SOX as Adjuvant Chemotherapy for Resectable Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and efficacy of S-1 plus oxaliplatin combination chemotherapy based on the adverse events and survival period by performing a phase I/II study of this combination in patients with D2 resection of gastric cancer.

Detailed Description
-----------------
This stage I/II study is designed to evaluate the appropriate dose of S-1 plus fixed-dose of oxaliplatin (SOX regimen) for Patients with D2 resection of gastric cancer and survival of SOX regimen for stage II-III patients(AJCC 7th). To assess the efficacy, data on recurrence and survival will be collected from the time of enrollment until 3 years after surgery. To evaluate safety, data on adverse events will be collected from the time of enrollment until 1 year after surgery.

Official Title
-----------------
Phase I/II Study of Oral S-1 Plus f Oxaliplatin as an Adjuvant Chemotherapy After Curative Resection of Stage II-IV(M0) Gastric Cancer

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Drug: s1
* Drug: Oxaliplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20-70 years Histologically proven adenocarcinoma of the stomach Curative D2 lymphadenectomy resection for gastric cancer, who can start chemotherapy be within 6 weeks after surgery Stage II, III (AJCC 7th edition) Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 No prior chemotherapy or radiotherapy Adequate bone marrow, renal, and liver function Exclusion Criteria: Any evidence of metastatic disease (including presence of tumor cells in the ascites). Previous cytotoxic chemotherapy, radiotherapy or immunotherapy except corticosteroids, for the currently treated gastric cancer. Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery. Pregnant or lactating women. History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix. Lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome likely to influence absorption of capecitabine, or inability to take oral medication. Organ allografts requiring immunosuppressive therapy. Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease. Prior unanticipated severe reaction to fluoropyrimidine therapy (with or without documented dihydropyrimidine dehydrogenase (DPD) deficiency) or patients with known DPD deficiency. Hypersensitivity to platinum compounds or any of the components of the study medications. Received any investigational drug or agent/procedure, i.e. participation in another trial, within 4 weeks before enter the trial.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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>s1+oxaliplatin | Drug: s1<br>* 60-90mg/m2/d P.O. day 1-14, repeated every 21 days<br>* Other names: TS-1;Drug: Oxaliplatin<br>* 130mg/m2 d1 repeated every 21 days<br>* Other names: Eloxatin;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| chemotherapy complete rate | percentage of patients who completed eight cycles of chemotherapy | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | assessed from surgery until 1 months after withdrawing from study | 3 years | 
| recurrence-free survival(RFS) | from the date of surgery until the occurrence of an event (relapse or death whichever came first) | 3 years | 
| overall survival(OS) | from the date of surgery to any cause of death | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastric cancer, S-1, oxaliplatin, adjuvant chemotherapy