NO Re-excision MelanomA - NORMA 2

Summary

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.

Eligibility

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Non-cutaneous melanoma (uveal, mucosal)
* Acral melanoma
* Lentigo malignant melanoma (LMM)
* Desmoplastic melanoma
* Neurotropic melanoma
* Spitz melanoma/malignant Spitz tumor melanoma
* Satellites, in-transit melanomas or macroscopic melanoma metastases
* Uncertain diagnosis of melanoma i.e. so-called 'melanocytic lesions of unknown malignant potential' (MELTUMP or STUMP)
* 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
* History of previous or concurrent (i.e., second primary) invasive melanoma
* Multiple melanomas
* Patient has undergone surgery on a separate occasion to clear the lymph nodes of the probable draining lymphatic field, except for previous SLNB
* 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

Conditions2

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