Comparing Dose Dense Chemoablation With Mitomycin C Versus Standard Bladder Tumor Resection and Chemotherapy in Recurrent Non-Muscle Invasive Bladder Cancer

What this Trial Is About

Researchers are evaluating a new treatment approach for patients with recurrent non-muscle invasive bladder cancer, specifically those with Ta low-grade tumors that have returned after previous treatment. This randomized, multinational Phase 4 study aims to compare the long-term effectiveness of dose-dense chemoablation using Mitomycin C MMC combined with adjuvant BCG against the current standard treatment involving transurethral resection of bladder tumors TURBT and intravesical instillation therapy. The study follows previous promising findings from the NICSA trial and seeks to improve clinical outcomes by tailoring treatment to patient response. Participants in the experimental group will receive MMC chemoablation three times a week for two weeks six total instillations, followed by a cystoscopy eight weeks later. Those who show complete tumor response will continue with monthly MMC maintenance instillations for six months before joining regular follow-up care. Patients without complete response will undergo TURBT or biopsy with tumor fulguration, followed by adjuvant BCG induction and maintenance therapy. The control group will receive TURBT or biopsy followed by standard intravesical therapy MMC weekly for six weeks plus monthly maintenance for low-grade tumors or BCG weekly for six weeks plus one-year maintenance for high-grade tumors. During the study, participants will be monitored for tumor recurrence through cystoscopies and other assessments over two and five years. Researchers will measure outcomes such as two-year and five-year recurrence-free survival, progression-free survival, overall survival, the number of surgeries required, and serious adverse events related to MMC treatment. The trial will last several years, with long-term follow-up to understand how well the treatments prevent tumor return and improve patient outcomes.

Chemoablation Or Bladder Resection With Adjuvant Chemotherapy in Recurrent Non-Muscle Invasive Bladder Cancer