Actively Recruiting
NO Re-excision MelanomA - NORMA 2
Led by Marieke Goodijk · Updated on 2026-04-15
1749
Participants Needed
21
Research Sites
415 weeks
Total Duration
On this page
Sponsors
M
Marieke Goodijk
Lead Sponsor
D
Dutch Cancer Society
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
NO Re-excision MelanomA - NORMA 2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be 18 years or older at time of consent
- ECOG performance score between 0 and 2
- Histologically confirmed stage pT1b to pT4b cutaneous primary melanoma
- Eligible histological subtypes: Superficial Spreading Melanoma (SSM), Nodular Melanoma (NM)
- Primary melanoma removed by diagnostic excision with at least 1 mm tumor-free margin for invasive and any in situ melanoma
- Patient provides informed consent and agrees to follow treatment and follow-up plans
- Life expectancy of at least 5 years from diagnosis excluding the melanoma
- Prior cancer survivors eligible if they had potentially curative therapy, have at least 5 years life expectancy, and are at low risk of recurrence per physician
You will not qualify if you...
- Non-cutaneous melanoma types (uveal, mucosal)
- Acral melanoma
- Lentigo malignant melanoma (LMM)
- Desmoplastic melanoma
- Neurotropic melanoma
- Spitz melanoma or malignant Spitz tumor melanoma
- Satellites, in-transit melanomas or visible melanoma metastases
- Uncertain melanoma diagnosis (e.g., MELTUMP or STUMP)
- Other non-SSM or NM subtypes
- Melanoma removed by shave excision, excogliation, or core biopsy
- Previous local flap reconstruction after primary excision
- History of previous or concurrent invasive melanoma
- Multiple melanomas
- Prior surgery to clear lymph nodes except previous sentinel lymph node biopsy
- Any additional solid tumor or blood cancer in past 5 years with life expectancy under 5 years
- History of organ transplantation
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 21 locations
1
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
Actively Recruiting
2
Noordwest Ziekenhuisgroep
Alkmaar, Netherlands
Actively Recruiting
3
Flevoziekenhuis
Almere Stad, Netherlands
Actively Recruiting
4
Antoni van Leeuwenhoek
Amsterdam, Netherlands
Actively Recruiting
5
Gelre ziekenhuizen
Apeldoorn, Netherlands
Actively Recruiting
6
Rijnstate Ziekenhuis
Arnhem, Netherlands
Actively Recruiting
7
Catharina ziekenhuis
Eindhoven, Netherlands
Not Yet Recruiting
8
Medisch Spectrum Twente
Enschede, Netherlands
Actively Recruiting
9
Groene Hart Ziekenhuis
Gouda, Netherlands
Not Yet Recruiting
10
Martini ziekenhuis
Groningen, Netherlands
Not Yet Recruiting
11
Tergooi MC
Hilversum, Netherlands
Not Yet Recruiting
12
Dijklander Ziekenhuis
Hoorn, Netherlands
Not Yet Recruiting
13
Alrijne Ziekenhuis
Leiden, Netherlands
Not Yet Recruiting
14
Leids Universitair Medisch Centrum
Leiden, Netherlands
Actively Recruiting
15
Maastricht UMC
Maastricht, Netherlands
Not Yet Recruiting
16
Maasstad Ziekenhuis
Rotterdam, Netherlands
Not Yet Recruiting
17
Haaglanden Medisch Centrum
The Hague, Netherlands
Actively Recruiting
18
Haga Ziekenhuis
The Hague, Netherlands
Not Yet Recruiting
19
Diakonessenhuis
Utrecht, Netherlands
Actively Recruiting
20
St. Antonius Ziekenhuis
Utrecht, Netherlands
Not Yet Recruiting
21
Isala Ziekenhuis
Zwolle, Netherlands
Not Yet Recruiting
Research Team
Y
Y. (Yvonne) M. Schrage, MD PhD
CONTACT
M
M. (Marieke) T. Goodijk, MD PhD Candidate
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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