Phase III Randomized Trial of Concurrent Chemoradiotherapy With or Without Atezolizumab in Localized Muscle Invasive Bladder Cancer
Categories (click each to see list of all clinical trials associated with that category): GU (ONC)
Current Status: Open
Phase: III
Principal Investigator: Baine, Michael
Eligibility: https://clinicaltrials.gov/study/NCT03775265?term=NCT03775265&rank=1
Summary
Primary Objective: To compare bladder intact event-free survival (BI-EFS) for concurrent chemoradiation therapy (CRT) with and without atezolizumab in localized muscle invasive bladder cancer (MIBC).
Secondary:
I. To compare overall survival between the two arms.
II. To compare modified bladder intact event-free survival including cancer related death between arms.
III. To compare complete and partial pathologic response between arms at 3 months after completing chemoradiation therapy.
IV. To estimate metastases-free survival by arm.
V. To compare the qualitative and quantitative adverse events from each arm.
VI. To estimate the rate of non-muscle invasive bladder cancer recurrence by arm.
VII. To estimate the rate of salvage cystectomy and reasons for cystectomy by arm.
VIII. To compare mean patient-reported global quality of life (QOL) at week 54 using the European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire (QLQ)-Core (C)30 Global Health Status (GHS) subscale score between patients with localized muscle-invasive bladder cancer randomized to chemoradiation with versus (vs.) without atezolizumab