GEM/Cisplatin/S-1 vs GEM/Cisplatin for Biliary Tract Cancer

Study Overview
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Brief Summary
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To validate the superiority of Gemcitabine/Cisplatin/S-1 over Gemcitabine/Cisplatin for unresectable biliary tract cancer.

Detailed Description
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Gemcitabine/cisplatin combination therapy (GC) has been the standard palliative chemotherapy for patients with advanced biliary tract cancer (BTC). Investigators have evaluated the efficacy and safety of gemcitabine/cisplatin/S-1 combination therapy (GCS) for patients with advanced BTC and observed the promising efficacy. In this randomized phase Ⅲ study, investigators aimed to compare GCS with GC in patients with advanced BTC.

Official Title
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Randomized Phase III Trial Comparing Gemcitabine/Cisplatin/S-1 With Gemcitabine/Cisplatin for Unresectable Biliary Tract Cancer

Conditions
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Biliary Tract Cancer

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with cytologically or histologically proved biliary tract cancer age >=20 years Performance Status (PS) 0-2 No prior history of chemotherapy or radiotherapy. Adequate bone marrow function (neutrophil count >=1,500/mm3, and platelet count >=100,000/mm3), liver function (total bilirubin >=3 mg/dL and AST/ALT >=150 IU/L), and renal function (creatinine clearance >=45 mL/min) Adequate oral intake Provided written informed consent - Exclusion Criteria: Patients with interstitial pneumonia or pulmonary fibrosis Patients with uncontrollable diabetes mellitus, liver disease, angina pectoris or a new onset of myocardial infarction within 3 months Patients with severe active infection Patients with moderate or marked pleural effusion or ascites necessitating drainage Patients with a history of severe drug allergy Patients with other serious comorbid disease Patients who are pregnant or lactating, or have an intention to get pregnant Patients with mental disease Patients who are judged inappropriate for the entry into the study by the principle doctor -

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 group<br>Gemcitabine and cisplatin are infused on day1, 8. The cycle is repeated every 3 weeks. | Drug: Gemcitabine/Cisplatin /S-1<br>* S-1 is given daily for 7 consecutive days and gemcitabine and cisplatin are infused on day1. The cycle is repeated every 2 weeks.<br>* Other names: Gemcitabine;gemzer, Cisplatin;Cispulan S-1;TS-1,;|
| Experimental: Gemcitabine/Cisplatin /S-1 group<br>S-1 is given daily for 7 consecutive days and gemcitabine and cisplatin are infused on day1. The cycle is repeated every 2 weeks. | Drug: Gemcitabine/Cisplatin<br>* Gemcitabine and cisplatin are infused on day1, 8. The cycle is repeated every 3 weeks.<br>* Other names: Gemcitabine;gemzer, Cisplatin;Cispulan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival rate | The primary endpoint is designated to evaluate overall survival rate at 12-month. | Probability of 1-year survival (%) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | The investigators will conduct CT test every 3 months in order to measure the tumor size of each patient and evaluate the best tumor response according to RECIST criteria. | Every 3 months, up to 24 months | 
| Progression free survival | In oredr to research the progression survival, the investigators will check the presence of progression disease for each patient every three months. | Every 3 months, up to 24 months | 
| Number of Participants with Adverse Events as a Measure of Safety | The investigators will examine the frequency and the degree of each side effect that will appear to the patient at each course of chemotherapy . | 24 months |