Multicenter Phase 3 Randomized Controlled Trial of NO Re-excision MelanomA - NORMA 2
This multicenter, phase III randomized controlled trial evaluates whether omitting re-excision after complete primary excision of cutaneous melanoma affects patient outcomes. A total of 1,749 patients with pT1b-pT4b cutaneous melanoma without evidence of metastases will be randomized to either standard re-excision according to current guidelines or no re-excision. Sentinel lymph node biopsy and adjuvant systemic therapy will be performed as indicated in both groups. The primary objective is to compare relapse-free survival (RFS) between the two groups. Secondary objectives include comparisons of overall survival (OS), local recurrence rates, recurrence of in-transit and lymph node metastases, distant metastasis-free survival (DMFS), surgical morbidity, quality of life, and health economic outcomes.
• Patients must be 18 years or older at time of consent
• Patients must have an ECOG performance score between 0 and 2
• Histologically confirmed, stage pT1b - pT4b (TNM AJCC 8th edition) cutaneous primary melanoma
• Histological subtypes that are eligible are:
‣ Superficial Spreading Melanoma (SSM)
⁃ Nodular Melanoma (NM)
• The primary melanoma must have been removed by diagnostic excision and must have at least a minimum of 1 mm tumor free margin for invasive melanoma AND any in situ melanoma
• Patient must provide informed consent and comply with the treatment protocol and follow-up plan
• Life expectancy of at least 5 years from the time of diagnosis, not considering the melanoma in question, as determined by the investigator
• A survivor of prior cancer is eligible provided that ALL of the following criteria are met and documented:
‣ The patient has undergone potentially curative therapy for all prior malignancies
⁃ Life expectancy should be at least 5 years and
⁃ The patient is deemed by their treating physician to be at low risk of recurrence from previous malignancies.