Clinical trial · Interventional
Sequential Gemcitabine Plus Docetaxel Versus Gemcitabine Plus Mitomycin C for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BCG-Unresponsive Bladder Cancer | — | UNRESOLVED | — |
| Non-Muscle-Invasive Bladder Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Gemcitabin | Drug | — | UNRESOLVED |
| Mitomicin C | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sequential Gemcitabine + Docetaxel
- description
- 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.
- interventionNames
- Drug: Gemcitabin
- Drug: Docetaxel
- type
- ACTIVE_COMPARATOR
- label
- Sequential Gemcitabine + Mitomycin C
- description
- 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.
- interventionNames
- Drug: Gemcitabin
- Drug: Mitomicin C
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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