A Randomized Phase III Study of Adjuvant Chemotherapy With or Without Chemo-radiotherapy in Patients With Local Advanced Gastric Cancer After D2 Resection.

Study Overview
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Brief Summary
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The purpose of this study is to explore the role of adjuvant chemo-radiotherapy in patients with local advanced gastric cancer.

Conditions
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Gastric Cancer

Intervention / Treatment
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* Radiation: Adjuvant Concurrent Chemo-radiotherapy
* Drug: Adjuvant chemotherapy for active comparator group
* Drug: Adjuvant chemotherapy for experimental group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gastric cancer; D2 and R0 resection; Pathologically confirmed stage anyT, N+, M0 (AJCC Cancer Staging); Karnofsky performance score (KPS) >= 70 or Eastern Cooperative Oncology Group(ECOG) score 0-1; Adequate blood counts: White blood cell count ≥3.5 x 109/L Haemoglobin levels ≥100g/L Platelet count ≥100 x 109/L Creatinine levels ≤1.0× upper normal limit（UNL） Urea nitrogen levels ≤1.0× upper normal limit（UNL） Alanine aminotransferase(ALT) ≤1.5× upper normal limit（UNL） Aspartate aminotransferase(AST) ≤1.5× upper normal limit（UNL） Alkaline phosphatase(ALP) ≤1.5× upper normal limit（UNL） Total bilirubin(TBIL) ≤1.5× upper normal limit（UNL） No allergic history of 5-Fu or Platinum drugs; No history of chemotherapy or other anti-cancer therapy; Informed consent should be signed. Exclusion Criteria: GEJ adenocarcinoma Concomitant malignancies;(except basocellular carcinoma or in-situ cervical carcinoma) Allergic to Fluorouracil or Platinum drugs; Concurrent uncontrolled medical condition; Known malabsorption syndromes or lack of physical integrity of upper gastrointestinal tract; Severe postoperative complications such as anastomotic leakage, etc.; Symptoms or history of peripheral neuropathy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Active Comparator: Adjuvant Chemotherapy<br>The interventions of adjuvant chemotherapy group is 8 cycles of SOX(S-1+Oxaliplatin) chemotherapy to be given. The SOX chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral, D1-14, Q21D; Oxaliplatin 130mg/m2, ivgtt, D1, Q21d. | Drug: Adjuvant chemotherapy for active comparator group<br>* 8 cycles of SOX adjuvant chemotherapy will be given to the patients in the active comparator group. The SOX chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral, D1-14, Q21D; Oxaliplatin 130mg/m2, ivgtt, D1, Q21d.<br>|
| Experimental: Adjuvant Chemo-radiotherapy<br>The interventions of adjuvant chemo-radiotherapy group is concurrent chemo-radiotherapy to be give after 4-6 cycles of chemotherapy. Total dose of 45Gy is delivered by IMRT Radiotherapy technique. The concurrent chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral. Six cycles of SOX chemotherapy to be given. The SOX chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral, D1-14, Q21D; Oxaliplatin 130mg/m2, ivgtt, D1, Q21d. | Radiation: Adjuvant Concurrent Chemo-radiotherapy<br>* Adjuvant concurrent chemo-radiotherapy will be given to the patients in the Experimental group after 4-6 cycles of SOX chemotherapy. Total dose of 45Gy is delivered by IMRT Radiotherapy technique. The concurrent chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral.<br>Drug: Adjuvant chemotherapy for experimental group<br>* 6 cycles of SOX adjuvant chemotherapy will be given to the patients in the experimental group. The SOX chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral, D1-14, Q21D; Oxaliplatin 130mg/m2, ivgtt, D1, Q21d.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local recurrence free survival |  | 3 years | 
| Distant metastasis free survival |  | 3 years | 
| Over all survival |  | 3 years | 
| Adverse Event |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric cancer, adjuvant chemo-radiotherapy