Comparing Selective Index Lymph Node Removal to Full Lymph Node Dissection After Immunotherapy for Stage III Melanoma

What this Trial Is About

Researchers are investigating two surgical methods for patients with clinical Stage III melanoma who have undergone 6 weeks of neoadjuvant immunotherapy. The study aims to show that removing only the largest affected lymph node selective index lymph node resection is no worse than the standard removal of all lymph nodes in the affected area therapeutic lymph node dissection in terms of recurrence-free survival at 2 years. The trial also evaluates differences in surgical complications, quality of life, and healthcare costs between these two approaches. Patients receive standard neoadjuvant immunotherapy with at least one PD-L-1 checkpoint inhibitor over a course of up to 6 weeks. After this treatment, they are randomly assigned to either have the largest affected lymph node removed or undergo the standard complete lymph node removal surgery. The amount of remaining tumor cells in the removed nodes is examined to guide further management. Those without a major pathological response undergo the standard surgery. The study follows patients for up to 10 years. Participants attend regular appointments with their surgeon to monitor for melanoma recurrence. The study collects data on recurrence-free survival at 2 years as the main outcome, along with secondary outcomes including surgical side effects, quality of life over several weeks, overall survival up to 10 years, and healthcare costs. Assessments include pathological examination of lymph nodes, patient-reported quality of life surveys, and monitoring for adverse events and disease progression throughout the study period.

The Multicentre Selective Lymphadenectomy Trial - 3