Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-23-020
Prinicipal Investigator
Kaag, Matthew
Phase
Phase III
Age Group
Adult
Scope
National
Secondary Protocol No.
EA8212
Title
A Randomized Phase III Trial of Intravesical BCG veRsus Intravesical Docetaxel and GEmcitabine Treatment in BCG Naive High Grade Non-Muscle Invasive Bladder Cancer (BRIDGE) EA8212
Objective
Primary Objectives
To determine the event free survival (EFS) of BCG-naive high grade non-muscle invasive bladder cancer (NMIBC) patients treated with intravesical BCG vs GEMDOCE.

Secondary Objectives
To compare changes in cancer-specific and bladder cancer-specific QOL from baseline to treatment between BCG-naive high grade NMIBC patients receiving BCG and GEMDOCE.

To determine the cystectomy free survival (CFS) of BCG-naive high grade NMIBC patients treated with intravesical BCG vs GEMDOCE.

To determine the progression free survival (PFS) of BCG-naive high grade NMIBC patients treated with intravesical BCG vs GEMDOCE.

To determine the safety and toxicity of BCG-naive high grade NMIBC patients treated with intravesical BCG vs GEMDOCE.
Applicable Disease Sites
Urinary Bladder
Status
Open
Participating Institutions
Hershey Medical Center