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

This prospective, randomized, open-label, phase II clinical trial compares two sequential intravesical chemotherapy regimens in patients with bacillus Calmette-Guérin (BCG)-unresponsive high-grade non-muscle-invasive bladder cancer (NMIBC) following complete transurethral resection of bladder tumor (TURBT). Participants are randomized in a 1:1 ratio to receive sequential intravesical gemcitabine plus docetaxel or sequential intravesical gemcitabine plus mitomycin C. The primary objective is to compare 12-month event-free survival between treatment groups. Secondary objectives include evaluatio

Trial Details

NCT ID
NCT07747740
Phase
PHASE2
Sponsor
Blokhin's Russian Cancer Research Center
Status
RECRUITING
Cancer Type
Urothelial Carcinoma Bladder Cancer
Interventions
  • Gemcitabin
  • Docetaxel
  • Mitomicin C
Locations (sample)
  • Moscow, Moscow, Russia|55.75204,37.61781

Key Eligibility Criteria

  • Age ≥18 years.
  • Histologically confirmed BCG-unresponsive non-muscle-invasive urothelial bladder cancer (NMIBC).
  • Complete transurethral resection of bladder tumor (TURBT) before study treatment.
  • Intermediate- or high-risk NMIBC according to current clinical guidelines.

For full eligibility, visit ClinicalTrials.gov.

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