NCT03860883
Melanoma Margins Trial-II: 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma
Recruiting · Not Applicable · Melanoma and Skin Cancer Trials Limited · registry updated 2024-11-27
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
Patients with a primary invasive melanoma are recommended to undergo excision of the primary lesion with a wide margin. There is evidence that less radical margins of excision may be just as safe. This is a randomised controlled trial of 1 cm versus 2 cm margin of excision of the primary lesion for adult patients with stage II primary invasive cutaneous melanomas (AJCC 8th edition) to determine differences in disease-free survival. A reduction in margins is expected to improve patient quality of life.
Inclusion
- Patients may be included in the study if they meet ALL of the following criteria:
- \. Patients must have a Stage II primary invasive cutaneous melanoma (pT2b-pT4b, AJCC 8th edition) with Breslow thickness \>1.0mm to 2.0mm; \>2.0mm to 4.0mm or \>4.0mm with ulceration, or \>2.0mm to 4.0mm; or \>4.0mm without ulceration (Table 1) as determined by diagnostic biopsy (narrow excision, incision, shave or punch biopsy) and subsequent histopathological analysis.
- Must have a primary melanoma that is cutaneous (including head, neck, trunk, extremity, scalp, palm or sole).
- An uninterrupted 2cm margin must be technically feasible around biopsy scar or primary melanoma.
- \. Surgical intervention (which refers to the staging -SLNB and WLE as these are both to be done on the same day) must be completed within 120 days of the original diagnosis. Surgical intervention must also be performed within 28 days of randomisation.
- Patients must be 18 years or older at time of consent.
Exclusion
- Patients will be excluded from the study for ANY of the following reasons:
- Uncertain diagnosis of melanoma i.e., so-called 'melanocytic lesion of unknown malignant potential'.
- Patient has already undergone WLE at the site of the primary index lesion.
- Patient unable or ineligible to undergo staging SLNB of the primary index lesion.
- Perineural invasion or neurotropic melanoma: Neurotropism or perineural invasion in any type of melanoma is an exclusion. Perineural invasion does not include entrapment of nerves within the main primary tumour mass.
- Desmoplastic melanoma: with any patient where pathology determines melanoma as PURE desmoplastic (as per WHO definition of \>90% desmoplasia), they are not eligible for this study. However melanomas with less than 90% desmoplasia or mixed desmoplastic subtypes are eligible unless there is neurotropism present (perineural invasion).