Randomized Phase II study of adjuvant chemotherapy with gemcitabine plus cisplatin versus gemcitabine plus S-1 in patients with biliary tract cancer undergoing curative resection without major hepatectomy(KHBO1901)
- Conditions
- biliary tract cancer
- Registration Number
- JPRN-UMIN000036449
- Lead Sponsor
- Kansai Hepatobiliary Oncology Group (KHBO)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 106
Not provided
1)Distant metastasis except of positive CY 2) Not performed lobectomy 3) Other concurrent active cancer (synchronous double cancer or heterochronous double cancer with a disease-free interval of 3 years or shorter, excluding lesions consistent with intraepithelial cancer, i.e., intramucosal cancer that are assessed as cured by endoscopical treatment.) 4) Patients with a history of severe drug hypersensitivity or drug allergy. 5) Serious complicating disorders (Interstitial pneumonia, pulmonary fibrosis or severe emphysema, hepatic cirrhosis, uncontrollable-diabetes, cardiac disease, renal failure, liver failure, hemorrhagic peptic ulcer etc). 6) Active infection requiring systemic therapy 7) Pregnant or lactating women, women with childbearing potential, males males who wish a pregnancy of his partner. 8) Severe psychiatric disease. 9) Inappropriate for this study judged by the attending physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recurrence-free survival (2-year recurrence-free survival rate)
- Secondary Outcome Measures
Name Time Method 1)Overall survival 2)Proportion of treatment completion 3)Relative dose intensity 4)Proportion of adverse events 5)Relapse-free survival rate and overall survival of lymph node positive/lymph node negative case 6)Relapse-free survival rate and overall survival of R0/R1 case 7)Relapse-free survival rate and overall survival of each primary site