Phase III Randomized Controlled Trial Comparing D2 Versus D3 Lymphadenectomy for Non-metastatic, Resectable, Locally Advanced Gastric Cancer Following Neoadjuvant Chemotherapy

What this Trial Is About

Gastric cancer is a leading cause of cancer-related deaths in India, and surgery to remove the stomach along with nearby lymph nodes offers the best chance for survival in cases where the cancer has not spread beyond the stomach area. Researchers are studying whether removing more lymph nodes beyond the current standard (D2 lymphadenectomy) to include additional nodes (D3 lymphadenectomy) after chemotherapy provides any extra survival benefit without increasing patient risk. The study aims to clarify the best surgical approach following chemotherapy by comparing these two methods. The trial compares two surgical methods: D2 lymphadenectomy, which removes lymph nodes around the stomach and major blood vessels, and D3 lymphadenectomy, which removes additional lymph nodes near major abdominal vessels. Participants receive chemotherapy before surgery (neoadjuvant chemotherapy) and then undergo one of the two lymph node removal procedures. Experienced surgeons perform both procedures, and the study monitors if removing more lymph nodes affects survival outcomes and patient safety. Participants will be evaluated before surgery and monitored over time to measure overall survival at five years as the primary outcome, along with disease-free survival at two years. The study involves detailed assessments including imaging and pathology to confirm cancer status, and participants must have started chemotherapy prior to surgery. The trial aims to develop clear guidelines on lymph node removal extent after chemotherapy for locally advanced but operable stomach cancer, with follow-up to assess long-term outcomes and safety.

"Phase III Randomized Trial Comparing D2 vs D3 Lymphadenectomy With Gastric Cancer Following Neoadjuvant Chemotherapy