Randomized controlled phase II trial of gemcitabine/radiation combination therapy and gemcitabine monotherapy in locally advanced biliary tract cancer.

INTERVENTION: Gemcitabine 1,000mg/m2 is administered with 30‐min intravenous infusion on day 1, 8, and 15. The cycle was repeated every 4 weeks until disease progression or unacceptable toxicity is remarked. 5 weeks concurrent chemo‐radiation therapy (CCRT). CCRT is combined radiation (total dose 50 Gy /25 fractions) and weekly Gemcitabine (250mg/m2 administered with 30‐min intravenous infusion). 2weeks after CCRT, same protocol with Gemcitabine monotherapy is started. CONDITION: locally advanced unresectable biliary tract cancer PRIMARY OUTCOME: a survival rate for 1 year SECONDARY OUTCOME: response rate/ safety INCLUSION CRITERIA: 1.Patients with pathologically confirmed locally advanced biliary tract cancer 2.Patients of 20 years old and above 3.Patients without simultaneous other cancers 4.Patients without history of prior therapy for primary disease, excluding biliary drainage 5.ECOG Performance status 0‐2 6.Patients with adequate organ function 7.Patients without concomitant diseases required therapy 8.Informed consents are obtained from all patients