Trial of S-1 Plus Cisplatin in Gastric Cancer

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effectiveness and safety of s-1 plus cisplatin versus 5-FU plus cisplatin as first-line therapy in the treatment of patients with advanced gastric cancer.

Detailed Description
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This is a randomized, controlled, open-label,multicenter study. Patients are randomized to one of two treatment arms : S-1 plus cisplatin and 5-FU plus cisplatin.

Official Title
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A Clinical Trial of S-1 Plus Cisplatin Versus 5-FU Plus Cisplatin in Patients With Unresectable or Advanced Gastric Cancer

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: s-1 plus cisplatin
* Drug: 5-Fu plus cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed adenocarcinoma of the stomach with inoperable locally advanced or recurrent and/or metastatic disease. Male or female. Age 18 -75. Previous chemotherapy for advanced/metastatic disease (prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study). Measurable disease, according to the Response Evaluation Criteria in Solid Tumours(RECIST) ECOG Performance status 0, 1 or 2 Haematological, Biochemical and Organ Function: Neutrophil count >2.0 × 10 9/L, platelet count > 100 ×10 9/L. Serum bilirubin< 1.5 × upper limit of normal (ULN); or, AST or ALT < 2.5 × ULN (or < 5 × ULN in patients with liver metastases); or, alkaline phosphatase< 2.5 × ULN (or > 5 × ULN in patients with liver metastases,Creatinine clearance > 60 mL/min. Signed informed consent. Exclusion Criteria: prior adjuvant/neoadjuvant therapy more than two regiments. Received any investigational drug treatment within 30 days of start of study treatment. Patients with active gastrointestinal bleeding. Neurological toxicity ≥ grade 2 NCI-CTCAE. Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma. History or clinical evidence of brain metastases. Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly controlled diabetes. Pregnancy women. Subjects with reproductive potential not willing to use an effective method of contraception. Patients with known active infection with HIV. Known hypersensitivity to any of the study drugs.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: S-1 plus cisplatin<br>S-1:80 mg/m2/day po twice daily on Day 1-21,cisplatin: 20mg/m2 iv on Day 1-4, repeat every 5 weeks.Number of Cycles: until progression or unacceptable toxicity develops. | Drug: s-1 plus cisplatin<br>* S-1:80 mg/m2/day po twice daily on Day 1-21,cisplatin: 20mg/m2 iv on Day 1-4, repeat every 5 weeks. Number of Cycles: until progression or unacceptable toxicity develops.<br>* Other names: Tegafur,Gimeracil and Oteracil Potassium Capsules;|
| Active Comparator: 5-Fu plus cisplatin<br>5-Fu 800 mg/m2/d CI 120h ,Cisplatin 20 mg/m2 as a 2 hour i.v. infusion(on day 1 to day 4 )repeat every 4 weeks.Number of Cycles: until progression or unacceptable toxicity develops. | Drug: 5-Fu plus cisplatin<br>* 5-Fu 800 mg/m2/d CI 120h ,Cisplatin 20 mg/m2 as a 2 hour i.v. infusion(on day 1 to day 4 )repeat every 4 weeks. Number of Cycles: until progression or unacceptable toxicity develops.<br>* Other names: 5-fluoroura;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression |  | The time from randomization until objective tumor progression or death | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric cancer