 2011'}] |
Title: TRASTUZUMAB BS for Intravenous Infusion 60 mg [Pfizer], TRASTUZUMAB BS for Intravenous Infusion 150 mg [Pfizer] General Investigation (Unresectable Advanced/Recurrent HER2-Overexpressing Gastric Cancer) | Condition: Gastric Cancer | Keywords: Recurrent HER2-Overexpressing Gastric Cancer, TRASTUZUMAB BS | Summary: | Description: N/A | ArmGroups: [{'label': 'TRASTUZUMAB BS', 'description': 'Unresectable Advanced/Recurrent HER2-Overexpressing Gastric Cancer patients injected TRASTUZUMAB BS', 'interventionNames': ['Drug: TRASTUZUMAB BS']}] | Interventions:[{'type': 'DRUG', 'name': 'TRASTUZUMAB BS', 'description': 'Regimen A or regimen B is used for HER2-overexpressing breast cancer.\n\nRegimenB is used for HER2-overexpressing unresectable advanced or recurrent gastric cancer in combination with other anti tumor agent(s).\n\nRegimen A: The recommended dose for trastuzumab (genetical recombination) \\[Trastuzumab Biosimilar 3\\] in adult patients is 4 mg/kg (weight) at initial dose and 2 mg/kg after the second dose, in both of them, by IV drip infusion over 90 minutes once daily every week.\n\nRegimen B: The recommended dose for trastuzumab (genetical recombination) \\[Trastuzumab Biosimilar 3\\] in adult patients is 8 mg/kg (weight) at initial dose and 6 mg/kg after the second dose, in both of them, by IV drip infusion over 90 minutes once daily every 3 weeks.\n\nIf the initial dose is well tolerated, the dosing time after the second dose can be shortened up to 30 minutes.', 'armGroupLabels': ['TRASTUZUMAB BS']}] | PrimaryOutcomes: [{'measure': 'The incidence of adverse drug reactions in this surveillance', 'timeFrame': '24 weeks'}] | SecondaryOutcomes: [{'measure': 'Assessment of tumor response: Assess the tumor response according to RECIST Ver. 1.1.', 'timeFrame': '24 Weeks'}] |
Title: A Clinical Trial Using 3-Dimensional Conformal Radiation Therapy to Reduce the Toxicity of Palliative Radiation for Lung Cancer | Condition: Lung Cancer | Keywords: recurrent non-small cell lung cancer, recurrent small cell lung cancer, extensive stage small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer | Summary: | Description: The primary purpose of this study is to demonstrate that using technically sophisticated 3-dimensional conformal radiation therapy for the palliative treatment of lung cancer patients will result in equivalent degrees of symptom relief and a reduction in the primary endpoint of oesophagitis.
Single arm therapeutic clinical study.
RT Treatment Regimens:
17 Gy/2 fractions or 20Gy/5 fractions or 39Gy/13 fractions
Primary Endpoint:
-The occurrence of Grade 3 or higher oesophagitis in the interval between start and 1-month post completion of treatment as determined by CTCAE Version 4.02
Patients will be assessed pre treatment, during treatment, 2 weeks post completion of treatment, one month post completion of treatment, three months post completion of treatment, and three monthly thereafter
-All patients who complete treatment (and whose on-treatment toxicity is documented) will be evaluable.
Secondary Endpoint:
* Quality of Life Assessment. All patients will be required to complete the EORTC QLQ-C15-PAL (Version 1) and the Lung Specific Module (LC 13)
* The occurrence of other AEs
Safety Endpoint:
-Radio-induced oesophagitis, acute and long term, using the CTCAE Version 4.02. | ArmGroups: [{'label': 'A', 'type': 'EXPERIMENTAL', 'description': 'A clinical trial using 3-dimensional conformal radiation therapy to reduce the toxicity of palliative radiation for lung cancer', 'interventionNames': ['Other: questionnaire administration', 'Procedure: quality-of-life assessment', 'Radiation: 3-dimensional conformal radiation therapy', 'Radiation: palliative radiation therapy', 'Radiation: whole-brain radiation therapy']}] | Interventions:[{'type': 'OTHER', 'name': 'questionnaire administration', 'armGroupLabels': ['A']}, {'type': 'PROCEDURE', 'name': 'quality-of-life assessment', 'armGroupLabels': ['A']}, {'type': 'RADIATION', 'name': '3-dimensional conformal radiation therapy', 'armGroupLabels': ['A']}, {'type': 'RADIATION', 'name': 'palliative radiation therapy', 'armGroupLabels': ['A']}, {'type': 'RADIATION', 'name': 'whole-brain radiation therapy', 'armGroupLabels': ['A']}] | PrimaryOutcomes: [{'measure': 'Occurrence of esophagitis grade 3 or higher according to CTCAE Version 4.02', 'timeFrame': '2015'}, {'measure': 'Quality of life as assessed using the EORTC QLQ-C15-PAL (Version 1) questionnaire and the Lung Specific Module (LC 13)', 'timeFrame': '2015'}] | SecondaryOutcomes: [{'measure': 'Local intra-thoracic symptoms', 'timeFrame': '2015'}] |
Title: A Multi-center, Prospective, Exploratory Study Evaluating the Effectiveness of Treatment Regimens for Metastatic Pancreatic and Gastric Cancer Guided by in Vitro Drug Sensitivity Testing of Tumor Organoids | Condition: Pancreatic Cancer, Gastric Cancer | Keywords: pancreatic cancer, gastric cancer, organoid, drug sensitivity | Summary: | Description: N/A | ArmGroups: [{'label': 'Organoid generation', 'type': 'EXPERIMENTAL', 'description': 'All patients will be included in a single-arm. Participants will undergo biopsy of tumor tissue for subsequent organoid generation', 'interventionNames': ['Procedure: Biopsy of tumor tissue for organoid culture']}] | Interventions:[{'type': 'PROCEDURE', 'name': 'Biopsy of tumor tissue for organoid culture', 'description': 'By collecting fresh tumor tissues (including ascites, pleural effusion, biopsy tissues, palliative surgery specimens, etc.) and culturing them into organoids in vitro, this study conducts drug sensitivity tests on various clinically approved drugs. The most sensitive drug for the patient is selected for treatment, and the study aims to evaluate the clinical effectiveness of the drug and its consistency with in vitro organoid drug sensitivity.', 'armGroupLabels': ['Organoid generation']}] | PrimaryOutcomes: [{'measure': 'PFS (Progressive free survival)', 'description': 'The time from initiation of treatment to the occurrence of disease progression or death.', 'timeFrame': '6 months'}] | SecondaryOutcomes: [{'measure': 'DCR (Disease control rate)', 'description': 'The percentage of patients who have achieved complete response, partial response and stable disease to a therapeutic intervention.', 'timeFrame': '6 months'}] |
Title: A Phase 1, First In Human, Single-arm, Open-label Study Of Once A Day, Orally Administered Talazoparib (Bmn 673) In Patients With Advanced Or Recurrent Solid Tumors | Condition: Advanced or Recurrent Solid Tumors, Breast Neoplasms, Ovarian Cancer, Epithelial, Ewing Sarcoma, Small Cell Lung Carcinoma, Prostate Cancer, Pancreas Cancer | Keywords: BRCA1 Protein, BRCA2 Protein | Summary: | Description: N/A | ArmGroups: [{'label': 'Talazoparib', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Talazoparib']}] | Interventions:[{'type': 'DRUG', 'name': 'Talazoparib', 'description': 'Oral capsule with multiple dosage forms given once daily', 'armGroupLabels': ['Talazoparib'], 'otherNames': ['BMN 673', 'MDV3800']}] | PrimaryOutcomes: [{'measure': 'Number of Participants With Objective Response', 'description': 'Objective response in participants was defined as the number of participants with complete response (CR) or partial response (PR) after treatment with talazoparib and maintained for at least 4 weeks (28 days) as assessed by response evaluation criteria in solid tumors (RECIST) version 1.1. CR defined as disappearance of all non-nodal target lesions (where all target lesions were recorded with a length of 0 millimeter \\[mm\\] on the case report form \\[CRF\\]) and the reduction of the shortest diameter of all nodal lesions to less than \\[\\<\\] 10 mm. PR was defined by a 30% or more decrease in the sum of the longest diameters (SLD) + sum of shortest diameters (SSD) of target lesions, taking as reference the baseline SLD+SSD.', 'timeFrame': 'From Baseline until disease progression or death due to any cause (maximum duration: 1071 days for Part 1; 834 days for Part 2)'}, {'measure': 'Number of Participants With Best Overall Response', 'description': 'Best overall response: best response (in the order of confirmed CR, confirmed PR, stable disease \\[SD\\] and progressive disease \\[PD\\]) among all overall response as RECIST 1.1, recorded from date of first dose of talazoparib until participant withdrew from study/data cut-off date, whichever earlier. CR defined as disappearance of all non-nodal target lesions (where all target lesions recorded with a length of 0 mm on the CRF) and the reduction of the shortest diameter of all nodal lesions to \\< 10 mm. PR defined as at least a 30% decrease in sum of the diameters of target lesions, reference to baseline sum diameters. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD defined as at least a 20% increase in sum of diameters of target lesions, reference to the smallest sum on study (this includes the baseline sum if that was the smallest on study).', 'timeFrame': 'From Baseline until disease progression or death due to any cause (maximum duration: 1071 days for Part 1; 834 days for Part 2)'}, {'measure': 'Progression-Free Survival (PFS)', 'description': 'PFS was defined as the time (in weeks) from the date of first dose of study drug to the earlier date of the documented PD or death due to any cause. PD as per RECIST 1.1 defined as at least a 20% increase in the sum of diameters of target lesions, reference to the smallest sum on study (this includes the baseline sum if that was the smallest on study).', 'timeFrame': 'Baseline, until PD or death due to any cause (maximum duration:1071 days for Part 1; 834 days for Part 2)'}, {'measure': 'Duration of Response', 'description': 'Duration of response was defined as the time (in weeks) from the date of the first documented objective response confirmed at least 28 days later to the date of the first documented PD or date of death, whichever occurred first. PD as per RECIST version 1.1 defined as at least a 20% increase in the sum of diameters of target lesions, reference to the smallest sum on study (this includes the baseline sum if that was the smallest on study).', 'timeFrame': 'Baseline until PD or death due to any cause (maximum duration: 1071 days for Part 1; 834 days for Part 2)'}, {'measure': 'Number of Participants With Stable Disease', 'description': 'SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD defined as at least a 20% increase in sum of diameters of target lesions, reference to the smallest sum on study (this includes the baseline sum if that was the smallest on study).', 'timeFrame': 'Baseline, until PD or death due to any cause (maximum duration: 1071 days for Part 1; 834 days for Part 2)'}, {'measure': 'Part 1: Maximum Tolerated Dose (MTD)', 'description': 'The MTD was defined as the highest dose at which no more than 1 of 6 participants experienced a Dose Limiting Toxicity (DLT). DLT defined as any of the following occurring during cycle 1 of part 1 of study, Hematologic toxicity: Any grade 4 or higher hematologic adverse event, Grade 3 thrombocytopenia associated with grade 2 or higher haemorrhage, Grade 3 thrombocytopenia or neutropenia that led to interruption of dosing for 5 or more days. Nonhematologic toxicity: grade 3 or higher laboratory AE which was asymptomatic and rapidly reversible adverse events (returned to baseline or to grade 1 or lower within 7 days), Grade 3 nausea, vomiting, or diarrhea that could be medically managed to grade 2 or lower with anti-emetics and/or anti-diarrheals within 24 hours, Grade 3 fatigue that improved to grade 2 or lower in 5 days or less, Alopecia. Grades based on National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.', 'timeFrame': 'Cycle 1 (Day 1 up to Day 42)'}, {'measure': 'Part 1: Recommended Part 2 Dose of Talazoparib', 'description': 'The Recommended dose of talazoparib for use in Part 2 was determined in Part 1 (dose escalation) on the basis of the totality of safety, pharmacokinetics (PK), pharmacodynamic and preliminary efficacy data observed in Cycles 1 and 2 and beyond.', 'timeFrame': 'Baseline up to Cycle 50 (each cycle 28 days)'}] | SecondaryOutcomes: N/A |
Title: High Intensity Focused Ultrasound Guided by MRI as Thermic Destruction in Primitive Small Size Breast Cancer. Phase II Pilot Study : Effectiveness and Procedures Standardization | Condition: Breast Cancer | Keywords: | Summary: | Description: Conservative Breast Treatment (BCT) :
The reference treatment for patients with stage T1 breast cancer is a partial mastectomy followed by radiotherapy (breast). This is a conservative treatment (BCT). Indeed, the survival results of this combined treatment are equivalent to those observed after a total mastectomy alone and is an aesthetically and psychologically more acceptable proposition for patients.
Adjuvant radiotherapy is an essential component of the success of conservative therapy most likely due to the impossibility of surgical treatment of removing all microscopically viable cancer cells. Indeed, in the absence of radiotherapy, partial mastectomy shows a local recurrence rate of 20-40% in case of N0 and 25-50% in case of N + on long-term follow-up data.
The results of the literature are very variable according to the length of the follow-up and the population studied but the adjuvant radiotherapy clearly allows to increase the rate of local control.
It reduces local recurrences to 10% at 12 years in the case of radiotherapy in the breast and 6% in case of boost on the tumor area.
The high sensitivity of breast MRI and emerging issues. The development of breast MRI revealed the incidental discovery of 10 to 40% of additional breast cancer in patients initially explored by mammography and ultrasound standards. These cancers discovered at early stages and of small size complicate the strategy of local management and incite to develop techniques alternative to the surgery.
Several minimally invasive treatments for the local treatment of breast cancers are being studied: BLES (Breast Lesion Excision Sample), cryotherapy, radiofrequency, laser and microwaves. Among them, focused ultrasound offers a completely non-invasive heat ablation technique.
High intensity focused ultrasound (FUS) and magnetic resonance imaging (MRI) guidance = FUS-MRI High intensity focused ultrasound thermal ablation is an attractive treatment modality for solid tumors because it does not require incision. Moreover, coupled with magnetic resonance, it offers precise targeting and control destruction.
An ablation procedure begins with the acquisition of a series of MRI images centered on the organ to be treated. The radiologist loads the images onto the processing machine and identifies the target volume to be destroyed by segmenting it from the MRI images. The console provides a treatment plan with the necessary parameters to efficiently process the defined region.
High intensity focussed ultrasonic destruction is possible due to the elevation of temperature at the focal point. By analogy, one can compare the technique to the use of a magnifying glass to focus the sun's rays and trigger a flame. In ultrasound diagnostic ultrasound is used without convergence of beams. In the therapeutic application, it is the focusing at a point and the use of high intensities which make it possible to deliver energy in the form of heat. This step is called "sonication". Sonication heats the tissue between 65 and 85 ° C in the well-defined region of the focal point and causes tissue thermo-coagulation.
MRI images acquired during heating allow real-time monitoring of the rise in temperature. This makes it possible to check the position of the sonication and the size of the zone thus coagulated. The sonications are thus repeated at multiple adjacent points to cover the prescribed ablation volume.
This combination of FUS-MRI has already shown convincing results on bone, prostate and uterine fibroid tumors, so the hypothesis is that it has a potential interest in the conservative treatment of breast cancer.
The Ex-Ablate 2000 system (trade name) It is a machine incorporating FUS-MRI technology. It consists of a high intensity focused ultrasound transducer mounted in the MRI examination table.
With its precision and unique ability to follow ablation, Ex-Ablate has been used in many tumor contexts and has demonstrated its ability to provide significant tumor destruction on small volumes.
On the breast, the system showed promising results in several Phase II protocols on the treatment of breast tumors with good aesthetic results and no major toxicity.
These arguments justify the choice of using Ex-Ablate as a means of thermic destruction for small size breast cancer. | ArmGroups: [{'label': 'HIGH INTENSITY FOCUSED ULTRASOUND', 'type': 'EXPERIMENTAL', 'description': 'HIGH INTENSITY FOCUSED ULTRASOUND', 'interventionNames': ['Procedure: HIGH INTENSITY FOCUSED ULTRASOUND']}] | Interventions:[{'type': 'PROCEDURE', 'name': 'HIGH INTENSITY FOCUSED ULTRASOUND', 'description': 'HIGH INTENSITY FOCUSED ULTRASOUND GUIDED BY MRI AS THERMIC DESTRUCTION', 'armGroupLabels': ['HIGH INTENSITY FOCUSED ULTRASOUND']}] | PrimaryOutcomes: [{'measure': 'Histological analysis of the surgical specimen will identify the tissue destroyed by ultrasound, residual healthy tissue and possibly residual viable cancerous tissue.', 'description': 'All surgical specimens will be collected and analyzed in full. The sterility of the surgical specimen will be assessed using the score proposed by the EORTC-STBSG (FUS-MRI) in the local treatment of infra-centimetric breast cancer by histological confrontation of the surgical specimen', 'timeFrame': 'up to 24 months'}] | SecondaryOutcomes: [{'measure': 'Early skin toxicity is assessed until surgery', 'description': 'clinical examination (radiation oncologist) using NCI-CTCAE version 4.03 for erythema, telangiectasia and edema,', 'timeFrame': 'up to 24 months'}, {'measure': 'The quality of life will be measured before treatment on D0, and during the visit between D21 and D28 using the QLQ-C30 questionnaire - breast module BR23-version 3.', 'description': 'The quality of life will be measured before treatment on D0, and during the visit between D21 and D28 using the QLQ-C30 questionnaire - breast module BR23-version 3.', 'timeFrame': 'up to 24 months'}] |
Title: Phase II Clinical Trial of Patients With High-Grade Glioma Treated With Intra-Arterial Carboplatin-Based Chemotherapy, Randomized to Treatment With or Without Delayed Intravenous Sodium Thiosulfate as a Potential Chemoprotectant Against Severe Thrombocytopenia | Condition: Malignant Glioma | Keywords: | Summary: | Description: PRIMARY OBJECTIVE:
I. Determine the effect of delayed administration of sodium thiosulfate on the rates of platelet toxicity (i.e. platelet count less than 20,000), in subjects with high-grade glioma undergoing treatment with carboplatin, cyclophosphamide and etoposide/etoposide phosphate.
SECONDARY OBJECTIVES:
I. Assess tumor response in subjects with high-grade glioma undergoing treatment with carboplatin, cyclophosphamide and etoposide/etoposide phosphate, with or without delayed sodium thiosulfate.
II. Assess the effect of delayed administration of sodium thiosulfate on granulocyte and erythrocyte counts, in subjects undergoing treatment with carboplatin, cyclophosphamide and etoposide/etoposide phosphate.
III. Assess hearing changes, if any, at the higher frequencies in the standard testing range (4000 and 8000 Hertz \[Hz\]), and at higher frequencies above standard testing (9000 to 16000 Hz).
IV. Assess quality of life in subjects undergoing treatment with carboplatin, cyclophosphamide and etoposide phosphate.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive cyclophosphamide intravenously (IV), etoposide phosphate IV, and carboplatin intra-arterially (IA) over 10 minutes on day 1.
ARM II: Patients receive cyclophosphamide IV, etoposide phosphate IV, and carboplatin IA as in Arm I. Patients also receive sodium thiosulfate IV over 15 minutes 4 and 8 hours after carboplatin.
In both arms, treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. | ArmGroups: [{'label': 'Arm I (combination chemotherapy)', 'type': 'EXPERIMENTAL', 'description': 'Patients receive cyclophosphamide IV, etoposide phosphate IV, and carboplatin IA over 10 minutes.\n\nTreatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Carboplatin', 'Drug: Cyclophosphamide', 'Drug: Etoposide Phosphate', 'Other: Quality-of-Life Assessment']}, {'label': 'Arm II (combination chemotherapy, sodium thiosulfate)', 'type': 'EXPERIMENTAL', 'description': 'Patients receive cyclophosphamide IV, etoposide phosphate IV, and carboplatin IA as in Arm I. Patients also receive sodium thiosulfate IV over 15 minutes 4 and 8 hours later.\n\nTreatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Carboplatin', 'Drug: Cyclophosphamide', 'Drug: Etoposide Phosphate', 'Other: Quality-of-Life Assessment', 'Drug: Sodium Thiosulfate']}] | Interventions:[{'type': 'DRUG', 'name': 'Carboplatin', 'description': 'Given IA', 'armGroupLabels': ['Arm I (combination chemotherapy)', 'Arm II (combination chemotherapy, sodium thiosulfate)'], 'otherNames': ['Blastocarb', 'Carboplat', 'Carboplatin Hexal', 'Carboplatino', 'Carboplatinum', 'Carbosin', 'Carbosol', 'Carbotec', 'CBDCA', 'Displata', 'Ercar', 'JM-8', 'Nealorin', 'Novoplatinum', 'Paraplatin', 'Paraplatin AQ', 'Paraplatine', 'Platinwas', 'Ribocarbo']}, {'type': 'DRUG', 'name': 'Cyclophosphamide', 'description': 'Given IV', 'armGroupLabels': ['Arm I (combination chemotherapy)', 'Arm II (combination chemotherapy, sodium thiosulfate)'], 'otherNames': ['(-)-Cyclophosphamide', '2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate', 'Carloxan', 'Ciclofosfamida', 'Ciclofosfamide', 'Cicloxal', 'Clafen', 'Claphene', 'CP monohydrate', 'CTX', 'CYCLO-cell', 'Cycloblastin', 'Cycloblastine', 'Cyclophospham', 'Cyclophosphamid monohydrate', 'Cyclophosphamide Monohydrate', 'Cyclophosphamidum', 'Cyclophosphan', 'Cyclophosphane', 'Cyclophosphanum', 'Cyclostin', 'Cyclostine', 'Cytophosphan', 'Cytophosphane', 'Cytoxan', 'Fosfaseron', 'Genoxal', 'Genuxal', 'Ledoxina', 'Mitoxan', 'Neosar', 'Revimmune', 'Syklofosfamid', 'WR- 138719']}, {'type': 'DRUG', 'name': 'Etoposide Phosphate', 'description': 'Given IV', 'armGroupLabels': ['Arm I (combination chemotherapy)', 'Arm II (combination chemotherapy, sodium thiosulfate)'], 'otherNames': ['Etopophos']}, {'type': 'OTHER', 'name': 'Quality-of-Life Assessment', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (combination chemotherapy)', 'Arm II (combination chemotherapy, sodium thiosulfate)'], 'otherNames': ['Quality of Life Assessment']}, {'type': 'DRUG', 'name': 'Sodium Thiosulfate', 'description': 'Given IV', 'armGroupLabels': ['Arm II (combination chemotherapy, sodium thiosulfate)'], 'otherNames': ['Cyanide Antidote Package', 'Disodium Thiosulfate', 'S-Hydril', 'Sodium Hyposulfate', 'Sodium Thiosulfate Pentahydrate', 'Sodium Thiosulphate', 'Sodothiol', 'Thiosulfate, Sodium, Pentahydrate', 'Thiosulfuric acid disodium salt']}] | PrimaryOutcomes: [{'measure': 'Rate of platelet toxicities (i.e. platelet count less than 20,000), graded according to the National Cancer Institute Common Toxicity Criteria version 3.0', 'description': 'The Pearson chi-square test will be the primary test to compare rates.', 'timeFrame': 'Up to 4 weeks after completion of study treatment'}] | SecondaryOutcomes: [{'measure': 'Number of dose reductions and transfusions due to platelet toxicity', 'description': 'Analyzed using generalized estimating equations and/or a generalized mixed model (for repeated measures analysis of variance) and the third using mixed model repeated measures analysis of variance model.', 'timeFrame': 'Up to 30 days after completion of study treatment'}, {'measure': 'Tumor response (complete response + partial response + stable disease) assessed by neurologic exams, radiographic studies, and steroid dose', 'description': 'The Pearson chi-square test will be the primary test to compare rates. Comparisons of rates will use the Pearson Chi-square test and logistic regression to adjust for potential confounders.', 'timeFrame': 'Up to 10 years'}, {'measure': 'Time to response', 'description': 'Descriptive summaries include Kaplan-Meier plots.', 'timeFrame': 'Up to 10 years'}, {'measure': 'Time to disease progression', 'description': 'Comparisons of time to disease progression will use the log rank test and the Cox proportional hazards model to adjust for potential confounders.', 'timeFrame': 'Up to 10 years'}, {'measure': 'Granulocyte count', 'description': 'The Pearson chi-square test will be the primary test to compare rates.', 'timeFrame': 'Up to 30 days after completion of study treatment'}, {'measure': 'Erythrocyte counts', 'description': 'The Pearson chi-square test will be the primary test to compare rates.', 'timeFrame': 'Up to 30 days after completion of study treatment'}, {'measure': 'Change in hearing levels, if any, at the higher frequencies in the standard testing range (4000 and 8000 Hz), and at higher frequencies above standard testing (9000 to 16000 Hz) based on American Speech-Language-Hearing Association criteria', 'description': 'Descriptive summaries for hearing levels will include means by time and plots of hearing levels by patient over time. The analyses for hearing will include both a time to oto-toxicity (based on American Speech-Language-Hearing Association criteria) comparison using the log rank test and a repeated measure analysis of covariance of the actual hearing levels (with baseline hearing levels as the covariate). Separate analyses will be performed for each hearing frequency with no adjustment for multiple comparisons (as these analyses are descriptive in nature).', 'timeFrame': 'Baseline up to 30 days after completion of study treatment'}, {'measure': 'Quality of life assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 and Quality of Life Questionnaire-Brain Module-20', 'description': 'Summarized by means over time and by plots of values over time for each patient. Quality of life data comparisons between the groups will use repeated measure analysis of covariance (baseline assessment as the covariate).', 'timeFrame': 'Up to 60 days after completion of study treatment'}] |
Title: Sensitivity of Multiparametric MRI in Differentiation Between Muscle Invasive and Non-muscle Invasive Urinary Bladder Cancer | Condition: Cancer, Bladder | Keywords: cancer bladder, multiparametric MRI, VIRADS score | Summary: | Description: N/A | ArmGroups: [{'label': 'muscle invasive cancer bladder', 'interventionNames': ['Radiation: multiparametric MRI on the bladder', 'Procedure: diagnostic cystoscopy +/- TURBT']}, {'label': 'non-muscle invasive cancer bladder', 'interventionNames': ['Radiation: multiparametric MRI on the bladder', 'Procedure: diagnostic cystoscopy +/- TURBT']}] | Interventions:[{'type': 'RADIATION', 'name': 'multiparametric MRI on the bladder', 'description': 'comparison between mpMRI and histopathology', 'armGroupLabels': ['muscle invasive cancer bladder', 'non-muscle invasive cancer bladder']}, {'type': 'PROCEDURE', 'name': 'diagnostic cystoscopy +/- TURBT', 'description': 'conventional way of diagnosis', 'armGroupLabels': ['muscle invasive cancer bladder', 'non-muscle invasive cancer bladder']}] | PrimaryOutcomes: [{'measure': 'to detect the sensitivity of multiparametric MRI in differentiation between muscle Invasive and non-muscle invasive Urinary Bladder Cancer in relation to the conventional cystoscopy and histopathological examination of the biopsy.', 'timeFrame': '6 month'}] | SecondaryOutcomes: [{'measure': 'the sensitivity of mpMRI to detect non-visible lesions during follow up cystoscopy while mpMRI reports a positive lesion.', 'timeFrame': '6 month'}] |
Title: Study of Factors Associated With Significant MYoCArdian Uptake on 68Ga-DOTATOC PET Scans for Oncology | Condition: Oncologic Disorders | Keywords: | Summary: | Description: Chemotherapy-related cardiovascular morbidity and mortality in cancer patients is a public health concern. Although several imaging techniques exist to prevent and monitor chemo-induced cardiotoxic effects, the lack of recommendation and consensus is a barrier to reducing cardiac adverse events in this population. PET/CT with Gallium-68-labeled somatostatin analogues (68Ga-DOTATOC, 68Ga-DOTATATE...) is now part of the reference imaging of neuroendocrine tumors (pulmonary, gastrointestinal, pancreatic, pheochromocytoma/paraganglioma, medullary thyroid cancer...), allowing to evaluate their extension and to perform follow-up . Their treatment, including a large arsenal of chemotherapy (etoposide, capecitabine, cisplatin, etc.), may cause cardiotoxicity, which is difficult to assess. However, significant cardiac area uptake has been found on some 68Ga-DOTATOC PET/CT scans in oncology. This uptake could be related either to the patient's cardiac history (inflammatory atheromatous valvular and/or coronary lesions), some studies having shown the association between the uptake of a somatostatin analogue and the presence of calcified plaques, or to a possible chemo-induced cardiotoxicity which, to our knowledge, no study has investigated. Thus, the identification of 68Ga-DOTATOC binding patterns in the cardiac area in relation to chemo-induced cardiotoxicity would have the advantage of avoiding the multiplication of examinations in the initial and follow-up work-up, thus allowing the combined evaluation of the disease and the cardiac adverse effects induced by its treatments, and thus a better control of the cardio-induced morbidity and mortality of patients with a neuroendocrine tumor.
The hypothesis of this study is that 68Ga-DOTATOC PET/CT scans with oncological indications sometimes show significant uptake in the cardiac area, which could be related to inflammatory atheromatous coronary/valvular lesions, or to a recent history of potentially cardiotoxic oncological treatments (or to diffuse somatic inflammation?) | ArmGroups: N/A | Interventions:N/A | PrimaryOutcomes: [{'measure': 'Correlation between measurements and cardiac hyperfixation', 'description': 'Correlation between measurements of myocardial activity ratios and possible cardiac hyperfixation sites with blood activity and presence of cardiovascular history, and health data collected such as cardiovascular risk factors (and their number), and the existence of recent chemotherapy or radiotherapy treatment.', 'timeFrame': '2 years'}] | SecondaryOutcomes: N/A |
Title: Prospective Monocentric Evaluation of the Autonomic Nervous System in Patients Undergoing Esophagectomy for Cancer | Condition: Esophageal Cancer | Keywords: Esophagectomy, surgery, Holter-ECG | Summary: | Description: The sympathomimetic balance was measured using a Holter-ECG heart rate monitor. The parameters collected were used to calculate the variability of the heart rate, the high frequencies (HF, reflection of the parasympathetic system), the low frequencies (LF, reflection of the sympathetic system and the parasympathetic system) and the ratio // LF / HF (reflection of the sympathetic activity) thanks to Fourier analysis and the use of HRVanalysis software.
The measurements were taken at night, to overcome the great sympathomimetic variabilities due to external stimulations during the day: one night 3 month before surgery/before the first chemotherapy, one night between 2 and 4 weeks before hospitalization (remotely of possible chemotherapy), the night before the intervention (context of hospitalization and preoperative stress), one night between D7 and D10 (context of hospitalization, and distance from anesthetic drugs), one night at home between 4 and 8 weeks post-operative, and one night at home at 3 months post-operative.
The measurements were therefore not carried out the first nights following the intervention to overcome the anesthetic drugs that affect the balance of the autonomic nervous system.
A baroreflex measurement was carried out at the patient's entrance, the day before the intervention, during hospitalization, and the day of discharge. This measure was renewed at 3 months.
A measurement of patient activity was carried out preoperatively by wearing an actimeter watch for 1 week then renewed at 3 months.
A Respiratory Functional Exploration associated with a stress test with calculation of the VO2max is systematically carried out before the esophageal surgery. A Respiratory Functional Exploration was renewed 4 to 8 weeks after the intervention, and then at 3 months. the 6-minute walk test was performed at the same time. | ArmGroups: N/A | Interventions:[{'type': 'DIAGNOSTIC_TEST', 'name': 'Holter ECG', 'description': 'Measurement of the modification of the sympathomimetic balance'}, {'type': 'BEHAVIORAL', 'name': 'Questionary', 'description': 'Lifestyle questionary (time spent in front of television, physical activity)'}, {'type': 'DIAGNOSTIC_TEST', 'name': 'Pupillometry', 'description': 'Monitoring of nociception and autonomic nervous system by pupillometry in intraoperative.'}] | PrimaryOutcomes: [{'measure': 'Analysis of Standard deviation of all NN (SDNN) (ms)', 'description': 'Analysis of Standard deviation of all NN (SDNN) intervals, over the entire registration period, provides information on global variability. Measured by Holter results. Day 0 = surgery', 'timeFrame': 'before surgery'}, {'measure': 'Analysis of Standard deviation of all NN (SDNN) (ms)', 'description': 'Analysis of Standard deviation of all NN (SDNN) intervals, over the entire registration period, provides information on global variability. Measured by Holter results. Day 0 = surgery', 'timeFrame': 'day 7 to day 90'}] | SecondaryOutcomes: [{'measure': 'HF activity', 'description': 'Day 0 = surgery measured with the Holter Electrocardiogram', 'timeFrame': 'before surgery : Day -82, Day -30, Day -1'}, {'measure': 'LF activity', 'description': 'Day 0 = surgery measured with the Holter Electrocardiogram', 'timeFrame': 'before surgery : Day -82, Day -30, Day -1'}, {'measure': 'LF/HF ratio', 'description': 'Day 0 = surgery measured with the Holter Electrocardiogram', 'timeFrame': 'before surgery : Day -82, Day -30, Day -1'}, {'measure': 'HF activity', 'description': 'Day 0 = surgery measured with the Holter Electrocardiogram', 'timeFrame': 'after surgery : day 7, day 60, day 90'}, {'measure': 'LF activity', 'description': 'Day 0 = surgery measured with the Holter Electrocardiogram', 'timeFrame': 'after surgery : day 7, day 60, day 90'}, {'measure': 'LF/HF ratio', 'description': 'Day 0 = surgery measured with the Holter Electrocardiogram', 'timeFrame': 'after surgery : day 7, day 60, day 90'}, {'measure': 'change in baroreflex', 'description': 'baroreflex sensitivity : ms/mmHg Day 0 = surgery', 'timeFrame': 'Day -1, Day 7, day discharge, day 90'}, {'measure': 'modify the respiratory functional exploration', 'description': 'Peak expiratory volume per second : L Day 0 = surgery', 'timeFrame': 'Day -30, Day 30, Day 60'}, {'measure': 'intraoperative pupillometry', 'description': 'pupillary diameter : mm', 'timeFrame': 'during surgery'}, {'measure': 'physical capacity', 'description': 'walking distance in 6 minutes Day 0 = surgery', 'timeFrame': 'Day-30, Day 30, Day 90'}] |
Title: Stereotactic Body Radiotherapy for Extra-cranial Oligorecurrent Tumor: Randomized Phase II Clinical Trial | Condition: Recurrent Cancer | Keywords: stereotactic body radiotherapy | Summary: | Description: N/A | ArmGroups: [{'label': 'Arm 1', 'type': 'ACTIVE_COMPARATOR', 'description': 'systemic therapy+palliative RT', 'interventionNames': ['Drug: systemic therapy (chemotherapy, hormon therapy, target therapy etc)', 'Radiation: palliative RT']}, {'label': 'Arm 2', 'type': 'EXPERIMENTAL', 'description': 'systemic therapy+SBRT', 'interventionNames': ['Radiation: SBRT', 'Drug: systemic therapy (chemotherapy, hormon therapy, target therapy etc)']}] | Interventions:[{'type': 'RADIATION', 'name': 'SBRT', 'description': '10 Gy x 3 - 20 Gy x 3 (BED 60Gy-180 Gy) or 8 Gy x 4 - 17 Gy x 4 (BED 58-184 Gy)', 'armGroupLabels': ['Arm 2'], 'otherNames': ['VMAT (Volumetric Modulated Arc Therapy )']}, {'type': 'DRUG', 'name': 'systemic therapy (chemotherapy, hormon therapy, target therapy etc)', 'description': 'Physicians can choose all the options available chemotherapy, hormon therapy, target therapy etc.\n\nUse of chemotherapy schemes containing potent enhancers of radiation damage (e.g. gemcitabine,adriamycin) are discouraged within the first month after SBRT.', 'armGroupLabels': ['Arm 1', 'Arm 2'], 'otherNames': ['chemotherapy, hormon therapy, target therapy etc.']}, {'type': 'RADIATION', 'name': 'palliative RT', 'description': 'fraction size of RT = \\< 3 Gy', 'armGroupLabels': ['Arm 1'], 'otherNames': ['conventional fractionation RT']}] | PrimaryOutcomes: [{'measure': 'disease progression free survival rate', 'timeFrame': '2 years'}] | SecondaryOutcomes: [{'measure': 'overall survival rate', 'timeFrame': '2 years'}, {'measure': 'local control rate', 'timeFrame': '2 years'}, {'measure': 'Number of participants with radiation induced acute or late toxicity', 'description': 'Acute and late toxicities would be evaluated using the Common Terminology Criteria of Adverse Events (CTCAE) version 4.0 and the Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer (RTOG/EORTC) radiation morbidity criteria, respectively.', 'timeFrame': '2 years'}] |
Title: Phase II Randomized Observation Versus Stereotactic Ablative RadiatIOn for OLigometastatic Prostate CancEr (ORIOLE) Trial | Condition: Prostate Cancer, Oligometastases | Keywords: Prostate Cancer, Stereotactic Body Radiation Therapy, Stereotactic Ablative Radiotherapy, Oligometastasis | Summary: | Description: This research is being done to determine if we can improve the outcome of prostate cancer patients who have failed primary treatment - surgery or local radiation to the prostate - and have 3 or fewer bone metastases. Patients with metastatic prostate cancer disease will usually be placed on hormonal therapy which can work well for a period of time, but hormonal therapy can have side effects that greatly trouble men. Any effort to delay the start of hormonal therapy would be an advantage to the patient. Radiation treatment usually takes many weeks to deliver and is not given in a high enough doses to metastases to prevent them from coming back locally. Stereotactic body radiation therapy (SBRT) is highly focused radiation, given in a very dose intensive fashion and delivered in usually less than one week. Stereotactic body radiation has been shown to be very effective on bone metastases. Therefore, we are studying the effects of stereotactic body radiation treatment on patients with five or fewer prostate cancer bone metastases to determine if we can stall the use of hormonal therapy and/or prevent other bone metastases from developing elsewhere in the body.
Additionally, fundamental analysis of the oligometastatic state with be achieved through correlation with investigational DCFPyL-positron emission tomography (PET) imaging, which can help us find cancer that has spread (metastatic disease) from its original site in people who have cancer in their prostate to other parts of their body.
Specifically, 54 men with biochemically recurrent, oligometastatic prostate adenocarcinoma will be accrued across 3 centers in the United States. Patients were stratified by primary intervention (surgery vs radiotherapy), prior hormonal therapy, and PSA doubling time, then randomized 2:1 to SBRT or observation. The primary clinical endpoint is progression at 6 months from randomization with the hypothesis that SBRT to all metastases will forestall progression by disrupting the metastatic process. Secondary clinical endpoints include local control at 6 months post-SBRT, SBRT-associated toxicity and quality of life, and ADT-free survival (ADT-FS).
Alterations in the biology of the oligometastatic state induced by stereotactic ablative radiotherapy (SABR) will be investigated using leading-edge correlatives, including: analysis of circulating tumor cells (CTCs; Epic Sciences, San Diego, CA), deep sequencing of circulating tumor DNA (ctDNA) using Cancer Personalized Profiling by deep sequencing (CAPP-Seq) to non-invasively assess tumor burden, and ImmunoSEQ profiling of T-cell repertoires to elucidate the immunological response to SABR (Adaptive Technologies, Seattle, WA). Lastly, the use of the Color Genomics platform (Burlingame, CA), a hereditary cancer assay assessing pathogenic mutations in 30 cancer predisposition genes that account for \>90% of the germline mutations known to occur in men with castrate resistant metastatic prostate cancer (mCRPC), will help inform and allow for efforts to advance a more personalized medicine approach to tailor screening and therapies in these men. | ArmGroups: [{'label': 'Observational (no SBRT)', 'type': 'NO_INTERVENTION', 'description': 'Men with oligometastatic prostate cancer lesions randomized to observation'}, {'label': 'SBRT', 'type': 'EXPERIMENTAL', 'description': 'Men with oligometastatic prostate cancer lesions randomized to stereotactic body radiation therapy (SBRT).', 'interventionNames': ['Radiation: SBRT']}] | Interventions:[{'type': 'RADIATION', 'name': 'SBRT', 'description': 'SBRT (1-5 fractions) will be administered.', 'armGroupLabels': ['SBRT'], 'otherNames': ['Stereotactic Body Radiation', 'Stereotactic Ablative Radiotherapy']}] | PrimaryOutcomes: [{'measure': 'Progression at 6 Months', 'description': 'Number of participants who progressed at 6 months. Progression is defined as either: 1) a ≥ 25% increase in PSA from nadir (and by ≥ 2 ng/mL), requiring confirmation ≥ 4 weeks later (PCWG2 criteria); and/or, 2) clinical/radiographic-progression defined as symptomatic progression (worsening disease-related symptoms or new cancer-related complications), or radiologic progression (on CT scan: ≥ 20% enlargement in sum diameter of soft-tissue target lesions \\[RECIST1.1 criteria\\]; on bone scan: ≥ 1 new bone lesions),initiation of ADT or death due to any cause, whichever occurs first.', 'timeFrame': '6 months'}] | SecondaryOutcomes: [{'measure': 'Time to Local Progression', 'description': 'Number of months until local progression in patients with oligometastatic disease.', 'timeFrame': 'up to 6 months'}, {'measure': 'Local Control of SBRT Group', 'description': 'Number of lesions that did not increase in size by at least 20% or more on CT from baseline to 6 months.', 'timeFrame': '6 months'}, {'measure': 'Toxicity as Assessed by Number of Participants With Adverse Events Grade 3 or Higher', 'description': 'Number of participants experiencing adverse events Grade 3 or higher, as defined by CTCAE.', 'timeFrame': 'up to 6 months'}, {'measure': 'Toxicity as Assessed by Number of Participants With Adverse Events Grades 1 or 2', 'description': 'Number of participants experiencing adverse events Grades 1 or 2, as defined by CTCAE', 'timeFrame': 'up to 6 months'}, {'measure': 'Change in Quality of Life as Assessed by Brief Pain Inventory', 'description': 'We will assess quality of life following completion of Stereotactic Body Radiation Therapy via Brief Pain Inventory questionnaire made up of 9 questions. Each question scores from 0-10, with higher scores mean worse outcome or more pain. An overall score, calculated by adding the scores for questions 2, 3, 4 and 5 and then dividing by 4, will be calculated pre-treatment and at the time of day 180. The change in score (between baseline and 6 months) will be evaluated.', 'timeFrame': 'Baseline and 6 months'}, {'measure': 'Change of DCFPyL-PET/MRI Positive Lesions', 'description': '18F-DCFPyL Positron Emission Tomography (PET)/MRI or -PET/CT positive sites that are positive for new or progressive metastatic disease by bone scan/CT at 6-months following SBRT.', 'timeFrame': '6 months'}, {'measure': 'Change in Survival of Two Groups as Assessed by PSA Level', 'description': 'The PSA levels in blood will be measured in units of nanograms per milliliter (ng/mL).', 'timeFrame': 'Baseline and 6 months'}, {'measure': 'Androgen Deprivation Therapy-free Survival', 'description': 'Androgen Deprivation Therapy-free survival will be assessed using the number of participants deceased at 6 months.', 'timeFrame': '6 month'}] |
Title: Multi-center Study Evaluating OraVescent Fentanyl Citrate for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients | Condition: Pain, Cancer | Keywords: cancer, pain, Breakthrough Pain in cancer patients | Summary: | Description: N/A | ArmGroups: N/A | Interventions:[{'type': 'DRUG', 'name': 'OraVescent fentanyl (OVF)'}] | PrimaryOutcomes: N/A | SecondaryOutcomes: N/A |
Title: Investigation of Early Hormonotherapy Efficacy of High Risk Patients for Progression of Prostate Cancer After Radical Prostatectomy | Condition: Prostate Cancer | Keywords: Prostate cancer | Summary: | Description: The primary purpose of this study is to evaluate the hypothesis, that early administration of adjuvant hormonotherapy (triptorelin) can prolong survival data for high risk patients. Control group (randomised study) will be treated with hormonotherapy, when PSA recidive appear (on demand treatment). Secondary purposes will be to compare PSA dinamics and quality of life data in the groups. | ArmGroups: N/A | Interventions:[{'type': 'DRUG', 'name': 'Triptorelin'}] | PrimaryOutcomes: [{'measure': 'Survival'}] | SecondaryOutcomes: [{'measure': 'PSA dinamics'}, {'measure': 'quality of life'}] |
Title: Explorative Trial to Identify the Impact of Denosumab on the Systemic Immunity and Local Immunologic Microenvironment in Postmenopausal Patients With HER2 Negative Breast Cancer | Condition: Breast Neoplasms | Keywords: Breast cancer, Denosumab, Chemotherapy, Immunity, Immune system, PERIDENO | Summary: | Description: In this study, postmenopausal patients with stage T1c + grade 3, stage II or III, HER2-negative breast cancer, which are planned to undergo surgery followed by adjuvant AC-T chemotherapy, are randomized between no denosumab, denosumab low dosing and denosumab high dosing. Denosumab administration will start one week before surgery and continue until the last chemotherapy cycle. | ArmGroups: [{'label': 'No denosumab', 'type': 'NO_INTERVENTION', 'description': 'All patients undergo surgery followed by adjuvant chemotherapy. Patients in this study arm are not additionally treated with denosumab.'}, {'label': 'Denosumab 120 mg', 'type': 'EXPERIMENTAL', 'description': 'All patients undergo surgery followed by adjuvant chemotherapy. Patients in this study arm are additionally treated with denosumab 120 mg every 3 weeks. First denosumab gift is before surgery, last denosumab gift is together with the last cycle of chemotherapy.', 'interventionNames': ['Drug: Denosumab 120 mg']}, {'label': 'Denosumab 60 mg', 'type': 'EXPERIMENTAL', 'description': 'All patients undergo surgery followed by adjuvant chemotherapy. Patients in this study arm are additionally treated with denosumab 60 mg every 6 months. First denosumab gift is before surgery, last denosumab gift is together with the last cycle of chemotherapy.', 'interventionNames': ['Drug: Denosumab 60 mg']}] | Interventions:[{'type': 'DRUG', 'name': 'Denosumab 120 mg', 'description': 'Denosumab 120 mg every 3 weeks.', 'armGroupLabels': ['Denosumab 120 mg'], 'otherNames': ['Xgeva']}, {'type': 'DRUG', 'name': 'Denosumab 60 mg', 'description': 'Denosumab 60 mg every 6 months.', 'armGroupLabels': ['Denosumab 60 mg'], 'otherNames': ['Prolia']}] | PrimaryOutcomes: [{'measure': 'Change in intratumoral T-cell (CD4, CD8 and Treg) numbers and function between the baseline biopsy and the surgical specimen.', 'description': 'The change will be determined by use of IHC and immunofluorescent stainings.', 'timeFrame': 'The change can be determined after the surgical specimen is obtained, which is around two weeks after enrolment.'}, {'measure': 'Change in myeloid cell (M1/M2 Macrophage, MDSC, DC) numbers and function between the baseline biopsy and the surgical specimen.', 'description': 'The change will be determined by use of IHC and immunofluorescent stainings.', 'timeFrame': 'The change can be determined after the surgical specimen is obtained, which is around two weeks after enrolment.'}] | SecondaryOutcomes: [{'measure': 'Shift in activated T effector cell levels.', 'description': 'Shifts will be determined by comparing PBMCs (using flow cytometry) before start treatment, at day of surgery before surgery and 7 days after last chemotherapy administration.', 'timeFrame': 'Measurements will be done in PBMCs from before start treatment, day of surgery and 7 days after last chemotherapy administration, which will be around 8 months after enrolment.'}, {'measure': 'Shift in regulatory T-cell levels.', 'description': 'Shifts will be determined by comparing PBMCs (using flow cytometry) before start treatment, at day of surgery before surgery and 7 days after last chemotherapy administration.', 'timeFrame': 'Measurements will be done in PBMCs from before start treatment, day of surgery and 7 days after last chemotherapy administration, which will be around 8 months after enrolment.'}, {'measure': 'Change in functional response of T-cells.', 'description': 'Changes will be determined by comparing PBMCs (using stimulation tests) before start treatment, at day of surgery before surgery and 7 days after last chemotherapy administration.', 'timeFrame': 'Measurements will be done in PBMCs from before start treatment, day of surgery and 7 days after last chemotherapy administration, which will be around 8 months after enrolment.'}, {'measure': 'Change in mature and immature myeloid cells (M1/M2 macrophage, MDSC, DC).', 'description': 'Shifts will be determined by comparing PBMCs (using flow cytometry) before start treatment, at day of surgery before surgery and 7 days after last chemotherapy administration.', 'timeFrame': 'Measurements will be done in PBMCs from before start treatment, day of surgery and 7 days after last chemotherapy administration, which will be around 8 months after enrolment.'}, {'measure': 'Shift in myeloid cell function.', 'description': 'Shifts will be determined by comparing PBMCs (using triggering tests) before start treatment, at day of surgery before surgery and 7 days after last chemotherapy administration.', 'timeFrame': 'Measurements will be done in PBMCs from before start treatment, day of surgery and 7 days after last chemotherapy administration, which will be around 8 months after enrolment.'}, {'measure': 'Change in stimulation capacity APCs.', 'description': 'Changes will be determined by comparing PBMCs (using restimulation tests) before start treatment, at day of surgery before surgery and 7 days after last chemotherapy administration.', 'timeFrame': 'Measurements will be done in PBMCs from before start treatment, day of surgery and 7 days after last chemotherapy administration, which will be around 8 months after enrolment.'}, {'measure': 'Change in serum levels of RANKL and OPG.', 'description': 'Changes will be determined by comparing serum before start treatment, at day of surgery before surgery and 7 days after last chemotherapy administration, using ELISA.', 'timeFrame': 'Measurements will be done in serum from before start treatment, day of surgery and 7 days after last chemotherapy administration, which will be around 8 months after enrolment.'}, {'measure': 'Change in serum cytokine levels (TNF-alpha, interleukines, IFN gamma).', 'description': 'Changes will be determined by comparing serum before start treatment, at day of surgery before surgery and 7 days after last chemotherapy administration, using luminex.', 'timeFrame': 'Measurements will be done in serum from before start treatment, day of surgery and 7 days after last chemotherapy administration, which will be around 8 months after enrolment.'}, {'measure': 'Correlation of tumor measurements with serum measurements.', 'description': 'Measurements in tumor and serum will be correlated.', 'timeFrame': 'Measurements will be done in tumor material and serum from before start treatment, day of surgery and 7 days after last chemotherapy administration, which will be around 8 months after enrolment and tumor material from baseline and surgery.'}, {'measure': 'Correlation of tumor measurements with PBMCs measurements.', 'description': 'Measurements in tumor and PBMCs will be correlated.', 'timeFrame': 'Measurements will be done in tumor material and PBMCs from before start treatment, day of surgery and 7 days after last chemotherapy administration, which will be around 8 months after enrolment and tumor material from baseline and surgery.'}, {'measure': 'Correlation of serum measurements and PBMCs measurements.', 'description': 'Measurements in serum and PBMCs will be correlated.', 'timeFrame': 'Measurements will be done in PBMCs/serum from before start treatment, day of surgery and 7 days after last chemotherapy administration, which will be around 8 months after enrolment and tumor material from baseline and surgery.'}, {'measure': 'Toxicity according to NCI CTCAE v4.03.', 'description': 'Toxicities are graded according to NCI CTCAE v4.03.', 'timeFrame': 'Toxicity will be assessed from start treatment up to 30 days following the last dose of treatment.'}, {'measure': 'Difference in descriptive event free survival (EFS) at 3 years based on immune response.', 'description': 'After 3 years of follow up, differences in EFS based on immune response will be determined.', 'timeFrame': 'EFS will be determined after 3 years.'}] |
Title: A Multi-center, Open, Single-arm Phase I Dose Exploratory Study to Evaluate the Safety, Tolerability, Pharmacokinetic Properties and Primary Antitumor Activity of FCN-098 in Patients With Advanced Solid Tumors | Condition: Solid Tumor | Keywords: Solid Tumor, NTRK | Summary: | Description: This study is a multicenter, open, single-arm Phase I clinical study. The safety, tolerance and PK characteristics of FCN-098 in patients with advanced solid tumors were determined, the MTD of oral FCN-098 was determined, and the RP2D of FCN-098 was determined, and the efficacy of FCN-098 was preliminarily evaluated. | ArmGroups: [{'label': 'Dose Escalation and Expansion', 'type': 'EXPERIMENTAL', 'description': 'FCN-098 will be given orally in ascending doses in patients with advanced solid tumor , until the maximum tolerated dose or recommended dose is reached.', 'interventionNames': ['Drug: FCN-098']}] | Interventions:[{'type': 'DRUG', 'name': 'FCN-098', 'description': 'FCN-098 will be given orally in ascending doses starting at 40 mg Q12h until the maximum tolerated dose or recommended dose is reached.', 'armGroupLabels': ['Dose Escalation and Expansion']}] | PrimaryOutcomes: [{'measure': 'Incidence of dose-limiting toxicity within 2 days of single administration and 28 days of continuous administration.', 'timeFrame': 'From first dose up to 28 days'}, {'measure': 'Determine the recommended phase II dose', 'timeFrame': 'From first dose up to 28 days'}] | SecondaryOutcomes: [{'measure': 'To quantify the occurrence of adverse events (AEs) reported in all subjects who received study drug', 'description': 'Incidence of untoward medical occurrences (adverse event = AE) in a participant who received study drug. Adverse events will be evaluated by dosing cohort and recorded according to NCI CTCAEv5 Common Toxicity Criteria.', 'timeFrame': 'From enrollment up to 30 days after last dose'}, {'measure': 'To quantify the occurrence of TESAE during the treatment and cause permanent withdrawal of toxic effects', 'timeFrame': 'From enrollment up to 30 days after last dose'}, {'measure': 'the death of the last medicine occurred within 30 days of frequency and cause of death', 'timeFrame': 'From enrollment up to 30 days after last dose'}, {'measure': 'To quantify the Plasma Concentration of FCN-098 and its metabolite M1 (FCN-097)', 'timeFrame': '2 months'}, {'measure': 'To determine the best overall response rate (ORR) by Response Criteria in Solid Tumors (RECIST) v1.1 in subjects with advanced solid tumors', 'description': 'To evaluate the proportion of patients with an objective response (SD, PR, CR) as defined by RECIST 1.1.', 'timeFrame': 'Baseline up to approximately 1 year'}] |
Title: Prevention of Radiation-induced Mucositis in Patients With Head and Neck Cancer Treated With Radiotherapy : A Double-blind Randomized Controlled Trial | Condition: Radiation- Induced Mucositis, Adverse Effect of Radiation Therapy, Head and Neck Cancer | Keywords: Radiation- induced mucositis, Head and Neck Cancer, Radiation therapy side effect | Summary: | Description: To compare the effect of each herb extracts in form of mouth wash to protect or delay the onset of the radiation-induced mucositis from the adverse effects of radiation therapy in patients with head and neck cancer. | ArmGroups: [{'label': 'Normal saline with salt/Soda', 'type': 'ACTIVE_COMPARATOR', 'description': 'Normal saline with salt/soda rinse 4 times a day/everyday and for each time 15 ml.', 'interventionNames': ['Other: Normal saline with salt/Soda']}, {'label': 'Clinacanthus nutans', 'type': 'EXPERIMENTAL', 'description': 'Clinacanthus nutans in form of mouth wash rinse 4 times a day/everyday and for each time 15 ml.', 'interventionNames': ['Other: Clinacanthus nutans']}, {'label': 'Boesenbergia rotunda', 'type': 'EXPERIMENTAL', 'description': 'Boesenbergia rotunda in form of mouth wash 4 times a day/everyday and for each time 15 ml.', 'interventionNames': ['Other: Boesenbergia rotunda']}] | Interventions:[{'type': 'OTHER', 'name': 'Normal saline with salt/Soda', 'description': 'Head and Neck cancer Patients have to rinse 4 times a day/everyday for 15 ml. each time during and after completed the radiation treatment', 'armGroupLabels': ['Normal saline with salt/Soda']}, {'type': 'OTHER', 'name': 'Clinacanthus nutans', 'description': 'Head and Neck cancer Patients have to rinse 4 times a day/everyday for 15 ml. each time during and after completed the radiation treatment', 'armGroupLabels': ['Clinacanthus nutans']}, {'type': 'OTHER', 'name': 'Boesenbergia rotunda', 'description': 'Head and Neck cancer Patients have to rinse 4 times a day/everyday for 15 ml. each time during and after completed the radiation treatment', 'armGroupLabels': ['Boesenbergia rotunda']}] | PrimaryOutcomes: [{'measure': 'Change of mucositis grading', 'description': 'RTOG (Radiation Therapy Oncology Group) Grade0: none Grade 1 : oral soreness, erythema Grade 2 : oral erythema, ulcer, solid diet tolerated Grade 3 : oral ulcers, liquid diet only Grade 4 : oral alimentation impossible', 'timeFrame': 'Change from baseline mucositis grading 1,2, 3, 4, 5 , 6 , 7, 8, 9 week and at 1 month after completed Radiation therapy'}] | SecondaryOutcomes: [{'measure': 'Patient satisfaction with the mouth wash', 'description': 'Scoring 1-4 not satisfied slightly satisfied moderately satisfied very satisfied', 'timeFrame': 'The last fraction of radiation therapy, through study completion, an average of 1 year'}] |
Title: A Phase 2, Randomized, Multicenter Study of PEGPH20 (PEGylated Recombinant Human Hyaluronidase) Combined With Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Subjects With Stage IV Previously Untreated Pancreatic Cancer | Condition: Metastatic Pancreatic Cancer | Keywords: pancreatic ductal carcinoma(PDA), Pancreatic ductal carcinoma, PEGPH20, Gemcitabine, Nab-paclitaxel | Summary: | Description: N/A | ArmGroups: [{'label': 'Run-in Phase - PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive 3.0 micrograms/kilogram (mcg/kg) PEGPH20 with 125 milligrams/square meter (mg/m\\^2) NAB and 1000 mg/m\\^2 GEM as intravenous (IV) infusion. In Cycle 1 Week 1, PEGPH20 will be administered alone on Days 1 and 4 and NAB+GEM will be given on Day 2 at approximately 24 hours after first dose of PEGPH20. In Cycle 1 Weeks 2 and 3, PEGPH20 will be given twice/week on Days 8, 11, 15 and 18 and NAB+GEM will be given once/week at 2 to 4 hours after PEGPH20 administration on Days 8 and15. In Cycle 2 onwards, PEGPH20, NAB, and GEM will be given once/week on Days 1 8 and 15. NAB+GEM will be given 2 to 4 hours after PEGPH20 dose. Each cycle will be of 4-weeks with Week 4 of every cycle as a rest week (no treatment will be given). Treatment will continue until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg will be given in each cycle within 2 hours prior and 8 to 12 hours after completion of each PEGPH20 infusion.', 'interventionNames': ['Drug: PEGPH20', 'Drug: Nab-paclitaxel', 'Drug: Gemcitabine', 'Drug: Dexamethasone']}, {'label': 'Run-in Phase - AG: Nab-paclitaxel + Gemcitabine', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants will receive 125 mg/m\\^2 NAB and 1000 mg/m\\^2 GEM, as an IV infusion once weekly on Days 1, 8, and 15 of each cycle. Each cycle will be of 4-weeks (28 days) with Week 4 of every cycle as a rest week (that is; no treatment will be given). Treatment will continue until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg will be given in each cycle within 2 hours prior to the beginning of each NAB infusion and 8 to 12 hours after the completion of GEM infusion.', 'interventionNames': ['Drug: Nab-paclitaxel', 'Drug: Gemcitabine', 'Drug: Dexamethasone']}, {'label': 'Phase 2: Stage 1 - PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive 3.0 mcg/kg PEGPH20 with 125 mg/m\\^2 NAB and 1000 mg/m\\^2 GEM as an IV infusion. In Cycle 1 Week 1, PEGPH20 will be given alone on Days 1 and Day 4 and NAB+GEM will be given on Day 2 at approximately 24 hours after first dose of PEGPH20. In Cycle 1 Weeks 2 and 3, PEGPH20 will be given twice/week on Days 8, 11, 15, and 18 and NAB+GEM will be given once/week at 2 to 4 hours after PEGPH20 administration on Days 8 and 15. In Cycle 2 onwards, PEGPH20, NAB, and GEM will be given once/week on Days 1, 8, and 15. NAB+GEM will be given 2 to 4 hours after dose of PEGPH20. Each cycle will be of 4-weeks with Week 4 of every cycle as a rest week (no treatment will be given). Treatment will continue until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg will be given in each cycle within 2 hours prior to the beginning and 8 to 12 hours after the completion of each PEGPH20 infusion.', 'interventionNames': ['Drug: PEGPH20', 'Drug: Nab-paclitaxel', 'Drug: Gemcitabine', 'Drug: Dexamethasone']}, {'label': 'Phase 2: Stage 1 - AG: Nab-paclitaxel + Gemcitabine', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants will receive 125 mg/m\\^2 NAB and 1000 mg/m\\^2 GEM as an IV infusion once weekly on Days 1, 8, and 15 of each cycle. Each cycle will be of 4-weeks (28 days) with Week 4 of every cycle as a rest week (that is; no treatment will be given). Treatment will continue until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg will be given in each cycle within 2 hours prior to the beginning of each NAB infusion and 8 to 12 hours after the completion of GEM infusion.', 'interventionNames': ['Drug: Nab-paclitaxel', 'Drug: Gemcitabine', 'Drug: Dexamethasone']}, {'label': 'Phase 2: Stage 2 - PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive 3.0 mcg/kg PEGPH20 with 125 mg/m\\^2 NAB and 1000 mg/m\\^2 GEM as an IV infusion. In Cycle 1 Week 1, PEGPH20 will be given alone on Days 1 and 4 and NAB+GEM will be given on Day 2 at approximately 24 hours after first dose of PEGPH20. In Cycle 1 Weeks 2 and 3, PEGPH20 will be given twice/week on Days 8, 11, 15, and 18 and NAB+GEM will be given once/week at 2 to 4 hours after PEGPH20 administration on Days 8 and 15. In Cycle 2 onwards, PEGPH20, NAB, and GEM will be given once/week on Days 1, 8, and 15. NAB+GEM will be given 2 to 4 hours after dose of PEGPH20. Each cycle will be of 4-weeks with Week 4 of every cycle as a rest week (no treatment will be given). Treatment will continue until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg will be given in each cycle within 2 hours prior to beginning and 8 to 12 hours after completion of each PEGPH20 infusion. Enoxaparin 40 mg/day or 1 mg/kg/day will be given subcutaneously (SC).', 'interventionNames': ['Drug: PEGPH20', 'Drug: Nab-paclitaxel', 'Drug: Gemcitabine', 'Drug: Dexamethasone', 'Drug: Enoxaparin']}, {'label': 'Phase 2: Stage 2 - AG: Nab-paclitaxel + Gemcitabine', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants will receive 125 mg/m\\^2 NAB and 1000 mg/m\\^2 GEM as an IV infusion once weekly on Days 1, 8, and 15 of each cycle. Each cycle will be of 4-weeks (28 days) with Week 4 of every cycle as a rest week (that is; no treatment will be given). Treatment will continue until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg will be given in each cycle within 2 hours prior to the beginning of each NAB infusion and 8 to 12 hours after the completion of GEM infusion. Enoxaparin 40 mg/day or 1 mg/kg/day will be given SC.', 'interventionNames': ['Drug: Nab-paclitaxel', 'Drug: Gemcitabine', 'Drug: Dexamethasone', 'Drug: Enoxaparin']}] | Interventions:[{'type': 'DRUG', 'name': 'PEGPH20', 'description': 'PEGPH20 will be administered as per the dose and schedule specified in the respective arms.', 'armGroupLabels': ['Phase 2: Stage 1 - PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine', 'Phase 2: Stage 2 - PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine', 'Run-in Phase - PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine']}, {'type': 'DRUG', 'name': 'Nab-paclitaxel', 'description': 'Nab-paclitaxel will be administered as per the dose and schedule specified in the respective arms.', 'armGroupLabels': ['Phase 2: Stage 1 - AG: Nab-paclitaxel + Gemcitabine', 'Phase 2: Stage 1 - PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine', 'Phase 2: Stage 2 - AG: Nab-paclitaxel + Gemcitabine', 'Phase 2: Stage 2 - PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine', 'Run-in Phase - AG: Nab-paclitaxel + Gemcitabine', 'Run-in Phase - PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine'], 'otherNames': ['Abraxane']}, {'type': 'DRUG', 'name': 'Gemcitabine', 'description': 'Gemcitabine will be administered as per the dose and schedule specified in the respective arms.', 'armGroupLabels': ['Phase 2: Stage 1 - AG: Nab-paclitaxel + Gemcitabine', 'Phase 2: Stage 1 - PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine', 'Phase 2: Stage 2 - AG: Nab-paclitaxel + Gemcitabine', 'Phase 2: Stage 2 - PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine', 'Run-in Phase - AG: Nab-paclitaxel + Gemcitabine', 'Run-in Phase - PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine'], 'otherNames': ['Gemzar']}, {'type': 'DRUG', 'name': 'Dexamethasone', 'description': 'Dexamethasone will be administered as per the dose and schedule specified in the respective arms.', 'armGroupLabels': ['Phase 2: Stage 1 - AG: Nab-paclitaxel + Gemcitabine', 'Phase 2: Stage 1 - PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine', 'Phase 2: Stage 2 - AG: Nab-paclitaxel + Gemcitabine', 'Phase 2: Stage 2 - PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine', 'Run-in Phase - AG: Nab-paclitaxel + Gemcitabine', 'Run-in Phase - PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine']}, {'type': 'DRUG', 'name': 'Enoxaparin', 'description': 'Enoxaparin will be administered as per the dose and schedule specified in the respective arms.', 'armGroupLabels': ['Phase 2: Stage 2 - AG: Nab-paclitaxel + Gemcitabine', 'Phase 2: Stage 2 - PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine']}] | PrimaryOutcomes: [{'measure': 'Progression-Free Survival (PFS)', 'description': 'PFS: time from randomization until first occurrence of disease progression, either by central radiologic determination (Response Evaluation Criteria in Solid Tumours \\[RECIST\\] version 1.1) or by clinical progression determined by Investigator, or death during treatment period from any cause. Radiological disease progression was defined as at least a 20 percent (%) increase in sum of diameters of target lesions, taking as reference the smallest sum on study thus far, nadir (this included baseline sum if that was the smallest on study); Sum must also demonstrate an absolute increase of at least 5 millimeters (mm); Appearance of one or more new lesions; Unequivocal progression of existing non-target lesions. Surviving participants without disease progression were censored for PFS analysis at the date of last evaluable post-baseline tumor assessment. Surviving participants without any post-baseline disease assessment were censored on Day 1. PFS was estimated using Kaplan-Meier (KM) method.', 'timeFrame': 'From the date of randomization until disease progression or death from any cause (maximum exposure: 30.72 months for PAG, and 20.27 months for AG)'}, {'measure': 'Percentage of Participants in the PAG Arm Who Experienced Any Thromboembolic (TE) Event in Stage 2 of the Study', 'description': "TE events were identified by applying the Medical Dictionary for Regulatory Activities (MedDRA) Standardized MedDRA Queries (SMQ) search strategy for 3 SMQs: TE arterial, TE venous, and TE vessel type unspecified and mixed arterial and venous. TE events were considered by the Sponsor to be adverse events (AEs) of special interest. All TE events, regardless of type of event, severity, or seriousness were reported. Participants with multiple events were counted only once. A summary of serious and all other non-serious adverse events regardless of causality is located in the 'Reported AE section'.", 'timeFrame': 'From first exposure to any study drug (PEGPH20, NAB, GEM) through 30 days after end of treatment visit (maximum exposure: 30.72 months for PAG)'}] | SecondaryOutcomes: [{'measure': 'PFS in Relation to Tumor Hyaluronan (HA) Levels', 'description': 'PFS was defined as time from randomization until first occurrence of disease progression, either by central radiologic determination (RECIST version 1.1) or by clinical progression determined by Investigator, or death during treatment period from any cause. Disease progression was defined as at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study thus far, nadir (this included baseline sum if that was the smallest on study); Sum must also demonstrate an absolute increase of at least 5 mm; Appearance of one or more new lesions; Unequivocal progression of existing non-target lesions. Surviving participants without disease progression were censored for PFS analysis at the date of last evaluable post-baseline tumor assessment. Surviving participants without any post-baseline disease assessment were censored on Day 1. PFS was estimated using KM method. PFS was measured in HA-high and HA-low participants.', 'timeFrame': 'From the date of randomization until disease progression or death from any cause (maximum exposure: 30.72 months for PAG, and 20.27 months for AG)'}, {'measure': 'Objective Response Rate (ORR): Percentage of Participants With Objective Response', 'description': 'ORR was defined as percentage of participants who achieved either a complete response (CR) or partial response (PR) regardless of confirmation, as assessed by RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions; Any pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\\<) 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.', 'timeFrame': 'From the date of randomization until last date on study treatment (maximum exposure: 30.72 months for PAG, and 20.27 months for AG)'}, {'measure': 'Overall Survival', 'description': 'Overall survival was defined as the time from randomization until death from any cause. Participants who died or were lost to follow-up by the date of analysis data cutoff were censored at their last contact date.', 'timeFrame': 'From randomization until death from any cause (maximum exposure: 30.72 months for PAG, and 20.27 months for AG)'}, {'measure': 'Percentage of Participants With AEs', 'description': "An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.", 'timeFrame': 'From first exposure to any study drug (PEGPH20, NAB, GEM) through 30 days after end of treatment visit (maximum exposure: 30.72 months for PAG and 20.27 months for AG)'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of PEGPH20', 'description': 'Samples were analyzed for PEGPH20 concentration using a validated electrochemiluminescence immunoassay. Plasma samples to assess the potential effects of NAB+GEM on PEGH20 pharmacokinetic (PK) were collected in the PAG treatment group in the run-in phases (Run-in Phase 1: Original PEGPH20 formulation \\[3.5 mg/mL\\], and Run-in Phase 2: New PEGPH20 formulation \\[0.3 mg/mL\\]).', 'timeFrame': 'Pre-PEGPH20 dosing and 15 minutes, 1 hour, 2 hours, and 4 hours post-PEGPH20 dosing on Days 1 and 15 of Cycle 1'}, {'measure': 'Time to Reach Cmax (Tmax) of PEGPH20', 'description': 'Samples were analyzed for PEGPH20 concentration using a validated electrochemiluminescence immunoassay. Plasma samples to assess the potential effects of NAB+GEM on PEGH20 PK were collected in the PAG treatment group in the run-in phases (Run-in Phase 1: Original PEGPH20 formulation \\[3.5 mg/mL\\], and Run-in Phase 2: New PEGPH20 formulation \\[0.3 mg/mL\\]).', 'timeFrame': 'Pre-PEGPH20 dosing and 15 minutes, 1 hour, 2 hours, and 4 hours post-PEGPH20 dosing on Days 1 and 15 of Cycle 1'}, {'measure': 'Area Under the Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) of PEGPH20', 'description': 'Samples were analyzed for PEGPH20 concentration using a validated electrochemiluminescence immunoassay. Plasma samples to assess the potential effects of NAB+GEM on PEGH20 PK were collected in the PAG treatment group in the run-in phases (Run-in Phase 1: Original PEGPH20 formulation \\[3.5 mg/mL\\], and Run-in Phase 2: New PEGPH20 formulation \\[0.3 mg/mL\\]).', 'timeFrame': 'Pre-PEGPH20 dosing and 15 minutes, 1 hour, 2 hours, and 4 hours post-PEGPH20 dosing on Days 1 and 15 of Cycle 1'}] |
Title: Prevalence of Sleep-disordered Breathing in Patients With a Newly Diagnosed Non Small Cell Lung Cancer | Condition: Bronchial Cancer | Keywords: | Summary: | Description: There is a possible implication of sleep apnea syndrome via night-time intermittent hypoxemia in perturbation of quality of life and tumour progression to patients with a bronchial cancer.
Enrollment 1200 patients This wide sample is expected to respond to the main and secondary objectives of the study | ArmGroups: [{'label': 'With and without SDB', 'type': 'OTHER', 'description': 'comparison of patients with and without sleep-disordered breathing', 'interventionNames': ['Device: With and without SDB']}] | Interventions:[{'type': 'DEVICE', 'name': 'With and without SDB', 'description': 'Screening of sleep-disordered breathing (SDB)', 'armGroupLabels': ['With and without SDB']}] | PrimaryOutcomes: [{'measure': 'Oxygen desaturation index', 'description': 'RECORDING BY POLYGRAPHY DEVICE between day 1 and day 15 after enrollment', 'timeFrame': 'Between day 1 and day 15'}] | SecondaryOutcomes: N/A |
Title: Phase I Study of the Pan-ERBB Inhibitor Neratinib Given in Combination With Everolimus, Palbociclib, or Trametinib in Advanced Cancer Subjects With EGFR Mutation/Amplification, HER2 Mutation/Amplification, or HER3/4 Mutation or KRAS Mutation | Condition: Advanced Malignant Solid Neoplasm, EGFR Gene Amplification, EGFR Gene Mutation, ERBB2 Gene Amplification, ERBB2 Gene Mutation, ERBB3 Gene Mutation, ERBB4 Gene Mutation, KRAS Gene Mutation, Metastatic Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm | Keywords: | Summary: | Description: PRIMARY OBJECTIVES:
I. To evaluate the safety and tolerability of neratinib when combined with one of the following agents:
Ia. Arm 1: Everolimus (mTOR inhibitor) Ib. Arm 2: Palbociclib (CDK 4/6 inhibitor) Ic. Arm 3: Trametinib (MEK inhibitor). II. To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of neratinib combination therapy.
SECONDARY OBJECTIVES:
I. To determine preliminary anti-tumor efficacy of neratinib combination therapy.
II. To determine pharmacodynamic markers in tissue, blood and plasma that may predict outcome.
III. To explore the potential of drug-drug interactions by evaluating the pharmacokinetic profile of each agent when administered in these combinations: neratinib+everolimus, neratinib+palbocclib, and neratinib+trametinib and blood-based biomarkers.
EXPLORATORY OBJECTIVES:
I. To determine baseline molecular markers (deoxyribonucleic acid \[DNA\], ribonucleic acid \[RNA\] and protein) that may predict clinical benefit.
II. To determine concordance of human epidermal growth factor receptor mutation (EGFR, HER2, HER3, and HER4) or EGFR, HER2 amplification in archival tissue and pre-treatment biopsies. Impact of these correlatives on response will be explored.
III. To determine concordance of human epidermal growth factor receptor mutation (EGFR, HER2, HER3, and HER4) or EGFR, HER2 amplification in tumor and cell-free DNA (cfDNA). Impact of these correlatives on response will be explored.
IV. To utilize cfDNA from plasma specimens collected during the course of treatment to explore mechanisms of primary and acquired resistance to neratinib combination therapy.
OUTLINE: This is a dose-escalation study. Participants are assigned to 1 of 3 arms.
ARM I: Participants receive neratinib orally (PO) daily and everolimus PO daily. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ARM II: Participants receive neratinib PO daily and palbociclib PO daily for 3 weeks followed by 1 week off. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ARM III: Participants receive neratinib PO daily and trametinib PO daily as directed. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up at 30 days. | ArmGroups: [{'label': 'Arm I (neratinib, everolimus)', 'type': 'EXPERIMENTAL', 'description': 'Participants receive neratinib PO daily and everolimus PO daily. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Everolimus', 'Drug: Neratinib']}, {'label': 'Arm II (neratinib, palbociclib)', 'type': 'EXPERIMENTAL', 'description': 'Participants receive Neratinib PO daily for 28 days and Palbociclib PO daily for 21 days. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Neratinib', 'Drug: Palbociclib']}, {'label': 'Arm III (neratinib, trametinib)', 'type': 'EXPERIMENTAL', 'description': 'Participants receive neratinib PO daily and trametinib PO daily as directed. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Neratinib', 'Drug: Trametinib']}] | Interventions:[{'type': 'DRUG', 'name': 'Everolimus', 'description': 'Given PO', 'armGroupLabels': ['Arm I (neratinib, everolimus)'], 'otherNames': ['42-O-(2-Hydroxy)ethyl Rapamycin', 'Afinitor', 'Certican', 'RAD 001', 'RAD001', 'Votubia', 'Zortress']}, {'type': 'DRUG', 'name': 'Neratinib', 'description': 'Given PO', 'armGroupLabels': ['Arm I (neratinib, everolimus)', 'Arm II (neratinib, palbociclib)', 'Arm III (neratinib, trametinib)'], 'otherNames': ['(2E)-N-(4-((3-chloro-4-((pyridin-2-yl)methoxy)phenyl)amino)-3-cyano-7-ethoxyquinolin-6-yl)-4-(dimethylamino)but-2-enamide', 'HKI 272', 'HKI-272', 'PB 272', 'PB-272']}, {'type': 'DRUG', 'name': 'Palbociclib', 'description': 'Given PO', 'armGroupLabels': ['Arm II (neratinib, palbociclib)'], 'otherNames': ['6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-8h-pyrido(2,3-d)pyrimidin-7-one', 'Ibrance', 'PD 0332991', 'PD 332991', 'PD 991', 'PD-0332991']}, {'type': 'DRUG', 'name': 'Trametinib', 'description': 'Given PO', 'armGroupLabels': ['Arm III (neratinib, trametinib)'], 'otherNames': ['GSK1120212', 'JTP-74057', 'MEK Inhibitor GSK1120212', 'Mekinist']}] | PrimaryOutcomes: [{'measure': 'Maximum tolerated dose (MTD) of neratinib when given in combination with everolimus, palbociclib, or trametinib', 'description': 'Defined by dose-limiting toxicity (DLT). The MTD will be defined as the highest dose at which no more than 1 of 6 evaluable subjects has had a DLT.', 'timeFrame': 'Up to 28 days'}] | SecondaryOutcomes: [{'measure': 'Incidence of adverse events of neratinib when given in combination with everolimus, palbociclib, or trametinib', 'description': 'National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 will be used to quantify the intensity of adverse events occurring during treatment in this study.', 'timeFrame': 'Up to 30 days post last dose'}, {'measure': 'Objective response', 'description': 'Per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. The anti-tumor efficacy of each combination will be evaluated by objective response by RECIST v1.1. This analysis will not utilize statistical analysis per standard phase I trials.', 'timeFrame': 'Up to 5 years'}, {'measure': 'Determination of pharmacodynamics markers in tissue, blood, and plasma', 'description': 'Pharmacodynamics markers in tissue, blood, and plasma will be determined that may predict outcome and exploration of the pharmacokinetic profile of each agent when administered in combination. Marker values will be compared between subjects with and without clinical benefit using chi-squared or Fisher exact tests for categorically-scaled markers and Wilcoxon rank sum tests for interval- and ordinal-scaled markers. Due to the large number of candidate markers, only those significant on univariate analysis will be combined into a single logistic regression model to assess their independent effects on clinical benefit. Analyses will be performed both within and across the three cohorts. Results will be considered exploratory and thus no corrections will be made for multiple testing.', 'timeFrame': 'Up to completion of treatment'}] |
Title: Adjuvant Toripalimab Versus Placebo Combined With Chemotherapy for EGFR/ALK Mutation Negative Stage II-IIIB(N2) Non-small-cell Lung Cancer (LungMate-008): a Randomised, Double-blind, Controlled, Phase 3 Trial | Condition: Non Small Cell Lung Cancer | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'Toripalimab', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Toripalimab']}, {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Drug: Toripalimab mimetic (placebo)']}] | Interventions:[{'type': 'DRUG', 'name': 'Toripalimab', 'description': 'Toripalimab: 240mg, IV, q3w, 4 cycles in total; Platinum-containing dual-drug chemotherapy: The specific dose is based on the standard of the selected protocol, IV, q3w, a total of 4 cycles.', 'armGroupLabels': ['Toripalimab'], 'otherNames': ['Cisplatin/Carboplatin', 'Pemetrexed (non-squamous cell carcinoma)/ Docetaxel/ Gemcitabine/ Vinorelbine/ Paclitaxel']}, {'type': 'DRUG', 'name': 'Toripalimab mimetic (placebo)', 'description': 'Placebo: 240mg, IV, q3w, 4 cycles in total; Platinum-containing dual-drug chemotherapy: The specific dose is based on the standard of the selected protocol, IV, q3w, a total of 4 cycles.', 'armGroupLabels': ['Placebo'], 'otherNames': ['Cisplatin/Carboplatin', 'Pemetrexed (non-squamous cell carcinoma)/ Docetaxel/ Gemcitabine/ Vinorelbine/ Paclitaxel']}] | PrimaryOutcomes: [{'measure': 'Disease-free survival (DFS)', 'description': 'It refers to the time from radical surgery to relapse or death of a participant due to disease progression. In the case of a patient who still survives at the time of analysis, the latest evaluation date will be used for interpolation (censoring).', 'timeFrame': 'up to 40 months'}] | SecondaryOutcomes: [{'measure': 'Overall survival (OS)', 'description': 'It is defined as the time from enrollment to death of participant due to any cause. In the case of a patient who still survives at the time of analysis, the date of last contact will be taken as the censoring date.', 'timeFrame': 'up to 60 months'}, {'measure': 'Safety: frequency of severe adverse events', 'description': 'The frequency of severe adverse events from the participants enrolling to 90 days after the last drug administration or 30 days after surgery or new anti-cancer therapy, which comes first.', 'timeFrame': 'up to 18 months'}, {'measure': 'Health related quality of life (HRQol)', 'description': "The assessment is made according to the Quality of Life Scale for Lung Cancer Patients (EORTC-QLQ-C30 \\& LC13, Version 3). EORTC's QLQ-C30 \\& LC13 (V3.0) is a core scale for lung cancer patients, with a total of 43 items. Among them, Item 29 and 30 are divided into seven grades, which are assigned with 1 to 7 scores according to the answer options. The other items are divided into 4 grades: Not at All, A Little, Quite a Bit, and Very Much, assigned with 1 to 4 scores respectively. The higher score, the worse quality.", 'timeFrame': 'up to 12 months'}, {'measure': '5-year overall survival rate', 'description': 'Five-year survival rate measures survival at 5 years after treatment.', 'timeFrame': 'From the completion of the intervention to 5 years.'}] |
Title: Pilot Study of Radiofrequency Ablation of Breast Cancer Lumpectomy Sites to Decrease Re-operation | Condition: Cancer of the Breast | Keywords: Breast cancer, Lumpectomy, Radiofrequency Ablation, Negative margins, Breast Conserving Surgery | Summary: | Description: While RFA alone is not approved for tumor destruction in breast it is FDA-approved for ablation of soft tissue after the breast cancer is removed. This study seeks to remove the tumor and then ablate a tumor-free zone (margin) of tissue around the lumpectomy site instead of removing more tissue. The primary short-term goal is to obviate the need for re-excision in the event of close or positive margins (\< 3 mm) which occurs on average in \~40 percent of the cases. Permanent pathology is only an estimation of margin status since 90% of recurrences occur at the site of the original lumpectomy. RFA ensures a sterilized margin regardless of the accuracy of the permanent pathology. | ArmGroups: [{'label': '1', 'type': 'OTHER', 'description': 'This is a non-randomized one arm study, all subjects receive treatment (radiofrequency ablation).', 'interventionNames': ['Device: AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe)']}] | Interventions:[{'type': 'DEVICE', 'name': 'AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe)', 'description': 'Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.', 'armGroupLabels': ['1']}] | PrimaryOutcomes: [{'measure': 'Number of Patients Requiring 2nd Surgery for Close or Positive Margins', 'description': 'A "close" surgical margin implies that cancer cells are found on pathology to be very close to the surgical margin, and a "wide" surgical margin implies the tumor exists far from the cut edge or the surgical margin. For this study, we defined "close" as less than 3 mm.', 'timeFrame': 'Margins assessed at Final Pathology, approximately 1 week post-RF surgery'}] | SecondaryOutcomes: [{'measure': 'Recurrence of Breast Cancer at Prior Site of Disease', 'timeFrame': 'Until study end (2 years)'}] |
Title: PSMAtrack-tracking Changes in PSMA-PET During Initial Therapy for Metastatic Hormone-sensitive Prostate Cancer | Condition: Metastatic Prostate Cancer, Hormone Sensitive Prostate Cancer, Metastatic Hormone-sensitive Prostate Cancer (mHSPC) | Keywords: PSMA, PET, Metastatic Hormone-sensitive Prostate Cancer (mHSPC), prostate cancer | Summary: | Description: The current approach to imaging metastatic hormone sensitive prostate cancer (mHSPC) is via conventional scans (CT/MRI/bone scan), but prostate specific membrane antigen (PSMA)-positron emission tomography (PET) is being increasingly used for imaging prostate cancer. Given its greater diagnostic accuracy compared to conventional imaging, there is a strong rationale to evaluate PSMA-PET in imaging mHSPC. Moreover, serial imaging with PSMA-PET may offer a better opportunity to evaluate disease response with systemic therapy and potentially use the results to guide therapy, given that PSMA-targeted radioligand therapy (177Lu-PSMA-617) is now approved for metastatic castrate-resistant prostate cancer (mCRPC). Furthermore, the 6-month timepoint after initiation of systemic therapy is an ideal time to perform interim PSMA-PET given that 6-month prostate specific antigen (PSA) has strong prognostic value in mHSPC in the era of intensified systemic therapy.
This is a prospective trial of 18F-rhPSMA-7.3 PSMA-PET/CT at baseline and after 6 months of therapy for mHSPC, with the aim of evaluating changes in disease extent during this timeframe and correlating this with the PSA response. Results from this pilot study could be used to plan trials assessing (de)intensification of therapy at 6 months based on PSMA-PET.
The primary study objective is to determine the proportion of patients with residual PSMA-avid disease on 18F-rhPSMA-7.3 PSMA-PET after 6 months of therapy for mHSPC.
Exploratory objectives are:
* To correlate presence/absence of residual PSMA-avid disease after 6 months with PSA ≤0.2 ng/mL at 6 months of therapy.
* To evaluate changes in SUVmax, SUVmean, total tumor volume and other PET imaging parameters between baseline and 6 months.
* To evaluate PET imaging parameters at baseline that predict for achievement of PSA ≤0.2 ng/mL at 6 months.
* To explore use of artificial intelligence (AI) and machine learning (ML) tools in delineating tumor burden and volume on 18F-rhPSMA-7.3 PSMA-PET.
Patients will undergo baseline 18F-rhPSMA-7.3 PSMA-PET/CT and 18F-rhPSMA-7.3 PSMA-PET/CT 6 months after starting treatment for mHSPC with androgen deprivation therapy and androgen receptor pathway inhibitor with or without docetaxel.
Patients will be followed via chart review for 1 year after the 6 month PSMA-PET/CT scan or death, whichever occurs first. | ArmGroups: [{'label': 'PSMA-PET/CT arm', 'type': 'EXPERIMENTAL', 'description': 'Patients will undergo 18F-rhPSMA-7.3 PSMA PET/CT scan before and after 6 months of treatment for metastatic hormone sensitive prostate cancer.\n\nPatients will undergo chart review every 3 months for 1 year after the second 18F-rhPSMA-7.3 PSMA PET/CT scan.', 'interventionNames': ['Drug: 18F-rhPSMA-7.3', 'Device: PET/CT']}] | Interventions:[{'type': 'DRUG', 'name': '18F-rhPSMA-7.3', 'description': 'radiopharmaceutical targeting PSMA and used to image prostate cancer with PET scan.', 'armGroupLabels': ['PSMA-PET/CT arm']}, {'type': 'DEVICE', 'name': 'PET/CT', 'description': 'Diagnostic imaging test', 'armGroupLabels': ['PSMA-PET/CT arm']}] | PrimaryOutcomes: [{'measure': 'Proportion of patients with residual PSMA-avid disease on 18F-rhPSMA7.3 PSMA PET after 6 months of treatment for metastatic hormone sensitive prostate cancer', 'description': 'metric use is percent of men with residual PSMA avid disease compared to all men undergoing the scan.', 'timeFrame': 'At the time of the 18F-rhPSMA-7.3 PSMA-PET/CT scan done 6 months after starting therapy for metastatic hormone sensitive prostate cancer'}] | SecondaryOutcomes: N/A |
Title: Safety and Efficacy Study of Chimeric Antigen Receptor T (CAR-T) Cells in the Treatment of Relapsed/Refractory Hematological Malignancies | Condition: Relapsed/Refractory Hematological Malignancies, Lymphoma, Myeloma, Leukemia | Keywords: CD19 CAR-T, BCMA CAR-T, CD7 CAR-T, CD123 CAR-T | Summary: | Description: CAR-T cells targeted CD19 have demonstrated unprecedented successes. Besides CD19, many other molecules such as CD123, BCMA, and CD7 may be potential in developing the corresponding CAR-T cells to treat patients with hematopoietic and lymphoid malignancies. UTC Therapeutics Inc. have developed an efficient platform for constructing CAR-T cells that can remodel of tumor microenvironment and enhance the anti-tumor immune response and persistence of CAR-T cells. In this study, all eligible subjects will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by investigational treatment, CAR-T cells. Safety and efficacy of the CAR-T cells will be assessed. | ArmGroups: [{'label': 'Autologous CAR-T cells', 'type': 'EXPERIMENTAL', 'description': 'A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, CAR-T cells. CAR-T cells targeted CD19/BCMA/CD123/CD7 are autologous genetically modified T cells.', 'interventionNames': ['Biological: Autologous CAR-T cells', 'Drug: Fludarabine', 'Drug: Cyclophosphamide']}] | Interventions:[{'type': 'BIOLOGICAL', 'name': 'Autologous CAR-T cells', 'description': 'D0: CAR-T cells will be infused intravenously.', 'armGroupLabels': ['Autologous CAR-T cells']}, {'type': 'DRUG', 'name': 'Fludarabine', 'description': 'D-5 to D-3: Fludarabine (30 mg/m\\^2/day) will be administered intravenously for 3 days.', 'armGroupLabels': ['Autologous CAR-T cells'], 'otherNames': ['Fludara']}, {'type': 'DRUG', 'name': 'Cyclophosphamide', 'description': 'D-5 to D-3: Cyclophosphamide (500 mg/m\\^2/day) will be administered intravenously for 3 days.', 'armGroupLabels': ['Autologous CAR-T cells'], 'otherNames': ['Cytoxan']}] | PrimaryOutcomes: [{'measure': 'TEAEs', 'description': 'Incidence and severity of Treatment Emergent Adverse Event.', 'timeFrame': '4 weeks'}, {'measure': 'TRAEs', 'description': 'Incidence and severity of Treatment Related Adverse Events.', 'timeFrame': '4 weeks'}, {'measure': 'AESIs', 'description': 'Incidence and severity of AEs of Special Interest.', 'timeFrame': '4 weeks'}] | SecondaryOutcomes: [{'measure': 'Objective Response Rate (ORR) (PR+CR)', 'description': 'The proportion of patients with complete response(CR) or partial response(PR)', 'timeFrame': '12 months'}, {'measure': 'Progression-Free Survival (PFS)', 'description': 'PFS was defined as the time from CAR-T infusion to the date of disease progression or death from any cause.\n\nParticipants not meeting the criteria for progression by the analysis data cutoff date were censored at their last evaluable disease assessment date.', 'timeFrame': '12 months'}, {'measure': 'Overall survival (OS)', 'description': 'OS was defined as the time from CAR-T infusion to the date of death. Participants who did not die by the analysis data cutoff date were censored at their last contact date.', 'timeFrame': '12 months'}] |
Title: Pilot Study to Improve Survivorship Care Related to Fertility and Family-building After Cancer | Condition: Cancer | Keywords: | Summary: | Description: Objective 1: Establish feasibility and acceptability of conducting research with YA-F cancer survivors at the Stanford Cancer Institute (SCI) and Lucile Packard Children's Hospital (LPCH).
Hypothesis 1: Study procedures will be feasible in the given timeframe and acceptable to patients, as evidence by recruitment, enrollment, and completion rates and participant feedback.
Objective 2: Evaluate the impact of using the tool as a part of survivorship care on patient reported outcomes (PROs; i.e., information needs, fertility distress, decision-making uncertainty, and satisfaction with care).
Hypothesis 2: In a single-arm pilot study (N=20), use of the decision aid tool will lead to improvements in fertility distress, decision-making uncertainty, and satisfaction with care. | ArmGroups: [{'label': 'Young adult female (YA-F) cancer survivors', 'type': 'EXPERIMENTAL', 'description': 'YA-F cancer survivors will complete a baseline survey (T1) of sociodemographic and patient reported outcomes (PRO) and then will be sent a link to access the decision aid tool (website) with instructions to review the website before their upcoming visit. A follow-up survey (T2) will be emailed 4-weeks post-baseline, prior to their clinic visit, to evaluate website access and PROs. A post-visit survey (T3) will be emailed 6- weeks post-baseline (after their survivorship care visit) to assess PROs.', 'interventionNames': ['Behavioral: Online decision aid tool']}] | Interventions:[{'type': 'BEHAVIORAL', 'name': 'Online decision aid tool', 'description': 'The decision aid intervention will be presented via a website', 'armGroupLabels': ['Young adult female (YA-F) cancer survivors']}] | PrimaryOutcomes: [{'measure': 'Decisional Conflict Scale (DCS)', 'description': 'The Decisional Conflict Scale (DCS) is a validated survey that assesses personal uncertainty in making healthcare decisions; modifiable factors contributing to uncertainty; and the quality of the decision made. It is reliable and responsive to change, and the most widely used measure of decision-making quality. The survey has 16 questions, with responses on a 5-point scale ranging from "strongly agree" (1) to "strongly disagree" (5).\n\nTotal scores range from 16 to 80, with higher scores indicating greater uncertainty (worse outcome). The outcome will be reported as the mean difference from baseline to 4-week and 6-week follow-up time points, with standard deviation.', 'timeFrame': '6 weeks'}] | SecondaryOutcomes: [{'measure': 'Unmet Fertility Information', 'description': 'This investigator-designed survey assesses perceived information needs about fertility topics such as the risk of infertility; risk of early menopause; options to assess fertility status; options to preserve fertility; and options for alternative family-building. The survey has 5 questions, each answered by a Yes / No response. Yes is scored as 1, and no is scored as 0. Total scores range from 0 to 5, with higher scores indicating greater perceived knowledge. The outcome will be reported as the mean difference from baseline to 4-week and 6-week follow-up time points, with standard deviation.', 'timeFrame': '6 weeks'}, {'measure': 'Reproductive Concerns After Cancer (RCAC) Scale', 'description': 'The Reproductive Concerns After Cancer (RCAC) Scale is a validated survey of cancer survivors\' fertility and health concerns. The survey has 18 questions, answered on a 5-point scale ranging from "strongly disagree" (1) to "strongly agree" (5). Total scores range from 18 to 90, with higher scores indicating greater distress (worse outcome). The outcome will be reported as the mean difference from baseline to 4-week and 6-week followup time points, with standard deviation.', 'timeFrame': '6 weeks'}, {'measure': 'COMRADE', 'description': 'The COMRADE is a measure of patient-based outcomes of risk communication within patient-provider interactions and treatment decision-making effectiveness. It consists of two subscales: Satisfaction with Communication \\& Confidence in Decision-making. Items were adapted to refer to fertility and reproductive health care options. The measure has 20 questions. Items are answered on a 5-point scale from "Strongly Disagree" to "Strongly Agree," with high scores indicating better outcomes.', 'timeFrame': '6 weeks'}] |
Title: Peroperative Assessment of Tumour Resection Margins Using High-resolution 18F-FDG-PET/CT in Malignancies of the Head and Neck, a Pilot Study | Condition: Head and Neck Neoplasms, Thyroid Neoplasm, Skin Neoplasm | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'intraoperative high-resolution PET-CT imaging of resected malignancy', 'type': 'EXPERIMENTAL', 'interventionNames': ['Diagnostic Test: high-resolution PET-CT specimen imaging.']}] | Interventions:[{'type': 'DIAGNOSTIC_TEST', 'name': 'high-resolution PET-CT specimen imaging.', 'description': 'Included patients are given a single weight-dependent activity of 18F-FDG at the department of Nuclear Medicine. After administration, patients are brought to the operating room where standard of care surgical removal of the malignancy is performed.\n\nThe resected specimen(s) are brought to the imaging lab and scanned using a preclinical and/or a dedicated specimen PET/CT device. Following PET/CT imaging, the specimen is brought to the department of pathology, where it is sliced. Some of these slices are then rescanned using the preclinical PET/CT device. Moreover, frozen sections are made from one of these slices with macroscopically visible malignant tissue and placed on an autoradiograph overnight. Finally, the imaging results are then correlated to the results found during histopathological analysis of the specimens.', 'armGroupLabels': ['intraoperative high-resolution PET-CT imaging of resected malignancy']}] | PrimaryOutcomes: [{'measure': 'Determine margin status in malignancies of the head and neck', 'description': 'To investigate the ability of high-resolution 18F-FDG-PET/CT-scan to determine the margin status in malignancies of the head and neck. This will be compared to the gold standard of histopathological examination.', 'timeFrame': '1 week after administration'}] | SecondaryOutcomes: [{'measure': 'Characterize the ideal activity of 18F-FDG', 'description': 'The characterization of the ideal dose of 18F-FDG necessary for specimen imaging with a sufficient signal-to-noise ratio. This dose will be identified using post-processing image reconstruction on the specimen resulting from patients given a standard diagnostic activity of 18F-FDG.', 'timeFrame': 'During data-analysis'}, {'measure': 'Identify positive lymph nodes using 18F-FDG PET/CT', 'description': 'To investigate the ability of high-resolution 18F-FDG-PET/CT to identify positive lymph nodes excised by neck dissection. This will be quantified as sensitivity and specificity compared to the gold standard of histopathological examination.', 'timeFrame': '1 week after administration'}, {'measure': 'Correlate distribution of 18F-FDG with histopathology', 'description': 'To correlate the distribution of 18F-FDG in and around tumoral tissue with the histopathology of the specimen. This will be performed by correlating the results obtained from the PET/CT-scan of (sliced) tumoral specimens and autoradiography of a frozen section of the tumour.', 'timeFrame': '1 day after administration'}] |
Title: A Phase 2 Trial Investigating Decitabine in Combination With a JAK-Inhibitor as a Bridge to Allogeneic Hematopoietic Stem Cell Transplant in Patients With Accelerated/Blast Phase Myeloproliferative Neoplasms | Condition: Acute Myeloid Leukemia, Essential Thrombocythemia, Myelodysplastic Syndrome, Myelodysplastic/Myeloproliferative Neoplasm, Myeloproliferative Neoplasm, Myeloproliferative Neoplasm, Unclassifiable, Polycythemia Vera, Primary Myelofibrosis, Secondary Myelofibrosis | Keywords: Myeloid and Monocytic Leukemia, Other Hematopoietic | Summary: | Description: OUTLINE:
Patients receive decitabine intravenously (IV) once daily (QD) over 1 hour on days 1-10, and either ruxolitinib orally (PO) twice daily (BID), fedratinib PO daily, or pacritinib PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for up to 5 years. | ArmGroups: [{'label': 'Treatment (decitabine, ruxolitinib, fedratinib, pacritinib)', 'type': 'EXPERIMENTAL', 'description': 'Patients receive decitabine IV QD over 1 hour on days 1-10, and either ruxolitinib PO BID, fedratinib PO daily, or pacritinib PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Decitabine', 'Drug: Ruxolitinib', 'Drug: Fedratinib', 'Other: Questionnaire Administration', 'Drug: Pacritinib']}] | Interventions:[{'type': 'DRUG', 'name': 'Decitabine', 'description': 'Given IV', 'armGroupLabels': ['Treatment (decitabine, ruxolitinib, fedratinib, pacritinib)'], 'otherNames': ['127716', "2''-Deoxy-5-azacytidine", "5-Aza-2''-deoxycytidine", 'Dacogen', 'Decitabine for Injection', 'Deoxyazacytidine', 'Dezocitidine']}, {'type': 'DRUG', 'name': 'Ruxolitinib', 'description': 'Given PO', 'armGroupLabels': ['Treatment (decitabine, ruxolitinib, fedratinib, pacritinib)'], 'otherNames': ['941678-49-5', 'INCB-18424', 'Jakafi', 'Oral JAK Inhibitor INCB18424']}, {'type': 'DRUG', 'name': 'Fedratinib', 'description': 'Given PO', 'armGroupLabels': ['Treatment (decitabine, ruxolitinib, fedratinib, pacritinib)'], 'otherNames': ['936091-26-8', 'SAR302503', 'TG101348']}, {'type': 'OTHER', 'name': 'Questionnaire Administration', 'description': 'Ancillary studies', 'armGroupLabels': ['Treatment (decitabine, ruxolitinib, fedratinib, pacritinib)']}, {'type': 'DRUG', 'name': 'Pacritinib', 'description': 'Given PO', 'armGroupLabels': ['Treatment (decitabine, ruxolitinib, fedratinib, pacritinib)'], 'otherNames': ['937272-79-2', 'Oral JAK2 Inhibitor SB1518', 'SB 1518', 'SB-1518', 'SB1518']}] | PrimaryOutcomes: [{'measure': 'Proportion of patients enrolled who receive hematopoietic stem cell transplantation (HCT)', 'timeFrame': 'Up to 5 years'}] | SecondaryOutcomes: [{'measure': 'Time from diagnosis of myeloproliferative neoplasm (MPN)-accelerated phase (AP)/blast phase (BP) to day 0 of HCT', 'description': 'Estimated as a simple proportion and informally compared to rates seen historically among patients treated with multi-agent chemotherapy or no pre-HCT therapy.', 'timeFrame': 'Up to day 0 of HCT'}, {'measure': 'Remission rate', 'description': 'Assessed via the Mascarenhas criteria. Estimated as a simple proportion and informally compared to rates seen historically among patients treated with multi-agent chemotherapy or no pre-HCT therapy.', 'timeFrame': 'At day 100'}, {'measure': 'Overall survival', 'description': 'Estimated as a simple proportion and informally compared to rates seen historically among patients treated with multi-agent chemotherapy or no pre-HCT therapy.', 'timeFrame': 'From day 0 of HCT, assessed until 12 months post HCT'}, {'measure': 'Relapse-free survival', 'description': 'Estimated as a simple proportion and informally compared to rates seen historically among patients treated with multi-agent chemotherapy or no pre-HCT therapy.', 'timeFrame': 'From day 0 of HCT, assessed until 12 months post HCT'}, {'measure': 'Mutational profiling', 'description': 'Mutational data will be descriptive. The study team will record mutations found on the next generation of sequencing assays and will watch how these profiles change over time', 'timeFrame': 'Up to 5 years'}, {'measure': 'Response rates regardless of transplant status', 'description': 'Assessed via Mascarenhas criteria. Estimated as a simple proportion and informally compared to rates seen historically among patients treated with multi-agent chemotherapy or no pre-HCT therapy.', 'timeFrame': 'From day 1 of study treatment, assessed up to 5 years'}, {'measure': 'Overall survival regardless of transplant status', 'description': 'Estimated as a simple proportion and informally compared to rates seen historically among patients treated with multi-agent chemotherapy or no pre-HCT therapy.', 'timeFrame': 'From day 1 of study treatment, assessed up to 5 years'}, {'measure': 'Relapse-free survival regardless of transplant status', 'description': 'Estimated as a simple proportion and informally compared to rates seen historically among patients treated with multi-agent chemotherapy or no pre-HCT therapy.', 'timeFrame': 'From day 1 of study treatment, assessed up to 5 years'}] |
Title: Imatinib Mesylate And Cyclophosphamide In Metronomic Administration: Dose Escalation Study Of Imatinib Mesylate in Patient With Rare Tumor (Phase I Study) | Condition: Cancer | Keywords: dermatofibrosarcoma, cylindroma, choroid melanoma, gastrointestinal stroma tumor, chordoma, ocular melanoma, conjunctival melanoma, malignant melanoma of the anus, gastric melanoma, desmoid tumor | Summary: | Description: N/A | ArmGroups: N/A | Interventions:[{'type': 'DRUG', 'name': 'Imatinib mesylate, Cyclophosphamide (Dosing level 1 )', 'description': 'CYCLE 1 (42 days):\n\n* Day 1 to 14 Imatinib mesylate : 400 mg/day, per os\n* Day 15 to 42 Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 400 mg/day, per os\n\nNEXT CYCLE (28 days):\n\nCyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 400 mg/day, per os'}, {'type': 'DRUG', 'name': 'Imatinib mesylate, Cyclophosphamide (Dosing level 2)', 'description': 'CYCLE 1 (42 days):\n\n* Day 1 to 14 Imatinib mesylate : 600 mg/day,(300 mg in the morning and 300 mg in the evening) per os\n* Day 15 to 42 Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 600 mg/day,(300 mg in the morning and 300 mg in the evening) per os\n\nNEXT CYCLE (28 days):\n\nCyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 600 mg/day,(300 mg in the morning and 300 mg in the evening)per os'}, {'type': 'DRUG', 'name': 'Imatinib mesylate, Cyclophosphamide (Dosing level 3)', 'description': 'CYCLE 1 (42 days):\n\n* Day 1 to 14 Imatinib mesylate : 800 mg/day,(400 mg in the morning and 400 mg in the evening) per os\n* Day 15 to 42 Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 800 mg/day,(400 mg in the morning and 400 mg in the evening) per os\n\nNEXT CYCLE (28 days):\n\nCyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 800 mg/day,(400 mg in the morning and 400 mg in the evening)per os'}, {'type': 'PROCEDURE', 'name': 'Blood sampling', 'description': 'ONLY FOR CYCLE 1, at day 15 and day 28 :\n\n11 sampling for dosing level 1 (pre-dose, imatinib mesylate + 30 min, +1, +2, +3, +4, +6, +10, +12 , +24 hours, cyclophosphamide + 12 hours) 10 sampling for the next dosing level (pre-dose, imatinib mesylate + 30 min, +1, +2, +3, +4, +6, +10, +12,cyclophosphamide + 12 hours)'}] | PrimaryOutcomes: [{'measure': 'For safety: NCI-CTCAE scale version 3.0', 'timeFrame': '42 days'}] | SecondaryOutcomes: [{'measure': 'For anti tumoral efficiency : RECIST criteria', 'timeFrame': '70 days'}] |
Title: Comparison of High-dose- Versus Low-dose-rate Brachytherapy as Monotherapy in the Treatment of Early, Organ Confined Prostate Cancer. | Condition: Adenocarcinoma of Prostate | Keywords: Prostate, Cancer, Brachytherapy, HDR, LDR, monotherapy | Summary: | Description: Permanent implant prostate brachytherapy (LDRPBT) is a well established and proved method in the treatment of patients with low or selected intermediate risk, organ confined prostate cancer.
There are number of studies with high-dose rate brachytherapy (HDRPBT) as monotherapy with several fractionation schedule treating the same group of patients. One phase II trial showed its effectiveness given in one fraction of 19 Gy.
In the trial investigators randomly select patients to treat with either LDR prostate brachytherapy (145Gy) or HDR prostate brachytherapy (1x19Gy) as monotherapy.
Patients are stratified into two pretreatment group: 1. low risk, 2. selected intermediate risk group.
Brachytherapy is given in spinal anaesthesia, using transrectal ultrasound based real time treatment planning. Dose constraints are defined for both methods. | ArmGroups: [{'label': 'LDRPBT', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients with low and selected intermediate risk prostate cancer are treated with Prostate LDR brachytherapy as monotherapy. 145 Gy is prescribed to the prostate. I-125 radioactive sources are used. Transperineal approach, rectal ultrasound guidance, inverse treatment planning, real time dose optimization is applied.', 'interventionNames': ['Radiation: LDR Brachytherapy']}, {'label': 'HDRPBT', 'type': 'EXPERIMENTAL', 'description': 'Patients with low and selected intermediate risk prostate cancer are treated with prostate HDR brachytherapy as monotherapy. The prescribed dose is 1x19 Gy to the whole prostate. Ir-192 radioactive source is used. Transperineal approach, rectal ultrasound guidance, inverse treatment planning, real time dose optimization is applied.', 'interventionNames': ['Radiation: HDR Brachytherapy']}] | Interventions:[{'type': 'RADIATION', 'name': 'LDR Brachytherapy', 'description': "In spinal anaesthesia patients' prostate are treated with low-dose-rate or brachytherapy using transrectal ultrasound guidance. Radiation sources (iodine-125 isotopes) are implanted into the prostate through transperineal needle insertion. Real time dose planning is applied. The prescribed dose to the whole prostate is 145 Gy.", 'armGroupLabels': ['LDRPBT'], 'otherNames': ['Seed brachytherapy', 'Permanent implantation prostate brachytherapy']}, {'type': 'RADIATION', 'name': 'HDR Brachytherapy', 'description': "In spinal anaesthesia patients' prostate are treated with one fraction of HDR brachytherapy. The prescribed dose to the whole prostate is 1x19 Gy. Ir-192 radioactive stepping source is used for the treatment with after-loading technique. Transperineal approach, rectal ultrasound guidance, inverse treatment planning, real time intraoperative needle position update and dose optimization is applied.", 'armGroupLabels': ['HDRPBT'], 'otherNames': ['temporary implant']}] | PrimaryOutcomes: [{'measure': 'Acute side effects', 'description': 'Acute gastrointestinal, urogenital and other side effects occuring within six months after the procedure, according to the Common Toxicity Criteria for Adverse Effects (CTCAE 4.0v) scale', 'timeFrame': '6 months'}, {'measure': 'Chronic side effects', 'description': 'Chronic gastrointestinal, urogenital and other side effects occuring within six months after the procedure, according to the CTCAE 4.0v scale', 'timeFrame': 'from 6 months to five year'}] | SecondaryOutcomes: [{'measure': 'quality of life', 'description': "Assessing patients' quality of life according to the a 25 question prostate module (PR-25) of the European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QlQ-30).", 'timeFrame': '5 years'}, {'measure': 'quality of life', 'description': "Assessing patients' quality of life according to the International Index for Erectile Function (IIEF) questionnaire", 'timeFrame': '5 years'}, {'measure': 'Biochemical relapse free survival (bRFS)', 'description': 'Censoring an event when biochemical relapse occurs using the American Society of Therapeutic Radiation and Oncology (ASTRO) Phoenix definition for PSA relapse (nadir + 2 ng/ml increase)', 'timeFrame': '5 years'}, {'measure': 'Locoregional tumor free survival', 'description': 'Censoring an event when either local or regional relapse occurs', 'timeFrame': '5 years'}, {'measure': 'Disease specific survival (DSS)', 'description': 'Censoring an event when patient dies due to prostate cancer', 'timeFrame': '5 years'}] |
Title: Phase II Double Blind Randomized Trial Evaluating the Biologic Effect of Levonorgestrel on the Double Blind Randomized Trial Evaluating the Biologic Effect of Levonorgestrel on the Ovarian Epithelium in Women at High Risk for Ovarian Cancer | Condition: Ovarian Carcinoma | Keywords: | Summary: | Description: PRIMARY OBJECTIVES:
I. Determine the impact of levonorgestrel on the relative frequency of apoptosis in the ovarian epithelium of patients at high risk for ovarian cancer.
SECONDARY OBJECTIVES:
I. Estimate the impact of this drug on proliferation and transforming growth factor-beta (TGF-beta) expression in the ovarian epithelium of these patients.
II. Assess the safety of this drug in these patients.
OUTLINE: This is a prospective, randomized, placebo-controlled, double-blind study. Patients are stratified according to menopausal status (premenopausal vs postmenopausal). Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive oral levonorgestrel once daily.
ARM II: Patients receive oral placebo once daily.
In both arms, treatment continues for 4-6 weeks in the absence of disease progression or unacceptable toxicity, including on the day of surgery. Patients then undergo prophylactic salpingo-oophorectomy. After completion of study therapy, patients are followed at 1 year.
NOTE: \* Patients who are unable to have surgery completed during the expected 4-6 weeks, may continue levonorgestrel or placebo for a time period no \> 5 months. Patients unable to undergo surgery within 5 months are removed from the study. | ArmGroups: [{'label': 'Arm I (levonorgestrel)', 'type': 'EXPERIMENTAL', 'description': 'Patients receive oral levonorgestrel once daily.', 'interventionNames': ['Other: Laboratory Biomarker Analysis', 'Drug: Levonorgestrel']}, {'label': 'Arm II (placebo)', 'type': 'PLACEBO_COMPARATOR', 'description': 'Patients receive oral placebo once daily.', 'interventionNames': ['Other: Laboratory Biomarker Analysis', 'Drug: Levonorgestrel', 'Other: Placebo']}] | Interventions:[{'type': 'OTHER', 'name': 'Laboratory Biomarker Analysis', 'description': 'Correlative studies', 'armGroupLabels': ['Arm I (levonorgestrel)', 'Arm II (placebo)']}, {'type': 'DRUG', 'name': 'Levonorgestrel', 'description': 'Given orally', 'armGroupLabels': ['Arm I (levonorgestrel)', 'Arm II (placebo)'], 'otherNames': ['18-Methylnorethisterone', 'D-(-)-Norgestrel', 'L-norgestrel', 'Mirena', 'Norplant', 'Plan B']}, {'type': 'OTHER', 'name': 'Placebo', 'description': 'Given orally', 'armGroupLabels': ['Arm II (placebo)'], 'otherNames': ['placebo therapy', 'PLCB', 'sham therapy']}] | PrimaryOutcomes: [{'measure': 'Median Proportion Cells That Are Apoptotic in Epithelial Ovarian Tissue', 'description': 'The median proportion of cells that are considered to be apoptotic are counted in the ovarian tissue sample, among the total number of cells available in the sample slide.', 'timeFrame': 'Surgical specimen (4 - 6 weeks after entry)'}, {'measure': 'Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0', 'description': 'Participants were graded using CTCAE v.30 criteria. Grade 1 is the least severe grade. Each adverse event lists criteria for grading, grade 1 being mild, up to grade 5. Grade 4 is generally life threatening. Grade 5 is death.', 'timeFrame': 'Up to 20 weeks'}] | SecondaryOutcomes: [{'measure': 'Proportion of Proliferation as Measured by Ki-67', 'timeFrame': 'Time of surgery (4 to 6 weeks after entry)'}, {'measure': 'Patients With High Expression of Transforming Growth Factor-beta 1', 'timeFrame': 'Baseline to time of surgery (4 to 6 weeks)'}] |
Title: Phase II Study of Gemcitabine, Trastuzumab, and Pertuzumab in the Treatment of Metastatic HER2-Positive Breast Cancer After Prior Trastuzumab/Pertuzumab- or Pertuzumab-Based Therapy | Condition: Metastatic HER2-Positive Breast Cancer | Keywords: Gemcitabine,, Trastuzumab, Pertuzumab, 14-124 | Summary: | Description: N/A | ArmGroups: [{'label': 'Gemcitabine, Trastuzumab, and Pertuzuma', 'type': 'EXPERIMENTAL', 'description': 'The regimen will consist of gemcitabine at 1000mg/m\\^2 IV weekly days 1 + 8 q 3 weeks + trastuzumab every 3 weeks (8 mg/kg loading dose followed by 6 mg/kg every 3 weeks) + pertuzumab every 3 weeks (840 mg as a loading dose followed by 420 mg every 3 weeks), all given intravenously (IV). Trastuzumab may be given IV weekly (4 mg/kg loading dose followed by 2 mg/kg weekly) in lieu of the every 3 week schedule. A loading dose of trastuzumab will not be required for patients who have received it \\< 6 weeks prior to Cycle 1 Day 1.', 'interventionNames': ['Drug: Gemcitabine', 'Drug: Trastuzumab', 'Drug: Pertuzumab']}] | Interventions:[{'type': 'DRUG', 'name': 'Gemcitabine', 'armGroupLabels': ['Gemcitabine, Trastuzumab, and Pertuzuma']}, {'type': 'DRUG', 'name': 'Trastuzumab', 'armGroupLabels': ['Gemcitabine, Trastuzumab, and Pertuzuma']}, {'type': 'DRUG', 'name': 'Pertuzumab', 'armGroupLabels': ['Gemcitabine, Trastuzumab, and Pertuzuma']}] | PrimaryOutcomes: [{'measure': 'progression free', 'description': 'Progression-free survival (PFS) is defined from time from treatment assignment to disease progression or death, whichever comes first. The primary endpoint is PFS and secondary endpoint will include the response rate using the RECIST criteria (version 1.1).', 'timeFrame': '3 months'}] | SecondaryOutcomes: [{'measure': 'progression-free survival', 'description': 'Progression-free survival (PFS) is defined from time from treatment assignment to disease progression or death, whichever comes first.', 'timeFrame': '2 years'}, {'measure': 'response', 'description': 'Response to treatment will be determined using both RECIST and PRC ( PET Response Criteria criteria).', 'timeFrame': '2 years'}, {'measure': 'overall survival', 'description': 'Progression-free survival and median overall survival will also be estimated by the Kaplan-Meier method.', 'timeFrame': '2 years'}, {'measure': 'safety', 'description': 'This study will use the NCI Common Toxicity Criteria (CTC) AE version 4.0 for toxicity.', 'timeFrame': '2 years'}] |
Title: Transperineal Laser Ablation for Low and Intermediate Risk Prostate Cancer: a Single Cohort Analysis | Condition: Prostate Cancer | Keywords: prostate cancer, focal therapy, Echolaser, transperineal laser ablation, TPLA | Summary: | Description: N/A | ArmGroups: [{'label': 'TPLA in patients with prostate cancer', 'type': 'EXPERIMENTAL', 'description': 'Patients diagnosed with low- and intermediate risk unifocal prostate cancer undergo to focal laser ablation therapy.', 'interventionNames': ['Procedure: Soractelite Echolaser Transperineal focal laser ablation']}] | Interventions:[{'type': 'PROCEDURE', 'name': 'Soractelite Echolaser Transperineal focal laser ablation', 'description': 'US/MRI fusion laser ablation of low- and intermediate risk prostate cancer', 'armGroupLabels': ['TPLA in patients with prostate cancer']}] | PrimaryOutcomes: [{'measure': 'Oncological outcomes MRI', 'description': 'Evaluation of transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by multiparametric prostate MRI. Specifically, 1. complete ablation, 2. partial ablation or 3. persistence of cancer will be identified.', 'timeFrame': '3 months after treatment'}, {'measure': 'Oncological outcomes MRI', 'description': 'Evaluation of transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by multiparametric prostate MRI. Specifically, 1. complete ablation, 2. partial ablation or 3. persistence of cancer will be identified.', 'timeFrame': '12 months after treatment'}, {'measure': 'Oncological outcomes PSA', 'description': 'Evaluation of transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by eventual reduction of PSA.', 'timeFrame': '3 months after treatment.'}, {'measure': 'Oncological outcomes PSA', 'description': 'Evaluation of transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by eventual reduction of PSA.', 'timeFrame': '6 months after treatment.'}, {'measure': 'Oncological outcomes PSA', 'description': 'Evaluation of transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by eventual reduction of PSA.', 'timeFrame': '12 months after treatment.'}, {'measure': 'Oncological outcomes Re-biopsy', 'description': 'Evaluation of histological outcomes after transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by eventual negativity for cancer in a re-biopsy.', 'timeFrame': '12 months after treatment'}] | SecondaryOutcomes: [{'measure': 'Functional outcomes IPSS and IPSS QoL', 'description': 'Evaluation of lower urinary tract symptoms and quality of life after transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by the IPSS, International Prostatic Symptoms Score.', 'timeFrame': '3, 6 and 12 months after treatment.'}, {'measure': 'Quality of life Pain', 'description': 'Evaluation of pain after transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by the visual analogue scale (VAS).\n\nThe VAS is a straight horizontal line of fixed length. The ends are defined as the extreme limits of the parameter to be measured (pain) from 0 to 10 orientated from the left (no pain) to the right (unbearable pain).', 'timeFrame': 'day after surgery'}, {'measure': 'Functional outcomes Continence', 'description': 'Evaluation of continence rate after transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by the ICIQ-SF, International Consulation on Incontinence Questionnaire - Short Form.', 'timeFrame': '3, 6 and 12 months after treatment.'}, {'measure': 'Functional outcomes Erection', 'description': 'Evaluation of erectile function after transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by the IIEF5, International Index of Erectile Function.', 'timeFrame': '3, 6 and 12 months after treatment.'}, {'measure': 'Functional outcomes Ejaculation', 'description': 'Evaluation of ejaculatory function after transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by the MSHQ SF, Male Sexual Health Questionnaire short form.', 'timeFrame': '3, 6 and 12 months after treatment.'}] |
Title: Prevention of Atrial Fibrillation in Patients Undergoing Thoracic Surgery for Lung Cancer | Condition: Lung Cancer, Atrial Fibrillation | Keywords: FAP= post-surgery atrial fibrillation, ACEI= angiotensin converting enzyme-inhibitors, ARBs= angiotensin II receptor blockers, NT-proBNP= brain natriuretic peptide | Summary: | Description: Postoperative atrial fibrillation is one of the most common complication after thoracic surgery for lung cancer, with an incidence ranging from 8 to 20% after lobectomy and up to 42% after pneumonectomy.
In a recent study we demonstrated that a high perioperative plasma levels of NT-proBNP is able to identify patients at risk for AF (incidence of 65%).
It has also been demonstrated that the renin-angiotensin system may play an important role in the pathophysiology of atrial fibrillation and that angiotensin converting enzyme inhibitors (ACEI) and angiotensin II receptor blockers (ARBs) are able to prevent atrial fibrillation in patients with heart failure, after myocardial infarction, in hypertensive patients and after electrical cardioversion. | ArmGroups: [{'label': 'Losartan', 'type': 'ACTIVE_COMPARATOR', 'description': 'angiotensin II-receptor blocker', 'interventionNames': ['Drug: Losartan']}, {'label': 'no treatment', 'type': 'NO_INTERVENTION', 'description': 'no preventive treatment'}, {'label': 'Metoprolol', 'type': 'ACTIVE_COMPARATOR', 'description': 'beta-adrenergic antagonist', 'interventionNames': ['Drug: Metoprolol']}] | Interventions:[{'type': 'DRUG', 'name': 'Metoprolol', 'description': 'Metoprolol; 100 mg x 2 die (tablets); started within 12 hours after surgery and continued for the duration of hospital stay', 'armGroupLabels': ['Metoprolol'], 'otherNames': ['SELOKEN, LOPRESOR']}, {'type': 'DRUG', 'name': 'Losartan', 'description': 'Losartan; 50 mg die (tablets); started within 12 hours after surgery and continued for the duration of hospital stay', 'armGroupLabels': ['Losartan'], 'otherNames': ['LORTAAN, NEOLOTAN, LOSAPREX']}] | PrimaryOutcomes: [{'measure': 'Incidence of postoperative atrial fibrillation', 'timeFrame': 'up to 10 days'}] | SecondaryOutcomes: [{'measure': 'Evaluation of NT-proBNP in the days following the start of treatment and post surgery duration of hospital stay', 'timeFrame': 'up to 10 days'}] |
Title: A Phase I/II Dose-Escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors With a KRAS G12D Mutation | Condition: Solid Tumor | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'Phase I Arm A', 'type': 'EXPERIMENTAL', 'description': 'Dose escalation and expansion arm', 'interventionNames': ['Drug: Phase I Arm A']}, {'label': 'Phase I Arm B', 'type': 'EXPERIMENTAL', 'description': 'Dose escalation and expansion arm', 'interventionNames': ['Drug: Phase I Arm B']}] | Interventions:[{'type': 'DRUG', 'name': 'Phase I Arm A', 'description': 'Dose escalation and expansion arm, with protocol-defined dose(s) of GDC-7035', 'armGroupLabels': ['Phase I Arm A']}, {'type': 'DRUG', 'name': 'Phase I Arm B', 'description': 'Dose escalation and expansion arm, with protocol-defined dose(s) of GDC-7035 in combination with other anti-cancer therapies', 'armGroupLabels': ['Phase I Arm B']}] | PrimaryOutcomes: [{'measure': 'Percentage of Participants with Adverse Events, with Severity Determined According to the CTCAE v5.0 Grading Scale', 'timeFrame': '4 Years'}, {'measure': 'Percentage of Participants with Dose Limiting Toxicity', 'timeFrame': '4 Years'}] | SecondaryOutcomes: [{'measure': 'Plasma Concentrations of GDC-7035 at Specified Timepoints', 'timeFrame': '4 Years'}, {'measure': 'Blood Concentrations of GDC-7035 at Specified Timepoints', 'timeFrame': '4 Years'}, {'measure': 'Plasma Concentrations at Specified Timepoints of GDC-7035 Administered in the Fasted State or with a Standardized High-Fat Meal', 'timeFrame': '4 Years'}, {'measure': 'Blood Concentrations at Specified Timepoints of GDC-7035 Administered in the Fasted State or with a Standardized High-Fat Meal', 'timeFrame': '4 Years'}, {'measure': 'Objective Response Rate Among Participants', 'timeFrame': '4 Years'}, {'measure': 'Duration of Response Among Participants', 'timeFrame': '4 Years'}, {'measure': 'Median Progression Free Survival Time Among Participants', 'timeFrame': '4 Years'}] |
Title: A Non-randomized Prospective Cohort Study to Improve Follow-up Adherence, Survivorship Knowledge and Late Effects Documentation at a Childhood Cancer Clinic in Western Kenya: A Study Protocol | Condition: Pediatric Cancer, Survivorship | Keywords: Aftercare, Health Education, Patient Compliance, Surveillance | Summary: | Description: This non-randomized prospective cohort study will be performed at a referral hospital in Western Kenya. Hundred caregivers of children diagnosed with cancer, who will complete treatment within two months, will be enrolled and followed for 24 months after completion of treatment. A caregiver control group receiving usual care will be recruited and sequentially, caregivers will be included in an intervention group to attend an educational group session and receive educational materials (video, booklet and Survivorship Card). Primary study outcome will be survivors' follow-up adherence. Survivors will be considered lost to follow-up after missing a scheduled appointment and subsequently do not revisit the clinic for more than six months. Mixed models regression analyses will be performed to determine intervention effects on follow-up adherence and secondly on caregiver survivorship knowledge uptake. Additionally, healthcare providers will be trained on follow-up care, whereafter a form will be introduced at the outpatient clinic to document late effects in pediatric survivors attending the clinic for the period of a year. Secondary outcomes will be late effects prevalence as documented in the Follow-Up Form and healthcare provider survivorship knowledge uptake. Implementation measures (reach, potential effectiveness, adoption, satisfaction and maintenance) will be evaluated for both programs. | ArmGroups: [{'label': '"Usual Care"', 'type': 'NO_INTERVENTION', 'description': 'Participants receiving "Usual Care" group (A), will be recruited during the last two months of treatment (T-2). At the end of treatment (T0), participants will complete a knowledge questionnaire and will be followed for another 24 months. At six months after treatment completion (T6), a final follow-up knowledge assessment will be conducted. Participants will be enrolled into group A until the intended sample size of 50 participants is reached. Investigators estimated to have reached this number within four to six months based on recent survival rates.'}, {'label': '"Educational Intervention"', 'type': 'EXPERIMENTAL', 'description': 'A similar procedure will apply to the "Educational Intervention" group (B). Participants will complete a knowledge assessment before receiving an educational intervention between T-2 and T0. To evaluate early and late knowledge uptake, participants will complete a post-education knowledge assessment at T0 and a follow-up knowledge assessment at T6. Follow-up adherence will be evaluated at every three months for the first year and at every six months during the second year after treatment completion for both groups. Implementation measures will be captured starting at T3 until T24, together with a satisfaction questionnaire that will be administered at T6.', 'interventionNames': ['Behavioral: Educational Program (video, information booklet, Survivorship Card)']}, {'label': '"Follow-Up Forms implementation"', 'type': 'OTHER', 'description': 'Healthcare provider training on survivorship will start at the same timepoint as recruitment of the "Educational Intervention" group (A) at T-2.\n\nFollow-Up Forms will be introduced at the outpatient clinic once an estimated 30 healthcare providers have done the training (anticipated at T0). Healthcare providers will fill in a knowledge assessment directly pre- and post-training (T-2) and at six months post-training (T4).\n\nDocumentation of late effect symptoms will be monitored for twelve months, starting at T0. Implementation measures will be collected weekly starting from T0 and healthcare providers will be assigned to a satisfaction questionnaire at T6.', 'interventionNames': ['Behavioral: Follow-Up Program (form and healthcare provider training)']}] | Interventions:[{'type': 'BEHAVIORAL', 'name': 'Educational Program (video, information booklet, Survivorship Card)', 'description': "Caregivers will be invited to attend an educational group session. Each session will be organized weekly to monthly. A maximum of ten caregivers can be present at a session.\n\nFirst a video will be displayed in which healthcare providers explain medical aspects of survivorship. Caregivers of survivors and young adult survivors discuss experiences after completing cancer treatment in the video.\n\nSecondly, the present healthcare provider will hand over an information booklet 'Life after childhood cancer' to the caregivers. The booklet covers similar topics as presented in the video.\n\nLastly, a Survivorship Card will be shared with the caregivers. The card contains a record of the patient's cancer and treatment history and the expected follow-up appointment schedule. The survivor and family take one card home and a duplicate copy of the card remains in the medical file.", 'armGroupLabels': ['"Educational Intervention"']}, {'type': 'BEHAVIORAL', 'name': 'Follow-Up Program (form and healthcare provider training)', 'description': 'Healthcare providers will attend a training session of approximately 90 minutes, in which investigators will discuss the same topics as covered in the educational group session supported by PowerPoint slides.\n\nA Follow-Up Form will be introduced to be used by healthcare providers in the outpatient follow-up clinic. The form will include questions referring to symptoms specific for certain late effects. Specific questions will be included per subcategory: hematological malignancies, solid tumors or central nervous system (CNS) tumors.', 'armGroupLabels': ['"Follow-Up Forms implementation"']}] | PrimaryOutcomes: [{'measure': 'Percentage of non-adherent study participants', 'description': 'When survivors do not appear at a scheduled visit within four weeks before or after the scheduled date.', 'timeFrame': '24 months: at 3, 6, 9, 12, 18 and 24 months.'}, {'measure': 'Percentage of participants lost to follow-up', 'description': 'When survivors miss a scheduled appointment and do not revisit the follow-up clinic after a missed appointment for more than six months.', 'timeFrame': '24 months: at 3, 6, 9, 12, 18 and 24 months.'}, {'measure': 'Reasons for non-adherence (questionnaire)', 'description': 'Reasons for non-adherence (death, relapse, other logistic issues) will be explored through a phone call.', 'timeFrame': '24 months: at 3, 6, 9, 12, 18 and 24 months.'}, {'measure': 'Intentions to revisit the follow-up clinic (questionnaire)', 'description': 'Intentions to revisit the follow-up clinic (yes/no, what can hospital do to support participant in adhering to follow-up visit) will be explored through a phone call.', 'timeFrame': '24 months: at 3, 6, 9, 12, 18 and 24 months.'}] | SecondaryOutcomes: [{'measure': 'Caregiver knowledge (questionnaire)', 'description': "Caregivers' knowledge about disease history, treatment exposure, associations between treatment and late effects, follow-up care, late effects risk and risk perception.\n\nLevels of knowledge (number of accurate/inaccurate/unknown responses), and knowledge uptake (changes in number of accurate responses) progression will be followed over time.", 'timeFrame': "Two months prior to survivor's treatment completion, assessed up to six months after completion of treatment"}, {'measure': 'Healthcare provider knowledge (questionnaire)', 'description': "Caregivers' and healthcare providers' knowledge about disease history, treatment exposure, associations between treatment and late effects, follow-up care, late effects risk and risk perception according\n\nLevels of knowledge (number of accurate/inaccurate/unknown responses), and knowledge uptake (changes in number of accurate responses) progression will be followed over time.", 'timeFrame': 'From start healthcare provider training up to six months after the completion of the training session'}, {'measure': 'Follow-Up Form documented late effects prevalence', 'description': 'The prevalence of late effects will be described as the percentage of individual survivors visiting the outpatient clinic for the duration of one year that reported a symptom (yes/no) as documented in the follow-up forms.\n\nLate effects are categorized into physical outcomes (e.g. relapsed disease, heart failure), physical aspects of quality of life (e.g. fatigue, challenges exercising), psychosocial aspects of quality of life (e.g. anxiety, exclusion), neurocognitive aspects of quality of life (memory, educational problems) according to the International Childhood Cancer Outcome Project.', 'timeFrame': '12 months: weekly.'}, {'measure': 'Reach caregivers (Implementation measures data collection tool)', 'description': 'Percentage eligible caregivers having received the booklet, video and Survivorship Card, characteristics of caregivers included in the study', 'timeFrame': '24 months: weekly'}, {'measure': 'Reach healthcare providers (Implementation measures data collection tool)', 'description': 'Percentage eligible healthcare providers trained, Characteristics of healthcare providers included in the study', 'timeFrame': '12 months: weekly.'}, {'measure': 'Adoption caregivers (Implementation measures data collection tool)', 'description': 'Percentage study participants taking the Survivorship Card to clinic appointment', 'timeFrame': '24 months: at 3, 6, 9, 12, 18 and 24 months'}, {'measure': 'Adoption healthcare providers (Implementation measures data collection tool)', 'description': 'Percentage eligible survivors having received the follow-up form in clinic; Percentage follow-up forms completely filled by clinician; Investigations and referrals done; Actions adhering to form instructions', 'timeFrame': '12 months: weekly.'}, {'measure': 'Caregiver satisfaction (questionnaire)', 'description': 'Satisfaction questionnaire rating satisfaction on a 3-point Likert scale (highest score indicating maximum satisfaction, and lowest score indicating maximum satisfaction for inverse questions). Values can range from minimum 1 (Disagree) to maximum 3 (Agree).', 'timeFrame': 'At 6 months after receiving the educational intervention'}, {'measure': 'Healthcare provider satisfaction (questionnaire)', 'description': 'Satisfaction questionnaire rating satisfaction on a 5-point Likert scale (highest score indicating maximum satisfaction, and lowest score indicating maximum satisfaction for inverse questions). Values can range from minimum 1 (Strongly Disagree) to maximum 5 (Strongly Agree).', 'timeFrame': 'At 6 months after receiving the healthcare provider training'}, {'measure': 'Caregiver recommendations', 'description': 'Open question exploring recommendations to improve educational intervention', 'timeFrame': 'At 6 months after receiving the educational intervention'}, {'measure': 'Healthcare provider recommendations', 'description': 'Open question exploring recommendations to improve the Follow-Up Form', 'timeFrame': 'At 6 months after receiving the healthcare provider training'}] |
Title: A Phase II Study of OSI-774 (Tarceva) in Combination With Oxaliplatin and Capecitabine in Previously Treated Patients With Stage IV Colorectal Cancer | Condition: Colorectal Cancer, Neoplasm Metastasis | Keywords: Colorectal, Metastatic Colorectal Cancer, Oxaliplatin, Tarceva, Capecitabine, Xeloda | Summary: | Description: Patients will be treated with OSI-774 (orally) daily, oxaliplatin (intravenously) every 3 weeks, and capecitabine (orally) twice daily for 14 days followed by a 7-day rest period. This will constitute a 21-day treatment cycle. Treatment will continue until disease progression or unacceptable toxicity occurs. | ArmGroups: N/A | Interventions:[{'type': 'DRUG', 'name': 'Tarceva (OSI-774)'}, {'type': 'DRUG', 'name': 'Capecitabine'}, {'type': 'DRUG', 'name': 'Oxaliplatin'}] | PrimaryOutcomes: [{'measure': 'To determine the response rate of OSI-774 when given in combination with oxaliplatin and capecitabine in patients with previously-treated locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma'}] | SecondaryOutcomes: [{'measure': 'To assess overall survival, progression-free survival, time to progression and duration of response'}, {'measure': 'To evaluate the toxicities of the combination of OSI-774, oxaliplatin and capecitabine in this population of patients with colorectal cancer'}] |
Title: A Phase II Pilot Study of Multi-Agent Neo-Adjuvant Chemoradiation in Patients With Locally Advanced Pancreatic Adenocarcinoma | Condition: Pancreatic Cancer | Keywords: stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, adenocarcinoma of the pancreas | Summary: | Description: OBJECTIVES:
Primary
* Determine the effect of neoadjuvant chemoradiotherapy and interferon alfa on converting patients with locally advanced unresectable adenocarcinoma of the pancreas to resectability.
Secondary
* Determine the rate and severity of early and late toxic effects of these regimens in these patients.
* Improve surgical morbidity profile and overall survival of patients who undergo surgical resection.
* Determine overall and progression-free survival of patients treated with this regimen.
OUTLINE: This is an pilot, single center study.
* Part 1 (neoadjuvant therapy): Patients receive fluorouracil IV continuously over 24 hours on days 1-38; cisplatin IV over 1 hour on days 1, 8, 15, 22, 29, and 36; and interferon alfa subcutaneously on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, and 38. Patients also undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38. Patients then undergo restaging. Patients with resectable disease undergo surgery, and 4-10 weeks later, proceed to part 2. Patients with unresectable disease proceed directly to part 2, 4 weeks after completion of neoadjuvant therapy.
* Part 2 (chemotherapy): Patients receive fluorouracil IV on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 56 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with unresectable disease undergo restaging after each course of fluorouracil. If the tumor subsequently becomes resectable, patients then undergo surgery.
After completion of study treatment, patients are followed periodically for 5 years and then annually thereafter. | ArmGroups: [{'label': 'Pancreatic Adenocarcinoma Patients', 'type': 'EXPERIMENTAL', 'description': 'Pancreatic Adenocarcinoma Patients treated with chemotherapy regimen and radiation (and or surgery).', 'interventionNames': ['Biological: recombinant interferon alfa', 'Drug: cisplatin', 'Drug: fluorouracil', 'Radiation: radiation therapy', 'Procedure: Resection of tumor']}] | Interventions:[{'type': 'BIOLOGICAL', 'name': 'recombinant interferon alfa', 'description': 'administered subcutaneously (SQ)at a dose of 3 million units Day 1,3, and 5 each week in Cycle 1', 'armGroupLabels': ['Pancreatic Adenocarcinoma Patients'], 'otherNames': ['IFN alpha', 'IFN-alpha-2b']}, {'type': 'DRUG', 'name': 'cisplatin', 'description': 'administered at a dose of 30 mg/m2 intravenously (IV) day 1 each week in Cycle 1', 'armGroupLabels': ['Pancreatic Adenocarcinoma Patients'], 'otherNames': ['cisplatinum', 'cis-diamminedichloroplatinum(II) (CDDP)']}, {'type': 'DRUG', 'name': 'fluorouracil', 'description': 'administered at a dose of 175 mg/m\\^2/day continuous infusion (CI) for 38 days in Cycle 1 and then 500 mg/m\\^2 intravenously (IV) each week for 6 weeks followed by a 2 week rest (1 cycle = 8 weeks)in Cycle 2 and 3', 'armGroupLabels': ['Pancreatic Adenocarcinoma Patients'], 'otherNames': ['5-FU']}, {'type': 'RADIATION', 'name': 'radiation therapy', 'description': '5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday -Friday, for 5½ weeks (days 1-5, 8-12, 15-19, 22-26, 29-33, 36-38).', 'armGroupLabels': ['Pancreatic Adenocarcinoma Patients']}, {'type': 'PROCEDURE', 'name': 'Resection of tumor', 'description': 'After Cycle 1 treatment (if resectable)- In the absence of metastatic disease, special emphasis will be paid to the local tumor. Evaluation of the growth/regression of the tumor will be made as it relates to resectability. Surgical exploration will start with a diagnostic laparoscopy. If no evidence of carcinomatosis, liver metastases or other evidence of metastatic disease is encountered, then a laparotomy will be performed. In the absence of clear technical unresectability, a radical pancreaticoduodenectomy, distal or total pancreatectomy (and resection of any involved structures) will be performed as mandated by tumor anatomy.', 'armGroupLabels': ['Pancreatic Adenocarcinoma Patients']}] | PrimaryOutcomes: [{'measure': 'Number of Patients in Whom Tumor Was Resectable', 'description': 'Tumor response is measured in terms of resectability, as measured by CT scan at 2 weeks after completion of each course. A CT scan of the chest abdomen and pelvis will be performed in order to evaluate for the presence of metastatic disease. If no metastatic disease, emphasis will be paid to the local tumor. Evaluation of the growth/regression of the tumor will be made as it relates to resectability. If potential for resection then surgery will be recommended. This protocol will be followed after each cycle.', 'timeFrame': 'Up to 5 Years or Until Disease Progression'}] | SecondaryOutcomes: [{'measure': 'Overall Survival', 'description': "In all patients, measured from the date of the patient's registration in this study, until the date of the patient's death or date last known alive (if observation was censored).", 'timeFrame': 'Up to 5 Years or Date of Death, Whichever Occurred First'}] |
Title: Total Neoadjuvant Therapy in Rectal Cancer Treatment | Condition: Rectal Cancer | Keywords: rectal cancer, total neoadjuvant therapy, colorectal disease | Summary: | Description: In this randomized, controlled, parallel study we will comparison total neoadjuvant therapy with standard neoadjuvant therapy in rectal cancer treatment. Complete pathological response rate will be the primary endpoint in patients, who will undergoing surgery. In cases of complete clinical response we will provide "watch and wait" approach. Compliance of treatment and oncologic results will be the second endpoint. | ArmGroups: [{'label': 'total neoadjuvant therapy', 'type': 'EXPERIMENTAL', 'description': 'Total neoadjuvant therapy consisted chemoradiotherapy with capecitabine and nine weeks of consolidation chemotherapy with XELOX prior to surgery and adjuvant therapy if necessary.', 'interventionNames': ['Combination Product: Concurrent Chemoradiotherapy', 'Procedure: TME', 'Drug: consolidation chemotherapy', 'Drug: adjuvant chemotherapy']}, {'label': 'standard therapy', 'type': 'ACTIVE_COMPARATOR', 'description': 'Standard therapy (neoadjuvant chemoradiotherapy, surgery, adjuvant chemotherapy)', 'interventionNames': ['Combination Product: Concurrent Chemoradiotherapy', 'Procedure: TME', 'Drug: adjuvant chemotherapy']}] | Interventions:[{'type': 'COMBINATION_PRODUCT', 'name': 'Concurrent Chemoradiotherapy', 'description': '50Gy in 25 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes.\n\nConcurrent chemotherapy:\n\nCapecitabine 1650 mg/m2/d', 'armGroupLabels': ['standard therapy', 'total neoadjuvant therapy'], 'otherNames': ['Radiotherapy']}, {'type': 'PROCEDURE', 'name': 'TME', 'description': 'Total mesorectal excision', 'armGroupLabels': ['standard therapy', 'total neoadjuvant therapy']}, {'type': 'DRUG', 'name': 'consolidation chemotherapy', 'description': 'Intravenous infusion of oxaliplatin (130 mg/m2 over 2 h) on day 1 and oral administration of capecitabine (1000 mg/m2 twice daily) from day 1 to day 14, is repeated every 3 weeks for 3 courses, 3 weeks per course', 'armGroupLabels': ['total neoadjuvant therapy'], 'otherNames': ['XELOX', 'CAPOX']}, {'type': 'DRUG', 'name': 'adjuvant chemotherapy', 'description': 'Administration of l-LV (400 mg/m2) and oxaliplatin (85 mg/ m2) by intravenous infusion over 2 h, followed by rapid intravenous infusion (iv) of 5-FU (400 mg/m2) and then slow infusion (civ) of 5-FU (2400 mg/m2 over 46 h), is repeated every 2 weeks for 6-12 cycles', 'armGroupLabels': ['standard therapy', 'total neoadjuvant therapy'], 'otherNames': ['mFOLFOX']}] | PrimaryOutcomes: [{'measure': 'The rate of complete responses', 'description': 'The rate of pathological or clinical complete responses', 'timeFrame': '3-6 months'}] | SecondaryOutcomes: [{'measure': 'Rate of R0-resections', 'description': 'Rate of R0-resections', 'timeFrame': 'immediately after surgery'}, {'measure': 'Rate of compliance with radiotherapy and chemotherapy', 'description': 'Rate of complications III-VI grade of radiotherapy (RTOG) and chemotherapy (NCI-CTC)', 'timeFrame': '6-8 months'}, {'measure': 'rate of intraoperative and postoperative complications', 'description': 'Frequency and structure of intraoperative and postoperative complications according to the Clavien-Dindo classification', 'timeFrame': '0-30 days after surgery'}] |
Title: Can Making Video Narratives Benefit Adolescents With Cancer | Condition: Pediatric Cancer | Keywords: Video Narrative | Summary: | Description: The current research aims to:
A. enlist teens with cancer to produce video narratives about their experiences with their illness B. explicitly characterize and investigate the videos' content and C. determine what aspects of the production were helpful to the teen making them and predicted to be helpful to those watching them. | ArmGroups: [{'label': 'Video Narrative with surveys', 'type': 'EXPERIMENTAL', 'description': 'Participants will be asked to create a 10-15 minute video narrative on their experiences after being diagnosed with cancer. Participants will also be asked to complete surveys including pediatric quality of life (PedsQL), Ten Item Personality Inventory (TIPI), Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test, and The Cognitive Log (Cog-Log)', 'interventionNames': ['Behavioral: Video narrative', 'Behavioral: PedsQL', 'Behavioral: Ten Item Personality Inventory', 'Behavioral: Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test', 'Behavioral: The Cognitive Log']}] | Interventions:[{'type': 'BEHAVIORAL', 'name': 'Video narrative', 'description': 'create a 10-15 minute video intervention about teen experiences after being diagnosed with cancer', 'armGroupLabels': ['Video Narrative with surveys']}, {'type': 'BEHAVIORAL', 'name': 'PedsQL', 'description': 'A generic 23-item Health Related Quality of Life measure initially developed using pediatric cancer patients', 'armGroupLabels': ['Video Narrative with surveys'], 'otherNames': ['Pediatric quality of life']}, {'type': 'BEHAVIORAL', 'name': 'Ten Item Personality Inventory', 'description': "The TIPI consists of ten items and measures personality based the subject's agreement of descriptions of themselves taken from the Big-5 model of personality", 'armGroupLabels': ['Video Narrative with surveys'], 'otherNames': ['TIPI']}, {'type': 'BEHAVIORAL', 'name': 'Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test', 'description': 'The D-KEFS Verbal Fluency Test consists of three subtests, which take approximately 6 minutes to complete', 'armGroupLabels': ['Video Narrative with surveys']}, {'type': 'BEHAVIORAL', 'name': 'The Cognitive Log', 'description': 'The Cog-Log is a 5-10 minute assessment designed to measure basic cognitive functioning and orientation', 'armGroupLabels': ['Video Narrative with surveys'], 'otherNames': ['Cog-Log']}] | PrimaryOutcomes: [{'measure': 'linear regression of pediatric quality of life (PedsQL), TIPI, and coded themes from video narratives on coherence, subjectivity and redemption', 'description': "Participants' composite scores of the 10 items that make up the emotional and social domains from the PedsQL, 15 items from the PedsQL cancer module, and the two items on the TIPI that measure Extroversion will positively covary with the resilient qualities of their narrative as measured by levels of narrative coherence, subjectivity, and redemption", 'timeFrame': 'at end of intervention - Approximately 60 minutes after enrolling on study'}] | SecondaryOutcomes: [{'measure': 'linear regression of coded resilient qualities of narrative with Post Video Impression Questionnaire', 'description': 'Resilient qualities of the narrative, as measured by levels of narrative coherence, subjectivity, and redemption, will predict the sum of 16 select items on the Post Video Impressions Questionnaire identifying positive impact associated with producing the narrative', 'timeFrame': 'at end of intervention - Approximately 60 minutes after enrolling on study'}, {'measure': 'linear regression of impact experienced from making the video narrative with summed scores of participants willingness to post online', 'description': "The sum of the 16 item composite scale measuring impact experienced from making the testimonial video, on the Post Video Impressions Questionnaire, will positively predict the summed scores of two items measuring participants' willingness to post the video online", 'timeFrame': 'at end of intervention - Approximately 60 minutes after enrolling on study'}, {'measure': 'linear regression of perceived impact with summed scores of participants willingness to post the video online', 'description': "The sum of the 7 item composite scale measuring the perceived impact on others who watch the video, on the Post Video Impressions Questionnaire, will positively predict the summed scores of two items measuring participants' willingness to post the video online", 'timeFrame': 'at end of intervention - Approximately 60 minutes after enrolling on study'}] |
Title: A Phase I Trial of MK-2206 and Hydroxychloroquine in Solid Tumors, Melanoma, Renal and Prostate Cancer to Examine the Role of Autophagy in Tumorigenesis | Condition: Advanced Malignant Solid Neoplasm, Stage III Cutaneous Melanoma AJCC v7, Stage III Prostate Cancer AJCC v7, Stage III Renal Cell Cancer AJCC v7, Stage IIIA Cutaneous Melanoma AJCC v7, Stage IIIB Cutaneous Melanoma AJCC v7, Stage IIIC Cutaneous Melanoma AJCC v7, Stage IV Cutaneous Melanoma AJCC v6 and v7, Stage IV Prostate Cancer AJCC v7, Stage IV Renal Cell Cancer AJCC v7 | Keywords: | Summary: | Description: PRIMARY OBJECTIVES:
I. To define the maximum tolerated dose (MTD) of MK-2206 (Akt inhibitor MK2206) and hydroxychloroquine (HCQ) when used in combination.
SECONDARY OBJECTIVES:
I. To determine side effects and activity of MK-2206 and hydroxychloroquine when used in combination.
II. To determine if hydroxychloroquine alters the pharmacokinetics of MK-2206 due to a drug-drug interaction.
III. To validate biomarkers for autophagy detection.
OUTLINE: This is a dose-escalation study of Akt inhibitor MK-2206.
Patients receive Akt inhibitor MK2206 orally (PO) on days 1, 8, and 15. Beginning on cycle 2, patients also receive hydroxychloroquine PO twice daily (BID) on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 4 weeks. | ArmGroups: [{'label': 'Treatment (Akt inhibitor MK2206, hydroxychloroquine)', 'type': 'EXPERIMENTAL', 'description': 'Patients receive Akt inhibitor MK2206 PO on days 1, 8, and 15. Beginning on cycle 2, patients also receive hydroxychloroquine PO BID on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Akt Inhibitor MK2206', 'Drug: Hydroxychloroquine']}] | Interventions:[{'type': 'DRUG', 'name': 'Akt Inhibitor MK2206', 'description': 'Given PO', 'armGroupLabels': ['Treatment (Akt inhibitor MK2206, hydroxychloroquine)'], 'otherNames': ['MK 2206', 'MK-2206', 'MK-2206 FREE BASE', 'MK2206']}, {'type': 'DRUG', 'name': 'Hydroxychloroquine', 'description': 'Given PO', 'armGroupLabels': ['Treatment (Akt inhibitor MK2206, hydroxychloroquine)']}] | PrimaryOutcomes: [{'measure': 'Maximum tolerated dose of Akt inhibitor MK-2206', 'description': 'Will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.', 'timeFrame': '21 days'}, {'measure': 'Dose-limiting toxicity rate', 'description': 'Will be assessed by CTCAE version 4.0.', 'timeFrame': '21 days'}] | SecondaryOutcomes: [{'measure': 'Changes in expression pattern of markers Beclin1, LC3, and p62', 'description': 'Will be assessed by immunohistochemistry (IHC), Western blotting, and number of autophagosomes by electron microscope (EM). Spaghetti plots or boxplots at time points will be produced for each marker and for EM. Appropriate transformations of the measurements will be carried out to normalize the data. Descriptive summary statistics will be provided for each type of measure at each time point.', 'timeFrame': 'Baseline to 4 weeks'}, {'measure': 'Change in autophagy activity induced by hydroxychloroquine', 'description': 'Will be measured by the amount of autophagosomes by EM. Student t-test and Wilcoxon nonparametric tests will be conducted.', 'timeFrame': 'Baseline to 4 weeks'}, {'measure': 'Validation of Beclin1, LC3, and p62 as markers for autophagy', 'description': 'Will be measured by EM. Linear mixed models will be fitted to the data, EM as the independent variable, the 3 markers and time points as fixed effects, plus a subject-specific random effect. A backward variable selection will be carried out for the 3 markers until a final model is selected. An ROC curve will be produced. The log-transformed ratio of LC3-II/LC3-I and difference in the log-transformed ratios of LC3-II./LC3-I pre-post treatment between high autophagy activity (HA, \\>= 6 AV/cell) and low autophagy activity (LA, \\< 6 AV/cell) will be analyzed for evaluating treatment effect using a two sided paired t-test.', 'timeFrame': 'Up to 4 weeks'}] |
Title: Obsidian in Anastomotic Healing After Rectal Cancer Resection: A Prospective Clinical Feasibility Study | Condition: Anastomotic Leak Rectum, Rectal Cancer, Anastomotic Leakage | Keywords: | Summary: | Description: N/A | ArmGroups: N/A | Interventions:[{'type': 'OTHER', 'name': 'Application of autologous fibrin matrix (Obsidian)', 'description': 'When the patient is anaesthetized, 120 ml venous blood is collected for preparation of the autologous fibrin matrix. The blood is processed in the Vivostat® unit for 30 minutes making a 5-6 ml concentrate ready for application by use of a specific endoscopic kit device.\n\nWhen the rectal cancer resection is completed and the specimen is extracted, the Obsidian will be applied using minimal invasive technique and the endoscopic kit device.\n\nStep 1: 1.5-2ml. Obsidian is applied onto the rectal stump, with the circular stapler device inserted into the rectal stump. The circular stapler is then closed, but not yet fired.\n\nStep 2: 2.5-3ml Obsidian is applied 360 degrees around the anastomosis, while taking care not to increase tension on the anal intestine end. The circular stapler is then fired and removed. The water-air-leak test is performed according to standard clinical practice. Step 3: The remaining part of the Obsidian is then sealed 360 degrees around the anastomosis.'}] | PrimaryOutcomes: [{'measure': 'The rate of successful use and application of Obsidian as a supplemental procedure in the creation of rectal anastomosis with minimal invasive technique', 'description': "Defined as the surgeon being able re-inforce the anastomosis with Obsidian as described in our protocol. Assessment of the Obsidian application must be graded using the following rating assessment scale:\n\n'Complete'\n\n'Almost complete'\n\n'Incomplete'\n\nEach of these are detailed in the study protocol.\n\nTo be able to view the use of Obsidian application as a successful method, then the application should be rated as 'Complete' or 'Almost complete' in at least 45 out of 50 (90%) patients.", 'timeFrame': 'This outcome is measured during the intervention.'}] | SecondaryOutcomes: [{'measure': 'Time spent for creating a rectal anastomosis with application of Obsidian', 'description': 'Time spent for creating the anastomosis with application of Obsidian is defined as: Time spent from inserting the circular stapler device in the rectal stump (Shortly before the start of Step 1 in Intervention Details), until the application around the circular anastomosis has been completed (End of Step 3 in Intervention Details).', 'timeFrame': 'This outcome is measured during the intervention.'}, {'measure': "The surgeon's self-assessment of the user-friendliness of using Obsidian", 'description': "Surgeon's self-assessment of the user-friendliness of using Obsidian is graded in three grades: 1. Easy, 2. Difficult, but can be performed, 3. Very difficult", 'timeFrame': 'This outcome is measured immediately after the intervention.'}, {'measure': 'Anastomotic leak rate', 'description': 'Anastomotic leak is defined according to the definition as described by Rahbari NN.', 'timeFrame': 'Measured within 30 days after surgery'}, {'measure': 'Length of hospital stay', 'description': 'Calculated as number of days', 'timeFrame': 'From, and including, day of surgery to, and including, day of discharge, or up to 90 days after surgery.'}, {'measure': 'Re-hospitalization within 30 days after surgery', 'description': 'All re-hospitalizations at departments of any kind at hospitals in Central Denmark Region after surgery will be recorded, including reason for re-hospitalization.', 'timeFrame': 'Measured within 30 days after surgery'}, {'measure': 'Morbidity within 30 days after surgery graded ≥3 severity according to the Clavien-Dindo classification', 'description': 'Morbidity within 30 days after surgery include surgical and medical complications graded ≥2 severity according to the Clavien-Dindo classification, will be recorded.\n\nSurgical complications include bleeding, fascia dehiscence, ileus, surgical site infection, intra-abdominal abscess, and anastomotic leakage. Medical complications include cerebral complications (transitory ischemic attack, stroke), pulmonary complications (pneumonia, atelectasis, pleural effusion), cardiac complications (atrial fibrillation, acute myocardial infarction, heart failure), gastrointestinal complications (high stoma output, paralysis \\>4 days), urogenital complications (urinary tract infections, urinary retention, acute kidney insufficiency), thromboembolic complications (deep venous thrombosis, pulmonary embolism).', 'timeFrame': 'Measured within 30 days after surgery'}, {'measure': '2-year mortality', 'description': 'For safety reasons, mortality within 2 years after surgery will be recorded.', 'timeFrame': 'Within 2 years after surgery'}] |
Title: A Randomized, Multicenter, Open-label, Phase III Study of Lapatinib (GW572016) in Combination With Weekly Paclitaxel Versus Weekly Paclitaxel Alone in the Second Line Treatment of ErbB2 Amplified Advanced Gastric Cancer | Condition: Neoplasms, Gastrointestinal Tract | Keywords: lapatinib, paclitaxel, ErbB2, Gastric cancer, Advanced gastric cancer | Summary: | Description: N/A | ArmGroups: [{'label': 'Paclitaxel plus Lapatinib', 'type': 'EXPERIMENTAL', 'description': '6 pills of lapatinib at 250 mg each once daily and infusion of paclitaxel at 80 mglm2 weekly', 'interventionNames': ['Drug: Lapatinib', 'Drug: Paclitaxel']}, {'label': 'Paclitaxel alone', 'type': 'ACTIVE_COMPARATOR', 'description': 'Infusion of paclitaxel at 80 mglm2 weekly', 'interventionNames': ['Drug: Paclitaxel']}] | Interventions:[{'type': 'DRUG', 'name': 'Lapatinib', 'description': '6 pills at 250 mg each once daily', 'armGroupLabels': ['Paclitaxel plus Lapatinib'], 'otherNames': ['Lapatinib: Tykerb', 'Tyverb']}, {'type': 'DRUG', 'name': 'Paclitaxel', 'description': 'Infusion at 80 mg/m2 weekly', 'armGroupLabels': ['Paclitaxel alone', 'Paclitaxel plus Lapatinib']}] | PrimaryOutcomes: [{'measure': 'Number of Participants With Dose Limiting Toxicities (DLTs) in the Pilot Part of the Study', 'description': 'DLTs consisted of only drug-related toxicities (neurologic and non-neurologic DLTs). A neurologic DLT was defined as grade 3/4 clinically significant peripheral motor and/or sensitive neuropathy. Non-neurologic DLTs mainly included the following: grade 3/4 clinically significant non-hematological toxicity (except nausea), grade 4 neutropenia lasting \\>=7 days, thrombocytopenia (\\<=25000 cells per cubic millimeter), inability to begin next treatment within 2 weeks of scheduled dosing due to unresolved toxicity, treatment delay (due to toxicity) of \\>5 days, for Days 8 or 15 of weekly paclitaxel.', 'timeFrame': '28 days'}, {'measure': 'Overall Survival (OS) in the Randomized Part of the Study', 'description': 'OS was defined as the time from randomization until death due to any cause. For participants who did not die, time to death was censored at the time of last contact. For censored participants, time to death was defined as the time from randomization to the time of last contact.', 'timeFrame': 'From randomization until death due to any cause (up to 42.58 months)'}] | SecondaryOutcomes: [{'measure': 'Maximum Plasma Concentration (Cmax) of Lapatinib in the Pilot Part of the Study', 'description': 'Pharmacokinetic (PK) samples were collected at pre-dose and at 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 8 and 14.', 'timeFrame': 'Days 8 and 14'}, {'measure': 'Time to Cmax (Tmax) of Lapatinib in the Pilot Part of the Study', 'description': 'PK samples were collected at pre-dose and at 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 8 and 14.', 'timeFrame': 'Days 8 and 14'}, {'measure': 'Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) of Lapatinib in the Pilot Part of the Study', 'description': 'PK samples were collected at pre-dose and at 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 8 and 14. AUC is defined as the area under the lapatinib concentration-time curve as a measure of drug exposure. AUC(0-24) is area under the plasma concentration-time curve from time 0 to 24 hours after oral adminisation.', 'timeFrame': 'Days 8 and 14'}, {'measure': 'Cmax of Paclitaxel in the Pilot Part of the Study', 'description': 'PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8.', 'timeFrame': 'Days 1 and 8'}, {'measure': 'Tmax of Paclitaxel in the Pilot Part of the Study', 'description': 'PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8.', 'timeFrame': 'Days 1 and 8'}, {'measure': 'AUC(0-24) of Paclitaxel in the Pilot Part of the Study', 'description': 'PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8. AUC is defined as the area under the paclitaxel concentration-time curve as a measure of drug exposure. AUC(0-24) is area under the plasma concentration-time curve from the start of infusion (time 0) to 24 hours after the start of the infusion.', 'timeFrame': 'Days 1 and 8'}, {'measure': 'Area Under the Concentration-time Curve From Time Zero to Infinity (AUC[0-inf]) of Paclitaxel in the Pilot Part of the Study', 'description': 'PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8. AUC is defined as the area under the paclitaxel concentration-time curve as a measure of drug exposure. AUC(0-inf) is area under the plasma concentration-time curve from the start of infusion (time 0) extrapolated to infinity.', 'timeFrame': 'Days 1 and 8'}, {'measure': 'Half-life of Paclitaxel in the Pilot Part of the Study', 'description': 'PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8. Half-life is defined as the time required for the amount of the drug in the plasma to decrease by half.', 'timeFrame': 'Days 1 and 8'}, {'measure': 'Clearance of Paclitaxel in the Pilot Part of the Study', 'description': 'PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8. Clearance is defined as the clearance of drug from plasma, which is defined as the volume of plasma from which drug is removed per unit time.', 'timeFrame': 'Days 1 and 8'}, {'measure': 'Distribution Volume at Steady State (Vss) of Paclitaxel in the Pilot Part of the Study', 'description': 'PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8. Vss is the volume of distribution at steady state of paclitaxel.', 'timeFrame': 'Days 1 and 8'}, {'measure': 'Progression-free Survival (PFS) in the Randomized Part of the Study', 'description': 'PFS was defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause. Per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0, PD is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions.', 'timeFrame': 'From randomization until disease progression or death due to any cause (up to 42.35 months)'}, {'measure': 'Time to Progression in the Randomized Part of the Study', 'description': 'Time to progression was defined as the time from randomization until the earliest date of disease progression or death due to disease. Per RECIST, version 1.0, PD is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions.', 'timeFrame': 'From randomization until disease progression or death due to disease (up to 42.35 months )'}, {'measure': 'Percentage of Participants With Overall Response in the Randomized Part of the Study', 'description': 'Overall response was defined as the percentage of participants achieving either complete response (CR) or partial response (PR). Per RECIST, version 1.0, CR was defined as the disappearance of all target lesions, and PR was defined as a greater than 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.', 'timeFrame': 'From randomization up to 5.62 months'}, {'measure': 'Number of Participants With the Indicated Time to Response in the Randomized Part of the Study', 'description': 'Time to response was defined as the time from randomization to CR (the disappearance of all target lesions) or PR (a greater than 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD). For participants who did not achieve a CR or PR, time to response was censored at the last assessment prior to other cancer therapies. For censored participants, time to response was defined as the time from randomization to the time of the last assessment prior to the administation of other cancer therapies.', 'timeFrame': 'up to 5.62 months'}, {'measure': 'Duration of Response in the Randomized Part of the Study', 'description': 'Duration of response was defined as the time from the first documented evidence of CR (the disappearance of all target lesions) or PR (a greater than 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD) until the first documented sign of disease progression (at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions) or death due to any cause, if sooner.', 'timeFrame': 'up to 18.27 months'}, {'measure': 'Number of Participants With the Indicated Grade 3 and Grade 4 Adverse Events (AEs) for Which All Grades of the AE Were Reported in >=10% of Participants, Regardless of Causality in the Randomized Part of the Study', 'description': 'The Common Terminology Criteria for Advere Events (CTCAE) is a descriptive terminology that can be used for AE reporting. Grade (G) refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade (G) refers to the severity of the AE: G 1, mild AE; G 2, moderate AE; G 3, severe AE; G 4, life-threatening/disabling AE; G 5, death related to the AE.', 'timeFrame': 'From the first dose of investigational product to 30 days after the last dose (up to 110.3 weeks in the Randomized part)'}, {'measure': 'Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life (QOL) Questionnaire (EORTC QLQ-C30) Global Health Status (GHS)/QOL Score at the End of Therapy in the Randomized Part of the Study', 'description': 'The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales \\[physical/role/emotional/cognitive/social\\]; 9 symptom scales \\[fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties\\]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.', 'timeFrame': 'Baseline and end of therapy (up to 42.58 months)'}, {'measure': 'Change From Baseline in the EORTC QLQ-C30 Physical Functioning Score at the End of Therapy in the Randomized Part of the Study', 'description': 'The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales \\[physical/role/emotional/cognitive/social\\]; 9 symptom scales \\[fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties\\]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.', 'timeFrame': 'Baseline and end of therapy (up to 42.58 months)'}, {'measure': 'Change From Baseline in the EORTC QLQ-C30 Role Functioning Score at the End of Therapy in the Randomized Part of the Study', 'description': 'The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales \\[physical/role/emotional/cognitive/social\\]; 9 symptom scales \\[fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties\\]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.', 'timeFrame': 'Baseline and end of therapy (up to 42.58 months)'}, {'measure': 'Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Score at the End of Therapy in the Randomized Part of the Study', 'description': 'The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales \\[physical/role/emotional/cognitive/social\\]; 9 symptom scales \\[fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties\\]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.', 'timeFrame': 'Baseline and end of therapy (up to 42.58 months)'}, {'measure': 'Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Score at the End of Therapy in the Randomized Part of the Study', 'description': 'The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales \\[physical/role/emotional/cognitive/social\\]; 9 symptom scales \\[fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties\\]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.', 'timeFrame': 'Baseline and end of therapy (up to 42.58 months)'}, {'measure': 'Change From Baseline in the EORTC QLQ-C30 Social Functioning Score at the End of Therapy in the Randomized Part of the Study', 'description': 'The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales \\[physical/role/emotional/cognitive/social\\]; 9 symptom scales \\[fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties\\]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.', 'timeFrame': 'Baseline and end of therapy (up to 42.58 months)'}, {'measure': 'Change From Baseline in the EORTC QLQ-C30 Fatigue Symptom Score at the End of Therapy in the Randomized Part of the Study', 'description': 'The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales \\[physical/role/emotional/cognitive/social\\]; 9 symptom scales \\[fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties\\]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.', 'timeFrame': 'Baseline and end of therapy (up to 42.58 months)'}, {'measure': 'Change From Baseline in the EORTC QLQ-C30 Nausea and Vomiting Symptom Score at the End of Therapy in the Randomized Part of the Study', 'description': 'The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales \\[physical/role/emotional/cognitive/social\\]; 9 symptom scales \\[fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties\\]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.', 'timeFrame': 'Baseline and end of therapy (up to 42.58 months)'}, {'measure': 'Change From Baseline in the EORTC QLQ-C30 Pain Symptom Score at the End of Therapy in the Randomized Part of the Study', 'description': 'The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales \\[physical/role/emotional/cognitive/social\\]; 9 symptom scales \\[fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties\\]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.', 'timeFrame': 'Baseline and end of therapy (up to 42.58 months)'}, {'measure': 'Change From Baseline in the EORTC QLQ-C30 Dyspnea Symptom Score at the End of Therapy in the Randomized Part of the Study', 'description': 'The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales \\[physical/role/emotional/cognitive/social\\]; 9 symptom scales \\[fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties\\]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.', 'timeFrame': 'Baseline and end of therapy (up to 42.58 months)'}, {'measure': 'Change From Baseline in the EORTC QLQ-C30 Insomnia Symptom Score at the End of Therapy in the Randomized Part of the Study', 'description': 'The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales \\[physical/role/emotional/cognitive/social\\]; 9 symptom scales \\[fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties\\]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.', 'timeFrame': 'Baseline and end of therapy (up to 42.58 months)'}, {'measure': 'Change From Baseline in the EORTC QLQ-C30 Appetite Loss Symptom Score at the End of Therapy in the Randomized Part of the Study', 'description': 'The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales \\[physical/role/emotional/cognitive/social\\]; 9 symptom scales \\[fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties\\]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.', 'timeFrame': 'Baseline and end of therapy (up to 42.58 months)'}, {'measure': 'Change From Baseline in the EORTC QLQ-C30 Constipation Symptom Score at the End of Therapy in the Randomized Part of the Study', 'description': 'The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales \\[physical/role/emotional/cognitive/social\\]; 9 symptom scales \\[fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties\\]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.', 'timeFrame': 'Baseline and end of therapy (up to 42.58 months)'}, {'measure': 'Change From Baseline in the EORTC QLQ-C30 Diarrhea Symptom Score at the End of Therapy in the Randomized Part of the Study', 'description': 'The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales \\[physical/role/emotional/cognitive/social\\]; 9 symptom scales \\[fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties\\]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.', 'timeFrame': 'Baseline and end of therapy (up to 42.58 months)'}, {'measure': 'Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Symptom Score at the End of Therapy in the Randomized Part of the Study', 'description': 'The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales \\[physical/role/emotional/cognitive/social\\]; 9 symptom scales \\[fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties\\]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.', 'timeFrame': 'Baseline and end of therapy (up to 42.58 months)'}, {'measure': 'Change From Baseline in the EORTC QLQ-STO22 Dysphagia Scale Score at the End of Therapy in the Randomized Part of the Study', 'description': 'The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.', 'timeFrame': 'Baseline and end of therapy (up to 42.58 months)'}, {'measure': 'Change From Baseline in the EORTC QLQ-STO22 Pain Scale Score at the End of Therapy in the Randomized Part of the Study', 'description': 'The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.', 'timeFrame': 'Baseline and end of therapy (up to 42.58 months)'}, {'measure': 'Change From Baseline in the EORTC QLQ-STO22 Reflux Symptoms Scale Score at the End of Therapy in the Randomized Part of the Study', 'description': 'The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.', 'timeFrame': 'Baseline and end of therapy (up to 42.58 months)'}, {'measure': 'Change From Baseline in the EORTC QLQ-STO22 Eating Restrictions Scale Score at the End of Therapy in the Randomized Part of the Study', 'description': 'The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.', 'timeFrame': 'Baseline and end of therapy (up to 42.58 months)'}, {'measure': 'Change From Baseline in the EORTC QLQ-STO22 Anxiety Scale Score at the End of Therapy in the Randomized Part of the Study', 'description': 'The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.', 'timeFrame': 'Baseline and end of therapy (up to 42.58 months)'}, {'measure': 'Change From Baseline in the EORTC QLQ-STO22 Dry Mouth Scale Score at the End of Therapy in the Randomized Part of the Study', 'description': 'The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.', 'timeFrame': 'Baseline and end of therapy (up to 42.58 months)'}, {'measure': 'Change From Baseline in the EORTC QLQ-STO22 Taste Scale Score at the End of Therapy in the Randomized Part of the Study', 'description': 'The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.', 'timeFrame': 'Baseline and end of therapy (up to 42.58 months)'}, {'measure': 'Change From Baseline in the EORTC QLQ-STO22 Body Image Scale Score at the End of Therapy in the Randomized Part of the Study', 'description': 'The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.', 'timeFrame': 'Baseline and end of therapy (up to 42.58 months)'}, {'measure': 'Change From Baseline in the EORTC QLQ-STO22 Hair Loss Scale Score at the End of Therapy in the Randomized Part of the Study', 'description': 'The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.', 'timeFrame': 'Baseline and end of therapy (up to 42.58 months)'}, {'measure': 'Number of Participants With the Indicated Epidermal Growth Factor Receptor (EGFR) Immunohistochemistry Intensity in the Randomized Part of the Study', 'description': 'EGFR protein expression on the surface of cells in gastric cancer tissue samples was measured using a moncolonal antibody specific for the extracellular region of EGFR, and the degree of membrane staining was evaluated. 3+ indicates positive EGFR expression; \\<3+ indicates negative EGFR expression.', 'timeFrame': 'Pretreatment'}, {'measure': 'Number of Participants With the Indicated Human Epidermal Growth Factor Receptor 2 (HER2) Immunohistochemistry Intensity in the Randomized Part of the Study', 'description': 'HER2 protein expression on the surface of cells in gastric cancer tissue samples was measured using a monoclonal antibody specific for the extracellulr region of HER2, and the degree of membrane staining was evaulated. The immunohistochemistry test gives a score of 0 to 3+ and measures the amount of HER2 receptor protein on the surface of cells in a gastric cancer tissue sample. Score of 0 to 1+, "HER2 negative"; score of 2+, "borderline"; score of 3+, "HER2 positive."', 'timeFrame': 'Pretreatment'}, {'measure': 'Number of Participants With Mutations That May Correlate With Response and Toxicity to Lapatinib', 'description': 'An inadequate number of tissue samples were obtained; thus, analysis could not be performed.', 'timeFrame': 'Pretreatment'}] |
Title: A Randomized Study Of TeleGenetics Versus Usual Care To Increase Access To Cancer Genetic Services | Condition: Breast Cancer, Ovarian Cancer, Colorectal Cancer | Keywords: meet National Comprehensive Cancer Network® criteria for cancer genetic testing for breast, ovarian and colorectal cancers | Summary: | Description: N/A | ArmGroups: [{'label': 'Remote cancer genetic services by videoconference', 'interventionNames': ['Behavioral: Penn genetic counselors provides counseling and test results disclosure by videoconferene to patient at community site']}, {'label': 'Remote cancer genetic services by telephone', 'interventionNames': ['Behavioral: Penn genetic counselor provides counseling and test results disclosure by telephone to patient at community site']}, {'label': 'Usual Care', 'interventionNames': ['Behavioral: Patient receives written information on how to find genetic services in their area']}] | Interventions:[{'type': 'BEHAVIORAL', 'name': 'Penn genetic counselors provides counseling and test results disclosure by videoconferene to patient at community site', 'description': 'Baseline and follow up survey', 'armGroupLabels': ['Remote cancer genetic services by videoconference']}, {'type': 'BEHAVIORAL', 'name': 'Penn genetic counselor provides counseling and test results disclosure by telephone to patient at community site', 'description': 'Baseline and follow up surveys', 'armGroupLabels': ['Remote cancer genetic services by telephone']}, {'type': 'BEHAVIORAL', 'name': 'Patient receives written information on how to find genetic services in their area', 'description': 'Baseline and follow up surveys', 'armGroupLabels': ['Usual Care']}] | PrimaryOutcomes: [{'measure': 'Completion of Surveys', 'timeFrame': '3 years'}] | SecondaryOutcomes: N/A |
Title: A Pilot Study of Teng-Long-Bu-Zhong-Tang Based Herbal Therapy in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer | Condition: Metastatic Colorectal Cancer | Keywords: Metastatic colorectal cancer, Chemotherapy, Traditional Chinese Medicine (TCM), Teng-Long-Bu-Zhong-Tang | Summary: | Description: A phase I/II, multicentric,randomized, controlled clinical trial. | ArmGroups: [{'label': 'chemotherapy', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients receive chemotherapy until disease progression or unacceptable toxicity', 'interventionNames': ['Drug: Chemotherapy']}, {'label': 'Herbal therapy plus chemotherapy', 'type': 'EXPERIMENTAL', 'description': 'Patients receive herbal therapy plus chemotherapy until disease progression or unacceptable toxicity', 'interventionNames': ['Drug: Chemotherapy', 'Drug: Herbal therapy']}] | Interventions:[{'type': 'DRUG', 'name': 'Chemotherapy', 'description': 'Oxaliplatin (130 mg/m2) was given intravenously (iv) for at least 2 h on day 1; Capecitabine (1000 mg/m2) was given orally, twice daily on days 1-14. Each cycle was 21 days. Cycles were repeated until disease progression or unacceptable toxicity.', 'armGroupLabels': ['Herbal therapy plus chemotherapy', 'chemotherapy'], 'otherNames': ['Oxaliplatin', 'Capecitabine']}, {'type': 'DRUG', 'name': 'Herbal therapy', 'description': 'TLBZT based herbal decoction administered orally twice a day', 'armGroupLabels': ['Herbal therapy plus chemotherapy'], 'otherNames': ['Traditional Chinese Medicine']}] | PrimaryOutcomes: [{'measure': 'Progression-free survival(PFS)', 'timeFrame': '2 months'}] | SecondaryOutcomes: [{'measure': 'Overall Survival (OS)', 'timeFrame': '2 months'}, {'measure': 'Symptoms', 'timeFrame': '2 months'}, {'measure': 'Adverse events', 'timeFrame': '1 month'}] |
Title: A Multi-part, Phase 1, Multi-center, Open-label Study of DKN-01 as a Monotherapy or in Combination With Paclitaxel or Pembrolizumab in Patients With Relapsed or Refractory Esophagogastric Malignancies | Condition: Esophageal Neoplasms, Adenocarcinoma of the Gastroesophageal Junction, Gastroesophageal Cancer, Squamous Cell Carcinoma, Gastric Adenocarcinoma | Keywords: | Summary: | Description: This is a dose-escalating, open-label study conducted in multiple parts (Part A dose-escalation, Parts B-F expansion cohorts, and a monotherapy substudy). Parts A-E (DKN-01 plus paclitaxel) and the DKN-01 monotherapy substudy includes 28-day cycle treatment cycles; Part F (DKN-01 plus pembrolizumab) includes 21-day treatment cycles. Depending on their cancer type, subjects with histologically confirmed recurrent or refractory esophageal, gastro-esophageal junction tumors, or gastric adenocarcinoma will be enrolled in each study part to receive DKN-01 150 mg or 300 mg in combination with paclitaxel or pembrolizumab. Subjects who are unable to receive paclitaxel or pembrolizumab for any reason are allowed to receive single agent DKN-01 300 mg as part of a monotherapy substudy. Results are reported by treatment group, irrespective of the study part in which the subject was enrolled. | ArmGroups: [{'label': 'DKN-01 150 mg plus paclitaxel', 'type': 'EXPERIMENTAL', 'description': 'DKN-01 150 mg administered on Days 1 and 15 and paclitaxel 80 mg per meter squared of body surface area (mg/m2) administered on Days 1, 8, 15, and 22', 'interventionNames': ['Drug: DKN-01 150 mg', 'Drug: Paclitaxel']}, {'label': 'DKN-01 300 mg plus paclitaxel', 'type': 'EXPERIMENTAL', 'description': 'DKN-01 300 mg administered on Days 1 and 15 and paclitaxel 80 mg per meter squared of body surface area (mg/m2) administered on Days 1, 8, 15, and 22', 'interventionNames': ['Drug: Paclitaxel', 'Drug: DKN-01 300 mg']}, {'label': 'DKN-01 150 mg plus pembrolizumab', 'type': 'EXPERIMENTAL', 'description': 'DKN-01 150 mg administered on Days 1 and 15 and pembrolizumab 200 mg administered on Day 1', 'interventionNames': ['Drug: DKN-01 150 mg', 'Drug: Pembrolizumab']}, {'label': 'DKN-01 300 mg plus pembrolizumab', 'type': 'EXPERIMENTAL', 'description': 'DKN-01 300 mg administered on Days 1 and 15 and pembrolizumab 200 mg administered on Day 1', 'interventionNames': ['Drug: Pembrolizumab', 'Drug: DKN-01 300 mg']}, {'label': 'DKN-01 300 mg monotherapy', 'type': 'EXPERIMENTAL', 'description': 'DKN-01 300 mg administered on Days 1 and 15', 'interventionNames': ['Drug: DKN-01 300 mg']}] | Interventions:[{'type': 'DRUG', 'name': 'DKN-01 150 mg', 'description': 'Administered by IV infusion', 'armGroupLabels': ['DKN-01 150 mg plus paclitaxel', 'DKN-01 150 mg plus pembrolizumab']}, {'type': 'DRUG', 'name': 'Paclitaxel', 'description': 'Administered by IV infusion', 'armGroupLabels': ['DKN-01 150 mg plus paclitaxel', 'DKN-01 300 mg plus paclitaxel'], 'otherNames': ['Taxol']}, {'type': 'DRUG', 'name': 'Pembrolizumab', 'description': 'Administered by IV infusion', 'armGroupLabels': ['DKN-01 150 mg plus pembrolizumab', 'DKN-01 300 mg plus pembrolizumab'], 'otherNames': ['Keytruda']}, {'type': 'DRUG', 'name': 'DKN-01 300 mg', 'description': 'Administered by IV infusion', 'armGroupLabels': ['DKN-01 300 mg monotherapy', 'DKN-01 300 mg plus paclitaxel', 'DKN-01 300 mg plus pembrolizumab']}] | PrimaryOutcomes: [{'measure': 'Number of subjects with dose limiting toxicities in each treatment arm', 'timeFrame': 'Baseline to End of Cycle 1 (each cycle is 28 days, except each cycle is 21 days when DKN-01 is administered with pembrolizumab)'}, {'measure': 'Number of subjects with treatment emergent adverse events related to study treatment (DKN-01 as monotherapy or in combination with paclitaxel or pembrolizumab)', 'timeFrame': 'Baseline until 30 days after last dose of study drug'}] | SecondaryOutcomes: [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Baseline to study completion (approximately 3 months)'}, {'measure': 'Duration of Response (DoR)', 'timeFrame': 'Baseline to study completion (approximately 3 months)'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Baseline to study completion (approximately 3 months)'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Baseline to study completion (approximately 3 months)'}] |
Title: Taking Time to Connect: A Randomized Clinical Trial for Hispanic Mothers Diagnosed With Cancer | Condition: Cancer Survivorship | Keywords: maternal, non-metastatic, anxiety, depression | Summary: | Description: The purpose of the proposed study is to test the short-term efficacy of a cancer parenting education program for diagnosed child-rearing Hispanic mothers, called Conexiones. This program was culturally adapted from a parenting program previously tested for efficacy in a Phase III, 6-state randomized clinical trial. However, the original program was tested on primarily non-Hispanic White (NHW) mothers with breast cancer. The Conexiones program represents a culturally adapted version of the original parenting program and is now ready for testing with Hispanic mothers living in the Border States of New Mexico and Texas. Eligible women will be diagnosed within the last 2 years with a primary, non-advanced cancer (stages 0-III) of any type and will be mothers of a child 5-17 years of age. Study participants will be recruited from medical providers, local channels (e.g. community health agencies, Community Health Worker networks, social media), and through self-referral in the recruitment counties. After completing signed informed consent and baseline measures, mothers will be randomized to an experimental or control group. All program materials/delivery are available in English and Spanish. All program education and data collection is conducted entirely by telephone so that the women can participate within the comfort of their homes and at times convenient for them. The experimental group will receive 5 fully scripted telephone-delivered educational sessions every 2 weeks by specially trained patient educators. The control group will receive "Taking Time," a NCI cancer education booklet, and 1 scripted telephone-delivered session with a patient educator. Assessments will occur at 3 months post-baseline for all participants and at 6 months post-baseline for 66% of participants. Post-intervention measures consist of standardized questionnaires with well-established validity and reliability, all available in Spanish. Linear Mixed Models will be used to analyze outcomes within an intent to treat analysis.. With an estimated Effect size of 0.52 for the primary outcome measure of the child's behavioral-emotional adjustment, the investigators need to retain a total sample size of 116 (58/group) for efficacy analysis. The investigators plan to enroll 156 eligible mothers, allowing for an expected 25% attrition rate from all causes. Study results will be essential as a next step in testing Conexiones with other Hispanic subgroups in a larger trial and readying the program for wider testing and dissemination to provider and non-profit organizations serving Hispanic parents with cancer throughout the United States. | ArmGroups: [{'label': 'Conexiones', 'type': 'EXPERIMENTAL', 'description': '5 telephone sessions of Conexiones, with each session delivered 2 weeks apart across a total period of 8 weeks', 'interventionNames': ['Behavioral: Conexiones']}, {'label': 'Taking Time', 'type': 'OTHER', 'description': "1 telephone session consisting of a scripted protocol guiding participants through the NCI's Taking Time Booklet.", 'interventionNames': ['Behavioral: Taking Time']}] | Interventions:[{'type': 'BEHAVIORAL', 'name': 'Conexiones', 'description': '5 Conexiones telephone sessions', 'armGroupLabels': ['Conexiones']}, {'type': 'BEHAVIORAL', 'name': 'Taking Time', 'description': '1 Taking Time telephone session', 'armGroupLabels': ['Taking Time']}] | PrimaryOutcomes: [{'measure': 'Child Behavior Checklist (CBCL)', 'description': 'A mother-reported scale of a broad range of behavior problems in children ages 6-18; Response options range from 0 to 2 from "Not True (as far as you know)" to "Somewhat or Sometimes True" to "Very True or Often True', 'timeFrame': '3 months'}] | SecondaryOutcomes: [{'measure': 'Center for Epidemiological Studies-Depression Scale (CES-D)', 'description': 'Measures maternal depressed mood; 15 items measured on a 4 point Likert-type scale (1 -Rarely or none of the time; 4-Most or all of the time)', 'timeFrame': '7 days'}, {'measure': 'Spielberger State-Trait Anxiety Inventory (STAI)', 'description': 'Measures maternal anxiety; 20 items; 4 point Likert-type scale (1-Not at all; 4-Very much so)', 'timeFrame': '1 hour'}, {'measure': 'Cancer Self-Efficacy Scale (CASE)', 'description': 'Three subscales (Help Child, Deal \\& Manage, and Stay Calm) measure parenting self-efficacy; 28 items; 11 point Likert-type scale (0-not at all confident; 10-Very Confident)', 'timeFrame': '1 hour'}, {'measure': 'Family-Peer Relationship Scale (FPRQ)', 'description': 'Measures parenting quality using 7 items that assess interpersonal communication between the mother and child; includes 2 subscales (Disclosure of Negative Feelings and Disclosure of Bad Things Happening); 5 point Likert-type scale (0-Never talks about it; 4-Always talks about it)', 'timeFrame': '3 months'}, {'measure': 'Parenting Skills Checklist', 'description': 'Assesses the interactional behaviors mothers used to assist their child to disclose, discuss, and cope with the breast cancer; 2 subscales (Elicitation subscale, Connecting \\& Coping subscale); 8 items; 6 point Likert-type scale (0-Never; 5-All of the time)', 'timeFrame': '1 hour'}] |
Title: MethylphenIdate for Fatigue in Haematological Cancer. A Randomized, Double-blind, Placebo-controlled, CROssover Trial - the MICRO Trial | Condition: Hematological Cancer | Keywords: hematological cancer, fatigue, quality of life | Summary: | Description: BACKGROUND Survival prognosis in haematological malignancies has improved considerably, however the frequency and impact of the most prevalent and debilitating symptoms - cancer related fatigue (CRF) - has not improved. Up to 40% of cancer patients has daily difficulties due to CRF and fatigue and weakness is affecting 2/3 of patients. In contrast to everyday fatigue CRF is defined as an unusual and persistent sense of tiredness, weakness, or even exhaustion that is not relieved by rest or sleep and leads to decreased physical or mental capacity.
Haematological cancer is often associated with fatigue due to both anemia and constitutional symptoms. Myeloablative chemotherapeutic regimens and stem cell transplantations are unique for haematological cancer treatment and these very potent regimens may result in CRF even after several years. CRF among haematological cancer patients is associated with reduced adherence to physicians recommendations \[11\] and permanent withdrawal from labor market. Patients express that their single most prevalent and severe problem is "dealing with feeling tired", exceeding the proportion who expresses problems "in dealing with not feeling sure that the cancer has gone" or "being told they had cancer".
An increasing emphasis has been given to rehabilitation in cancer patients and individualized exercise programs; however, these will only be feasible among a minority of haematological cancer patients. In recent years, studies using methylphenidate (MTP) in the treatment of CRF in solid cancer have been conducted, some of which have found improvements in fatigue with MTP and without significant adverse effects. These studies show that MTP may be beneficial in management of CRF. However, patients in concurrent chemotherapy were unlikely to benefit.
STUDY RATIONALE AND OBJECTIVE Patients with haematological malignancies have a severe unmet need in dealing with CRF and hardly any patients with haematological malignancies have been included in previous intervention studies. MTP treatment has been found to be safe in this setting . The current study aims at studying whether MTP can be used for management of CRF in patients with haematological cancer in order to improve also functional capacity and quality of life (QoL). Many of the patients in the current study will have no other treatment options to improve their fatigue, QoL, and functional capacity.
STUDY END-POINTS The primary end point it patient reported fatigue after six weeks of MTP treatment measured by the FACIT-F scale. A good clinical response is defined as a 25% reduction in fatigue from baseline score. Secondary end-points are changes in hours awake, in time spend at work, being social, house work / gardening, being outside, participating in exercise, in muscle strength and endurance, in QoL, and in number of blood transfusions.
STUDY POPULATION AND DESIGN The study population comprises 150 patients with haematological malignancies who are not in current chemotherapy. The patients will be included from seven haematological out-patient clinics in Denmark. The haematological out-patient clinics have a large group of chronic severely fatigued haematological cancer patients that will be approached for inclusion in the trial. Power calculations, and assumptions behind as well as a detailed list of inclusion and exclusion criteria are available from full study protocol.
Patients will be randomized (1:1) to MTP or placebo treatment for 6 weeks. After this time points patients treated with MTP will after one week wash-out cross over to placebo treatment and vice versa (Figure). The rationale for the crossover design is that the study includes a variety of different haematological malignancies with different symptomatology, course, management and different degree of bone-marrow failure. When using patients as their own controls the effects of these factors are accounted for. Treatment will be blinded to the patient, treating investigators, staff, sponsor, and study secretariat. Patients will be randomized to start either MTP or matching placebo twice daily. The dosage will start at 5 mg twice daily at 8 am and 1 pm or matching placebo and can be titrated to a maximum of 20mg twice daily or matching placebo. From day 1 in week 8 treatments will be crossed over from either MTP to placebo or vice versa (Figure).
FATIGUE AND QUALITY OF LIFE ASSESSMENT TOOLS The fatigue assessment scale - FACIT-F - has been widely used in studies of cancer related fatigue and a FACIT-F score change both as a covariate and as the main outcome measure in interventional studies. In line with us previous clinical trials used a single VAS-fatigue assessment for inclusion prior to treatment. The visual analogous scale is 100 mm long and ranges from 0 = "not tired" to 10 = "worst possible tiredness". The European Organisation for Research and Treatment of Cancer (EORTC) QoL questionnaires are among the most widely used tools for assessing physical and psychosocial symptoms in cancer patients. The EORTC-QLQ-C15-PAL was developed for the palliative setting \[24\]. Permission to include the fatigue and QoL scales has been granted to the trial.
EFFICACY EVALUATION Efficacy of MTP treatment will be evaluated using FACIT-F, EORTC-QLQ-C15-Pal, VAS-F as well as patients' perception on their energy and diaries on activities. The study is powered to show a 4.25 point reduction in the FACIT-F scale (corresponding to an estimated 25% reduction from baseline) that has been suggested as a minimal important difference in studies of CRF. Assessments of functional capacity (muscle strength and endurance) as well as patients' actual daily chores are also included in this evaluation. | ArmGroups: [{'label': 'Methylphenidate - Placebo', 'type': 'OTHER', 'description': 'Methylphenidate before placebo', 'interventionNames': ['Drug: Methylphenidate', 'Drug: Placebo']}, {'label': 'Placebo - Methylphenidate', 'type': 'OTHER', 'description': 'Methylphenidate after placebo', 'interventionNames': ['Drug: Methylphenidate', 'Drug: Placebo']}] | Interventions:[{'type': 'DRUG', 'name': 'Methylphenidate', 'description': 'Titration of MTP for treatment of fatigue', 'armGroupLabels': ['Methylphenidate - Placebo', 'Placebo - Methylphenidate']}, {'type': 'DRUG', 'name': 'Placebo', 'description': 'Placebo', 'armGroupLabels': ['Methylphenidate - Placebo', 'Placebo - Methylphenidate']}] | PrimaryOutcomes: [{'measure': 'Fatigue score', 'timeFrame': 'end of 6th or 13th week'}] | SecondaryOutcomes: N/A |
Title: Integrating Telehealth to Advance Lung Cancer Screening | Condition: Early Detection of Cancer, Telemedicine, Decision Making | Keywords: | Summary: | Description: Annual lung cancer screening using low-dose computed tomography (LDCT) is associated with decreased lung cancer mortality but also with harms. As such, it is recommended, and required for reimbursement, that patients complete an shared decision-making visit (SDM) prior to screening to discuss potential risks and benefits in the context of patient values. Despite guidelines recommending screening and national insurance coverage of LDCT, uptake of SDM visits and subsequent LDCT is remarkably low. We aim to address these gaps by comparing the effectiveness of synchronous and asynchronous telehealth strategies on SDM visits and subsequent LDCT in a pragmatic trial using a Sequential Multiple Assignment Randomized Trial (SMART) design. The specific first stage strategies to be tested are: a) Active Choice Outreach (invitation to schedule a telehealth or in-person SDM visit) vs b) Telehealth Only Outreach (invitation to schedule a telehealth SDM visit). The specific second stage strategies (delivered only if participants do not respond to first stage interventions) are a) text message reminders encouraging SDM visit completion (low-touch) alone or b) in combination with phone-based digital care coordination (high-touch). We will also assess non-inferiority of strategies by race and sex to assess equity of effectiveness. | ArmGroups: [{'label': 'Active Choice (Stage 1) + Low Touch (Stage 2)', 'type': 'EXPERIMENTAL', 'description': 'Participants in this arm will be offered the option via outreach letter to complete an SDM visit via telehealth or in-person (Stage 1) and if individuals do not schedule an SDM visit within 30 days (non-responders), they will receive asynchronous text messages alone (Stage 2)', 'interventionNames': ['Behavioral: Active Choice', 'Behavioral: Low Touch Strategy']}, {'label': 'Active Choice (Stage 1) + High Touch (Stage 2)', 'type': 'EXPERIMENTAL', 'description': 'Participants in this arm will be offered the option via outreach letter to complete an SDM visit via telehealth or in-person (Stage 1) and if individuals do not schedule an SDM visit within 30 days (non-responders), they will receive asynchronous text messages in combination with synchronous digital care coordination (Stage 2).', 'interventionNames': ['Behavioral: Active Choice', 'Behavioral: High Touch Strategy']}, {'label': 'Telehealth Only (Stage 1) + Low Touch (Stage 2)', 'type': 'EXPERIMENTAL', 'description': 'Participants in this arm will be offered the option via outreach letter to complete an SDM visit via telehealth only (Stage 1) and if individuals do not schedule an SDM visit within 30 days (non-responders), they will receive asynchronous text messages alone (Stage 2).', 'interventionNames': ['Behavioral: Telehealth Only', 'Behavioral: Low Touch Strategy']}, {'label': 'Telehealth Only (Stage 1) + High Touch (Stage 2)', 'type': 'EXPERIMENTAL', 'description': 'Participants in this arm will be offered the option via outreach letter to complete an SDM visit via telehealth only (Stage 1) and if individuals do not schedule an SDM visit within 30 days (non-responders), they will receive asynchronous text messages in combination with synchronous digital care coordination (Stage 2).', 'interventionNames': ['Behavioral: Telehealth Only', 'Behavioral: High Touch Strategy']}] | Interventions:[{'type': 'BEHAVIORAL', 'name': 'Active Choice', 'description': 'The participant will be send a letter inviting them to complete a SDM visit either in-person or via telehealth.', 'armGroupLabels': ['Active Choice (Stage 1) + High Touch (Stage 2)', 'Active Choice (Stage 1) + Low Touch (Stage 2)']}, {'type': 'BEHAVIORAL', 'name': 'Telehealth Only', 'description': 'The participant will be send a letter inviting them to complete a SDM visit via telehealth only.', 'armGroupLabels': ['Telehealth Only (Stage 1) + High Touch (Stage 2)', 'Telehealth Only (Stage 1) + Low Touch (Stage 2)']}, {'type': 'BEHAVIORAL', 'name': 'Low Touch Strategy', 'description': 'Patient will be sent asynchronous text messaging reminders encouraging SDM for LCS using framed messaging.', 'armGroupLabels': ['Active Choice (Stage 1) + Low Touch (Stage 2)', 'Telehealth Only (Stage 1) + Low Touch (Stage 2)']}, {'type': 'BEHAVIORAL', 'name': 'High Touch Strategy', 'description': 'Patient will be sent asynchronous text messaging reminders encouraging SDM for LCS using framed messaging in combination with synchronous telephone-based digital care coordination.', 'armGroupLabels': ['Active Choice (Stage 1) + High Touch (Stage 2)', 'Telehealth Only (Stage 1) + High Touch (Stage 2)']}] | PrimaryOutcomes: [{'measure': 'Shared decision making (SDM) for lung cancer screening (LCS)', 'description': 'Completion of an SDM visit (in person or telehealth) defined as any completed encounter that has documented SDM for LCS as indicated by 1) procedure code (G0296 or equivalent), or documentation of SDM conversation related to LCS in associated progress notes.', 'timeFrame': '90 days after randomization'}] | SecondaryOutcomes: [{'measure': 'Low-dose computed tomography (LDCT)', 'description': 'Completion of LDCT within 6 months of randomization date among individuals who complete SDM and are determined to be eligible for LCS.', 'timeFrame': '6 months after randomization'}] |
Title: Phase I Study of Continuous Weekly Dosing of Dimethyl Benzoylphenylurea (BPU) in Patients With Solid Tumors Not Responding to Conventional Therapy | Condition: Unspecified Adult Solid Tumor, Protocol Specific | Keywords: unspecified adult solid tumor, protocol specific | Summary: | Description: OBJECTIVES:
* Determine the maximum tolerated dose of benzoylphenylurea in patients with advanced solid tumors.
* Evaluate the acute and chronic toxicity profile of this regimen in these patients.
* Evaluate the pharmacokinetics and metabolites of this regimen and any potential correlation with pharmacodynamic effects in these patients.
* Determine the antitumor activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive oral benzoylphenylurea (BPU) once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of BPU until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience a dose-limiting toxicity. Once the MTD is determined, 12 additional patients are accrued and treated with BPU as above to confirm the MTD.
Patients are followed for 30 days.
PROJECTED ACCRUAL: Approximately 18-24 patients will be accrued for this study. | ArmGroups: [{'label': 'benzoylphenylurea', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: benzoylphenylurea']}] | Interventions:[{'type': 'DRUG', 'name': 'benzoylphenylurea', 'armGroupLabels': ['benzoylphenylurea']}] | PrimaryOutcomes: [{'measure': 'Determine Maximum Tolerated Dose of BPU', 'description': 'Toxicity was assessed weekly during the first 2 cycles, and monthly thereafter, using the National Cancer Institute Common Toxicity Criteria (NCI CTCv2). Dose limiting toxicity (DLT) was defined as dose delays \\>2 weeks, grade 4 haematologic toxicity (except grade 4 neutropenia lasting \\<5 days), or grade 3 nonhaematologic toxicity. The maximum tolerated dose (MTD) is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience a dose-limiting toxicity.', 'timeFrame': '4 weeks (1 course of treatment for each subject)'}] | SecondaryOutcomes: [{'measure': 'Number of Patients With Adverse Events', 'timeFrame': 'every 4 weeks'}, {'measure': 'Area Under the Plasma Concentration Versus Time Curve (AUC) of BPU', 'timeFrame': '8 weeks'}, {'measure': 'Test for Antitumor Activity in Blood and Tissue', 'timeFrame': 'baseline'}] |
Title: A Pilot, Non-Randomized Phase II Protocol of Irinotecan for Patients With Previously Treated, Advanced, Non-Small Cell Lung Cancer With High ISG 15 Expression | Condition: Non-small Cell Lung Cancer | Keywords: Lung, non small cell, NSCLC, Irinotecan | Summary: | Description: The goal of this trial is to demonstrate the potential clinical benefit of targeted irinotecan chemotherapy in NSCLC patients whose tumors display a specific phenotype that is associated with increased sensitivity to this drug, ISG15H. | ArmGroups: [{'label': 'Irinotecan', 'type': 'EXPERIMENTAL', 'description': 'The starting dose of irinotecan for the study is 180 mg/m2, given intravenously every 14 days. Each 14 day period will constitute one cycle of treatment.', 'interventionNames': ['Drug: Irinotecan']}] | Interventions:[{'type': 'DRUG', 'name': 'Irinotecan', 'description': '180 mg/m2 Irinotecan intravenously over 60 minutes on day 1 of each cycle\n\nPre-medication for irinotecan: palonosetron 0.25 mg and dexamethasone 8 - 16 mg, both administered intravenously. Atropine 0.25 - 0.5 mg subcutaneously or IV is at the discretion of the treating physician', 'armGroupLabels': ['Irinotecan'], 'otherNames': ['Camptosar; Campto']}] | PrimaryOutcomes: [{'measure': 'Tumor Response', 'description': 'Change in tumor size will be measured by CT scan using RECIST criteria.', 'timeFrame': '8 weeks'}] | SecondaryOutcomes: [{'measure': 'Time to Progression (TTP)', 'description': 'Time to progression will be measured from the time of first treatment until there is evidence of progressive disease or death, from the date of first documented progression or date of death from any cause, whichever occurs first, assessed up to 100 months. Death will be treated as a progression event.', 'timeFrame': 'Up to 100 months'}, {'measure': 'Retrospectively Evaluate the Role of Tumor SULF2 Gene Methylation Status in Treatment Efficacy', 'description': 'Patients who have a loss of SULF2 gene expression have a better outcome than those whose tumors express SULF2. High level of ISG15 expression in NSCLC may indicate a subgroup of tumors that may be more sensitive to the cytotoxic effects of irinotecan. In patients who consent to screening, 10 unstained slides of archived diagnostic tissue will be obtained from formalin-fixed, paraffin-embedded specimens and analyzed in the laboratories of our Lovelace Respiratory Research Institute co-investigators.', 'timeFrame': '1 year'}, {'measure': 'Toxicity of Irinotecan Salvage Chemotherapy', 'description': 'Use blood samples to measure possible 1) Neutropenia, 2) Thrombocytopenia, 3)Diarrhea; 4) Other measures of toxicity other than alopecia, anorexia, and asthenia as listed in the National Cancer Institute Common Toxicity Criteria v. 4.03', 'timeFrame': '2 days preceding each cycle of therapy'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Up to 100 months'}, {'measure': 'Median Duration of Response', 'timeFrame': 'Up to 100 months'}, {'measure': 'Median Overall Survival (OS)', 'timeFrame': '100 months'}] |
Title: Mental Health Care Initiation Intervention for Older Adults with Cancer | Condition: Breast Cancer, Colorectal Cancer, Lung Cancer, Prostate Cancer | Keywords: 65 years and older, Mental health care, 23-218 | Summary: | Description: N/A | ArmGroups: [{'label': 'Open Door for Cancer (OD-C)', 'type': 'EXPERIMENTAL', 'description': 'OD-C includes five components delivered in three 30-minute telephone or videoconference visits over six weeks and one booster telephone call. All sessions are audio-recorded.', 'interventionNames': ['Other: 30-minute telephone or videoconference sessions']}, {'label': 'Usual Care', 'type': 'ACTIVE_COMPARATOR', 'description': "Participants assigned to Usual Care (n=50) will receive standard care. MSK's current usual care for distress screening is that all patients are screened for distress when they initiate care at MSK. Additional distress screening is conducted based on the determination of the oncology team. In addition, patients are referred to social work, psychology, and/or psychiatry based on the judgment of the oncology team.", 'interventionNames': ['Other: Questionnaires', 'Other: Interviews']}] | Interventions:[{'type': 'OTHER', 'name': 'Questionnaires', 'description': 'Patient demographic characteristics, Clinical variables, Cornell Service Index-Short Form (CSI), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder scale-7 (GAD-7), Client Satisfaction Questionnaire (CSQ-8), Intention to Seek Help Scale, Health Beliefs about Mental Illness Instrument (HBMII) - Emotional/Nervous Severity Scale, Health Beliefs about Mental Illness Instrument (HBMII) - Emotional/Nervous Benefits Scale, Barriers to Mental Health Services Scale-Revised, Cues to action, Self-Efficacy to Seek Mental Health Care (SE-SMHC)', 'armGroupLabels': ['Usual Care']}, {'type': 'OTHER', 'name': 'Interviews', 'description': 'Interviews will be conducted by the qualitative methods specialist and trained study staff and will last 30-45 minutes.', 'armGroupLabels': ['Usual Care']}, {'type': 'OTHER', 'name': '30-minute telephone or videoconference sessions', 'description': 'Includes five components delivered in three 30-minute telephone or videoconference visits over six weeks and one booster telephone call. All sessions are audio-recorded. The five components are:\n\n1. Provide education about depression and treatment options\n2. Identify treatment preferences and a personal goal achievable with mental health care\n3. Assess barriers to treatment initiation\n4. Recommend a referral using standardized referral options\n5. Address barriers to accessing care', 'armGroupLabels': ['Open Door for Cancer (OD-C)']}] | PrimaryOutcomes: [{'measure': 'Refusal rates', 'description': '≥75% of eligible patients enroll in the study', 'timeFrame': '2 years'}, {'measure': 'Attrition rates', 'description': '≥80% of patients who enroll complete all study procedures', 'timeFrame': '2 years'}] | SecondaryOutcomes: [{'measure': 'Treatment satisfaction', 'description': 'Client Satisfaction Questionnaire-8 mean score of ≥3', 'timeFrame': '2 years'}] |
Title: Effects of Combining a Neuromuscular Electrical Stimulation Intervention With Nutritional Support in Deconditioned Patients With Advanced Gastrointestinal Cancer - DIG'ELECTROSTIM-01 | Condition: Cancer Digestive | Keywords: electrostimulation | Summary: | Description: Sarcopenia and cachexia are observed in more than 50% of patients with gastrointestinal (GI) cancer.
Both negatively affect patient survival and health-related quality of life (HRQoL) due to decreased tolerance to anticancer treatments and increased susceptibility to infections and other complications. Therefore, sarcopenia and cachexia represent a major clinical issue in this setting. A multimodal therapeutic approach to the sarcopenia and cachexia management is recommended, including nutritional support and exercise with personalized oncology care and family-centered education.
Neuromuscular electrical stimulation (NMES) generates muscle contractions using portable devices connected to surface electrodes.
NMES is safe, does not require the active cooperation of the patient and can be self-administered at home, thereby providing an acceptable physical therapy for patients with advanced cancer and an altered Eastern Cooperative Oncology Group performance status (ECOG PS) and/or a high-symptom burden, for whom attendance to hospital-based exercise training is difficult.
In this study, we hypothesize that NMES is a safe and effective physical-therapy strategy to improve HRQoL and to reduce cancer-induced sarcopenia in patients with metastatic GI cancer and altered ECOG PS (ECOG PS of 2). | ArmGroups: [{'label': 'Neuromuscular electrical stimulation (NMES)', 'type': 'OTHER', 'description': '30 NMES sessions will be performed by patients for 30 min, for a period of 8 weeks, according to a standardized protocol.\n\nThe number of sessions per week will be gradually increased to reach 5 sessions/week at week 4.', 'interventionNames': ['Other: NMES']}] | Interventions:[{'type': 'OTHER', 'name': 'NMES', 'description': 'Standardized strength program (75 Hz frequency, 40 cycles). The stimulation intensity will be increased up to the highest tolerated level in order to evoke strong muscle contractions.', 'armGroupLabels': ['Neuromuscular electrical stimulation (NMES)']}] | PrimaryOutcomes: [{'measure': 'Step 1 : Number of patients who completed the neuromuscular electrical stimulation (NMES) program', 'description': 'Step 1: Feasibility study will be performed on the first 10 patients. The NMES adherence will be satisfactory if the patient achieves ≥ 40% of planned sessions (12 in total). The NMES will be considered feasible if ≥ 70% of the first 10 patients included achieve this goal.', 'timeFrame': 'At 6 months'}, {'measure': 'Step 2 : Number of patients with improvement of 10 points between baseline and week 8, assessed using the EORTC QLQ-C30 physical functioning scale', 'description': 'At baseline, at week 8', 'timeFrame': 'Up to 24 months'}] | SecondaryOutcomes: [{'measure': 'Time between inclusion and the observation of the first deterioration of at least 10 points as compared to the baseline score', 'description': 'Every 2 moths until 12 months after inclusion', 'timeFrame': 'Up to 24 months'}, {'measure': 'Progression-free survival (PFS)', 'description': 'PFS defined as the time between inclusion and tumor progression (according to RECIST v1.1) or death (all causes), whichever occurs first', 'timeFrame': 'Up to 24 months'}, {'measure': 'Overall Survival (OS)', 'description': 'OS defined as the time between inclusion and death (from all causes)', 'timeFrame': 'Up to 24 months'}] |
Title: Investigation of Immune Modulation by Modern Acupuncture in Gastroenterologic Cancers | Condition: Hepatocellular Cancer, Gastrointestinal Cancer, Immunosuppression | Keywords: gastrointestinal, Hepatocellular, immunosuppression, acupuncture | Summary: | Description: According to the total population of cancer patients, hepatocellular carcinoma (HCC) and colorectal cancer (CRC), two of gastroenterological cancers are involved in the most acquired five cancers. Colorectal cancer (CRC) is a leading cause of tumor-related morbidity and mortality worldwide, and HCC is one of the top ten cancers in China. Currently, the intervention for gastrointestinal cancers mainly focuses on surgical removal, but patients still have a high risk of recurrence. Thus, the prevention of cancer recurrence is the most crucial topic for the intervention. The pathophysiology of gastroenterological cancers is multifactorial and not yet completely understood. However, immunosuppression is a major contributing factor in tumor cells play a central part in disease progression. It determines the prognosis of patients.
The immune checkpoint or complementary therapy in the course of cancer treatment has been reported as effective methods for patients. In recent years, more integrated treatment studies have found that acupuncture can improve the discomfort and pain caused by chemotherapy. In addition, the treatment of rheumatoid arthritis has shown that acupuncture can effectively regulate the immunity of patients. In this study, investigators are considering to apply modern acupuncture as the immune modulation in gastroenterological cancers. Modern acupuncture is to use the scalp and ear acupuncture methods to identify diseases and checkpoints and apply them to regulate the immune function of patients with gastroenterological cancers. The infiltration of a specific subtype of T-cell and the expression of PD-L1 in tumors may be applied as indicators of cancer prognosis. These CD8 T cells (also called Tex cells) often fail to eradicate tumors and can become dysfunctional or exhausted. The magnitude of the reinvigoration of circulating Tex cells determined in relation to pretreatment tumor burden correlated with clinical response. By monitoring Tex cells, investigators will evaluate the feasibility of acupuncture as a complementary therapy to regulate the immune functions of patients with gastroenterological cancers | ArmGroups: [{'label': 'the scalp and ear acupuncture', 'type': 'EXPERIMENTAL', 'description': 'CHIAN HUEI ACUPUNCTURE NEEDLE', 'interventionNames': ['Other: Modern acupuncture']}] | Interventions:[{'type': 'OTHER', 'name': 'Modern acupuncture', 'description': 'use the scalp and ear acupuncture methods to identify diseases and checkpoints and apply them to regulate the immune function of patients with gastroenterological cancers.', 'armGroupLabels': ['the scalp and ear acupuncture']}] | PrimaryOutcomes: [{'measure': 'The number of CD8+ T', 'description': 'Using PBMC to analyze the number of CD8+ T that is NK, NKT, DC, and Monocyte.\n\nAt the start of acupuncture adjuvant therapy (week 0, week 2, and week 4) blood was collected.\n\nBlood draw - 15 ml/each\n\nWeek0- baseline, the original data of CD8+T before receiving acupuncture\n\nWeek2- the data of CD8+T after receiving acupuncture\n\nWeek4- the data of CD8+T after two weeks that the patients did not receive acupuncture\n\nCompare with week0 and week2 data, if week2 data is higher than week0, it means the acupuncture has effective to add the number of CD8+ T.\n\nCompare with week 2 and week 4 data results and confirm the data change of the number of CD8+ T after stopping the acupuncture. If the data do not decline, it means the effect of acupuncture remains to exist. If the data declines, it means the effect of acupuncture weakens.', 'timeFrame': '4 weeks'}] | SecondaryOutcomes: N/A |
Title: A Phase II Trial of Haplotype Mismatched Hematopoietic Stem Cell Transplantation Using Highly Purified CD34 Cells in Patients With Hematological Malignancies | Condition: Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplasia, Chronic Myeloid Leukemia | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': '1', 'type': 'ACTIVE_COMPARATOR', 'description': 'Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;', 'interventionNames': ['Radiation: Total Body Irradiation', 'Drug: Thiotepa', 'Drug: Fludarabine', 'Biological: Rabbit ATG']}, {'label': '2', 'type': 'EXPERIMENTAL', 'description': 'Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG', 'interventionNames': ['Radiation: Total Body Irradiation', 'Drug: Thiotepa', 'Drug: Fludarabine', 'Biological: Rabbit ATG', 'Drug: Palifermin']}] | Interventions:[{'type': 'RADIATION', 'name': 'Total Body Irradiation', 'description': '8 Gy on Day -9', 'armGroupLabels': ['1', '2']}, {'type': 'DRUG', 'name': 'Thiotepa', 'description': '5 mg/kg/d on Day -8 to -7', 'armGroupLabels': ['1', '2']}, {'type': 'DRUG', 'name': 'Fludarabine', 'description': '40 mg/m2/d on Day -6 to -3', 'armGroupLabels': ['1', '2']}, {'type': 'BIOLOGICAL', 'name': 'Rabbit ATG', 'description': '2.5 mg/kg/d on Day -5 to -2', 'armGroupLabels': ['1', '2'], 'otherNames': ['Antithymocyte globulin', 'Thymoglobulin']}, {'type': 'DRUG', 'name': 'Palifermin', 'description': '60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2', 'armGroupLabels': ['2'], 'otherNames': ['Recombinant human keratinocyte growth factor', 'Kepivance']}] | PrimaryOutcomes: [{'measure': 'Treatment-related Mortality (TRM) Rate at 6 Months After Transplantation', 'description': 'To determine if haplotype-mismatched HSCT is associated with a ≤40% treatment-related mortality (TRM) rate at 6 months after transplantation; a TRM ≥60% being considered unacceptable. The percent of patients with the exact 95% confidence interval who had treatment-related mortality within 6 months of their transplant is presented.', 'timeFrame': 'thru 6 months after transplant'}] | SecondaryOutcomes: [{'measure': 'Regimen-related Toxicity', 'description': 'The number of unique patients who had adverse events that were possibly/probably/definitely related to treatment/regimen.', 'timeFrame': 'Up to 1 year'}, {'measure': 'Time to Neutrophil Engraftment', 'description': 'Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophil is defined as the time from transplant until absolute neutrophil count (ANC) \\> 500 uL for 3 consecutive days. The median and 95% confidence intervals will be provided.', 'timeFrame': 'Transplant (Day 0) up to 1 year'}, {'measure': 'Time to Platelet Engraftment', 'description': 'Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of seven consecutive days after transplantation during which the platelet count is at least 20 x109/l without transfusion support. Only patients who achieved engraftment of platelets will be included in the analysis. The median and 95% confidence intervals will be provided.', 'timeFrame': 'Transplant (Day 0) up to 1 year'}, {'measure': 'Acute Graft vs. Host Disease (GvHD)', 'description': 'Number of unique patients who had acute Graft vs. Host Disease (GvHD) diagnosed while on the study.', 'timeFrame': 'Up to 1 year'}, {'measure': 'Chronic Graft vs. Host Disease (GvHD)', 'description': 'Number of unique patients who had chronic Graft vs. Host Disease (GvHD) diagnosed while on the study.', 'timeFrame': 'Up to 1 year'}, {'measure': 'Frequency of Infection', 'description': 'Number of unique patients with bacterial and/or viral infections reported.', 'timeFrame': 'Day 0 through 1 year post transplantation'}] |
Title: Prospective Observational Trial to Evaluate Quality of Life After Definitive Chemoradiation in Patients With Anal Cancer (LANACARE) | Condition: Anal Cancer, Quality of Life, Chemoradiation | Keywords: anal cancer, quality of life, chemoradiation | Summary: | Description: Observational study to evaluate longitudinal quality of life according to standardized EORTC questionaires as well as functional outcome, oncological outcome and toxicity in patients treated with definitive chemoradiation for anal cancer. Qol will be evaluated by standardized EORTC questionaires QLQ C30 and QLQ CR29. Acute and late toxicity will be assessed according to CTCAE 4.03. Oncological outcome will be assessed with regard to local and distant control, patterns of recurrence, freedom from treatment failure and overall survival. Correlations of physicians- and patients-assessed functional outcomes are planned. | ArmGroups: N/A | Interventions:[{'type': 'OTHER', 'name': 'EORTC QLQ C30', 'description': 'standardized questionaire'}, {'type': 'OTHER', 'name': 'EORTC QLQ CR29', 'description': 'standardized questionaire'}] | PrimaryOutcomes: [{'measure': 'Qol (EORTC QLQC30) absolute values and change over time', 'description': 'Quality of life measured by EORTC questionaire QLQC30 in absolute values at different time points and change over time', 'timeFrame': 'day 0, end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266'}, {'measure': 'Qol (EORTC QLQCR29) absolute values and change over time', 'description': 'Quality of life measured by EORTC questionaire QLQCR29 in absolute values at different time points and change over time', 'timeFrame': 'day 0, end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266'}] | SecondaryOutcomes: [{'measure': 'local control', 'description': 'absence of disease progression inside the target volume of radiation therapy', 'timeFrame': 'end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266'}, {'measure': 'distant control', 'description': 'absence of disease progression outside the target volume of radiation therapy', 'timeFrame': 'end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266'}, {'measure': 'freedom from treatment failure', 'description': 'absence of disease progression inside or outside the target volume of radiation therapy', 'timeFrame': 'end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266'}, {'measure': 'overall survival', 'description': 'absence of death from any cause', 'timeFrame': 'end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266'}, {'measure': 'acute toxicity', 'description': 'acute toxicity caused by chemoradiation according to CTCAE 4.03', 'timeFrame': 'day 0, end of week 6, 12, 19'}, {'measure': 'late toxicity', 'description': 'late toxicity caused by chemoradiation according to CTCAE 4.03', 'timeFrame': 'end of week 32, 58, 84, 110, 162, 214, 266'}] |
Title: Supportive Care Needs of Former Child, Adolescent and Young Adult Cancer Patients, and of Their Parents: Evaluation During Long-term Follow-up | Condition: Solid Tumor or Lymphoma | Keywords: Psycho-oncology, Health Psychology, Paediatric oncology, Supportive care, Survivorship, Caregiver, Children, Adolescents and Young Adults | Summary: | Description: Rational Each year, there are 2100 new cases of cancer in children and adolescents/young adults (AYA) in France. Due to a significant improvement in the effectiveness of therapies, the survival rate of all types of cancer combined after 5 years is 80-85%. This is leading to the emergence of new problems, which require an adaptation of the long-term care of these former patients. Many studies highlight that 60 to 65% of pediatric oncology patients will present medical and/or psychosocial complications in the 20 years following their oncological treatment, with a cumulative incidence of a serious adverse event of 40% 30 years after the cancer diagnosis. Nevertheless, although some medical complications have been widely described and are the subject of recommendations, many questions remain unanswered regarding the real long-term needs of patients and of their main caregivers, in this project their parents. It is therefore necessary to identify the risk factors by determining the expectations and the supportive care needs of patients and their caregivers in the long-term follow-up in order to intervene early and thus reduce the incidence of these later complications.
However, only 30 to 50% of former patients in pediatric oncology-hematology and their family attend a long-term follow-up medical consultation. We hypothesize that this lack of commitment is multifactorial (e.g. unmet supportive care needs, geographical distance from home, lack of information about the importance of long-term follow-up and follow-up structures nearby) and that a precise study of the needs expressed by former patients and their family should lead to an improved attendance at these consultations.
A better understanding of the supportive care needs of these patients and their families, as well as the brakes/obstacles or lers of their compliance with a long-term follow-up, is therefore essential to improve their quality of life, prevent or detect the sequela of therapies and reduce the risk of morbidity/mortality.
Objectives The main objective of this study is to assess not only the specific supportive care needs of former onco-hematology patients treated before the age of 25 years, but also those of their parents up to 6 months after the end of the oncological follow-up, i.e. 3 to 5 years after the diagnosis.
The secondary objectives aim to:
1. Assess adherence to long-term follow-up medical consultation
2. Assess the early complications presented by the patients
3. Assess the quality of life and the anxiety-depression of former patients and their parents
4. Describe and evaluate the offer and use of the network of health professionals aware of the post-treatment issues; assess the referral to the network of health professionals aware of the post-treatment issues.
Methodology Depending on the objectives, the methodology used in this study is mixed, qualitative and quantitative. The study will be proposed systematically to all former patients of the hospital department diagnosed before the age of 25 years and at least 6 years of age at the time of inclusion as well as to their parents. The experiences and the specific needs of each person (patients, mothers and fathers) will be assessed independently. Three independent groups will be formed based on the age of the patient when included in the study. For each group, the parents may or may not be paired with the patients. A sample of 60 former pediatric patients (20 per age group) and 60-120 parents (ideally 40 per age group) is expected.
Expected results At the scientific level, this study will provide a better understanding of the cognitive and emotional processes involved in the long-term follow-up, in particular by identifying the supportive care needs of different participants (former patients and parents) and their experiences and quality of life during the long-term follow-up phase. This first stage will be followed by more powerful studies on the modalities of following-up patients after cancer, in order to add to previously published research on the long-term medical and psychological side effects.
At the individual level, this pilot study will enable the development of a multiprofessional structure, expert in cancer after-care from the end of the oncological follow-up. This support could be initiated early and the link with the local network established quickly. It should reduce the experience of being abandoned presented by former patients and their families. At the family level, studying the needs expressed by parents could lead to a family psychological approach in order to restore the family links impacted by the disease.
At the organizational level, this study should serve as a basis for developing a structure that can carry out tertiary prevention, and thus reduce the costs attributable to long-term side effects (e.g. educational and professional absenteeism, use of treatments, private consultations or even hospitalization). | ArmGroups: [{'label': 'Patients 6-14 years old', 'description': "Individual interview + Self-report questionnaire + long-term follow-up medical consultation + At 1 year : Assessment of prescription's adherence", 'interventionNames': ['Other: Interview', 'Other: Self-report questionnaire', 'Other: Medical consultation']}, {'label': 'Parents of 6-14 years old patients', 'description': 'Individual interview + Self-report questionnaire', 'interventionNames': ['Other: Interview', 'Other: Self-report questionnaire']}, {'label': 'Patients 15-25 years old', 'description': "Individual interview + Self-report questionnaire + long-term follow-up medical consultation + At 1 year : Assessment of prescription's adherence", 'interventionNames': ['Other: Interview', 'Other: Self-report questionnaire', 'Other: Medical consultation']}, {'label': 'Parents of 15-25 years old patients', 'description': 'Individual interview + Self-report questionnaire', 'interventionNames': ['Other: Interview', 'Other: Self-report questionnaire']}, {'label': 'Patients > 25 years old', 'description': "Individual interview + Self-report questionnaire + long-term follow-up medical consultation + At 1 year : Assessment of prescription's adherence", 'interventionNames': ['Other: Interview', 'Other: Self-report questionnaire', 'Other: Medical consultation']}, {'label': 'Parents of > 25 years old patients', 'description': 'Individual interview + Self-report questionnaire', 'interventionNames': ['Other: Interview', 'Other: Self-report questionnaire']}] | Interventions:[{'type': 'OTHER', 'name': 'Interview', 'description': 'The qualitative interview aims to identify the supportive care needs of patients and parents as well as their expectations with regard to a long-term follow-up.', 'armGroupLabels': ['Parents of 15-25 years old patients', 'Parents of 6-14 years old patients', 'Parents of > 25 years old patients', 'Patients 15-25 years old', 'Patients 6-14 years old', 'Patients > 25 years old']}, {'type': 'OTHER', 'name': 'Self-report questionnaire', 'description': "To assess the quality of life, anxiety/depression of former patients and relatives:\n\nFor child and adolescent patients (less than 15 years old at inclusion):\n\n* Pediatric Quality of Life Inventory Cancer module\n* Screen for Child Anxiety Related Emotional Disorders Revised\n* Children's Depression Inventory\n\nFor patients over 15 years of age at the time of inclusion and parents:\n\n* 36-Item Short Form Health Survey\n* Hospital Anxiety and Depression Scale\n\nTo describe and evaluate the offer and use of the network of health professionals who are aware of post-treatment issues: number of consultations, speciality and location of the professionals requested following the long-term follow-up consultation, time between referral and first consultation, evaluation of the geographical accessibility of care around the patient's home.", 'armGroupLabels': ['Parents of 15-25 years old patients', 'Parents of 6-14 years old patients', 'Parents of > 25 years old patients', 'Patients 15-25 years old', 'Patients 6-14 years old', 'Patients > 25 years old']}, {'type': 'OTHER', 'name': 'Medical consultation', 'description': 'To assess adherence to long-term follow-up medical consultation:\n\n- number of patients summoned/ number of consultations carried out ; reason for refusal of long-term follow-up medical consultation To assess medical complications through clinical data collection', 'armGroupLabels': ['Patients 15-25 years old', 'Patients 6-14 years old', 'Patients > 25 years old']}] | PrimaryOutcomes: [{'measure': 'Qualitative interview', 'description': 'To identify the supportive care needs of patients and parents as well as their expectations with regard to a long-term follow-up', 'timeFrame': 'From 1 to 6 months after the standard monitoring consultation'}] | SecondaryOutcomes: [{'measure': 'Quantitative measures to assess adherence to long-term follow-up medical consultation', 'description': 'Number of patients summoned/ number of consultations carried out ; reason for refusal of long-term follow-up medical consultation', 'timeFrame': 'From 1 to 6 months after the standard monitoring consultation'}, {'measure': 'Clinical Case Report Form to assess the early complications presented by the patients', 'description': 'Clinical data : cardiac/renal/bones/digestive/hepatic/endocrine/dermatological/sexual/pulmonary/nutritional damages, pain, physical activity, addictology, tiredness, psychological follow-up', 'timeFrame': 'From 1 to 6 months after the standard monitoring consultation'}, {'measure': 'Scores of quality of life', 'description': 'For child and adolescent patients (less than 15 years old at inclusion):\n\n- Pediatric Quality of Life Inventory Cancer module\n\nFor patients over 15 years of age at the time of inclusion and parents:\n\n- 36-Item Short Form Health Survey', 'timeFrame': 'From 1 to 6 months after the standard monitoring consultation'}, {'measure': 'Scores of anxiety-depression', 'description': "For child and adolescent patients (less than 15 years old at inclusion):\n\n* Screen for Child Anxiety Related Emotional Disorders Revised\n* Children's Depression Inventory\n\nFor patients over 15 years of age at the time of inclusion and parents:\n\n- Hospital Anxiety and Depression Scale", 'timeFrame': 'From 1 to 6 months after the standard monitoring consultation'}, {'measure': 'Quantitative measures to describe and evaluate the offer and use of the network of health professionals who are aware of post-treatment issues', 'description': "number of consultations, speciality and location of the professionals requested following the long-term follow-up consultation, time between referral and first consultation, evaluation of the geographical accessibility of care around the patient's home", 'timeFrame': 'One year after the long-term follow-up consultation'}] |
Title: HER2+ Breast Cancer Neo-Adjuvant Coordination of Care Program | Condition: Breast Cancer | Keywords: | Summary: | Description: The HER2+ Breast Cancer Neo-Adjuvant Coordination of Care Program will evaluate the feasibility, effectiveness, and adoption of evidence based medicine for patients with HER2+ breast cancer through a care coordination application hosted on CECity's MedConcert™ platform. The goal is to implement evidence into practice using existing patient data, and to improve care based on knowledge that will enable care coordination between medical oncologists and surgeons.
PHASE 1: Workflow Design The steering committee from Duke has created a workflow process related to the HER2+ Neo-Adjuvant Therapy Treatment. The goal of the workflow is to establish a coordinated approach to care and identifying key steps in the process. The workflow will identify if the patient had a timely engagement of the multidisciplinary team; if a pre-treatment assessment was performed; if neo-adjuvant therapy treatment was prescribed; if appropriate management and adherence to treatment as prescribed occurred; if surgery was performed and the identification of the type of surgery; and if any subsequent therapy was prescribed. Data collection will be performed at each of the steps in the workflow.
PHASE 2: Engagement Three sites were identified to participate in the project. Each is affiliated with the Duke Cancer Network and are free standing hospital systems and clinics. A coordinator will be designated at each site to guide the process, enter data and communicate patient progress to the sites multidisciplinary project team. Routine communication will be maintained between each site and the project team to ensure timely resolution of any issues or to answer questions.
PHASE 3: Feedback Performance measures have been identified for which data will be collected and aggregated. The data will be displayed in a performance monitor in the CECity MedConcert™ application to provide feedback to providers on their performance related to the measures. Providers will also be provided access to educational resources and improvement opportunities through the application.
PHASE 4: Assessment of Change and Dissemination of Findings Currently, many patients with HER2+ Breast Cancer do not have the opportunity to be evaluated by an oncologist for neo-adjuvant treatment because of a lack of coordinated care between surgeons and oncologists. This project will evaluate adopting evidence-based medicine for patients with HER2+ through the use of a coordinated care application. The goal is to facilitate greater coordination of care between oncologists and surgeons and to identify interventions for improved care. A final report will outline the results of the coordinated care approach. The results of this QI initiative will be developed into a manuscript for publication. | ArmGroups: N/A | Interventions:[{'type': 'OTHER', 'name': 'chart abstraction', 'description': 'abstraction of breast cancer patients with de-identified data'}] | PrimaryOutcomes: [{'measure': 'Coordination of Care efforts evaluation score', 'description': 'Multiple measurements will be aggregated from across study sites to evaluate coordination of care efforts across different disciplines involved in the care of a breast cancer patient.This evaluation will result in the formation of a multidisciplinary approach to care for breast cancer subjects.', 'timeFrame': '6 months to one year'}] | SecondaryOutcomes: N/A |
Title: An Open Label Study to Evaluate the Effect of First Line Treatment With Tarceva in Combination With Gemcitabine on Overall Survival and Disease Progression in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer | Condition: Pancreatic Cancer | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': '1', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: erlotinib [Tarceva]', 'Drug: gemcitabine']}] | Interventions:[{'type': 'DRUG', 'name': 'erlotinib [Tarceva]', 'description': '100mg po daily', 'armGroupLabels': ['1']}, {'type': 'DRUG', 'name': 'gemcitabine', 'description': '1000mg/m2 iv weekly for 8 weeks, then weekly for 3 weeks of each 4 week cycle', 'armGroupLabels': ['1']}] | PrimaryOutcomes: [{'measure': 'Overall survival; time to progression', 'timeFrame': '6 months'}] | SecondaryOutcomes: [{'measure': 'Duration of response; disease-free survival', 'timeFrame': 'Event driven'}, {'measure': 'AEs, lab parameters', 'timeFrame': 'Throughout study'}] |
Title: Palliative Hypofractionated Radiotherapy in Non-operable Rectal Cancer: A Retrospective Study | Condition: Rectal Cancer | Keywords: palliative radiotherapy, rectal bleeding, hypofractionated radiotherapy | Summary: | Description: Many patients with rectal cancer were not candidates for surgical resection because advanced age, comorbidities, or multiple synchronous metastases. In this scenario only comfort measures or different palliative radiotherapy regimens are applied, from single doses to treatments lasting several weeks. The aim of this prospective study is to describe the preliminary results of our protocol of hypofractionated palliative radiotherapy in patients with non-operable rectal cancer.
Patients with rectal cancer who were not candidates for surgical resection because advanced age, comorbidities, or multiple synchronous metastases at the time of diagnosis were considered eligible.
Patients were immobilized in the prone position with a belly-board in order to reduce small bowel irradiation. To limit organ motion patient were instructed to empty the bladder and drink 500cm3 of water 45-60 minutes before CT simulation and before every treatment fraction.
A conformal three-dimensional radiotherapy technique was planned to deliver to the primary tumor and the enlarged pelvic nodes a total dose of 39Gy in 13 sessions of 3Gy in 17 days.
Symptomatic response after the end of treatment has been measured for bleeding and pain and acute toxicity were reported according to CTCAEv4.0 scale. | ArmGroups: N/A | Interventions:[{'type': 'RADIATION', 'name': 'rectal cancer radiotherapy', 'description': 'Conformal three-dimensional radiotherapy to deliver to the primary tumor and the enlarged pelvic nodes a total dose of 39Gy in 13 sessions of 3Gy in 17 days.'}] | PrimaryOutcomes: [{'measure': 'Symptomatic response after palliative radiotherapy (bleeding)', 'description': 'number of patients with bleeding ( worst, no change, better or without)', 'timeFrame': 'two months afer the end of radiotherapy'}, {'measure': 'Symptomatic response after palliative radiotherapy (pain)', 'description': 'number of patients with pain ( worst, no change, better or without)', 'timeFrame': 'two months afer the end of radiotherapy'}, {'measure': 'Gastrointestinal toxicity after the end of radiotherapy', 'description': 'Gastrointestinal toxicity after the end of radiotherapy were reported according to CTCAE v4.0 scale', 'timeFrame': 'two months afer the end of radiotherapy'}, {'measure': 'Genitourinary toxicity after the end of radiotherapy', 'description': 'Genitourinary toxicity after the end of radiotherapy were reported according to CTCAE v4.0 scale.', 'timeFrame': 'two months afer the end of radiotherapy'}] | SecondaryOutcomes: [{'measure': 'palliative colostomy after the end of palliative radiotherapy', 'description': 'number of patients with colostomy', 'timeFrame': 'two months afer the end of radiotherapy'}] |
Title: A Clinical Study on the Safety and Efficacy of 9MW2821 in Patients With High-risk Non-muscle-invasive Bladder Cancer (NMIBC) That Have Previously Failed to Intravesical Therapy | Condition: Bladder Cancer | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'dose escalation and expansion', 'type': 'EXPERIMENTAL', 'description': 'Induction period: once a week, 6 times in total. Maintenance period: once per 28 days, 9 times in total. Intravesical therapy', 'interventionNames': ['Drug: 9MW2821']}] | Interventions:[{'type': 'DRUG', 'name': '9MW2821', 'description': 'Patients will be evaluated from low dose to high dose through intravesical therapy and then select the suitable doses to expand according to study data.', 'armGroupLabels': ['dose escalation and expansion']}] | PrimaryOutcomes: [{'measure': 'Safety and tolerability', 'description': 'assess the incidence of AE/SAE', 'timeFrame': 'up to 12 months'}, {'measure': 'RP2D and MTD', 'description': 'Determine the recommended phase 2 dose (RP2D) and the maximum tolerated dose (MTD) that may occur.', 'timeFrame': 'up to 12 months'}] | SecondaryOutcomes: [{'measure': 'DFS rate of 12 months', 'description': 'Disease-free survival rate of 12 months', 'timeFrame': 'Up to 12 months'}, {'measure': 'DoR of CR', 'description': 'Duration of complete response', 'timeFrame': 'Up to 20 months'}, {'measure': 'CR rate of 3/6/12 months', 'description': 'Complete response rate of 3/6/12 months', 'timeFrame': 'Up to 12 months'}, {'measure': 'DFS', 'description': 'Disease-free survival', 'timeFrame': 'Up to 20 months'}, {'measure': 'Duration to radical cystectomy', 'description': 'Duration to radical cystectomy', 'timeFrame': 'Up to 20 months'}, {'measure': 'Proportion of radical cystectomy', 'description': 'Proportion of radical cystectomy', 'timeFrame': 'Up to 20 months'}, {'measure': 'Biomarker parameter', 'description': 'Expression of Nectin-4', 'timeFrame': 'Up to 20 months'}] |
Title: Acupuncture for the Treatment of Pancreatic Cancer Pain: A Single Arm Phase II Study | Condition: Pain, Pancreatic Cancer | Keywords: stage III pancreatic cancer, recurrent pancreatic cancer, pain, stage IV pancreatic cancer | Summary: | Description: OBJECTIVES:
* Assess the effects of acupuncture and acupressure on pain, sedation, and use of opiate medication in patients with moderate or severe pain related to stage III or IV pancreatic cancer.
* Determine whether controlled trials of this therapy are warranted in this patient population.
* Provide data to aid design of further warranted studies of this therapy in this patient population.
OUTLINE: Patients receive acupuncture treatment comprising 20 minutes of needle insertion into the arms and abdomen to the depth used in traditional Chinese medicine on approximately days 4, 7, 11, and 14. After each acupuncture treatment, the acupuncturist applies/reapplies acupressure devices by inserting 2-6 smaller needles (studs) into the abdomen (which are held in place with surgical tape) and taping tiny metal balls to 3 points in each ear. Patients or caregivers are instructed to administer acupressure by pressing on the ear points (metal balls) for 1-2 minutes per point and moving the semi-permanent abdominal needles in small circular movements with the fingers, at a rate of 2-3 cycles per second, for 1-2 minutes per point, upon waking in the morning and in the early afternoon. Patients or caregivers are also instructed to stimulate a "rescue point" (the Shenmen auricular point) if patients experience pain exacerbations at other times during the day. Patients who respond well to acupuncture are offered further treatment.
Pain is assessed using the numerical rating scale on approximately days 1-4, 7, 11, and 14-17. Sedation is assessed using the Profile of Mood States (POMS) on approximately days 3 and 17. Analgesic medication use is assessed on approximately days 1-3 and 15-17.
PROJECTED ACCRUAL: A total of 10-29 patients will be accrued for this study within approximately 2 years. | ArmGroups: N/A | Interventions:[{'type': 'PROCEDURE', 'name': 'complementary or alternative medicine procedure'}, {'type': 'PROCEDURE', 'name': 'pain therapy'}] | PrimaryOutcomes: N/A | SecondaryOutcomes: N/A |
Title: A Phase 1 Study Evaluating Safety, Tolerability, and Pharmacokinetics of Escalating Doses of AGS67E Given as Monotherapy in Subjects With Refractory or Relapsed Lymphoid Malignancies | Condition: Relapsed Lymphoid Malignancy, Refractory Lymphoid Malignancy | Keywords: Refractory or relapsed chronic lymphocytic leukemia (CLL) prolymphocytic leukemia (PLL), Relapsed lymphoid malignancy, Refractory lymphoid malignancy, Pharmacokinetics of AGS67E, hairy cell leukemia (HCL), AGS67C, non-Hodgkin lymphoma (NHL), AGS67E | Summary: | Description: The dose escalation study will have two parts:
1. Dose Escalation of AGS67E without myeloid growth factor (GF)
2. Dose Escalation of AGS67E with myeloid growth factor (GF)
Subjects will be enrolled sequentially into dose cohorts starting with AGS67E without GF.
All subjects will receive a single 30 minute intravenous (IV) infusion of AGS67E once every three weeks. Subjects will continue treatment until disease progression, intolerability of AGS67E, investigator decision or consent withdrawal.
This dose escalation will first determine the maximum tolerated dose (MTD) of AGS67E without GF and then determine the MTD of AGS67E with GF. Once an MTD has been established, the study may enroll subjects into respective expansion cohorts of 12 subjects each at doses recommended by the data review team (DRT) (expansion cohort without GF and/or expansion cohort with GF).
During dose escalation, the Data Review Team will review cumulative unaudited data on an interim basis to review subject safety, recommend exploring additional doses and/or schedules, or the expansion of existing cohorts. | ArmGroups: [{'label': 'Dose Escalation of AGS67E 0.05 mg/kg Without GF', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive 0.05 milligram per kilogram (mg/kg) AGS67E without growth factor (GF) by intravenous infusion once every three weeks.', 'interventionNames': ['Drug: AGS67E']}, {'label': 'Dose Escalation of AGS67E 0.1 mg/kg Without GF', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive 0.1 mg/kg AGS67E without GF by intravenous infusion once every three weeks.', 'interventionNames': ['Drug: AGS67E']}, {'label': 'Dose Escalation of AGS67E 0.3 mg/kg Without GF', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive 0.3 mg/kg AGS67E without GF by intravenous infusion once every three weeks.', 'interventionNames': ['Drug: AGS67E']}, {'label': 'Dose Escalation of AGS67E 0.6 mg/kg Without GF', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive 0.6 mg/kg AGS67E without GF by intravenous infusion once every three weeks.', 'interventionNames': ['Drug: AGS67E']}, {'label': 'Dose Escalation of AGS67E 0.9 mg/kg Without GF', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive 0.9 mg/kg AGS67E without GF by intravenous infusion once every three weeks.', 'interventionNames': ['Drug: AGS67E']}, {'label': 'Dose Escalation of AGS67E 1.2 mg/kg Without GF', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive 1.2 mg/kg AGS67E without GF by intravenous infusion once every three weeks.', 'interventionNames': ['Drug: AGS67E']}, {'label': 'Dose Expansion of AGS67E 0.9 mg/kg Without GF', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive 0.9 mg/kg AGS67E without GF by intravenous infusion once every three weeks.', 'interventionNames': ['Drug: AGS67E']}, {'label': 'Dose Escalation of AGS67E 1.2 mg/kg With GF', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive 1.2 mg/kg AGS67E with GF by intravenous infusion once every three weeks.', 'interventionNames': ['Drug: AGS67E']}, {'label': 'Dose Escalation of AGS67E 1.5 mg/kg With GF', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive 1.5 mg/kg AGS67E with GF by intravenous infusion once every three weeks.', 'interventionNames': ['Drug: AGS67E']}, {'label': 'Dose Escalation of AGS67E 1.8 mg/kg With GF', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive 1.8 mg/kg AGS67E with GF by intravenous infusion once every three weeks.', 'interventionNames': ['Drug: AGS67E']}, {'label': 'Dose Expansion of AGS67E 1.5 mg/kg With GF', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive 1.5 mg/kg AGS67E with GF by intravenous infusion once every three weeks.', 'interventionNames': ['Drug: AGS67E']}] | Interventions:[{'type': 'DRUG', 'name': 'AGS67E', 'description': 'intravenous (IV) infusion', 'armGroupLabels': ['Dose Escalation of AGS67E 0.05 mg/kg Without GF', 'Dose Escalation of AGS67E 0.1 mg/kg Without GF', 'Dose Escalation of AGS67E 0.3 mg/kg Without GF', 'Dose Escalation of AGS67E 0.6 mg/kg Without GF', 'Dose Escalation of AGS67E 0.9 mg/kg Without GF', 'Dose Escalation of AGS67E 1.2 mg/kg With GF', 'Dose Escalation of AGS67E 1.2 mg/kg Without GF', 'Dose Escalation of AGS67E 1.5 mg/kg With GF', 'Dose Escalation of AGS67E 1.8 mg/kg With GF', 'Dose Expansion of AGS67E 0.9 mg/kg Without GF', 'Dose Expansion of AGS67E 1.5 mg/kg With GF']}] | PrimaryOutcomes: [{'measure': 'Incidence and nature of adverse events', 'timeFrame': 'up to 34 months'}, {'measure': 'Pharmacokinetic parameter for total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE): Concentration at the end of infusion (CEOI)', 'timeFrame': 'Escalation: Days 1-4, 8, 15, 22, 43-46, 50, 64 for Cycles 1-4 and predose once every 3 weeks in subsequent cycles. Expansion: Days 1, 3, 8, 22, 43, 45, 64 in Cycles 1-4 and predose once every 3 weeks in subsequent Cycles up to an average of 4 months'}, {'measure': 'Pharmacokinetic parameter for total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE): Maximum observed concentration (Cmax)', 'timeFrame': 'Escalation: Days 1-4, 8, 15, 22, 43-46, 50, 64 for Cycles 1-4 and predose once every 3 weeks in subsequent cycles. Expansion: Days 1, 3, 8, 22, 43, 45, 64 in Cycles 1-4 and predose once every 3 weeks in subsequent Cycles up to an average of 4 months'}, {'measure': 'Pharmacokinetic parameter for Monomethyl Auristatin E (MMAE): Time to maximum concentration (Tmax)', 'timeFrame': 'Escalation: Days 1-4, 8, 15, 22, 43-46, 50, 64 for Cycles 1-4 and predose once every 3 weeks in subsequent cycles. Expansion: Days 1, 3, 8, 22, 43, 45, 64 in Cycles 1-4 and predose once every 3 weeks in subsequent Cycles up to an average of 4 months'}, {'measure': 'Pharmacokinetic parameter for total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE): Partial area under the serum concentration-time curve after first dose and as appropriate (AUC0-21)', 'timeFrame': 'Escalation: Days 1-4, 8, 15, 22, 43-46, 50, 64 for Cycles 1-4 and predose once every 3 weeks in subsequent cycles. Expansion: Days 1, 3, 8, 22, 43, 45, 64 in Cycles 1-4 and predose once every 3 weeks in subsequent Cycles up to an average of 4 months'}, {'measure': 'Pharmacokinetic parameter for total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE): Terminal or apparent terminal half-life (t1/2)', 'timeFrame': 'Escalation: Days 1-4, 8, 15, 22, 43-46, 50, 64 for Cycles 1-4 and predose once every 3 weeks in subsequent cycles. Expansion: Days 1, 3, 8, 22, 43, 45, 64 in Cycles 1-4 and predose once every 3 weeks in subsequent Cycles up to an average of 4 months'}, {'measure': 'Pharmacokinetic parameter for total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE): Systemic clearance (CL)', 'timeFrame': 'Escalation: Days 1-4, 8, 15, 22, 43-46, 50, 64 for Cycles 1-4 and predose once every 3 weeks in subsequent cycles. Expansion: Days 1, 3, 8, 22, 43, 45, 64 in Cycles 1-4 and predose once every 3 weeks in subsequent Cycles up to an average of 4 months'}, {'measure': 'Pharmacokinetic parameter for total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE): Volume of distribution at steady state (Vss)', 'timeFrame': 'Escalation: Days 1-4, 8, 15, 22, 43-46, 50, 64 for Cycles 1-4 and predose once every 3 weeks in subsequent cycles. Expansion: Days 1, 3, 8, 22, 43, 45, 64 in Cycles 1-4 and predose once every 3 weeks in subsequent Cycles up to an average of 4 months'}] | SecondaryOutcomes: [{'measure': 'Incidence of Anti-Drug Antibody (ADA) formation to the fully human monoclonal antibody (AGS67C) and antibody-drug conjugate (AGS67E)', 'timeFrame': 'Up to 34 months'}, {'measure': 'Incidence of tumor response', 'description': 'Tumor response is defined as either a complete response (CR) or partial response (PR)', 'timeFrame': 'Up to 34 months'}, {'measure': 'Objective response rate (ORR)', 'description': 'ORR for a cohort is defined as the percentage of subjects who experience a best response of either complete response (CR) or partial response (PR) in that cohort.', 'timeFrame': 'Up to 34 months'}] |
Title: Non-invasive Isolation and Characterization of Prostate Tumor Cells for Prostate Cancer Diagnosis | Condition: Prostate Cancer | Keywords: Prostate cancer, Liquid biopsy, Biological samples, Non-invasive diagnosis | Summary: | Description: Prostate cancer is one of the most frequently diagnosed cancers and a leading cause of cancer death in men worldwide. Existing methods of diagnosis and monitoring of prostate cancer are inadequate due to their invasiveness, inaccuracy, cost, access uneven, etc., making difficult the diagnosis and patient's follow up. New techniques and methods are necessary to improve diagnosis.
Biological liquids might represent an attractive target to isolate prostate tumour cells for these purposes. In recent years, several studies have been carried out with the aim of reducing and / or avoiding the limits of sensitivity and specificity of current methods of screening for prostate cancer and thus obtain new biomarkers for the diagnosis and / or non-invasive monitoring.
However, due to technical and technological difficulties few studies have been performed to investigate the non-invasive isolation and direct analysis of tumour cells. Our project is therefore an innovative project which aims to study a new approach for the early diagnosis of prostate cancer, with better sensitivity and specificity. | ArmGroups: [{'label': 'Confirmed diagnosis group', 'description': 'Patients with a diagnosis of prostate cancer (metastatic or advanced) before prostatectomy.', 'interventionNames': ['Other: Results obtained by biopsy and MRI results.', 'Other: Clinical data']}, {'label': 'Pre-diagnosis group', 'description': 'Patients undergoing prostate biopsy in the context of prostate cancer diagnosis: PSA increases, and / or abnormal digital rectal examination (DRE) and / or an MRI detected signal.', 'interventionNames': ['Other: Results obtained by biopsy and MRI results.', 'Other: Clinical data']}] | Interventions:[{'type': 'OTHER', 'name': 'Results obtained by biopsy and MRI results.', 'description': 'Results obtained by biopsy and MRI results.', 'armGroupLabels': ['Confirmed diagnosis group', 'Pre-diagnosis group']}, {'type': 'OTHER', 'name': 'Clinical data', 'description': 'Clinical data', 'armGroupLabels': ['Confirmed diagnosis group', 'Pre-diagnosis group']}] | PrimaryOutcomes: [{'measure': 'Presence and number of prostate tumour cells in biological samples', 'description': 'Cell enrichment will be carried out using the ISET® (Isolation by SizE of Tumor/Trophoblastic cells) technology. Identification will be performed by different spectroscopic and/or immune-molecular and/or cytological approaches', 'timeFrame': 'One month after biopsy or until the histological diagnosis will be obtained'}] | SecondaryOutcomes: N/A |
Title: Breast Cancer and Resistance Exercise Program (B-REP): A Feasibility and Acceptability Trial | Condition: Breast Cancer, Resistance Training | Keywords: online, breast cancer, physical activity, breast neoplasm, resistance exercise, survivor | Summary: | Description: The project will use a 2-arm randomized controlled trial study. The intervention will include a 12, weekly, supervised, online-delivered, individualized resistance-based exercise program. The attention control arm will include a printed, individualized resistance-based physical activity program. A total of 50 breast cancer survivors will be recruited from Rutgers Cancer Institute of New Jersey (CINJ) and randomized to one of two study arms. The intervention arm will test the feasibility and acceptability of the intervention compared to the control arm, which will receive a printed or digital copy of an individualized physical activity program. Participants from both arms will receive an accelerometer (ActiGraph GT3X+), resistance bands (TheraBand®), and additional free weights (if required). Outcome measures will be assessed at baseline (pre-intervention), Week 12 (post-intervention) and Week 24 (follow-up). Data collection will occur both in-person and online. Data will be both objective (10RM, functional strength, physical activity measured by accelerometers, physical function assessments, and attendance) and subjective (self-reported physical activity program adherence, satisfaction, physical activity levels, health-related quality of life, and exercise and barrier self-efficacy).
Additionally, participants will complete one-on-one interviews with the PI or research staff over videoconferencing software (Rutgers Zoom). The interview will be 45 to 60 minutes in duration and participants will be asked to discuss their experiences in the program. | ArmGroups: [{'label': 'Intervention arm', 'type': 'EXPERIMENTAL', 'description': 'Participants will engage in 12, weekly, supervised, exercise sessions using Zoom with the exercise trainer. Once a week, the exercise trainer and participant will each log on to Zoom from their locations to begin the supervised exercise session. The exercise trainer will record all sessions. Sessions will be 30 to 45 minutes long and be structured as follows: review of previous session and an opportunity to ask questions; 5-minute warm-up; 20- to 25-minute workout; 5- to10-minute cool down and reminder of next session and/or data collection time period. Supervised sessions will be scheduled once a week over the 12-week intervention. Participants will be expected to complete their resistance-based physical activity program for an additional 1-2 days a week as per the intervention schedule to meet as physical activity guidelines. The exercise trainer will track participant attendance. During the session, participants must have another person in the same location in case of an emergency.', 'interventionNames': ['Behavioral: Online-delivered physical activity intervention.']}, {'label': 'Control Arm', 'type': 'OTHER', 'description': 'The attention control arm will include a printed, individualized resistance-based physical activity program.\n\nParticipants randomized to the control arm will be given a printed or digital individualized, resistance-based physical activity program and told to aim to for three exercise sessions per week. Control participants will follow the same measurement schedule as intervention participants.', 'interventionNames': ['Behavioral: Printed, individualized resistance-based physical activity program.']}] | Interventions:[{'type': 'BEHAVIORAL', 'name': 'Online-delivered physical activity intervention.', 'description': 'Participants randomized to the intervention arm will engage in 12, weekly, supervised, exercise sessions using Zoom with the exercise trainer.', 'armGroupLabels': ['Intervention arm']}, {'type': 'BEHAVIORAL', 'name': 'Printed, individualized resistance-based physical activity program.', 'description': 'Without the supervision of an exercise trainer, participants will be given a printed, individualized resistance-based physical activity program to complete over the course of 12 weeks.', 'armGroupLabels': ['Control Arm']}] | PrimaryOutcomes: [{'measure': 'Feasibility (participant retention)', 'description': 'Participant retention at assessment timepoints (attendance and completing assessments)', 'timeFrame': '14 weeks including pre-intervention and post-intervention questionnaire completion'}, {'measure': 'Acceptability (program adherence)', 'description': 'Adherence to physical activity program/intervention (attendance and exercise logs)', 'timeFrame': '12 weeks to complete the intervention'}, {'measure': 'Internet Evaluation and Utility Questionnaire', 'description': "Satisfaction will be measured as participants' experience and perceptions of an internet intervention. Scale values: Not at all, slightly, somewhat, mostly \\& very. Higher scores are associated with a greater level of satisfaction.", 'timeFrame': 'After the 12 week intervention and captured in follow-up questionnaire for intervention arm participants'}] | SecondaryOutcomes: [{'measure': '10 Repetition Maximum Test', 'description': 'Changes in strength measured by 10RM assessment', 'timeFrame': 'During the baseline assessment, week 12 assessment and week 24 follow up assessment'}, {'measure': 'Godin Leisure Time Exercise Questionnaire', 'description': 'Self-report exercise frequency (times per week) and intensity (mild, moderate, and vigorous). Higher scores indicate that individuals are more active.', 'timeFrame': 'During the baseline assessment, week 12 assessment and week 24 follow up assessment'}, {'measure': 'Accelerometer (ActiGraph)', 'description': 'Objective measure of total physical activity levels with intensity and duration (minutes). No scale.', 'timeFrame': 'Prior to intervention start and following the Week 12 and week 24 assessments'}, {'measure': 'Senior Fitness Test', 'description': 'Functional assessments including senior fitness test, which includes the 6 minute walk test, chair sit to stand test and arm curl test. Scores are compared to age-matched, national averages.', 'timeFrame': 'During the baseline assessment, week 12 assessment and week 24 follow up assessment'}, {'measure': 'Exercise Self-Efficacy Questionnaire', 'description': 'Confidence to exercise over the next three months rated on a scale of 0% to 100% confidence. High scores indicate higher perceived confidence to exercise.', 'timeFrame': 'During the baseline assessment, week 12 assessment and week 24 follow up assessment'}, {'measure': 'Barrier Self-Efficacy Questionnaire', 'description': 'Confidence to overcome commonly-reported barriers rated on a scale of 0% to 100%. Higher scores indicated higher perceived confidence to overcome barriers.', 'timeFrame': 'During the baseline assessment, week 12 assessment and week 24 follow up assessment'}, {'measure': 'Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)', 'description': 'Scale measures physical wellbeing, social/family wellbeing, emotional wellbeing and functional wellbeing with items specifically for breast cancer (additional concerns). Scale - Not at all, a little bit, some-what, quite a bit, very much. Higher scores indicate better outcomes.', 'timeFrame': 'Completed at baseline assessment, after completion of the intervention at week 12 and at the week 24 follow up'}] |
Title: Chemotherapy and Anti-angiogenic Agents- Induced Thrombosis in Cancer. | Condition: Multiple Myeloma, Plasma Cell Neoplasm, Thromboembolism | Keywords: thromboembolism, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma | Summary: | Description: OBJECTIVES:
Primary
* To measure levels of circulating tissue factor (TF) in patients with newly diagnosed multiple myeloma at several time points before, during, and after the administration of chemotherapy and/or antiangiogenic agents.
Secondary
* To measure the correlation of TF with two markers of coagulation activation (i.e., D-dimer, thrombin-antithrombin \[TAT\] complexes) and two markers of endothelial activation (i.e., soluble E-selectin, soluble thrombomodulin) in these patients.
* To measure and compare (descriptively) our microparticle-associated TF procoagulant activity assay with two other assays using samples from these patients.
OUTLINE: Patients undergo blood sample collection at baseline and then periodically during treatment. Circulating tissue factor (TF) activity levels and coagulation and endothelial activation (by ELISA) are measured. Medical charts are reviewed for sociodemographic and medical information.
After completion of study, patients are followed up for 3 months. | ArmGroups: N/A | Interventions:[{'type': 'OTHER', 'name': 'enzyme-linked immunosorbent assay', 'description': 'Measurement of markers of coagulation and endothelial activation'}, {'type': 'OTHER', 'name': 'laboratory biomarker analysis', 'description': 'The PPP will be used for in vitro assays to measure TF activity, coagulation markers and markers of endothelial cell damage'}, {'type': 'OTHER', 'name': 'medical chart review', 'description': "The patient's clinical course with respect to development of venous thromboembolism and response to treatment will be monitored for a total of 3 months from enrollment."}] | PrimaryOutcomes: [{'measure': 'Levels of circulating tissue factor (TF)', 'timeFrame': '5 years'}] | SecondaryOutcomes: [{'measure': 'Alteration in coagulation parameters', 'timeFrame': '5 years'}, {'measure': 'Correlation of TF with markers of coagulation activation and endothelial activation', 'timeFrame': '5 years'}, {'measure': 'Incidence of venous thromboembolism', 'timeFrame': '5 years'}] |
Title: An Open-label, Single-arm, Phase II Study of Regorafenib and Nivolumab in Patients With Mismatch Repair-Proficient (pMMR)/Microsatellite Stable (MSS) Colorectal Cancer (CRC) | Condition: Colorectal Cancer | Keywords: | Summary: | Description: N/A | ArmGroups: [{'label': 'Regorafenib + Nivolumab', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Regorafenib (Stivarga, BAY73-4506)', 'Biological: Nivolumab (Opdivo)']}] | Interventions:[{'type': 'DRUG', 'name': 'Regorafenib (Stivarga, BAY73-4506)', 'description': 'Regorafenib administered as oral tablets given every day for 3 weeks of each 28 days treatment cycle (i.e., 3 weeks on, 1 week off)', 'armGroupLabels': ['Regorafenib + Nivolumab']}, {'type': 'BIOLOGICAL', 'name': 'Nivolumab (Opdivo)', 'description': 'Administered on day 1 of every treatment cycle.', 'armGroupLabels': ['Regorafenib + Nivolumab']}] | PrimaryOutcomes: [{'measure': 'Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 Assessed by Investigator', 'description': 'ORR was defined as the percentage of participants with overall response of complete response (CR) or partial response (PR).\n\nCR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have decreased in size to have a short axis of \\< 10 mm.\n\nPR: At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.', 'timeFrame': 'Through database cut-off date of 11-NOV-2020 (Primary Completion Date) (up to 13 months)'}] | SecondaryOutcomes: [{'measure': 'Duration of Response (DOR)', 'description': 'DOR was defined for responders only as the time from first documentation of response (i.e. CR or PR) until disease progression or death (if death without documented disease progression).\n\nCR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have decreased in size to have a short axis of \\< 10 mm.\n\nPR: At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.', 'timeFrame': 'Through last patient last visit (LPLV) at date of 28 MAR 2022 (up to 30 months)'}, {'measure': 'Disease Control Rate (DCR) at 8 and 16 Weeks', 'description': 'DCR was defined as the percentage of participants with tumor response of complete response (CR), partial response (PR) or stable disease (SD).\n\nCR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have decreased in size to have a short axis of \\< 10 mm.\n\nPR: At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.\n\nSD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.', 'timeFrame': 'At 8, 16, 24, 32 and 40 weeks'}, {'measure': 'Progression-free Survival (PFS)', 'description': 'PFS was the time from first dose of study medication to disease progression or death, whichever was earlier.', 'timeFrame': 'Through last patient last visit (LPLV) at date of 28 MAR 2022 (up to 30 months)'}, {'measure': 'Overall Survival (OS)', 'description': 'OS was defined as time from first dose of the study treatment to death. For patients who did not die, OS was censored at the last time point at which the survival status was known to be alive.', 'timeFrame': 'Through last patient last visit (LPLV) at date of 28 MAR 2022 (up to 30 months)'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Different Severity Types of TEAEs Per Common Terminology Criteria for Adverse Events (CTCAE) v5', 'description': 'TEAEs were started during treatment or within the post-treatment time window (30 days after last dose of regorafenib and 100 days after last dose of nivolumab.).\n\nTEAEs were summarized by system organ class (SOC) and preferred term, severity (based on CTCAE v5 grades). Laboratory data considered as AE were graded according to CTCAE v5.\n\nGrade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.\n\nGrade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living.\n\nGrade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living.\n\nGrade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.', 'timeFrame': '30 days after last dose of regorafenib and 100 days after last dose of nivolumab until study completion (up to 30 months)'}] |
Title: Development and Implementation of a Structured Educational Programme to Increase Patients Knowledge About Fatigue and to Evaluate the Effect of Increased Knowledge on Cancer Patients Experience of Fatigue | Condition: Cancer, Fatigue | Keywords: Fatigue, Cancer, Radiation therapy, Chemotherapy, Hormones, Surgery, Breast cancer | Summary: | Description: N/A | ArmGroups: [{'label': 'Standard care', 'type': 'NO_INTERVENTION', 'description': 'Patients received standard education about fatigue by clinicians.', 'interventionNames': ['Behavioral: Psychoeducational intervention for cancer-related fatigue']}, {'label': 'Education arm', 'type': 'EXPERIMENTAL', 'description': 'Patients received education on fatigue management in groups of ten patients over two weeks in three two hour sessions.', 'interventionNames': ['Behavioral: Psychoeducational intervention for cancer-related fatigue']}] | Interventions:[{'type': 'BEHAVIORAL', 'name': 'Psychoeducational intervention for cancer-related fatigue', 'description': 'Patients received education on fatigue management in groups of ten patients over two weeks in three two hour sessions', 'armGroupLabels': ['Education arm', 'Standard care'], 'otherNames': ['Standard care', 'Educational intervention']}] | PrimaryOutcomes: [{'measure': 'Level of fatigue', 'timeFrame': '6 months'}] | SecondaryOutcomes: N/A |
Title: Patient-Centered Cancer Prevention In Chinese Americans | Condition: H. Pylori Infection | Keywords: H. pylori, H. pylori infection | Summary: | Description: N/A | ArmGroups: [{'label': 'Health systems-level intervention', 'type': 'ACTIVE_COMPARATOR', 'description': 'using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies;', 'interventionNames': ['Other: Test-and-treat EHR-CHW intervention']}, {'label': 'CHW-led patient navigation program', 'type': 'ACTIVE_COMPARATOR', 'description': 'a community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability', 'interventionNames': ['Other: Usual care of EHR-only intervention']}] | Interventions:[{'type': 'OTHER', 'name': 'Test-and-treat EHR-CHW intervention', 'description': 'a health systems-level intervention using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies', 'armGroupLabels': ['Health systems-level intervention']}, {'type': 'OTHER', 'name': 'Usual care of EHR-only intervention', 'description': 'a community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability.', 'armGroupLabels': ['CHW-led patient navigation program']}] | PrimaryOutcomes: [{'measure': 'Number of Participants With Eradication of H. Pylori (ITT)', 'description': 'Measured using breath ammonia measurement, fecal stool antigen test or other clinically approved H. pylori infection diagnostic test. Data extracted from patient EHR. Includes positive results for those with self-reported or missing results.', 'timeFrame': 'Up to Month 3-Post Treatment'}] | SecondaryOutcomes: [{'measure': 'Number of Participants With Eradication of H. Pylori (Clinically Confirmed)', 'description': 'Measured using breath ammonia measurement, fecal stool antigen test or other clinically approved H. pylori infection diagnostic test. Data extracted from patient EHR.', 'timeFrame': 'Up to Month 3-Post Treatment'}, {'measure': 'Change in Ottawa Decision Self-Efficacy Scale Score From Baseline to 6 Months', 'description': "Participants completed the Ottawa Decision Self-Efficacy Scale, which assessed participants' confidence in making an informed choice, at baseline and 6-month follow-up. The scale consists of 11 questions on a 5-point Likert scale from 0 (not at all confident) to 4 (very confident). The raw score is the sum of responses. The raw score is converted to a standardized total score that ranges from 0 to 100; higher total scores indicate greater decision self-efficacy.", 'timeFrame': 'Baseline, Month 6'}, {'measure': 'Change in Medication Adherence Report Scale (MARS-5) Score From Baseline to Month 6', 'description': 'Participants completed the MARS-5 self-assessment of medication adherence at baseline and 6-month follow-up. One item assessed unintentional non-adherence, while four items assessed intentional non-adherence. Participants indicated how often each statement applied to them in the past month on a 5-point Likert scale (1=always, 2=often, 3=sometimes, 4=rarely, 5=never), resulting in a total score ranging from 5 to 25. Adherence is defined as a score of 25.', 'timeFrame': 'Baseline, Month 6'}, {'measure': 'Change in Stomach Cancer Knowledge Between Baseline and 6-months', 'description': 'Participants were asked about associations with the risk of getting stomach cancer (alcohol, spicy food, stress, family history, h. pylori infection, smoking, salty food, being physically inactive, pickled food, food high in sugar). True or false was chosen. Variables were recoded to correct (1) and incorrect (0), and summed for a final score (0-10, 10=highest knowledge)', 'timeFrame': 'Baseline, Month 6'}, {'measure': 'Change in H. Pylori Knowledge Between Baseline and 6-months', 'description': 'Participants were asked about associations with h. pylori (blood, untreated/contaminated water, rats, mosquitoes, contaminated food, vomit, poor sanitation). True or false was chosen. Variables were recoded to correct (1) and incorrect (0), and summed for a final score (0-7, 7=highest knowledge)', 'timeFrame': 'Baseline, Month 6'}, {'measure': 'Change in PROMIS Global Physical Health T-Score Between Baseline and 6-months', 'description': "Participants completed the PROMIS Global Physical Health Scale, which assessed participants' physical health, at baseline and 6-month follow-up. Four questions assessed global physical health. Three questions were administered using five-category response scales, and one item used a response scale of 0-10 that was recoded to five categories. Responses are recoded into t-scores, which rescales the raw sum score into a standardized score from 0-100, with a mean of 50 and a standard deviation of 10. Higher scores indicate more of the concept being measured.", 'timeFrame': 'Baseline, Month 6'}, {'measure': 'Change in PROMIS Global Mental Health T-Score Between Baseline and 6-months', 'description': "Participants completed the PROMIS Global Mental Health Scale, which assessed participants' mental health, at baseline and 6-month follow-up. Four questions assessed global mental health, and all were administered using five-category response scales. Responses are recoded into t-scores, which rescales the raw sum score into a standardized score from 0-100, with a mean of 50 and a standard deviation of 10. Higher scores indicate more of the concept being measured.", 'timeFrame': 'Baseline, Month 6'}] |
Title: A Phase II, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of Volrustomig Priming Regimens in Combination With Other Anticancer Agents in Participants With Solid Tumors (eVOLVE-01) | Condition: Non-small Cell Lung Cancer | Keywords: Solid Tumor, Programmed cell death-ligand-1, Tumor proportion score | Summary: | Description: This is a platform, randomized, open-label, multicenter, global study.
Enrolled participants with Stage IV non-squamous non-small cell lung cancer (NSQ NSCLC) who are treatment-naïve and have not received previous treatment for advanced or metastatic disease.
These participants will be randomized in a 1:1 ratio to one of the two treatment arms: Arm 1A and Arm 1B.
Both arms will test a volrustomig dosing in combination with chemotherapy. | ArmGroups: [{'label': 'Arm 1A: Volrustomig dose regimen 1 + Carboplatin and Pemetrexed', 'type': 'EXPERIMENTAL', 'description': 'Volrustomig priming dose followed by volrustomig dosing regimen 1 in combination with carboplatin and pemetrexed.', 'interventionNames': ['Drug: Volrustomig', 'Drug: Carboplatin', 'Drug: Pemetrexed']}, {'label': 'Arm 1 B Volrustomig dose regimen 2 + Carboplatin and Pemetrexed', 'type': 'EXPERIMENTAL', 'description': 'Volrustomig priming dose followed by volrustomig dosing regimen 2 in combination with carboplatin and pemetrexed.', 'interventionNames': ['Drug: Volrustomig', 'Drug: Carboplatin', 'Drug: Pemetrexed']}] | Interventions:[{'type': 'DRUG', 'name': 'Volrustomig', 'description': 'Participants will receive volrustomig via intravenous (IV) infusion.', 'armGroupLabels': ['Arm 1 B Volrustomig dose regimen 2 + Carboplatin and Pemetrexed', 'Arm 1A: Volrustomig dose regimen 1 + Carboplatin and Pemetrexed'], 'otherNames': ['MEDI5752']}, {'type': 'DRUG', 'name': 'Carboplatin', 'description': 'Participants will receive carboplatin via IV infusion.', 'armGroupLabels': ['Arm 1 B Volrustomig dose regimen 2 + Carboplatin and Pemetrexed', 'Arm 1A: Volrustomig dose regimen 1 + Carboplatin and Pemetrexed']}, {'type': 'DRUG', 'name': 'Pemetrexed', 'description': 'Participants will receive pemetrexed via IV infusion.', 'armGroupLabels': ['Arm 1 B Volrustomig dose regimen 2 + Carboplatin and Pemetrexed', 'Arm 1A: Volrustomig dose regimen 1 + Carboplatin and Pemetrexed']}] | PrimaryOutcomes: [{'measure': 'Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'description': 'The safety and tolerability of volrustomig in combination with other anticancer drugs in participants with specified solid tumors will be assessed.', 'timeFrame': 'From screening (Days -28 to Day -1) up to 2.4 years'}, {'measure': 'Objective Response rate (ORR)', 'description': 'ORR is defined as the percentage of participants who have a complete response (CR) or partial response (PR), as per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).', 'timeFrame': 'Up to 2.4 years'}] | SecondaryOutcomes: [{'measure': 'Disease Control Rate (DCR)', 'description': 'DCR is defined as the percentage of participants who have a CR or PR or who have stable disease (SD) after the date of randomization or first dose.', 'timeFrame': 'Up to 2.4 years'}, {'measure': 'Duration of Response (DOR)', 'description': 'DOR is defined as the time from the date of first documented response until the date of documented progression or death due to any cause (in the absence of progression).', 'timeFrame': 'Up to 2.4 years'}, {'measure': 'Progression Free Survival (PFS)', 'description': 'PFS is defined as the time from randomization or first dose until radiological progression or death due to any cause (in the absence of progression).', 'timeFrame': 'Up to 2.4 years'}, {'measure': 'Overall Survival (OS)', 'description': 'OS is defined as the time from randomization or first dose until the date of death due to any cause.', 'timeFrame': 'Up to 2.4 years'}, {'measure': 'Serum Concentration of Volrustomig', 'description': 'The serum concentrations volrustomig alone and when used in combination with other anticancer agents in participants with pre-specified solid tumors will be assessed.', 'timeFrame': 'Up to 2.4 years'}, {'measure': 'Trough concentration (Ctrough)', 'description': 'The trough concentrations volrustomig alone and when used in combination with other anticancer agents in participants with pre-specified solid tumors will be assessed.', 'timeFrame': 'Up to 2.4 years'}, {'measure': 'Maximum Observed Concentration (Cmax)', 'description': 'The serum concentrations volrustomig alone and when used in combination with other anticancer agents in participants with pre-specified solid tumors will be assessed.', 'timeFrame': 'Up to 2.4 years'}, {'measure': 'Area Under the Curve (AUC)', 'description': 'The AUC concentrations of volrustomig alone and when used in combination with other anticancer agents in participants with pre-specified solid tumors will be assessed.', 'timeFrame': 'Up to 2.4 years'}, {'measure': 'Number of Participants with Positive Antidrug Antibodies (ADAs)', 'description': 'The incidence of ADAs against volrustomig or other anticancer agents in serum will be assessed.', 'timeFrame': 'Up to 2.4 years'}] |
Title: Phase II Randomized Trial of an Oral Formulation Containing a Mucoadhesive Polymer Hydrogel Vehicle (MucoLox®) to Mitigate Mucositis Symptoms in Head/Neck Cancer Patients Receiving Radiation ± Chemotherapy | Condition: Mucositis Oral, Head and Neck Cancer | Keywords: Oral rinse, Chemotherapy and Radiation Side Effects | Summary: | Description: The primary objective of this double-arm, single-blinded, Phase II randomized study is to compare the area under the curve (AUC) for the Oral Mucositis Daily Questionnaire (OMDQ) mouth and throat soreness (MTS) question 2 (Q2) score over a one-month period in subjects receiving the MucoLox formulation versus sodium bicarbonate rinse (as the control) for the prevention of severe mucositis in subjects with head/neck cancer receiving radiation ± chemotherapy. Secondary objectives include comparing the time to OMDQ MTS Q2 \> 2 between the two arms; estimating and comparing opioid use defined as the average morphine equivalent daily dose (MEDD) at each clinic visit; assessing and comparing changes in the remaining OMDQ questions longitudinally throughout study; evaluating and comparing the duration of symptom relief in those who experience any degree of oral mucositis; evaluating and comparing the frequency of delays in \[chemotherapy and/or radiation\] therapy throughout the study period; and summarizing and comparing the prevalence and grade of oral mucositis at each clinic visit. The safety objective is to summarize the rates of potential side effects related to each oral formulation. A total of 60 eligible subjects will be enrolled and randomized in a 1:1 fashion to one of the treatment arms. Subjects on the control arm (sodium bicarbonate) who experience severe mucositis will have the option to crossover to the Mucolox arm for an additional 7 ± 2 days or until day 29 ± 5 days, whichever is longer. | ArmGroups: [{'label': 'A', 'type': 'EXPERIMENTAL', 'description': 'Mucolox Arm', 'interventionNames': ['Other: MucoLox']}, {'label': 'B', 'type': 'ACTIVE_COMPARATOR', 'description': 'Sodium Bicarb Control Arm', 'interventionNames': ['Other: Sodium Bicarbonate']}] | Interventions:[{'type': 'OTHER', 'name': 'MucoLox', 'description': 'MucoLox formulation, with MucoLox as the delivery vehicle, combined with preserved water, beta-glucan, dexpanthenol, and glutamine', 'armGroupLabels': ['A']}, {'type': 'OTHER', 'name': 'Sodium Bicarbonate', 'description': 'Sodium bicarbonate oral rinse', 'armGroupLabels': ['B']}] | PrimaryOutcomes: [{'measure': 'AUC for the Oral Mucositis Daily Questionnaire mouth and throat soreness question #2', 'description': 'To compare the area under the curve (AUC) for the Oral Mucositis Daily Questionnaire (OMDQ) mouth and throat soreness (MTS) question 2 (Q2) score over a one-month period in subjects receiving the MucoLox formulation versus sodium bicarbonate rinse (as the control) for the prevention of severe mucositis in subjects with head/neck cancer receiving radiation ± chemotherapy', 'timeFrame': 'One month'}] | SecondaryOutcomes: [{'measure': 'Time to OMDQ MTS > 2', 'description': 'To compare the time to OMDQ MTS Q2 \\> 2 between the two arms', 'timeFrame': 'One month'}, {'measure': 'Opioid use (morphine equivalent daily dose)', 'description': 'To estimate opioid use defined as the average morphine equivalent daily dose (MEDD) at each clinic visit: baseline, day 8 ± 2, day 15 ± 2, day 22 ± 2, and the final study visit (day 29 ± 5) and compare between the two arms', 'timeFrame': 'Weekly during the one-month study period'}, {'measure': 'Assess remaining OMDQ questions', 'description': 'To assess changes in the remaining OMDQ questions longitudinally throughout study treatment and compare between the two arms.', 'timeFrame': 'One month'}, {'measure': 'Duration of symptom relief', 'description': 'To evaluate and compare the duration of symptom relief in those who experience any degree of oral mucositis between the two arms', 'timeFrame': 'One month'}, {'measure': 'Frequency of chemoradiation delays', 'description': 'To evaluate the frequency of delays in \\[chemotherapy and/or radiation\\] therapy throughout the study period and compare between the two arms.', 'timeFrame': 'One month'}, {'measure': 'Oral mucositis grade', 'description': 'To summarize the prevalence and grade of oral mucositis at each clinic visit: baseline, day 8 ± 2, day 15 ± 2, day 22 ± 2, and the final study visit (day 29 ± 5), as assessed by the treating investigator using the WHO criteria for grading, and compare between the two arms.', 'timeFrame': 'Weekly during the one month study period'}, {'measure': 'Comparison of self-reported OMDQ scores versus investigator-assessed mucositis', 'description': "The Generalized McNemar's test will be used to analyze correlation between patient report OMDQ Q2 scores and oral mucositis grading assessed by treating investigator using WHO criteria.", 'timeFrame': 'Weekly during the one month study period'}] |
Title: The EMPrint™ Ablate and RESect Study in Patients With Metastatic Lung Tumors (EMPRESS) | Condition: Lung Cancer | Keywords: primary, recurrent, metastatic lung tumor, ablation | Summary: | Description: Primary Endpoint: Dose response as indicated by CT imaging, measurement of maximum diameter and volume.
Secondary Endpoint: Assessment of complete tumor ablation immediately post-procedure. | ArmGroups: [{'label': 'Ablation and Surgical Resection', 'type': 'OTHER', 'description': 'Ablation of lung tumor; followed by surgical resection of the ablation zone.', 'interventionNames': ['Device: Ablation', 'Procedure: Surgical Resection']}] | Interventions:[{'type': 'DEVICE', 'name': 'Ablation', 'description': 'Percutaneous antenna will be placed into the target tumor under CT image guidance. Target tumor will be ablated and the antenna will be removed.', 'armGroupLabels': ['Ablation and Surgical Resection']}, {'type': 'PROCEDURE', 'name': 'Surgical Resection', 'description': 'The planned surgical resection of the lung tumor will be conducted as scheduled post ablation procedure.', 'armGroupLabels': ['Ablation and Surgical Resection']}] | PrimaryOutcomes: [{'measure': 'Dose Response', 'description': 'Dose response was assessed by comparing actual ablation zone size and volume to predicted ablation zone size and volume prescribed by the physician using the Emprint™ Procedure Planning Application. Dose response was measured for each ablation zone using CT imaging immediately post ablation and prior to the surgical resection.', 'timeFrame': '1 Day'}, {'measure': 'Ablation Zone Shape', 'description': 'Ablation width (X) / height (Y), ratio of 1 indicates spherical ablation zone shape', 'timeFrame': 'Same day'}] | SecondaryOutcomes: [{'measure': 'Number of Participants With Complete or Incomplete Tumor Ablation', 'description': 'The secondary endpoint was complete tumor ablation immediately post-procedure for each target tumor using histologic analysis. Complete ablation was defined as 100% nonviable tumor cells.', 'timeFrame': 'Same Day'}] |
Title: Alkaline Water Consumption to Reduce Skin Radiation Toxicity in Women With Breast Cancer | Condition: Radiation Toxicity, Recurrent Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer | Keywords: skin reactions secondary to radiation therapy | Summary: | Description: OBJECTIVES:
I. The goal of this two-phase study is to assess the rate of grade 2 or higher radiation-related skin toxicity in adult patients with breast malignancies after administration of alkaline (pH 9.0) or distilled (pH 7.0) water consumed immediately prior to and after daily radiation treatments.
OUTLINE:
FEASIBILITY PHASE: Patients undergo external beam radiation therapy once daily (QD), 5 days a week for 6 weeks. Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.
INTERVENTION PHASE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks. Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.
ARM II: Patients undergo external beam radiation therapy as in arm I. Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy.
Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 1 month. | ArmGroups: [{'label': 'Arm I: alkaline water', 'type': 'EXPERIMENTAL', 'description': 'Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks. Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.', 'interventionNames': ['Dietary Supplement: alkaline water', 'Radiation: external beam radiation therapy (EBRT)']}, {'label': 'Arm II: distilled water', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients undergo external beam radiation therapy as in arm I. Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy', 'interventionNames': ['Dietary Supplement: distilled water', 'Radiation: external beam radiation therapy (EBRT)']}] | Interventions:[{'type': 'DIETARY_SUPPLEMENT', 'name': 'alkaline water', 'description': 'Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.', 'armGroupLabels': ['Arm I: alkaline water']}, {'type': 'DIETARY_SUPPLEMENT', 'name': 'distilled water', 'description': 'Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy.', 'armGroupLabels': ['Arm II: distilled water']}, {'type': 'RADIATION', 'name': 'external beam radiation therapy (EBRT)', 'description': 'Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks.', 'armGroupLabels': ['Arm I: alkaline water', 'Arm II: distilled water']}] | PrimaryOutcomes: [{'measure': 'Acute and Grade 2 or Higher Radiation-related Skin Toxicity as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0', 'description': 'Information will include the type, severity, time of onset and resolution of its onset, and its probable association with the study regimen. Frequency tables will be constructed to summarize observed incidents by severity and type of toxicity during weekly radiation treatment and 1 month after radiation treatment. Observed toxicity differences among the treatment arms may be reported in frequency tables.', 'timeFrame': 'at 1 month after treatment'}] | SecondaryOutcomes: [{'measure': 'Change in Urine pH', 'description': 'A paired sample t-test (a=0.05) assessing change in urine pH between before treatment day 0 and after radiation and alkaline water treatment day 33.', 'timeFrame': 'at baseline and at week 5 (day 33)'}] |
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