D1 Versus D2 Lymphadenectomy in High Risk Elderly With Gastric Adenocarcinoma

Background: Literature often shows limited and discordant data regarding the prognostic value of age in gastric-cancer patients. Generally, disease-specific survival does not seem to be worse in the elderly when compared with younger patients, and therefore gastrectomy with extended lymphadenectomy for non-early tumors is considered the "standard" surgical therapy for all of operable patients, despite any age- or comorbidity-related limitations. Recent trials reported a survival benefit for extended nodal dissection compared with the more limited method, but some Authors found age (and comorbidities) to be a relevant predictor of postoperative complications, conditioning the safety of the surgical procedure itself. Methods/Design: The LELEGA Trial (Limited versus Extended Lymphadenectomy in high risk Elderly with Gastric Adenocarcinoma) is a randomized, clinical multicenter trial. All patients \>75 years and with Charlson Comorbidity Score \>5 with resectable M0 gastric cancer are eligible for inclusion and randomization. The primary endpoint is 5-year Disease-Specific Survival (DSS). Secondary endpoints include 5-year Overall Survival (OS) and postoperative complications classified according to Clavien-Dindo. Assuming an alpha (two-sided) of 5%, 232 patients per group are necessary to achieve an 80% power to detect a 13% survival difference (from 56% to 69%) between groups. Discussion: LELEGA trial is a prospective, multicenter randomized study to define optimal extent of lymphadenectomy (extended versus limited) in elderly and high-comorbidity gastric cancer patients.