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Cisplatin and Gemcitabine in High-Risk Muscle-Invasive Bladder Cancer
NCT03061630Phase 2
Key facts
- Status
- Unknown
- Start
- Feb 2017
- Primary completion
- Mar 2022
- Countries
- 1
- Sponsor
- Samsung Medical Center
- Modality
- Small Molecules
- Drugs
- gemcitabinecisplatin
- Conditions
- muscle-invasive bladder cancer (MIBC)
01
Overview
Phase 2, open-label, single-arm trial of gemcitabine and cisplatin in muscle-invasive bladder cancer (MIBC), sponsored by Samsung Medical Center. Primary endpoint: Pathologic Response at 30 months. Status: unknown.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
gemcitabine
cisplatin 60 mg/m2 on day 1 and gemcitabine 1000 mg/m2 on days 1, 8 and 15. On day 1
03
Who it enrols
Adults aged 20 or older with previously untreated, high-risk muscle-invasive bladder cancer (T2-T4 or N+) with ECOG PS 0-1, adequate organ function, and life expectancy of at least 6 months.
04
Endpoints
Primary
Pathologic Response
Secondary
Progression-Free Survival
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