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

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

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.