Melanoma Margins Trial-II: 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma
Purpose
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.
Condition
- Cutaneous Melanoma, Stage II
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm A (Wide Local Excision = 1cm Margin) |
1cm Wide Local Excision margin + Sentinel Lymph Node Biopsy +/- Reconstruction |
|
|
Active Comparator Arm B (Wide Local Excision = 2cm Margin) |
2 cm Wide Local Excision margin + Sentinel Lymph Node Biopsy +/- Reconstruction |
|
Recruiting Locations
Mobile, Alabama 36604
Gilbert, Arizona 85234
Little Rock, Arkansas 72205
Irvine, California 92868
Maki Yamamoto, MD
Los Angeles, California 90033
Los Angeles, California 90033
Los Angeles, California 90033
Los Angeles, California 90033
Los Angeles, California 90048-1804
Dr Mark Faries
Orange, California 92868
Orange, California 92868
Palo Alto, California 94304
Pasadena, California 91105
San Jose, California 95124
Amanda Kirane
Vallejo, California 94589
Walnut Creek, California 94596
Guilford, Connecticut 06437
Washington, District of Columbia 20007
Washington, District of Columbia 20010
Aventura, Florida 33180
Coral Gables, Florida 33146
Coral Springs, Florida 33065
Deerfield Beach, Florida 33442
Hollywood, Florida 33021
Jacksonville, Florida 32207
Lakeland, Florida 33805
Miami, Florida 33136
Miami, Florida 33176
Plantation, Florida 33324
Tampa, Florida 33612
Tampa, Florida 33612
Atlanta, Georgia 30322
Dr Michael Lowe
Atlanta, Georgia 30342
Savannah, Georgia 31405
Chicago, Illinois 60657
DeKalb, Illinois 60115
Geneva, Illinois 60134
Lake Forest, Illinois 60045
Park Ridge, Illinois 60068
Warrenville, Illinois 60555
Indianapolis, Indiana 46202
Karl Bilimoria, MD
Indianapolis, Indiana 46202
Indianapolis, Indiana 46237
Overland Park, Kansas 66211
Westwood, Kansas 66205
Baltimore, Maryland 21237
Ann Arbor, Michigan 48109
Brighton, Michigan 48116
Grand Rapids, Michigan 49503
Creve Coeur, Missouri 63141
Saint Louis, Missouri 63110
Springfield, Missouri 65807
Srikant Nannapaneni
Bellevue, Nebraska 68123
Omaha, Nebraska 68118
Omaha, Nebraska 68198
Livingston, New Jersey 07039
Piscataway, New Jersey 08854
Professor Adam Berger
Albuquerque, New Mexico 87110
Albuquerque, New Mexico 87110
Bay Shore, New York 11706
Buffalo, New York 14203
Lake Success, New York 11042
Mineola, New York 11501
Mount Kisco, New York 10549
New York, New York 10016
New York, New York 10032
New York, New York 10065
Associate Professor Danielle Bello
Poughkeepsie, New York 12601
Sleepy Hollow, New York 10591
Syracuse, New York 13210
Syracuse, New York 13215
Webster, New York 14580
Chapel Hill, North Carolina 27599
Hillsborough, North Carolina 27278
Fargo, North Dakota 58102
Fargo, North Dakota 58102
Avon, Ohio 44011
Centerville, Ohio 45459
Chardon, Ohio 44024
Cleveland, Ohio 44106
Columbus, Ohio 43210
Orange Village, Ohio 44122
West Chester, Ohio 45069
Westlake, Ohio 44145
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73120-8362
Clackamas, Oregon 97015
Portland, Oregon 97227
Allentown, Pennsylvania 18104
Bethlehem, Pennsylvania 18015
Easton, Pennsylvania 18045
Philadelphia, Pennsylvania 19111
Dr Stephanie Greco
Quakertown, Pennsylvania 18951
Quakertown, Pennsylvania 18951
Sayre, Pennsylvania 18840
Charleston, South Carolina 29425
Sioux Falls, South Dakota 57105,
Sioux Falls, South Dakota 57105,
Houston, Texas 77030
San Antonio, Texas 78284-7884
Salt Lake City, Utah 84112
Professor John Hynstrom
Burlington, Vermont 05401
Burlington, Vermont 05405
Charlottesville, Virginia 22903
Newport News, Virginia 23601
Roanoke, Virginia 24014
Winchester, Virginia 22601
Madison, Wisconsin 53718
Madison, Wisconsin 53792
Marshfield, Wisconsin 54449
Milwaukee, Wisconsin 53215
Milwaukee, Wisconsin 53226
Weston, Wisconsin 54476
More Details
- NCT ID
- NCT03860883
- Status
- Recruiting
- Sponsor
- Melanoma and Skin Cancer Trials Limited
Detailed 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.