Randomized Phase II Trial Comparing Sequential Gemcitabine with Docetaxel Versus Gemcitabine with Mitomycin C for BCG-Unresponsive High-Grade Non-Muscle-Invasive Bladder Cancer

What this Trial Is About

This research investigates treatments for patients with high-grade non-muscle-invasive bladder cancer that does not respond to bacillus Calmette-Gurin BCG therapy. The study aims to compare two sequential intravesical chemotherapy methods to improve outcomes after complete removal of bladder tumors. It is a phase II, randomized, open-label trial designed to assess how these treatments affect event-free survival over 12 months. Participants are randomly assigned to one of two treatment groups one receives sequential intravesical gemcitabine followed by docetaxel, and the other receives sequential intravesical gemcitabine followed by mitomycin C. Both treatments involve six weekly induction instillations, followed by monthly maintenance instillations for one year. The chemotherapy solutions are retained in the bladder for specific times after administration. During the study, participants undergo regular clinical follow-up including cystoscopy, urine cytology, and pelvic ultrasonography. Researchers monitor treatment safety, tolerability, and quality of life using standardized questionnaires. The main outcome measured is event-free survival at 12 months, with secondary measures including cystectomy-free survival, progression-free survival, adverse events, and patient-reported quality of life. Total participation lasts up to one year with continuous assessments.

Sequential Gemcitabine Plus Docetaxel Versus Gemcitabine Plus Mitomycin C for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer