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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
78
D1,D8 Gemcitabine 1000mg/m2 + N/S 150cc miv over 30mins D1,D8 Cisplatin 25/m2 + N/S 150cc miv over 60mins repeated every 3weeks
D1-14 S-1 40mg/m2 po bid D1,D8 Cisplatin 25/m2 + N/S 150cc miv over 60mins Repeated every 3 weeks
Gyeongsang University Hospital
Jinju, Gyeongsangnam-do, South Korea
Time to progression
Time frame: 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
Response rate Overall survival Safety profile
Time frame: Overall survival is measured from the first day of assignment until death or the last day of the follow-up.Clinically assessment would be done every cycle (month) and radiologically assessed every 2 cycles (6 weeks) with CT scan
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.