Adjuvant Chemotherapy With S-1 Plus Oxaliplatin Versus S-1 Alone in Locally Advanced Gastric Cancer

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the efficacy and safety of S-1 plus Oxaliplatin versus S-1 only as adjuvant chemotherapy after curative distal gastrectomy in patients with locally advanced gastric cancer.

Detailed Description
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The study is a multi-central, controlled, randomized Phase III trial. The protocol has been approved by the Ethics Committee of Beijing Cancer Hospital. The primary endpoint is the 3-year progression-free survival (PFS) rate. The secondary endpoints are the overall survival (OS) and safety.

Official Title
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A Randomized, Multicentral, Controlled, Phase III Study to Compare Adjuvant Chemotherapy With S-1 Plus Oxaliplatin to S-1 Alone After Curative Distal Gastrectomy in Locally Advanced Gastric Cancer

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: Oxaliplatin plus S-1
* Drug: S-1 only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: sign written informed consent form age ≥ 18 years, ≤69 years ECOG status: 0 2 pathologically confirmed gastric cancer at stage II or IIIA (AJCC 7th version) negative peritoneal cytology underwent curative distal gastrectomy with D2 lymph node dissection no prior antitumor treatment is allowed, including chemotherapy, radiotherapy, immune therapy or target therapy adequate organ function as defined below: Hematologic ANC ≥ 2*109/L, Platelets ≥ 100*109/L, AST and ALT ≤ 2.5×ULN, TBIL ≤ 1.5×ULN. Exclusion Criteria: be enrolled in other clinical trials underwent prior antitumor treatment allergic reaction to S-1 or oxaliplatin abnormal GI tract function female in pregnancy or lactation, or refuse to receive Contraception measures during chemotherapy other situation to be judged not adaptive to the study by investigators

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 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: A: postoperative Oxaliplatin plus S-1<br>Patients in arm A will receive standard distal gastrectomy with D2 lymphadenectomy first, and 8 cycles of adjuvant Oxaliplatin plus S-1 (SOX) later. Oxaliplatin: 130mg/m2, iv drip for 2h, d1, q3W S-1: 40 60mg bid, po, d1 14, q3W (6 months) | Drug: Oxaliplatin plus S-1<br>* 8 cycles of adjuvant chemotherapy with Oxaliplatin plus S-1<br>* Other names: SOX;|
| Active Comparator: B: postoperative S-1 only<br>Patients in arm B will receive standard distal gastrectomy with D2 lymphadenectomy first, and 16 cycles of adjuvant S-1 later. S-1: 40 60mg bid, po, d1 14, q3W (12 months) | Drug: S-1 only<br>* 16 cycles of adjuvant chemotherapy with S-1 only<br>* Other names: S-1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free survival |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | To evaluate the 1-year, 3-year and 5-year overall survival of GC patients underwent post-operative chemotherapy of S-1 compared with post-operative SOX | up to 5 years | 
| Incidence of Treatment-Emergent Adverse Events [Safety] | The incidence of chemotherapy related adverse events in GC patients underwent post-operative chemotherapy of S-1 compared with post-operative SOX | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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S1, Gastric cancer, Adjuvant chemotherapy, Oxaliplatin, Survival