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RECRUITING
NCT07530887
PHASE3

NO Re-excision MelanomA - NORMA 2

Sponsor: Marieke Goodijk

View on ClinicalTrials.gov

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.

Official title: Multicenter Phase 3 Randomized Controlled Trial of NO Re-excision MelanomA - NORMA 2

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

1749

Start Date

2025-11-13

Completion Date

2033-11

Last Updated

2026-04-15

Healthy Volunteers

No

Interventions

PROCEDURE

Re-excision

Prior to the re-excision, before any local anesthetic is given, the margin will be measured by a ruler and marked on the skin of the patient. The melanoma free margin of the diagnostic excision may be subtracted from the re-excision margin. The re-excision should be performed by cutting vertically down along the margins of the re-excision for its entire length until the required margin or until the fascia is reached in the depth. Removal of the fascia is left to the resecting surgeon's discretion. Preservation of anatomical structures, such as veins or nerves is allowed, if they are not clearly involved with tumor. In case of melanoma ≥pT3a any margin between 1 and 2 centimeter is accepted according to the surgeons preference. The amount of margin (in mm) taken during the re-excision needs to be documented perioperatively by the surgeon in the operation report. The specimen should be marked for anatomical navigation and sent off for pathological assessment.

PROCEDURE

No re-excision

In case a patient is randomized toward the no-re-excision treatment arm, there is no need to perform any procedures to the primary tumor site.

Locations (21)

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, Netherlands

Noordwest Ziekenhuisgroep

Alkmaar, Netherlands

Flevoziekenhuis

Almere Stad, Netherlands

Antoni van Leeuwenhoek

Amsterdam, Netherlands

Gelre ziekenhuizen

Apeldoorn, Netherlands

Rijnstate Ziekenhuis

Arnhem, Netherlands

Catharina ziekenhuis

Eindhoven, Netherlands

Medisch Spectrum Twente

Enschede, Netherlands

Groene Hart Ziekenhuis

Gouda, Netherlands

Martini ziekenhuis

Groningen, Netherlands

Tergooi MC

Hilversum, Netherlands

Dijklander Ziekenhuis

Hoorn, Netherlands

Alrijne Ziekenhuis

Leiden, Netherlands

Leids Universitair Medisch Centrum

Leiden, Netherlands

Maastricht UMC

Maastricht, Netherlands

Maasstad Ziekenhuis

Rotterdam, Netherlands

Haaglanden Medisch Centrum

The Hague, Netherlands

Haga Ziekenhuis

The Hague, Netherlands

Diakonessenhuis

Utrecht, Netherlands

St. Antonius Ziekenhuis

Utrecht, Netherlands

Isala Ziekenhuis

Zwolle, Netherlands