Randomized phase II study comparing Gemcitabine versus TS-1 for advanced bile duct cancer

INTERVENTION: Group A:Gemcitabine 1,000mg/m2 is administered with 30‐min intravenous infusion on day 1, 8, and 15 every 4 weeks. Group B:TS‐1 80mg/m2/day is administered orally for 4 consecutive weeks every 6 weeks. CONDITION: Advanced bile duct cancer PRIMARY OUTCOME: Overall survival(OS) SECONDARY OUTCOME: Progression free survival(PFS); Adverse events; QOL; Response rate INCLUSION CRITERIA: 1.Patients with non‐resectable bile duct cancer (intrahepatic bile duct cancer, extrahepatic bile duct cancer, gall bladder cancer and ampulla vater cancer) or recurrent bile duct cancer 2.Histologically or cytologically confirmed adenocarcinoma,squamous cell carcinoma or adeosquamous carcinoma of the bile duct cancer(extrahepatic bile duct cancer, gall bladder cancer and ampulla vater cancer). Histologically or cytologically confirmed adenocarcinoma of the intrahepatic bile duct cancer. 3.Patients without the prior treatment except surgery and biliary drainage 4.Patients who received adjuvant chemotherapy 6 months or more ago can be registered. 5.Performance Status:0‐1(ECOG) 6.Oral intake is possible. 7.Patients of age =>20 and 80> 8.Sufficient organ functions (1)hemoglobin>=10.0g/dl (2)WBC >=3,000/mm3 (3)neutrophils>=1,500/mm3 (4)platelets>=100,000/mm3 (5)AST(GOT)<=100IU (or <=150IU if biliary dra