Docetaxel Versus Oxaliplatin as Addition to S-1 for Stage II / III Gastric Adenocarcinoma

Study Overview
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Brief Summary
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S-1 plus oxaliplatin has been proved better than S-1 alone for stage II or III gastric cancer. Docetaxel also showed excellent efficacy with S-1 in the postoperative setting for stage III gastric cancer. This trial is designed to investigate the efficacy and safety of S-1 plus docetaxel versus S-1 plus oxalipltin as adjuvant chemotherapy after D2 resection in stage II / III gastric cancer.

Detailed Description
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In this study, patients with gastric or EGJ adenocarcinoma who received D2 dissection and staged II or III, aged from 18 to 75 years and with ECOG PS ≤2 and adequate organ function, are stratified randomized according to pstage and location of primary lesion. Group DS: S-1 is orally administer by BSA (<1.25m2, 80 mg; 1.25 to 1.5m2, 100 mg; >1.5m2,120 mg) divided into two doses a day after breakfast and dinner for 14 days every three weeks to a total of 16 cycles postoperatively. Docetaxel 40mg/m2/3w from the second to the seventh cycles. Group SOX: S-1 is orally administer by BSA (<1.25m2, 80 mg; 1.25 to 1.5m2, 100 mg; >1.5m2,120 mg) divided into two doses a day after breakfast and dinner for 14 days every three weeks to a total of 16 cycles postoperatively. Oxaliplatin 130mg/m2/3w from the first to the eight cycles. The primary end point is disease-free survival(DFS). The overall survival (OS), safty and quality of life are secondary end points.

Official Title
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S-1 Plus Docetaxel(DS) Versus S-1 Plus Oxaliplatin(SOX) as Postoperative Therapy for Stage II / III Gastric Cancer, a Randomized Controlled Trial

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: Docetaxel
* Drug: Oxaliplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: informed consensus of patients be able to receive oral administration from 18 to 75 years old be proven to be primary adenocarcinoma of stomach and staged II or III by pathological evidences without other chemotherapy and/or radiation against to the disease normal function of other organs including heart,liver ,kidney and so on Eastern Cooperative Oncology Group performance status:0 2 Exclusion Criteria: history of other malignancy allergic reaction to S-1 or oxaliplatin of docetaxel be enrolling in other clinical trials abnormal GI tract function dysfunction of other organs 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: 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DS<br>D2 resection -- S1 * 1 cycle + DS * 6 cycles + S1 * 9 cycles | Drug: Docetaxel<br>* S-1 (BSA <1.25m2, 80 mg; 1.25 to 1.5m2, 100 mg; >1.5m2,120 mg) divided into two doses /day after breakfast and dinner, 14 days / 3 weeks, totally 16 cycles. Docetaxel 40mg/m2/3w from the second to the seventh cycles.<br>* Other names: S-1;|
| Active Comparator: SOX<br>D2 resection -- SOX * 8 cycles + S1 * 8 cycles | Drug: Oxaliplatin<br>* S-1 (BSA <1.25m2, 80 mg; 1.25 to 1.5m2, 100 mg; >1.5m2,120 mg) divided into two doses /day after breakfast and dinner, 14 days / 3 weeks, totally 16 cycles. Oxaliplatin 130mg/m2/3w from the first to the eight cycles.<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 | The interval from randomization to local recurrence, distant metastasis, death or the last follow-up | 3 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | The interval from randomization to death or the last follow-up | 5 year | 
| Treatment related Adverse Events | According to CTC version 5 | 1 year |