A Phase II Trial of Adjuvant Chemotherapy With S-1 Plus Oxaliplatin for Locally Advanced Gastric Cancer

Study Overview
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Brief Summary
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Patients with advanced gastric cancer have showed poor prognosis. Only 81% of the patients could underwent curative surgery. In those, about 60% of patients would survive after 5 years from the surgery. As a result, role of chemotherapy has been increased. In ACTS-GC trial, S-1 adjuvant therapy after D2 gastrectomy increased overall survival rate in advanced gastric cancer patients. However, subgroup analysis showed that S-1 adjuvant therapy was insufficient in patients with stage III or IV (according to the AJCC 6th criteria) gastric cancer. In addition, CLASSIC trial demonstrated that oxaliplatin plus capecitabine adjuvant therapy could increase disease-free survival after D2 gastrectomy in advanced gastric cancer patients. Notwithstanding these trial, optimal adjuvant regimen of advanced gastric cancer has not been established. We aimed to evaluate efficacy of S-1 plus oxaliplatin as adjuvant chemotherapy after D2 gastrectomy in stage III (according to the AJCC 7th criteria) gastric cancer patients.

Conditions
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Advanced Gastric Cancer

Intervention / Treatment
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* Drug: S-1 plus oxaliplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age, between 19 and 75 Histologically proven advanced gastric cancer R0 resection after D2 gastrectomy Stage III (according to the AJCC 7th criteria) ECOG status 0 to 2 Exclusion Criteria: Malignancy history other than gastric cancer Previous chemotherapy history for gastric cancer Previous radiotherapy history for gastric cancer Pregnancy or breast milk feeding Grade 3 or more of neuropathy Active infection Severe hepatic dysfunction Severe renal dysfunction Severe bone marrow dysfunction Significant neurologic or psychologic disease Inadequate condition for receiving chemotherapy due to significant systemic disease Patients who receives drugs which can be interacted with S-1

Ages Eligible for Study
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Minimum Age: 19 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: Treatment group<br> | Drug: S-1 plus oxaliplatin<br>* Patients will receive adjuvant chemotherapy of eight 3-week cycles of oral S-1 (70 mg/m2/day on days 1 to 14 of each cycle) plus intravenous oxaliplatin (130 mg/m2 on day 1 of each cycle) for 6 months after D2 gastrectomy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year disease-free survival | 3-year disease-free survival will be assessed by imaging study including CT and PET. | 3 years from the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxaliplatin, S-1, Gastric cancer, Adjuvant chemotherapy