The Efficacy of Oxaliplatin Plus S-1 for Treatment of Gastric Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy and safety of oxaliplatin and s1 as first-line treatment of advanced gastric cancer.

Detailed Description
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There was no evidence of standard chemotherapy for advanced gastric cancer (AGC) in China. Fluoropyrimidines and cisplatin have been widely used in a variety of combinations in the treatment of AGC. Capecitabine/cisplatin combination therapy showed an overall response rate (ORR) of 41- 55%, a median time to progression/progression free survival (TTP/PFS) of 5.6-6.3 months, and a median overall survival (OS) of 10.1-10.5 months. Though no studies have compared two oral fluoropyrimidines in combination with oxaliplatin, both S-1 and capecitabine appear to be comparable in terms of efficacy and safety. The investigators conducted a phase II trial of oxaliplatin combined with S-1 in the treatment of first-line AGC.

Official Title
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a Phase II Study of Oxaliplatin Plus S-1 (SOX) as First-line Treatment for Patients With Advanced Gastric Cancer

Conditions
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Stomach Neoplasms

Intervention / Treatment
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* Drug: Oxaliplatin
* Drug: s1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven in operable advanced gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction) or relapse gastric adenocarcinoma Measurable lesion and/or non-measurable lesion defined by RECIST ECOG performance status ≦ 1 Hgb ≧ 8g/dL, WBC 4000-12000/mm3, platelets ≧ 100,000/mm3 Creatine ≦ upper normal limit (UNL) Total bilirubin ≦ 1.5 X UNL AST, ALT and ALP ≦ 2.5 x UNL Subjects must be able to take orally No prior chemotherapy Life expectancy estimated than 3 months Written informed consent Exclusion Criteria: Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant Known brain metastases History of hypersensitivity to fluoropyrimidines, oxaliplatin Active double cancer Treatment with any investigational product during the last 4 weeks prior to study entry Symptomatic peripheral neuropathy ≧ garde 2. by NCI-CTCAE ver.3.0 Any previous chemotherapy or radiotherapy for AGC

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment<br>oxaliplatin+s1 | Drug: Oxaliplatin<br>* 130mg/m2 d1,repeated q21d<br>* Other names: eloxatin;Drug: s1<br>* 80mg/m2/d, d1-14,repeated q21d<br>* Other names: TS-1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | from date of treatment was administered until the date of first documented progression or death from any cause whichever first, assessed every 6 weeks | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate | From date of treatment was administered until the date of first documented response to treatment according to RECIST criteria,assessed every 2 cycles | 2 years | 
| overall survival | From date of treatment was administered until the date of death from any cause,assessed every 3 months | 2 years | 
| number of participants with adverse events | assessed from treatment was administered until 1 months after withdrawing from study | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stomach Neoplasms, drug therapy, oxaliplatin, s1