RecruitingPhase 2NCT06388720

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


Sponsor

National Cancer Center, Korea

Enrollment

82 participants

Start Date

Nov 19, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination bladder wash (intravesical) treatment using mitomycin-C and gemcitabine given alternately for patients with high-risk non-muscle-invasive bladder cancer (cancer that stays in the bladder lining) that has not responded to the standard BCG treatment. **You may be eligible if...** - You are 20 or older - You have confirmed high-risk bladder cancer (T1, high-grade, or with CIS) that did not respond to BCG therapy - You recently had a procedure to remove the bladder tumor (TURBT) within the past 8 weeks - You are not eligible for or have refused radical bladder removal surgery **You may NOT be eligible if...** - Your cancer has grown into the muscle of the bladder wall - Your cancer has spread to lymph nodes or other parts of the body - You have a rare non-transitional cell type of bladder cancer - You received systemic chemotherapy for another cancer within the last 3 years - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMitomycin-C

Intravesical instillation of Mitomycin-c 40 mg in 20 ml as the first agent in sequential treatment.

DRUGgemcitabine

Intravesical instillation of Gemcitabine 2000 mg in 50 ml following Mitomycin-c administration.


Locations(1)

National Cancer Center

Goyang-si, South Korea

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NCT06388720


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