Omitting re-excision after complete primary melanoma excision

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, phase III randomized non-inferiority trial that will enroll 1,749 patients with pT1b–pT4b cutaneous melanoma and no evidence of metastasis. Participants are randomized 1:1 to standard re-excision according to local guidelines or to omission of re-excision, with sentinel lymph node biopsy and adjuvant therapy performed as indicated in both groups. The primary endpoint is relapse-free survival, with secondary endpoints including overall survival, local and regional recurrence patterns, surgical morbidity, quality of life, and health economic outcomes. Patients will be followed for up to five years to capture recurrence and survival events.

Why it matters

Who can join: the full rules

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

Where it's running

• Jeroen Bosch Ziekenhuis
  's-Hertogenbosch, Netherlands Recruiting
• Noordwest Ziekenhuisgroep
  Alkmaar, Netherlands Recruiting
• Flevoziekenhuis
  Almere Stad, Netherlands Recruiting
• Antoni van Leeuwenhoek
  Amsterdam, Netherlands Recruiting
• Gelre ziekenhuizen
  Apeldoorn, Netherlands Recruiting
• Rijnstate Ziekenhuis
  Arnhem, Netherlands Recruiting

Study contacts

• Study coordinator: Y. (Yvonne) M. Schrage, MD PhD
• Email: y.schrage@nki.nl
• Phone: 020 512 9111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.