A Randomized Phase III Trial of Intravesical BCG veRsus Intravesical Docetaxel and GEmcitabine Treatment in BCG Naïve High Grade Non-Muscle Invasive Bladder Cancer (BRIDGE)
Categories (click each to see list of all clinical trials associated with that category): GU (ONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Schober, Jared
Contact Information:
Heather Mittelstedt
hmittelstedt@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT05538663?term=NCT05538663&rank=1
Summary
2.1 Primary Objectives
2.1.1 To determine the event free survival (EFS) of BCG-naïve high grade non-muscle invasive bladder cancer (NMIBC) patients treated with intravesical BCG vs GEMDOCE.
2.2 Secondary Objectives
2.2.1 To compare changes in cancer-specific and bladder cancer-specific QOL from baseline to treatment between BCG-naïve high grade NMIBC patients receiving BCG and GEMDOCE.
2.2.2 To determine the cystectomy free survival (CFS) of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE.
2.2.3 To determine the progression free survival (PFS) of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE.
2.2.4 To determine the safety and toxicity of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE.