“…The study protocol was approved by the JCOG Protocol Review Committee and the institutional review boards (IRBs) of each of the 17 participating Japanese hospitals before the activation of the study. The inclusion criteria were as follows: histologically confi rmed adenocarcinoma of the stomach, a c-stage IA (T1N0) or IB (T1N1/T2N0) tumor according to the Japanese classifi cation of gastric carcinoma, 2nd English edition [17], no indications for endoscopic mucosal resection (EMR) according to the Japanese endoscopic treatment guidelines [2] ("no indications for EMR" corresponds to a clinical node-positive or clinical nodenegative status with any of the following criteria: a tumor size 2 cm or larger, invasion to the submucosa or deeper, a histologically undifferentiated type, the presence of an ulcer or ulcerative scar [in the case of depressed type], or the impossibility of an en-bloc resection), a distal gastrectomy-treatable tumor located in the middle or lower third of the stomach, no involvement of the duodenum, a patient age of 20-80 years, an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1, a body mass index (BMI) of less than 30 kg/m 2 , the absence of a recurrent tumor after EMR, no prior upper abdominal surgery or intestinal resection other than an appendectomy, no prior chemotherapy or radiotherapy for any malignancy, adequate organ function, and written informed consent. The exclusion criteria were as follows: a synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ or mucosal cancer, pregnancy or lactation, severe mental disease, the systemic administration of corticosteroids, unstable angina or myocardial infarction within 6 months before registration, uncontrolled hypertension, diabetes mellitus (both uncontrolled and controlled with insulin), and severe respiratory disease requiring continuous oxygen therapy.…”