Randomized Trial of Gemcitabine/Cisplatin Versus S-1/Cisplatin in Advanced Biliary Cancer

Randomized Phase II Trial of Gemcitabine/Cisplatin Versus S-1/Cisplatin in Advanced Biliary Cancer Patients

The purpose of this study is to compare the efficacy between gemcitabine/cisplatin and S-1/cisplatin in the first-line treatment in advanced biliary tract cancer.

Standard chemotherapy regimen for biliary tract cancer(BTC) has not been established due to the difficulty associated with performing clinical trials in this field.

Gemcitabine or fluoropyrimidines, including 5-fluorouracil and S-1, are routinely used for BTC chemotherapy. The European Society for Medical Oncology (ESMO) and the National Comprehensive Cancer Network guidelines published in 2009 recommend either gemcitabine-based or fluoropyrimidine-based chemotherapy or clinical trials for first-line treatment.

Inclusion Criteria:

• Age : older than 20
• Eastern Cooperative Oncology Group (ECOG) performance status 0 -2
• Histologically confirmed adenocarcinoma of the biliary tract
• Metastatic or unresectable biliary cancer
• No prior chemotherapy for biliary cancer
• A patient with at least one measurable primary lesion of which the diameter is confirmed to be 10mm in Spiral CT or multidetector CT (MD CT)
• Adequate bone marrow, liver, renal function

Exclusion Criteria:

• A patient with no measurable disease
• A patient who received previous palliative chemotherapy for biliary cancer
• A patient who received adjuvant chemotherapy for biliary cancer within 1year
• A patient with previous active or passive immunotherapy.
• A pregnant or lactating patient