1 cm vs 2 cm wide surgical excision margins for primary cutaneous melanoma

Not Applicable

• Conditions: Cutaneous melanoma; Cancer; Melanoma and other malignant neoplasms of skin

• Registration Number: ISRCTN99703266
• Lead Sponsor: Melanoma and Skin Cancer Trials Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-06
• Last Update Posted: 26 August 2024
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 2998

Inclusion Criteria

1. Patients must have a stage II primary invasive cutaneous melanoma with Breslow thickness >2 mm without ulceration, or >1 mm (with ulceration only) (pT2b-pT4b, AJCC 8th edition) as determined by diagnostic biopsy (narrow excision, incision or punch biopsy) and subsequent histopathological analysis
2. Must have a primary melanoma that is cutaneous (including head, neck, trunk, extremity, scalp, palm, or sole)
3. An uninterrupted 2 cm margin must be technically feasible around biopsy scar or primary melanoma
4. Staging sentinel node biopsy must be completed within 3 months (92 days) of the original diagnosis
5. Patients must be 18 years or older at time of consent
6. Patient must be able to give informed consent and comply with the treatment protocol and follow-up plan
7. Life expectancy of at least 5 years from the time of diagnosis, not considering the melanoma in question, as determined by the principal investigator (PI)
8. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance score between 0 and 1
9. A survivor of prior cancer is eligible provided that ALL of the following criteria are met and documented:
9.1. The patient has undergone potentially curative therapy for all prior malignancies
9.2. 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
9.3. The patient is deemed by their treating physician to be at low risk of recurrence from previous malignancies

Exclusion Criteria

1. Uncertain diagnosis of melanoma i.e. so-called 'melanocytic lesion of unknown malignant potential'
2. Patient has already undergone wide local excision at the site of the primary index lesion
3. Patient unable or ineligible to undergo staging sentinel lymph node biopsy of the primary index lesion
4. Desmoplastic or neurotropic melanoma
5. Microsatellitosis as per AJCC 8th edition definition
6. Subungual melanoma
7. 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
8. History of previous or concurrent (i.e., second primary) invasive melanoma
9. 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
10. Physical, clinical, radiographic or pathologic evidence of satellite, in-transit, regional, or distant metastatic melanoma
11. 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
12. 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
13. Melanoma-related operative procedures not corresponding to criteria described in the protocol
14. 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
15. History of organ transplantation
16. 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. The researchers 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. They would strongly advise contacting the central trial office to discuss the case prior to enrolling on the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease-free survival: time from randomisation to any clinically, histologically or radiologically confirmed local recurrence of melanoma including satellite lesions and in transit metastases to regional draining lymph nodes (time frame: 0-60 months)