Sequential Gemcitabine Plus Docetaxel Versus Gemcitabine Plus Mitomycin C for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer
Recruiting
Phase 2
Interventional Study
Non-Muscle-Invasive Bladder Cancer
BCG-Unresponsive Bladder Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 228 (estimated)
- Sponsor
- Blokhin's Russian Cancer Research Center · Other
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About This Trial
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 p…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age ≥18 years.
2. Histologically confirmed BCG-unresponsive non-muscle-invasive urothelial bladder cancer (NMIBC).
3. Complete transurethral resection of bladder tumor (TURBT) before study treatment.
4. Intermediate- or high-risk NMIBC according to current clinical guidelines…
Contacts