Melanoma Margins Trial-II: 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma

  • STATUS
    Recruiting
  • End date
    Dec 31, 2034
  • participants needed
    2998
  • sponsor
    Melanoma and Skin Cancer Trials Limited
Updated on 20 October 2021
Investigator
MASC Trials Project Officer
Primary Contact
Sunnybrook Health Sciences Centre (8.1 mi away) Contact
+40 other location

Summary

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.

Description

This study will determine whether there is a difference in disease-free survival rates for patients with primary cutaneous melanoma with Breslow thickness > 2mm or 1-2mm with ulceration (pT2b-pT4b, AJCC 8th edition), treated with either a 1cm excision margin or 2cm margin. The study is designed to be able to prove or disprove that there is no difference in risk of the tumour recurring around the scar or anywhere else in the body between the two groups of patients. If the study shows no risk of tumour recurrence then we will also be able to determine how much of an impact the narrower excision has on patients in terms of improved quality of life and reduced side effects from the surgery and melanoma disease. This trial will also evaluate and determine the economic impact of narrower excision margins on the health services and society in general.

Details
Condition Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Stage II
Treatment Wide Local Excision = 1cm Margin, Wide Local Excision = 2cm Margin
Clinical Study IdentifierNCT03860883
SponsorMelanoma and Skin Cancer Trials Limited
Last Modified on20 October 2021

Eligibility

Yes No Not Sure

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
Staging sentinel node biopsy must be completed within three months (92 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

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
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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