Randomized phase II study of gemcitabine and S-1 combination therapy versus gemcitabine in advanced biliary tract cancer (GS-COMBI)

INTERVENTION: Patients receive gemcitabine (1,000 mg/m2, day 1,15) plus S‐1 (80 mg/m2, day 1‐14) combination therap every 4 weeks. Patients receive gemcitabine (1,000 mg/m2, day 1,8,15) every 4 weeks. CONDITION: Advanced biliary tract cancer PRIMARY OUTCOME: Tumor response (Response rate, Disease control rate) SECONDARY OUTCOME: progression‐free survival, overall survival, adverse events INCLUSION CRITERIA: 1) Patients with non‐resectable or post‐operative recurrent biliary tract cancer 2) Patients with pathologically proven or graphically confirmed biliary tract cancer 3) Patients with no prior therapy except surgery 4) Patients with one or more bidimentionally measurable lesions 5) Patients with Eastern Chemotherapy Oncology Group(ECOG) performance status of 0‐2 6) Patients of age >= 20 years 7) Patients have an adequate organ function defined as white cell count >= 3,000/mm3, platelet count >= 100,000/mm3, hemoglobin >= 9g/dl, total bilirubin <= 3 times the upper limit of normal, AST and ALT <= 5 times the upper limit of normal, creatinine <= 1.5 times the upper limit of normal, and creatinine clearance >= 50ml/min. 8) Patients have an ability for a sufficient oral intake 9) Written informed consent is required from all patients.