NO Re-excision MelanomA - NORMA 2

Recruiting Phase 3 Interventional Study
Melanoma (Skin Cancer)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
1,749 (estimated)
Sponsor
Marieke Goodijk · Other
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About This Trial
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 ad…
Trial Locations
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Eligibility Criteria
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 …
Contacts

Y. (Yvonne) M. Schrage, MD PhD

020 512 9111

y.schrage@nki.nl

CONTACT

M. (Marieke) T. Goodijk, MD PhD Candidate

020 512 2546

m.goodijk@nki.nl

CONTACT