Major trial questions need for extra surgery in melanoma patients
NCT ID NCT07530887
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether people with melanoma can safely avoid a second surgery (re-excision) after the initial tumor is removed with clear margins. About 1,749 adults with stage pT1b to pT4b melanoma will be randomly assigned to either standard follow-up care including re-excision or no re-excision. The goal is to see if skipping the extra surgery affects cancer recurrence, survival, and quality of life.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 1,749 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Nov 2033
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
21 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Alrijne Ziekenhuis
NOT_YET_RECRUITINGLeiden, Netherlands
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Antoni van Leeuwenhoek
RECRUITINGAmsterdam, Netherlands
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Catharina ziekenhuis
NOT_YET_RECRUITINGEindhoven, Netherlands
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Diakonessenhuis
RECRUITINGUtrecht, Netherlands
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Dijklander Ziekenhuis
NOT_YET_RECRUITINGHoorn, Netherlands
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Flevoziekenhuis
RECRUITINGAlmere Stad, Netherlands
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Gelre ziekenhuizen
RECRUITINGApeldoorn, Netherlands
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Groene Hart Ziekenhuis
NOT_YET_RECRUITINGGouda, Netherlands
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Haaglanden Medisch Centrum
RECRUITINGThe Hague, Netherlands
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Haga Ziekenhuis
NOT_YET_RECRUITINGThe Hague, Netherlands
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Isala Ziekenhuis
NOT_YET_RECRUITINGZwolle, Netherlands
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Jeroen Bosch Ziekenhuis
RECRUITING's-Hertogenbosch, Netherlands
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Leids Universitair Medisch Centrum
RECRUITINGLeiden, Netherlands
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Maasstad Ziekenhuis
NOT_YET_RECRUITINGRotterdam, Netherlands
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Maastricht UMC
NOT_YET_RECRUITINGMaastricht, Netherlands
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Martini ziekenhuis
NOT_YET_RECRUITINGGroningen, Netherlands
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Medisch Spectrum Twente
RECRUITINGEnschede, Netherlands
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Noordwest Ziekenhuisgroep
RECRUITINGAlkmaar, Netherlands
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Rijnstate Ziekenhuis
RECRUITINGArnhem, Netherlands
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St. Antonius Ziekenhuis
NOT_YET_RECRUITINGUtrecht, Netherlands
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Tergooi MC
NOT_YET_RECRUITINGHilversum, Netherlands
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