Two bladder chemotherapy combinations for bladder cancer that stopped responding to BCG
Compares gemcitabine with docetaxel against gemcitabine with mitomycin C in adults with BCG-unresponsive bladder cancer.
Plain-language title generated from the registry record
Registry title: Sequential Gemcitabine Plus Docetaxel Versus Gemcitabine Plus Mitomycin C for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer
Key facts
- Where
- Moscow, RussiaSee the site
- Phase
- Phase 2
Where in Russia
- N.N.Blokhin National Medical Research Center of OncologyMoscow, RussiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Blokhin's Russian Cancer Research Center
- Trial code
- NCT07747740
- Record updated
- 5 August 2026
- Original description
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 evaluation of cystectomy-free survival, progression-free survival, treatment safety, tolerability, and patient-reported quality of life.Read full original descriptionShow less
A Prospective, Randomized, Open-Label, Phase II Trial Comparing Sequential Intravesical Gemcitabine Plus Docetaxel With Sequential Intravesical Gemcitabine Plus Mitomycin C in Patients With 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 evaluation of cystectomy-free survival, progression-free survival, treatment safety, tolerability, and patient-reported quality of life.
Inclusion: 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; Candidate for intravesical chemotherapy; ECOG performance status 0-2; Adequate hematologic, renal, and hepatic function; Written informed consent.
Exclusion: Previous hypersensitivity to gemcitabine, docetaxel, mitomycin C, or formulation components; Concurrent participation in another interventional clinical trial; Active uncontrolled urinary tract infection; Any serious uncontrolled medical condition that, in the investigator's opinion, would interfere with study participation or interpretation of results; Muscle-invasive (≥T2), locally advanced, or metastatic urothelial carcinoma; Upper urinary tract urothelial carcinoma requiring treatment; Pregnancy or breastfeeding.