Trial of S-1 Plus Cisplatin (SP) Versus Gemcitabine Plus Cisplatin (GP) in Advanced Biliary Tract Adenocarcinoma

Study Overview
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Brief Summary
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To select a better agent between S-1 or gemcitabine in combination with cisplatin for the conventional chemotherapy platform for future development in advanced Biliary Tract Adenocarcinoma (BTA), the investigators conduct a randomized phase II trial of S-1 and cisplatin (SP) versus gemcitabine and cisplatin (GP) as first line therapy in advanced BTA.

Official Title
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Randomized Phase II Trial of SP vs. GP in Advanced Biliary Cancer

Conditions
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Metastatic Biliary Cancer

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically proven biliary adenocarinoma Age > 18 Evaluable disease ECOG performance status of 2 or better No prior exposure to chemotherapy, but adjuvant chemotherapy (or chemoradiotherapy) completed 6 moths or more before study enrollment is allowed Adequate bone marrow function A. WBCs > 4,000/µL, absolute neutrophil count [ANC]>1,500/µL B. Hemoglobin >9.0 g/dL C. Platelets > 100,000/µL Adequate kidney function (creatinine<1.5 mg/dL) Adequate liver function (bilirubin<1.5 mg/dL [< 2.5 mg/dL for obstructive jaundice with adequately decompressed bile duct obstruction], transaminases levels<3 times the upper normal limit, and serum albumin of >2.5 mg/dL) No serious medical or psychological condition that would preclude study treatment Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures Exclusion Criteria: Other tumor type than adenocarcinoma Evidence of GI bleeding or GI obstruction Presence or history of CNS metastasis Pregnancy or breastfeeding Other serious illness or medical conditions Axial skeletal radiotherapy within 6 months Neuropathy grade 2 or worse

Ages Eligible for Study
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Minimum Age: 18 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: SP treatment<br>S-1 plus cisplatin combination chemotherapy | Drug: S-1 plus cisplatin<br>* S-1 40 mg/m2 D1-D14 Cisplatin 60 mg/m2 D1 every 3 weeks<br>|
| Active Comparator: GP treatment<br>Gemcitabine plus Cisplatin combination chemotherapy | Drug: Gemcitabine plus Cisplatin<br>* Gemcitabine 1000 mg/m2 IV D1, D8 Cisplatin 60 mg/m2 IV D1 Every 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival rate at 6 months | progression-free survival wad defined as the time from the date of enrollment to the date of the first occurrence of objective disease progression or death from any cause, which occur first. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | Response to chemotherapy will be assessed using RECIST 1.0 criteria. | 6 months | 
| Toxicities | Toxicities associated chemotherapy will be assessed and categorized using NCI CTCAE v3.0. The types of toxicities and the proportions of patients who experience each toxicity will be described. | Up to 24 months | 
| overall survival | Overall survival is calculated from the date of enrollment to the date of death from any cause. | up to 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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S-1, biliary cancer, systemic chemotherapy, gemcitabine, cisplatin