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.
1. 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.
4. 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.
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.
Parallel
Wide Local Excision = 1cm Margin
Procedure/SurgeryA wide local excision involves removing an extra "safety margin" of skin surrounding the original melanoma site, to ensure that any remaining scattered melanoma tumour cells that may have been left behind after the first initial biopsy/surgery are removed.
Wide Local Excision = 2cm Margin
Procedure/SurgeryA wide local excision involves removing an extra "safety margin" of skin surrounding the original melanoma site, to ensure that any remaining scattered melanoma tumour cells that may have been left behind after the first initial biopsy/surgery are removed.
Disease-Free Survival
Time from randomisation until the first clinically, histologically or radiologically confirmed recurrence of melanoma at any body site, or death from any cause.
Local Recurrence
Time from randomisation to any clinically, histologically or radiologically confirmed LR of melanoma including satellite lesions and in transit metastases between the primary site and the regional draining lymph nodes or death from any cause.
Distant Disease-Free Survival
Time from randomisation to any clinically, histologically or radiologically confirmed distant recurrence of melanoma or death from any cause
Melanoma-Specific Survival
Time from randomisation to death due to melanoma
Overall Survival
Time from randomisation to death from any cause
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Melanoma and Skin Cancer Trials Limited
Lead sponsor
Norfolk and Norwich University Hospitals NHS Foundation Trust
Collaborator
Canadian Cancer Trials Group
Collaborator
Cancer Trials Ireland
Collaborator
Zuyderland Medical Centre
Collaborator
