Out or 737 patients with histologically proven gastric adenocarcinoma registered, 337 patients were ineligible by staging laparotomy because of advanced disease and 400 were randomized, The g-year survival rates were 35% for D-1 resection and 33% for D-2 resection (difference -2%, 95% CI = -12%-8%), There was no difference in the overall 5-year survival between the two arms (HR = 1.10, 95% CI 0.87-1.39, where HR > 1 implies a survival benefit to D-1 surgery). Survival based on death from gastric cancer as the event was similar in the D-1 and D-2 groups (HR = 1.05, 95% CI 0.79-1.39) as was recurrence-free survival (HR = 1.03, 95% CI 0.82-1.29). In a multivariate analysis, clinical stages II and III, old age, male sex and removal of spleen and pancreas were independently associated with poor survival. These findings indicate that the classical Japanese D-2 resection offers no survival advantage over D-1 surgery. However, the possibility that D-2 resection without pancreatico-splenectomy may be better than standard D-1 resection cannot be dismissed by the results of this trial.