NO Re-excision MelanomA - NORMA 2

Prior treatment

• History of previous or concurrent (i.e., second primary) invasive melanoma
• Patient has undergone surgery on a separate occasion to clear the lymph nodes of the probable draining lymphatic field, except for previous SLNB

Other illness

• Lentigo malignant melanoma (LMM)
• Spitz melanoma/malignant Spitz tumor melanoma
• Uncertain diagnosis of melanoma i.e. so-called 'melanocytic lesions of unknown malignant potential' (MELTUMP or STUMP)
• Any additional solid tumor or hematologic malignancy during the past 5 years with a life expectancy of less than 5 years
• History of organ transplantation

Other

• Non-cutaneous melanoma (uveal, mucosal)
• Acral melanoma
• Desmoplastic melanoma
• Neurotropic melanoma
• Satellites, in-transit melanomas or macroscopic melanoma metastases
• Other non-SSM or NM subtypes
• Melanoma removed by shave excision, excogliation or core biopsy
• Patient has already undergone a local flap reconstruction of the defect after excision of the primary
• Multiple melanomas

• 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.