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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Metastatic Biliary Tract Cancer, Locally Advanced Biliary Tract Cancer

Intervention / Treatment
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* Drug: Gemcitabine, Cisplatin
* Drug: S-1, Cisplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gemcitabine/Cisplatin<br> | Drug: Gemcitabine, Cisplatin<br>* 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<br>* Other names: Cisplatin - Cispulan;|
| Experimental: S-1/Cisplatin<br>D1-14 S-1 40mg/m2 po bid D1,D8 Cisplatin 25/m2 + N/S 150cc miv over 60mins Repeated every 3 weeks | Drug: S-1, Cisplatin<br>* D1-14 S-1 40mg/m2 po bid D1,D8 Cisplatin 25/m2 + N/S 150cc miv over 60mins Repeated every 3 weeks<br>* Other names: Cisplatin ; Cispulan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gemcitabine, Cisplatin, S-1, bile duct cancer