Phase 3 Randomized Trial Comparing Re-excision to No Re-excision After Primary Skin Melanoma Removal

What this Trial Is About

Researchers are investigating whether skipping the usual follow-up surgery called re-excision after removing primary cutaneous melanoma affects patient outcomes. This large, phase III trial involves 1,749 patients with melanoma stages pT1b to pT4b who have no signs of metastases. The study compares relapse-free survival between those who receive standard re-excision and those who do not, while also examining overall survival, recurrence rates, surgical side effects, quality of life, and economic impact. Participants are randomly assigned to either undergo re-excision surgery with margins of 1 to 2 centimeters according to local guidelines or to receive no further surgery after the initial tumor removal. Sentinel lymph node biopsy and additional systemic treatments are given as needed in both groups. Re-excision, if performed, occurs within 12 weeks of the first surgery and follows standardized procedures to ensure clear margins. Patients will be monitored for up to five years to track recurrence and other outcomes. During the study, patients will have regular follow-ups including assessments of cancer recurrence, surgical complications, and quality of life using validated questionnaires at various time points up to two years. Health economic data will also be collected to evaluate cost-effectiveness. The main measure is relapse-free survival over five years, with additional measures including overall survival and different types of melanoma recurrence. Safety and quality of life are carefully tracked, with management of recurrences left to treating physicians throughout the study period.

NO Re-excision MelanomA - NORMA 2