Randomized controlled phase II trial of gemcitabine/radiation combination therapy and gemcitabine monotherapy in locally advanced biliary tract cancer.
Phase 2
- Conditions
- locally advanced unresectable biliary tract cancer
- Registration Number
- JPRN-UMIN000000625
- Lead Sponsor
- First Dept. Internal Medicine Gifu University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
1.Patients with interstitial pneumonia, pulmonary fibrosis. 2.Patients with intractable diabetes mellitus, liver dysfunction, angina pectoris, or myocardinal infarction within months after onset. 3.Patients with suspicious of serious infection, or serious infection. 4.Patients with pregnacy, during lactation, or patient with hope of pregnant 5.Patients with severe drug allergy 6.Patients with severe concomitant disease 7.Patients with pleural effusion or ascites 8.Patients with active multiple cancers 9.The patients judged inappropriate in enrolling into this study by the investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method a survival rate for 1 year
- Secondary Outcome Measures
Name Time Method response rate/ safety