Sequential Gemcitabine Plus Docetaxel Versus Gemcitabine Plus Mitomycin C for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Gemcitabin, Docetaxel, Mitomicin C.
- Who it may be relevant to
- Registry conditions: Non-Muscle-Invasive Bladder Cancer, BCG-Unresponsive Bladder Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
High-grade BCG-unresponsive non-muscle-invasive bladder cancer remains a major therapeutic challenge. Radical cystectomy is considered the standard treatment; however, many patients are unwilling or medically unfit to undergo surgery. Sequential intravesical chemotherapy has emerged as a bladder-preserving treatment strategy with encouraging oncological outcomes.
This prospective, randomized, open-label, single-center phase II trial is designed to compare the efficacy and safety of two sequential intravesical chemotherapy regimens following complete TURBT.
Eligible patients with histologically confirmed BCG-unresponsive high-grade NMIBC will be randomized in a 1:1 ratio to receive either sequential intravesical gemcitabine followed by docetaxel or sequential intravesical gemcitabine followed by mitomycin C.
Both treatment regimens consist of a six-week induction course followed by monthly maintenance instillations for twelve months according to the study protocol. Clinical follow-up includes cystoscopy, urine cytology, pelvic ultrasonography, adverse event assessment according to CTCAE criteria, and quality-of-life evaluation using the EORTC QLQ-C30 and EORTC QLQ-NMIBC24 questionnaires.
The primary endpoint is 12-month event-free survival. Secondary endpoints include cystectomy-free survival, progression-free survival, safety, tolerability, and comparative efficacy of both treatment strategies.
A total of 228 participants will be enrolled. Statistical analyses will be performed according to the intention-to-treat principle using Kaplan-Meier survival analysis, log-rank testing, and Cox proportional hazards regression.
Interventions
- Drug Gemcitabin
Intravesical gemcitabine 1 g dissolved in 50 mL of 0.9% sodium chloride. The solution is retained in the bladder for 90 minutes before drainage. - Drug Docetaxel
Intravesical docetaxel 37.5 mg dissolved in 50 mL of 0.9% sodium chloride. The solution is retained in the bladder for 90 to 120 minutes following gemcitabine administration. - Drug Mitomicin C
Intravesical mitomycin C 40 mg dissolved in 40 mL of 0.9% sodium chloride. The solution is retained in the bladder for 90 minutes following gemcitabine administration.
Primary outcome measures
- 12-Month Event-Free Survival [Time frame: 12 months after randomization]
Secondary outcome measures (5)
- Progression-Free Survival [Time frame: Up to 12 months]
- Cystectomy-Free Survival [Time frame: Up to 12 months]
- Treatment-Related Adverse Events [Time frame: Throughout study treatment and follow-up]
- Health-Related Quality of Life (EORTC QLQ-C30) [Time frame: Baseline through 12 months]
- Health-Related Quality of Life (EORTC QLQ-NMIBC24) [Time frame: Baseline through 12 months]
Eligibility criteria
Inclusion 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.
- Candidate for intravesical chemotherapy.
- ECOG performance status 0-2.
- Adequate hematologic, renal, and hepatic function.
- Written informed consent.
Exclusion criteria
- Muscle-invasive (≥T2), locally advanced, or metastatic urothelial carcinoma.
- Upper urinary tract urothelial carcinoma requiring treatment.
- Previous hypersensitivity to gemcitabine, docetaxel, mitomycin C, or formulation components.
- Active uncontrolled urinary tract infection.
- Pregnancy or breastfeeding.
- Concurrent participation in another interventional clinical trial.
- Any serious uncontrolled medical condition that, in the investigator's opinion, would interfere with study participation or interpretation of results.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Russia · 1 center
- N.N. Blokhin National Medical Research Center of Oncology — Moscow
Identifiers
NCT: NCT07747740 · NMIBC-GEMDOC-001