NO Re-excision MelanomA - NORMA 2

Recruiting now · Phase 3

Conditions studied: Melanoma (Skin Cancer)

In brief

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.

Key facts

Study ID

NCT07530887

Run by

Marieke Goodijk

People needed

1749

Starts

2025-11-13

Expected to finish

2033-11-01

Last updated by the study team

2026-04-15

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Rijnstate Ziekenhuis — Arnhem, Netherlands (enrolling)
• Noordwest Ziekenhuisgroep — Alkmaar, Netherlands (enrolling)
• Leids Universitair Medisch Centrum — Leiden, Netherlands (enrolling)
• Medisch Spectrum Twente — Enschede, Netherlands (enrolling)
• Flevoziekenhuis — Almere Stad, Netherlands (enrolling)
• Haaglanden Medisch Centrum — The Hague, Netherlands (enrolling)
• Antoni van Leeuwenhoek — Amsterdam, Netherlands (enrolling)
• Diakonessenhuis — Utrecht, Netherlands (enrolling)
• Gelre ziekenhuizen — Apeldoorn, Netherlands (enrolling)
• Jeroen Bosch Ziekenhuis — 's-Hertogenbosch, Netherlands (enrolling)
• St. Antonius Ziekenhuis — Utrecht, Netherlands
• Isala Ziekenhuis — Zwolle, Netherlands
• Catharina ziekenhuis — Eindhoven, Netherlands
• Groene Hart Ziekenhuis — Gouda, Netherlands
• Martini ziekenhuis — Groningen, Netherlands
• Tergooi MC — Hilversum, Netherlands
• Dijklander Ziekenhuis — Hoorn, Netherlands
• Alrijne Ziekenhuis — Leiden, Netherlands
• Maastricht UMC — Maastricht, Netherlands
• Maasstad Ziekenhuis — Rotterdam, Netherlands
• Haga Ziekenhuis — The Hague, Netherlands

Full record on ClinicalTrials.gov

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