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S1806, Phase III Randomized Trial of Concurrent Chemoradiotherapy with or without Atezolizumab in Localized Muscle Invasive Bladder Cancer
This phase III trial studies how well chemotherapy and radiation therapy work with or without atezolizumab in treating patients with localized muscle invasive bladder cancer.
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 Objectives: - To compare overall survival between the two arms. - To compare modified bladder intact event-free survival (mBI-EFS see Section 10) including cancer related death between arms. - To compare complete and partial pathologic response between arms at 3 months after completing chemoradiation therapy. - To estimate metastases-free survival by arm. - To compare the qualitative and quantitative adverse events from each arm. - To estimate the rate of non-muscle invasive bladder cancer recurrence by arm. - To estimate the rate of salvage cystectomy and reasons for cystectomy by arm. - To compare mean patient-reported global quality of life (QOL) at week 54 using the EORTC QLQ-C30 Global Health Status (GHS) subscale score between patients with localized muscle-invasive bladder cancer randomized to chemoradiation with vs. without atezolizumab.
Chemotherapy (NOS); Immunotherapy; Radiotherapy
5-fluorouracil (); Atezolizumab (Tecentriq); Gemzar (gemcitabine); cisplatin (); gemcitabine (); mitomycin c ()
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