Melanoma
Conditions
Interventions
Omission of the re-excision 
Sponsors
Antoni van Leeuwenhoek (AVL)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients must be 18 years or older at time of consentPatients must have an ECOG performance score between 0 and 2Histologically confirmed, stage pT1b – pT4b (TNM AJCC 8th edition) cutaneous primary melanomaHistological 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 melanomaPatient must provide informed consent and comply with the treatment protocol and follow-up planLife expectancy of at least 5 years from the time of diagnosis, not considering the melanoma in question, as determined by the investigatorA 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 malignanciesLife expectancy should be at least 5 years andThe patient is deemed by their treating physician to be at low risk of recurrence from previous malignancies.
Exclusion criteria
Exclusion criteria: Non-cutaneous melanoma (uveal, mucosal)Acral melanomaLentigo malignant melanoma (LMM)Desmoplastic melanomaNeurotropic melanomaSpitz melanoma/malignant Spitz tumor melanomaSatellites, 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 subtypesMelanoma removed by shave excision, excogliation or core biopsyPatient 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 melanomaMultiple melanomasPatient has undergone surgery on a separate occasion to clear the lymph nodes of the probable draining lymphatic field, except for previous SLNBAny additional solid tumor or hematologic malignancy during the past 5 years with a life expectancy of less than 5 yearsHistory of organ transplantation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse-Free Survival (RFS), defined as time from randomization to any first melanoma recurrence or melanoma-related death, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS), defined as time from randomization to death, no matter what the cause of death was.Local Recurrence Rate (LRR), defined as the frequency of local recurrences within the study population, calculated from randomization until the occurrence of the first local recurrence. A local recurrence is defined as recurrence within the scar and/or any satellite metastasis within 2 cm.Recurrence rate of in-transit metastases, defined as the frequency of in-transit metastasis recurrences within the study population, calculated from randomization until the first occurrence of an in-transit metastasis. An in-transit metastasis is defined as any skin or subcutaneous metastasis that occurs more than 2 cm from the primary lesion, but not beyond the regional nodal basin. Recurrence rate of lymph node metastases, defined as the frequency of lymph node metastases within the study population, calculated from randomization until the occurrence of the first lymph node metastasis. Distant Metastasis-Free Survival (DMFS), defined as time from randomization until the occurrence of a distant metastasis.Surgical complication rates according to Clavien-Dindo surgical classification and frequency of reconstructive surgery. Quality of life as measured by EORTC-QLQ C30 and FACT-M Melanoma Surgery Scale complemented with questions from the Cancer Worry Scale (CWS). Scar assessment will be evaluated using (patient-reported) POSAS 3.0 questionnaire.Health Technology Assessments as measured by EQ-5D-5L, iMCQ and iPCQ questionnaires. | — |
Countries
Netherlands
Contacts
Public ContactY. M. Schrage
Antoni van Leeuwenhoek (AVL)
Outcome results
None listed