S-1/Oxaliplatin for High Risk Patients Who Underwent Gastrectomy

Study Overview
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Brief Summary
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After curative resection, patients with stage IIIB-IV (M0) gastric cancer were given chemotherapy as follows: S-1 orally at 80 mg/m2 divided in two daily doses for 14 days and oxaliplatin at 130 mg/m2 intravenously over 2 h every 21 days as one cycle. S1 was administered for 16 cycles (12 months) and oxaliplatin for 8 cycles (6 months).

Official Title
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A Phase II Study of Adjuvant Chemotherapy of S-1 With Oxaliplatin in Gastric Cancer at Stage IIIB/ IV (AJCC 6th) After D2 Resection

Conditions
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Stomach Cancer

Intervention / Treatment
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* Drug: S-1 (452500ACH)
* Drug: OXALIPLATIN (205803BIJ)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who voluntarily provide written informed consent prior to entering into this study Newly definitely diagnosed with primary gastric or gastroesophageal junction adenocarcinoma histologically Patients who underwent radical resection with wide lymph node dissection TNM stage (6th AJCC) of IIIB or IV on post-operative staging Patients who can be randomized within 6 weeks after surgery Exclusion Criteria: Aged < 20 years or ≥ 76 years Eastern Cooperative Oncology Group (ECOG) performance status >2 Patients who underwent surgery for neoplasm in stomach in the past History of malignant disease The following cases can be included in this study - adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ Gastric or gastroesophageal junction adenocarcinoma with distant metastasis (M1) including distant lymph node (behind the pancreas, along the aorta, portal vein, behind the peritoneum, mesenteric lymph node) Residual cancer on post-operative staging (R1 and R2 resection) Patients who received adjuvant chemotherapy, or neoadjuvant chemotherapy and/or radiotherapy and/or immunotherapy in the past for treatment of gastric cancer Any of the following within 6 months prior to the study recruitment: Myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack, serious cardiac arrhythmia requiring treatment Patients of childbearing potential who do not agree to use generally accepted effective method of birth control during the study treatment period and for at least 6 months after the end of study treatment Pregnant women, breastfeeding women, or women of childbearing potential whose pregnancy test result is positive• History of hypersensitivity to the investigational products (S1 and Oxaliplatin)

Ages Eligible for Study
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Minimum Age: 20 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S-1/Oxaliplatin<br>S-1 80 mg/m²/day from day 1 to day 14, every 21 days, for 12 months; Oxaliplatin 130 mg/m² for day 1, every 21 days, for 6 months | Drug: S-1 (452500ACH)<br>* S-1 80 mg/m²/day from day 1 to day 14, every 21 days, for 12 months<br>* Other names: TS-1 (tegafur+gimeracil+oteracil);Drug: OXALIPLATIN (205803BIJ)<br>* Oxaliplatin 130 mg/m² for day 1, every 21 days, for 6 months<br>* Other names: PLEOXTIN (645402430);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year recurrence-free survival, RFS |  | 3-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-year overall survival, OS |  | 5-year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stomach Cancer