Randomized Phase II Trial of Gemcitabine/Cisplatin Versus S-1/Cisplatin in Advanced Biliary Cancer Patients
Overview
- Phase
- Phase 2
- Intervention
- Gemcitabine, Cisplatin
- Conditions
- Metastatic Biliary Tract Cancer
- Sponsor
- Gyeongsang National University Hospital
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Time to progression
- Status
- Terminated
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Gemcitabine/Cisplatin
Intervention: Gemcitabine, Cisplatin
S-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
Intervention: S-1, Cisplatin
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)