Wide Local Excision = 1cm MarginWide Local Excision = 2cm Margin
Wide Local Excision = 1cm Margin: A 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: A 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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
Patients may be included in the study if they meet ALL of the following criteria:
1. 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.
2. Must have a primary melanoma that is cutaneous (including head, neck, trunk, extremity, scalp, palm or sole).
3. An uninterrupted 2cm margin must be technically feasible around biopsy scar or primary melanoma.
4. 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.
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 PI.
8. Patients must have an ECOG performance score between 0 and 1 at screening.
9. 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 (with the exception of successfully treated uterine/cervical or non-melanoma skin cancers (SCCs/BCCs) 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:
1. Uncertain diagnosis of melanoma i.e., so-called 'melanocytic lesion of unknown malignant potential'.
2. Patient has already undergone WLE at the site of the primary index lesion.
3. Patient unable or ineligible to undergo staging SLNB of the primary index lesion.
4. 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.
5. 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).
6. 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.
7. Subungual melanoma
8. 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.
9. History of previous or concurrent (i.e. \>1 primary melanoma) invasive melanoma.
10. 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.
11. Physical, clinical, radiographic or pathologic evidence of satellite, in-transit, regional, or distant metastatic melanoma.
12. 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.
13. 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).
14. Melanoma-related operative procedures not corresponding to criteria described in the protocol.
15. 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.
16. History of organ transplantation.
17. 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 SLNB until the pregnancy has been completed, which may 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.
Primary outcome measure(s)
Disease-Free Survival — 0-60 months Time from randomisation until the first clinically, histologically or radiologically confirmed recurrence of melanoma at any body site, or death from any cause.
Trial sites (192)
Facility
City
Region
Status
University of South Alabama Mitchell Cancer Institute
Mobile
Alabama
Recruiting
Banner MD Anderson Cancer Center
Gilbert
Arizona
Recruiting
Mayo Clinic Phoenix
Phoenix
Arizona
Recruiting
University of Arkansas for Medical Sciences
Little Rock
Arkansas
Recruiting
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine
California
Recruiting
Los Angeles General Medical Center
Los Angeles
California
Recruiting
Los Angeles General Medical Center
Los Angeles
California
Recruiting
USC Norris Comprehensive Cancer Center
Los Angeles
California
Recruiting
USC Norris Comprehensive Cancer Center
Los Angeles
California
Recruiting
The Angeles (Cedars-Sinai Medical Center and its Affiliates)
Los Angeles
California
Recruiting
UC Irvine Health - Chao Family Comprehensive Cancer Center
Orange
California
Recruiting
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Orange
California
Recruiting
Stanford Cancer Institute
Palo Alto
California
Recruiting
Huntington Memorial Hospital
Pasadena
California
Recruiting
Stanford Cancer Center South Bay
San Jose
California
Recruiting
Kaiser Permanente - Vallejo Medical Center
Vallejo
California
Recruiting
Kaiser Permanente - Walnut Creek Medical Center
Walnut Creek
California
Recruiting
Smilow Hospital Care Center, Guilford
Guilford
Connecticut
Recruiting
Yale University
New Haven
Connecticut
Recruiting
MedStar Georgetown University Hospital
Washington D.C.
District of Columbia
Recruiting
MedStar Washington Hospital Center
Washington D.C.
District of Columbia
Recruiting
University of Miami Sylvester Comprehensive Cancer Center at Aventura
Aventura
Florida
Recruiting
University of Miami Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables
Florida
Recruiting
University of Miami Sylvester Cancer Center at Coral Springs
Coral Springs
Florida
Recruiting
University of Miami Sylvester Comprehensive Center at Deerfield Beach
Deerfield Beach
Florida
Recruiting
University of Miami Sylvester Comprehensive Center at Hollywood
Hollywood
Florida
Recruiting
Baptist MD Anderson Cancer Center
Jacksonville
Florida
Recruiting
Mayo Clinic in Florida
Jacksonville
Florida
Recruiting
Lakeland Regional Health Hollis Cancer Center
Lakeland
Florida
Recruiting
University of Miami Miller School of Medicine-Sylvester Cancer Centre
Miami
Florida
Recruiting
University of Miami Comprehensive Cancer Center at Kendall
Miami
Florida
Recruiting
University of Miami Comprehensive Cancer Center at Plantation
Plantation
Florida
Recruiting
Moffitt Cancer Center - McKinley Campus
Tampa
Florida
Recruiting
Moffitt Cancer Center, Magnolia Campus
Tampa
Florida
Recruiting
Emory University Hospital Midtown
Atlanta
Georgia
Recruiting
Emory University
Atlanta
Georgia
Recruiting
Emory Saint Joseph's Hospital
Atlanta
Georgia
Recruiting
Northside Hospital Atlanta
Atlanta
Georgia
Recruiting
Northside Hospital Cancer Institute
Atlanta
Georgia
Not Yet Recruiting
Nancy N and JC Lewis Cancer & Research Pavilion St. Joseph's/Candler
Savannah
Georgia
Recruiting
+ 152 more sites — see the full list on the official registry below.
More Melanoma and Skin Cancer Trials Limited trials in Australia
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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