Melanoma Margins Trial: 1cm v 2cm Wide Excision Margins for Primary Cutaneous Melanoma

Summary

This study focuses on individuals who have been diagnosed with a form of skin cancer called melanoma, which develops from melanocytes (pigment cells). During surgery for melanoma, the skin cancer and a small margin of healthy tissue around it are removed. This study will evaluate how much skin should be removed from around the melanoma. Specifically, researchers will compare the usual surgery (with a 2-cm margin) to surgery with a 1-cm margin. The use of the 1-cm margin skin removal approach may cause fewer side effects and improve quality of life. The study will evaluate how long after surgery it takes for melanoma to return, as well as any side effects of the 2 approaches. Participants will be randomly assigned to undergo surgery with a 1-cm margin or surgery with a 2-cm margin. All participants will also have a sentinel lymph node biopsy (SLNB), which is a staging procedure and routine part of treatment.

Inclusion Criteria

Patients must have a stage II primary invasive cutaneous melanoma with Breslow thickness >2mm without ulceration), or >1mm (with ulceration only) (pT2b-pT4b, AJCC 8th edition) as determined by diagnostic biopsy (narrow excision, incision 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.
Surgery (which refers to the staging sentinel node biopsy and wide local excision as these are both to be done on the same day) must be completed within 120 days of the original diagnosis.

Inclusion Criteria:

Patients must have a stage II primary invasive cutaneous melanoma with Breslow thickness >2mm without ulceration), or >1mm (with ulceration only) (pT2b-pT4b, AJCC 8th edition) as determined by diagnostic biopsy (narrow excision, incision 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.
Surgery (which refers to the staging sentinel node biopsy and wide local excision as these are both to be done on the same day) must be completed within 120 days of the original diagnosis.
Patients must be 18 years or older at time of consent.
Patient must be able to give 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 PI.
Patients must have an ECOG performance score between 0 and 1.
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,
There has been no evidence of recurrence of any prior malignancies for at least FIVE years (except for successfully treated cervical or non-melanoma skin cancer with no evidence of recurrence), and
The patient is deemed by their treating physician to be at low risk of recurrence from previous malignancies.

Exclusion Criteria:

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 wide local excision at the site of the primary index lesion.
Patient unable or ineligible to undergo staging sentinel lymph node biopsy of the primary index lesion.
Desmoplastic or neurotropic 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 other desmoplasia or mixed subtypes are eligible unless there is neurotropism present (peri-neural invasion).Peri-neural invasion does not include entrapment of nerves within the main primary tumour mass. Microsatellitosis as per AJCC 8th edition definition
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., second primary) 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.
Patient has undergone surgery on a separate occasion to clear the lymph nodes of the probable draining lymphatic field, including sentinel lymph node biopsy, of the index melanoma.
Any additional solid tumour or hematologic malignancy during the past 5 years except T1 skin lesions of squamous cell carcinoma, basal cell carcinoma, or uterine/cervical cancer.
Melanoma-related operative procedures not corresponding to criteria described in the protocol.
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 enrolment 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 sentinel node biopsy until the pregnancy has been completed, which is likely to exclude the patient due to violation of inclusion criterion 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.

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Study Location(s)

Cedars-Sinai Cancer at The Angeles Clinic and Research Institute : Saba Mukarram

More about this Clinical Trial

Full Title

S2015 Melanoma Margins Trial : A Phase III, Multi-Centre, Multi-National Randomised Control Trial Investigating 1cm v 2cm Wide Excision Margins for Primary Cutaneous Melanoma,

Details

Disease Type/Condition

Melanoma

Principal Investigator

Faries, Mark

Co-Investigators

Inderjit Mehmi, Katelyn Atkins, Omid Hamid

Age Group

Adult

Phase

III

IRB Number