Adjuvant Chemotherapy With Gemcitabine in Patients Undergoing Curative-Intent Resection of Biliary Cancer: a Phase I/II Trial
Phase 1
- Conditions
- Biliary Cancer
- Registration Number
- JPRN-UMIN000000598
- Lead Sponsor
- Department of Surgery Graduate School of Medicine Kyoto University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 26
Inclusion Criteria
Not provided
Exclusion Criteria
Pulmonary fibrosis or interstitial pneumonia with radiological or clinical findings Uncontrollable pleural effusion Uncontrollable diabetes mellitus or liver dysfunction With distant metastasis except lymph node metastasis With uncured other malignancies Active infection Severe major postoperative complication such as peritonitis and massive bleeding With active peptic ulcer A history of myocardial infarction within 3 months Psychiatric disorder Pregnant or breast-feeding women, Women wishing for baby
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I: Safety Phase II: Feasibility
- Secondary Outcome Measures
Name Time Method Phase II: Safety