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

NCT07747740 | Recruiting Phase 2

• 1 other identifier: NMIBC-GEMDOC-001
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

Brief Summary

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

BCG-Unresponsive Bladder Cancer; Non-Muscle-Invasive Bladder Cancer

Keywords

Gemcitabine; Docetaxel; Mitomycin C; Intravesical Chemotherapy; BCG-Unresponsive NMIBC; Randomized Trial; Bladder Preservation; TURBT; Event-Free Survival

Outcome Measures

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.

  12 months after randomization

Secondary Outcomes (5)

• Progression-Free Survival

  Up to 12 months

• Cystectomy-Free Survival

  Up to 12 months

• Treatment-Related Adverse Events

  Throughout study treatment and follow-up

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

  Baseline through 12 months

• Health-Related Quality of Life (EORTC QLQ-NMIBC24)

  Baseline through 12 months

Study Arms (2)

Sequential Gemcitabine + Docetaxel

EXPERIMENTAL

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; Drug: Docetaxel

Sequential Gemcitabine + Mitomycin C

ACTIVE COMPARATOR

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; Drug: Mitomicin C

Interventions

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.

Sequential Gemcitabine + Docetaxel; Sequential Gemcitabine + Mitomycin C

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.

Also known as: Taxotere

Sequential Gemcitabine + Docetaxel

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.

Sequential Gemcitabine + Mitomycin C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Blokhin's Russian Cancer Research Center: lead

Study Sites (1)

N.N. Blokhin National Medical Research Center of Oncology

Moscow, Moscow, 115522, Russia

RECRUITING

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Interventions

Gemcitabine; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Vsevolod Matveev, MD, PhD

  N.N. Blokhin National Medical Research Center of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nshan Sedrakyan, MD

CONTACT

+79165663100; nick977773@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study because both treatment regimens are administered according to predefined clinical protocols and blinding is not feasible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in a 1:1 ratio to receive sequential intravesical gemcitabine plus docetaxel or sequential intravesical gemcitabine plus mitomycin C following complete TURBT. Randomization will be stratified according to the study protocol.

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 5, 2026
• Study Start: July 9, 2026
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): December 30, 2030
• Last Updated: August 5, 2026

Record last verified: 2026-07

Locations

RU (1)