D1 Versus D2 Lymphadenectomy in High Risk Elderly With Gastric Adenocarcinoma

Launched by ITALIAN RESEARCH GROUP FOR GASTRIC CANCER · Feb 9, 2017

Keywords

ClinConnect Summary

The LELEGA Trial is a research study that aims to find the best surgical approach for elderly patients with a specific type of stomach cancer called gastric adenocarcinoma. It compares two different methods of removing lymph nodes during surgery: a limited approach versus a more extensive one. The goal is to see which method helps patients live longer without their cancer returning, especially for those over 75 years old who may have other health issues.

To participate in this trial, patients must be over 75 years old and have a certain score indicating their overall health (called the Charlson Comorbidity Score) that is above 5. They will undergo surgery to remove their cancer, and researchers will monitor their health and recovery over the next five years. This study is important because it seeks to improve outcomes for older patients with a serious illness while considering their unique health challenges. If you or a loved one fit the eligibility criteria, you might be able to join this study and contribute to valuable research in cancer treatment.

Gender

ALL

Eligibility criteria

• 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.