Spots Global Cancer Trial Database for The Clinical Effectiveness and Safety of Intravesical Mitomycin-C and Gemcitabine Sequential Therapy
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Trial Identification
Brief Title: The Clinical Effectiveness and Safety of Intravesical Mitomycin-C and Gemcitabine Sequential Therapy
Official Title: 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
Study ID: NCT06388720
Conditions
Interventions
Study Description
Brief 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.
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
National Cancer Center, Goyang-si, , Korea, Republic of
Contact Details
Name: Ho Kyung Seo, MD
Affiliation: National Cancer Center, Korea
Role: PRINCIPAL_INVESTIGATOR
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