NCT06388720

The Clinical Effectiveness and Safety of Intravesical Mitomycin-C and Gemcitabine Sequential Therapy

A Study to Assess the Clinical Effectiveness and Safety of Intravesical Mitomycin-C and Gemcitabine Sequential Therapy in Patients With High Risk Non-muscle Invasive Bladder Cancer (NMIBC) Unresponsive to BCG Therapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the effectiveness and safety of mitomycin-c and gemcitabine sequential instillation in BCG unresponsive high risk non-muscle invasive bladder cancer patients.

Detailed description

Phase 2 clinical, multi-institutional, open assignment prospective study Primary Outcome Measures: 1-year recurrence-free survival period in high-risk groups after sequential injection of Mitomycin-c 40 mg/20 ml and Gemcitabine 2000 mg/50 ml in non-muscle invasive bladder cancer patients in BCG-free high-risk groups. Secondary Outcome Measures: Progression Free Survival (PFS), Cystectomy free survival (CFS), Cancer specific survival (CSS), Overall survival (OS) and safety after Mitomycin-c 40mg/20ml and Gemcitabine 2000mg/50ml treatment in non-muscle invasive bladder cancer patients in BCG-free high-risk groups.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
DRUG	Mitomycin-C	Intravesical instillation of Mitomycin-c 40 mg in 20 ml as the first agent in sequential treatment.
DRUG	gemcitabine	Intravesical instillation of Gemcitabine 2000 mg in 50 ml following Mitomycin-c administration.

Timeline

• Start date: 2024-11-19
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2024-04-29
• Last updated: 2026-04-13

Locations

1 site across 1 country: South Korea