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 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. 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. 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. 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. 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 (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: 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: 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 5. Subungual melanoma 6. 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. 7. History of previous or concurrent (i.e., second primary) invasive melanoma. 8. 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. 9. Physical, clinical, radiographic or pathologic evidence of satellite, in-transit, regional, or distant metastatic melanoma. 10. 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. 11. 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. 12. Melanoma-related operative procedures not corresponding to criteria described in the protocol. 13. 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. 14. History of organ transplantation. 15. 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.
Study Design
- Phase
- Phase 3
- 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
Los Angeles, California 90048-1804
Dr Mark Faries
Orange, California 92868
Palo Alto, California 94304
Vallejo, California 94589
Walnut Creek, California 94596
Guilford, Connecticut 06437
Washington, District of Columbia 20007
Washington, District of Columbia 20010
Jacksonville, Florida 32207
Lakeland, Florida 33805
Tampa, Florida 33612
Tampa, Florida 33612
Atlanta, Georgia 30322
Dr Michael Lowe
Atlanta, Georgia 30342
Savannah, Georgia 31405
DeKalb, Illinois 60115
Geneva, Illinois 60134
Lake Forest, Illinois 60045
Park Ridge, Illinois 60068
Warrenville, Illinois 60555
Overland Park, Kansas 66211
Westwood, Kansas 66205
Baltimore, Maryland 21237
Grand Rapids, Michigan 49503
Creve Coeur, Missouri 63141
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
Bay Shore, New York 11706
Buffalo, New York 14203
Lake Success, New York 11042
Mineola, New York 11501
New York, New York 10016
New York, New York 10065
Associate Professor Danielle Bello
Poughkeepsie, New York 12601
Syracuse, New York 13210
Syracuse, New York 13215
Webster, New York 14580
Chapel Hill, North Carolina 27599
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
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 53792
Marshfield, Wisconsin 54449
Milwaukee, Wisconsin 53215
Milwaukee, Wisconsin 53226
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.