Randomized phase II study of gemcitabine and S-1 combination therapy versus S-1 in advanced biliary tract cancer. (JCOG 0805)

INTERVENTION: A: Patients receive gemcitabine(1,000 mg/m2, day1,8) plus S‐1(60‐100 mg/day, day1‐14) every 3 weeks. It is repeated until obvious evidence of disease progression, patient refusal, or unacceptable toxicity. B: Patients receive S‐1 alone (80‐120 mg/day, day1‐28 every 6 weeks). It is repeated until obvious evidence of disease progression, patient refusal, or unacceptable toxicity. CONDITION: biliary tract neoplasm PRIMARY OUTCOME: overall survival (1‐year survival) SECONDARY OUTCOME: progression‐free survival, response rate, adverse events, severe adverse events INCLUSION CRITERIA: 1) Diagnosed as biliary tract cancer which includes intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, and ampulla of vater cancer 2) Recurrent or unrespectable biliary tract cancer 3) Histologically proven papillary adenocarcinoma, tubular adenocarcinoma, or adenosquamous carcinoma for extrahepatic cholangiocarcinoma, gallbladder cancer, and ampulla of vater cancer patients. Histologically proven adenocarcinoma for intrahepatic cholangiocarcinoma 4) Without CNS metastasis 5) Without moderate or more ascites/pleural effusion 6) No previous therapy against biliary tract cancer 7) No previous chemotherapy or radiotherapy against any other malignancies 8) ECOG PS of 0 or 1 9) Sufficient oral intake 10) Aged 20 to 79 years old 11) Adequate organ functions 12) Written informed consent