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 Sex
- 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 4076598, Alabama 4829764 36604
Gilbert 5295903, Arizona 5551752 85234
Phoenix 5308655, Arizona 5551752 85054
Little Rock 4119403, Arkansas 4099753 72205
Irvine 5359777, California 5332921 92868
Maki Yamamoto, MD
Los Angeles 5368361, California 5332921 90033
Los Angeles 5368361, California 5332921 90033
Los Angeles 5368361, California 5332921 90033
Los Angeles 5368361, California 5332921 90033
Los Angeles 5368361, California 5332921 90048-1804
Dr Mark Faries
Orange 5379513, California 5332921 92868
Orange 5379513, California 5332921 92868
Palo Alto 5380748, California 5332921 94304
Pasadena 5381396, California 5332921 91105
San Jose 5392171, California 5332921 95124
Amanda Kirane
Vallejo 5405380, California 5332921 94589
Walnut Creek 5406990, California 5332921 94596
Guilford 4835512, Connecticut 4831725 06437
New Haven 4839366, Connecticut 4831725 06520
Washington D.C. 4140963, District of Columbia 4138106 20007
Washington D.C. 4140963, District of Columbia 4138106 20010
Aventura 4146429, Florida 4155751 33180
Coral Gables 4151871, Florida 4155751 33146
Coral Springs 4151909, Florida 4155751 33065
Deerfield Beach 4153071, Florida 4155751 33442
Hollywood 4158928, Florida 4155751 33021
Jacksonville 4160021, Florida 4155751 32207
Jacksonville 4160021, Florida 4155751 32224
Lakeland 4161438, Florida 4155751 33805
Miami 4164138, Florida 4155751 33136
Miami 4164138, Florida 4155751 33176
Plantation 4168782, Florida 4155751 33324
Tampa 4174757, Florida 4155751 33612
Tampa 4174757, Florida 4155751 33612
Atlanta 4180439, Georgia 4197000 30308
Atlanta 4180439, Georgia 4197000 30322
Dr Michael Lowe
Atlanta 4180439, Georgia 4197000 30342
Atlanta 4180439, Georgia 4197000 30342
Savannah 4221552, Georgia 4197000 31405
Chicago 4887398, Illinois 4896861 60657
DeKalb 4889553, Illinois 4896861 60115
Evanston 4891382, Illinois 4896861 60208
Geneva 4893591, Illinois 4896861 60134
Lake Forest 4899012, Illinois 4896861 60045
Park Ridge 4905367, Illinois 4896861 60068
Warrenville 4915525, Illinois 4896861 60555
Indianapolis 4259418, Indiana 4921868 46202
Karl Bilimoria, MD
Indianapolis 4259418, Indiana 4921868 46202
Indianapolis 4259418, Indiana 4921868 46237
Overland Park 4276873, Kansas 4273857 66211
Westwood 4281639, Kansas 4273857 66205
Lexington 4297983, Kentucky 6254925 40506
Baltimore 4347778, Maryland 4361885 21237
Ann Arbor 4984247, Michigan 5001836 48109
Brighton 4986994, Michigan 5001836 48116
Grand Rapids 4994358, Michigan 5001836 49503
Grand Rapids 4994358, Michigan 5001836 49503
Kalamazoo 4997787, Michigan 5001836 49007
Creve Coeur 4382837, Missouri 4398678 63141
Kansas City 4393217, Missouri 4398678 64154
Springfield 4409896, Missouri 4398678 65807
Srikant Nannapaneni
St Louis 4407066, Missouri 4398678 63110
Bellevue 5063805, Nebraska 5073708 68123
Omaha 5074472, Nebraska 5073708 68118
Omaha 5074472, Nebraska 5073708 68198
Livingston 5100572, New Jersey 5101760 07039
Piscataway 5102713, New Jersey 5101760 08854
Professor Adam Berger
Albuquerque 5454711, New Mexico 5481136 87110
Albuquerque 5454711, New Mexico 5481136 87110
Bay Shore 5108169, New York 5128638 11706
Buffalo 5110629, New York 5128638 14203
Lake Success 5123853, New York 5128638 11042
Mineola 5127134, New York 5128638 11501
Mount Kisco 5127744, New York 5128638 10549
New York 5128581, New York 5128638 10016
New York 5128581, New York 5128638 10032
New York 5128581, New York 5128638 10065
Associate Professor Danielle Bello
Poughkeepsie 5132143, New York 5128638 12601
Rochester 5134086, New York 5128638 14642
Sleepy Hollow 5138371, New York 5128638 10591
Syracuse 5140405, New York 5128638 13210
Syracuse 5140405, New York 5128638 13215
Webster 5143495, New York 5128638 14580
Chapel Hill 4460162, North Carolina 4482348 27599
Durham 4464368, North Carolina 4482348 27710
Greenville 4469160, North Carolina 4482348 27858
Hillsborough 4471241, North Carolina 4482348 27278
Fargo 5059163, North Dakota 5690763 58102
Fargo 5059163, North Dakota 5690763 58102
Avon 5146277, Ohio 5165418 44011
Centerville 4508204, Ohio 5165418 45459
Chardon 5149818, Ohio 5165418 44024
Cincinnati 4508722, Ohio 5165418 45219
Cleveland 5150529, Ohio 5165418 44106
Columbus 4509177, Ohio 5165418 43210
Orange 5165695, Ohio 5165418 44122
West Chester 4520522, Ohio 5165418 45069
Westlake 5176517, Ohio 5165418 44145
Oklahoma City 4544349, Oklahoma 4544379 73104
Oklahoma City 4544349, Oklahoma 4544379 73120-8362
Clackamas 5719308, Oregon 5744337 97015
Portland 5746545, Oregon 5744337 97227
Allentown 5178127, Pennsylvania 6254927 18104
Bethlehem 5180225, Pennsylvania 6254927 18015
Easton 5188140, Pennsylvania 6254927 18045
Philadelphia 4560349, Pennsylvania 6254927 19111
Dr Stephanie Greco
Quakertown 5207381, Pennsylvania 6254927 18951
Quakertown 5207381, Pennsylvania 6254927 18951
Sayre 5211037, Pennsylvania 6254927 18840
Charleston 4574324, South Carolina 4597040 29425
Sioux Falls 5231851, South Dakota 5769223 57105,
Sioux Falls 5231851, South Dakota 5769223 57105,
Houston 4699066, Texas 4736286 77030
San Antonio 4726206, Texas 4736286 78284-7884
Murray 5778755, Utah 5549030 84157
Salt Lake City 5780993, Utah 5549030 84112
Professor John Hynstrom
Burlington 5234372, Vermont 5242283 05401
Burlington 5234372, Vermont 5242283 05405
Charlottesville 4752031, Virginia 6254928 22903
Newport News 4776024, Virginia 6254928 23601
Richmond 4781708, Virginia 6254928 23298
Roanoke 4782167, Virginia 6254928 24014
Winchester 4794120, Virginia 6254928 22601
Madison 5261457, Wisconsin 5279468 53718
Madison 5261457, Wisconsin 5279468 53792
Marshfield 5261969, Wisconsin 5279468 54449
Milwaukee 5263045, Wisconsin 5279468 53215
Milwaukee 5263045, Wisconsin 5279468 53226
Weston 5278693, Wisconsin 5279468 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.