Randomized Phase II Trial of Gemcitabine/Cisplatin Versus S-1/Cisplatin in Advanced Biliary Cancer Patients
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to progression
From the assigned day to the disease progression or the last day of follow-up without progression. Clinically assessment would be done every cycle (month) and radiologically assessed every 6 weeks with CT scan
Hyuk-Chan Kwon, M.D.
Dong-A University Hospital
South Korea: Korea Food and Drug Administration (KFDA)