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

July 31, 2026 updated by: Blokhin's Russian Cancer Research Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

228

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Russia
    • Moscow
      • Moscow, Moscow, Russia, 115522
        • Recruiting
        • N.N. Blokhin National Medical Research Center of Oncology
        • Contact:
          • Nshan Sedrakyan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequential Gemcitabine + Docetaxel
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.
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.
Other Names:
  • Taxotere
Active Comparator: Sequential Gemcitabine + Mitomycin C
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.
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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
12-Month Event-Free Survival
Time Frame: 12 months after randomization
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.
12 months after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival
Time Frame: Up to 12 months
Time from randomization to progression to muscle-invasive or metastatic urothelial carcinoma.
Up to 12 months
Cystectomy-Free Survival
Time Frame: Up to 12 months
Time from randomization to radical cystectomy for bladder cancer.
Up to 12 months
Treatment-Related Adverse Events
Time Frame: Throughout study treatment and follow-up
Incidence and severity of adverse events graded according to CTCAE.
Throughout study treatment and follow-up
Health-Related Quality of Life (EORTC QLQ-C30)
Time Frame: Baseline through 12 months
Change from baseline in EORTC QLQ-C30 scores.
Baseline through 12 months
Health-Related Quality of Life (EORTC QLQ-NMIBC24)
Time Frame: Baseline through 12 months
Change from baseline in EORTC QLQ-NMIBC24 scores.
Baseline through 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Blokhin's Russian Cancer Research Center

Investigators

  • Principal Investigator: Vsevolod Matveev, MD, PhD, N.N. Blokhin National Medical Research Center of Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2026

Primary Completion (Estimated)

December 30, 2029

Study Completion (Estimated)

December 30, 2030

Study Registration Dates

First Submitted

July 31, 2026

First Submitted That Met QC Criteria

July 31, 2026

First Posted (Actual)

August 5, 2026

Study Record Updates

Last Update Posted (Actual)

August 5, 2026

Last Update Submitted That Met QC Criteria

July 31, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMIBC-GEMDOC-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe