Metastatic Biliary Tract Cancer, Locally Advanced Biliary Tract Cancer
Conditions
Keywords
Gemcitabine, Cisplatin, S-1, bile duct cancer
Brief summary
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.
Detailed description
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.
Interventions
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
DRUGS-1, Cisplatin
D1-14 S-1 40mg/m2 po bid D1,D8 Cisplatin 25/m2 + N/S 150cc miv over 60mins Repeated every 3 weeks
Sponsors
Samsung Medical Center
Dong-A University
Chung-Ang University
Gyeongsang National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Response rate Overall survival Safety profile | 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 |
Countries
South Korea
Outcome results
None listed