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.
Key facts
- Who runs it
- Blokhin's Russian Cancer Research Center
- Where
- Moscow, RussiaSee the site
- Trial code
- Registry title
- Sequential Gemcitabine Plus Docetaxel Versus Gemcitabine Plus Mitomycin C for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 228 people, planned
- Started
- 9 Jul 2026
- Expected to end
- 30 Dec 2030
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Gemcitabin
- Docetaxel
- Mitomicin C
- Record updated
- 5 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults whose non-muscle-invasive bladder cancer did not respond to BCG treatment and whose tumour was fully removed by surgery (TURBT). It compares two chemotherapy treatments placed into the bladder.
- Age
- 18 years or older.
- Sex
- All sexes can join.
- Disease stage
- Non-muscle-invasive bladder cancer (urothelial) that did not respond to BCG, at intermediate or high risk. The tumour must have been completely removed by TURBT before treatment.
- Earlier treatment
- Earlier BCG treatment that did not work. Complete removal of the tumour by TURBT (surgery through the urethra) before the study treatment.
Main reasons for not taking part
- Cancer that has grown into the bladder muscle (T2 or more), spread locally or to other parts of the body
- Cancer of the upper urinary tract that needs treatment
- Past allergic reaction to gemcitabine, docetaxel, mitomycin C or their ingredients
- Active urinary tract infection that is not under control
- Pregnancy or breastfeeding
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Russia
- N.N.Blokhin National Medical Research Center of OncologyMoscow, RussiaContact: Nshan Sedrakyan, MDTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Sequential Gemcitabine + DocetaxelTreatment being tested
Participants receive sequential intravesical gemcitabine followed by docetaxel after complete TURBT. Treatment consists of six weekly induction instillations followed by monthly maintenance instillations for 12 months.
Treatment: Gemcitabin and Docetaxel
- Sequential Gemcitabine + Mitomycin CExisting treatment, for comparison
Participants receive sequential intravesical gemcitabine followed by mitomycin C after complete TURBT. Treatment consists of six weekly induction instillations followed by monthly maintenance instillations for 12 months.
Treatment: Gemcitabin and Mitomicin C
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Two bladder chemotherapy combinations for bladder cancer that stopped responding to BCGGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 5 August 2026