Comparing Wide Local Excision = 1cm Margin with Wide Local Excision = 2cm Margin for stage II cutaneous melanoma

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 siteTrial siteA hospital or clinic where a study is actually run.Read more → 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 exclusionExclusion criteriaThe things that would prevent someone from taking part.Read more →. 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).
• −Microsatellitosis (a nest of metastatic tumour cells found to be growing away from the primary tumour) as per AJCC 8th edition definition is an exclusion.
• −Subungual melanoma
• −Patient has already undergone a local flap reconstruction of the defect after excision of the primary and determination of an accurate excision margin is impossible.
• −History of previous or concurrent (i.e. \>1 primary melanoma) invasive melanoma.
• −Melanoma located distal to the metacarpophalangeal joint; on the tip of the nose; the eyelids or on the ear; genitalia, perineum or anus; mucous membranes or internal viscera.
• −Physical, clinical, radiographic or pathologic evidence of satellite, in-transit, regional, or distant metastatic melanoma.
• −Any additional solid tumour or hematologic malignancy during the past 5 years (with exception of non- melanoma skin cancers (T1 skin lesions of squamous cell carcinoma (SCCs), basal cell carcinoma (BCCs)), or uterine/cervical cancer).
• −Melanoma-related operative procedures not corresponding to criteria described in the protocolProtocolThe detailed plan a study must follow.Read more →.
• −Planned adjuvant radiotherapy to the primary melanoma site after wide local excision is not permitted as part of the protocol and any patients given this treatment would be excluded from the study.
• −History of organ transplantation.
• −Oral or parenteral immunosuppressive agents (not topical or inhaled steroids) at enrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more → or within 6 months prior to enrolment.
• −Pregnancy is not a specific exclusion criterion for this trial, though it may not be clinically appropriate to perform a wide excision and SLNB until the pregnancy has been completed, which may exclude the patient due to violation of inclusion criterionInclusion criteriaThe things you must have or be for a study to consider you.Read more → 4. We would advise careful counselling of the patient prior to enrolling the patient, which would include a discussion at the treating centre's multidisciplinary team meeting or tumour board. We would strongly advise contacting the central trial office to discuss the case prior to enrolling on the study.
• −Patient has undergone surgery on a separate occasion to clear the lymph nodes of the probable draining lymphatic field, including -SLNB, of the index melanoma.