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Study identifier: NCT07530887 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: RecruitingNORMA-2

NO Re-excision MelanomA - NORMA 2

Condition: Melanoma (Skin Cancer)  ·  Sponsor: Marieke Goodijk

PhasePhase 3
Planned participants1749
Who can joinAll sexes, N/A to no upper limit
Healthy volunteersNoCheck eligibility criteria ↓
Where21 locations

Interested? Contact the study team ↓

For sponsors, CROs & site teams
Professional view of this study — listed sites, countries and recruiting context from the public registry. Everything below is written for patients and caregivers.See where this study is running →

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Y. (Yvonne) M. Schrage, MD PhD  ·  020 512 9111  ·  y.schrage@nki.nl

M. (Marieke) T. Goodijk, MD PhD Candidate  ·  020 512 2546  ·  m.goodijk@nki.nl

There is no obligation to join — the study team can answer your questions about taking part.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (21)

Jeroen Bosch Ziekenhuis's-Hertogenbosch, NetherlandsRecruiting
Noordwest ZiekenhuisgroepAlkmaar, NetherlandsRecruiting
FlevoziekenhuisAlmere Stad, NetherlandsRecruiting
Antoni van LeeuwenhoekAmsterdam, NetherlandsRecruiting
Gelre ziekenhuizenApeldoorn, NetherlandsRecruiting
Rijnstate ZiekenhuisArnhem, NetherlandsRecruiting
Catharina ziekenhuisEindhoven, NetherlandsNot Yet Recruiting
Medisch Spectrum TwenteEnschede, NetherlandsRecruiting
Groene Hart ZiekenhuisGouda, NetherlandsNot Yet Recruiting
Martini ziekenhuisGroningen, NetherlandsNot Yet Recruiting
Tergooi MCHilversum, NetherlandsNot Yet Recruiting
Dijklander ZiekenhuisHoorn, NetherlandsNot Yet Recruiting

+ 9 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

's-HertogenboschAlkmaarAlmere StadAmsterdam

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