Two institutional trial to evaluate the feasibility and efficacy of combined adjuvant therapy with gemcitabine and cisplatin for biliary tract cancer
Phase 1
- Conditions
- Biriary tract cancer
- Registration Number
- JPRN-UMIN000001294
- Lead Sponsor
- Chiba Cancer Center
- Brief Summary
Among 29 evaluable patients, the protocol was completed in 21 (72%) patients. Relative dose intensity (RDI) of gemcitabine and CDDP was 77% and 81%, respectively. There was no difference in the completion rate and the RDI between patients who underwent resection with vs. without major hepatectomy. Grade 3-4 toxicities included leukopenia (14%) and neutropenia (27%). Two-year RFS and 2-year OS was 59% and 90%, respectively.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
Apparent infection Fever Heart disease Interstitial pneumonia, pulmonary fibrosis Other active cancers Brain metastasis Pericardial effusion Allergy of the drugs Pregnancy or patient's hope to be pregnant
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method