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Sequential Gemcitabine Plus Docetaxel Versus Gemcitabine Plus Mitomycin C for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer

ConditionsNon-Muscle-Invasive Bladder CancerBCG-Unresponsive Bladder Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBlokhin's Russian Cancer Research Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Gemcitabin

    Drug

    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.

  • Docetaxel

    Drug

    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.

  • Mitomicin C

    Drug

    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.

Treatment groups

228 Participants
are divided into 2 treatment groups
Group A: Sequential Gemcitabine + DocetaxelExperimental treatment 2 interventions
Group B: Sequential Gemcitabine + Mitomycin CActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

12-Month Event-Free Survival

Event-free survival is defined as the time from randomization to the first occurrence of histologically confirmed recurrence, disease progression to muscle-invasive bladder cancer, radical cystectomy, distant metastasis, or death from any cause.

Time frame
12 months after randomization

Secondary outcomes

1

Progression-Free Survival

Time from randomization to progression to muscle-invasive or metastatic urothelial carcinoma.

Time frame
Up to 12 months
2

Cystectomy-Free Survival

Time from randomization to radical cystectomy for bladder cancer.

Time frame
Up to 12 months
3

Treatment-Related Adverse Events

Incidence and severity of adverse events graded according to CTCAE.

Time frame
Throughout study treatment and follow-up
4

Health-Related Quality of Life (EORTC QLQ-C30)

Change from baseline in EORTC QLQ-C30 scores.

Time frame
Baseline through 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Blokhin's Russian Cancer Research Center

Lead sponsor

Source ClinicalTrials.gov
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