Trimodality Therapy With/Out Durvalumab to Treat Patients With Muscle-Invasive Bladder Cancer
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|ClinicalTrials.gov Identifier: NCT03768570|
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : April 13, 2021
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Drug: Durvalumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||238 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase II Trial Assessing Trimodality Therapy With or Without Adjuvant Durvalumab to Treat Patients With Muscle-Invasive Bladder Cancer|
|Actual Study Start Date :||December 21, 2018|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2024|
|No Intervention: Surveillance|
|Active Comparator: Durvalumab||
1500 mg IV on day 1 of 4 week cycle every 4 weeks for 12 months
- Disease-free survival [ Time Frame: 5 years ]defined as the time from the randomization to the time of the first event that is either recurrent (local or distant) bladder cancer, a new primary bladder cancer or death from any cause
- Non-muscle invasive bladder cancer recurrence rate [ Time Frame: 5 years ]
- Loco-regional control rate between study arms at the 12 week visit [ Time Frame: 5 years ]defined as proportion of patients with a confirmed locoregional complete response at 3 months post randomization
- Patterns of disease recurrence between study arms [ Time Frame: 5 years ]The two treatment arms will be compared using the log-rank test stratified by ECOG Performance Status (0, 1 vs. 2+), Neoadjuvant chemotherapy (Yes/No), whole bladder versus partial bladder versus bladder plus regional lymph nodes RT field, and disease stage (T2 vs T3/4). A table will be presented summarizing the patterns of disease recurrence by treatment arms
- Compare overall and bladder intact disease-free survival between study arms [ Time Frame: 5 years ]
- Metastasis-free survival between study arms [ Time Frame: 5 years ]
- Number and severity of adverse events between study arms [ Time Frame: 5 years ]
- Quality of Life between treatment arms using Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-BL) questionnaire [ Time Frame: 5 years ]It consists of 39 questions, of which 12 are specific to bladder cancer. The questionnaire consists of 5 subscales: physical well-being (PWB), social/family well-being (SWB), emotional well-being (EWB), functional well-being (FWB), and a final subscale focusing specifically on bladder cancer.
- Cost-effectiveness between study arms [ Time Frame: 5 years ]Estimate an incremental cost-effectiveness ratio reported as a difference in cost per Disease free survival-year gained of durvalumab vs. surveillance. analyses will focus on the incremental cost-effectiveness of durvalumab from a government payer perspective, over a disease-free survival time horizon by prospectively collecting economic and resource utilization information during the clinical trial.
- Cost-utility between study arms [ Time Frame: 5 years ]A partitioned-survival model (Markov model) will be developed using data obtained from the trial. Different parametric models will be evaluated to fit data from the trial in order to evaluate the incremental cost-utility over a 3-, 5- and 10-y horizon.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03768570
|Contact: Wendy Parulekarfirstname.lastname@example.org|
|Study Chair:||Wassim Kassouf||The Research Institute of the McGill University, Montreal QC Canada|