The role of adjuvant radiotherapy in patients with radical ressected gastric cancer with D2 lymph node dissection is controversial. Patients with high risk factors including late T stage (T4) and positive lymph nodes (N+) were likely to be benefit from adjuvant concurrent chemoradiotherapy. This trial was designed to compare adjuvant chemoradiotherapy, oxaliplatin plus S-1(SOX) and concurrent radiotherapy, with SOX alone in gastric cancer patients with D2 lymph node dissection and high risk factors.
This study is a multiple center randomized phased III controlled trial undertaken by The Western Cooperative Gastrointestinal Oncology Group of China (WCGOG). Patients underwent R0 and D2 gastrectomy and pathologic diagnosed ≥ T4a or positive lymph node (N+) disease per AJCC 7th edition were enrolled in this study. Eligible patients were randomly assigned to receive adjuvant chemotherapy of SOX regimen and concurrent 3D-CRT/IMRT (50.4Gy/28f) or six cycles of SOX alone. Block randomization was done and stratified by disease stage. Primary endpoints are disease-free survival (DFS). Secondary endpoints are overall survival (OS), local control rate (LCR) and toxicity.
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All authors have declared no conflicts of interest.