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

Trial Details

NCT ID
NCT07530887
Phase
PHASE3
Sponsor
Marieke Goodijk
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Re-excision
  • No re-excision
Locations (sample)
  • 's-Hertogenbosch, Netherlands|51.69917,5.30417
  • Alkmaar, Netherlands|52.63167,4.74861
  • Almere Stad, Netherlands|52.37025,5.21413
  • Amsterdam, Netherlands|52.37403,4.88969
  • Apeldoorn, Netherlands|52.21,5.96944

Key Eligibility 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:

For full eligibility, visit ClinicalTrials.gov.

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