A randomized phase II study of Gemcitabine or Gemcitabine + S-1 as adjuvant chemotherapy for resected biliary tract cancer
Phase 2
- Conditions
- Biliary tract cancer (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder carcinoma)
- Registration Number
- JPRN-UMIN000007244
- Lead Sponsor
- Adjuvant Therapy for BTC Research Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 130
Inclusion Criteria
Not provided
Exclusion Criteria
(1) active interstitial pneumonia (2) unstable pleural effusion (3) with metastasis (4) patients with uncured other malignancies (5) active severe infection (6) patients with severe complication (7) patients with uncontrollable angina pectoris or a new onset of myocardial infarction within 3 months (8) uncontrollable diabetes mellitus, hypertension (9) psychiatric disorder (10) women in pregnancy, potential pregnancy, or breast feeding (11) other inappropriate cases according to primary doctor's evaluation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease Free Survival
- Secondary Outcome Measures
Name Time Method Overall Survival Safety Completion rate