Sequential Gemcitabine Plus Docetaxel vs Gemcitabine Plus Mitomycin C for BCG-Unresponsive NMIBC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, open-label, phase II trial conducted at a single center. Eligible adults with BCG-unresponsive high-grade NMIBC who have had a complete TURBT are randomized 1:1 to receive either sequential intravesical gemcitabine followed by docetaxel or sequential gemcitabine followed by mitomycin C. Each regimen includes a six-week induction course and twelve months of maintenance instillations, with follow-up assessments including cystoscopy, urine cytology, imaging, adverse events, and quality-of-life questionnaires. The primary endpoint is 12-month event-free survival; secondary endpoints include cystectomy-free survival, progression-free survival, safety, tolerability, and comparative efficacy. The trial plans to enroll 228 participants to evaluate bladder-preserving strategies in this high-risk population.

Why it matters

Who can join: the full rules

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.
5. Candidate for intravesical chemotherapy.
6. ECOG performance status 0-2.
7. Adequate hematologic, renal, and hepatic function.
8. Written informed consent.

Exclusion Criteria:

1. Muscle-invasive (≥T2), locally advanced, or metastatic urothelial carcinoma.
2. Upper urinary tract urothelial carcinoma requiring treatment.
3. Previous hypersensitivity to gemcitabine, docetaxel, mitomycin C, or formulation components.
4. Active uncontrolled urinary tract infection.
5. Pregnancy or breastfeeding.
6. Concurrent participation in another interventional clinical trial.
7. Any serious uncontrolled medical condition that, in the investigator's opinion, would interfere with study participation or interpretation of results.

Where it's running

• N.N. Blokhin National Medical Research Center of Oncology
  Moscow, Moscow, Russia Recruiting

Study contacts

• Principal investigator: Vsevolod Matveev, MD, PhD — N.N. Blokhin National Medical Research Center of Oncology
• Study coordinator: Nshan Sedrakyan, MD
• Email: nick977773@gmail.com
• Phone: +79165663100

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.