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.

Sex

All

Minimum age

75 Years

Inclusion Criteria:

* Patients aged \>75 years, with CCS \>5, undergoing curative surgery for locally advanced M0 gastric adenocarcinoma. All patients aged \>75 years with a Charlson Comorbidity Score (CCS) \[17\] of at least 5, with an endoscopic and histological diagnosis of gastric adenocarcinoma underwent standard preoperative staging: contrast enhanced computed tomography of chest, abdomen (with gastric distention) and pelvis. Preoperative staging laparoscopy should be performed in order to exclude peritoneal carcinomatosis.
* Patients with ability to understand the nature or consequences of the trial.
* Patients with ability to provide written informed consent.

Exclusion Criteria:

* Previous surgery of the stomach.
* Patients with a previous history of cancer (\< 5 year) or presenting with a co-existing cancer.
* Patients with bulky nodes at the second level stations;
* Patients requiring multi-organ resection;
* Patients refusing blood transfusions;
* Patients recruited for other trial;
* Patients operated in an acute setting are excluded to allow for appropriate inclusion and randomization.

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