Melanoma Clinical Trial
Melanoma Margins Trial-II: 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma
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.
Full 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.
Eligibility Criteria
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.
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.
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:
Patients will be excluded from the study for ANY of the following reasons:
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: 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
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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There are 130 Locations for this study
Mobile Alabama, 36604, United States More Info
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Gilbert Arizona, 85234, United States More Info
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Little Rock Arkansas, 72205, United States More Info
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Los Angeles California, 90048, United States More Info
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Orange California, 92868, United States More Info
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Vallejo California, 94589, United States More Info
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Walnut Creek California, 94596, United States More Info
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Guilford Connecticut, 06437, United States More Info
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New Haven Connecticut, 06520, United States More Info
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Washington District of Columbia, 20007, United States More Info
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Washington District of Columbia, 20010, United States More Info
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Jacksonville Florida, 32207, United States More Info
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Jacksonville Florida, 32224, United States More Info
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Lakeland Florida, 33805, United States More Info
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Tampa Florida, 33612, United States More Info
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Tampa Florida, 33612, United States More Info
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Atlanta Georgia, 30308, United States More Info
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Atlanta Georgia, 30322, United States More Info
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Atlanta Georgia, 30342, United States More Info
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Atlanta Georgia, 30342, United States More Info
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Atlanta Georgia, 30342, United States More Info
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Savannah Georgia, 31405, United States More Info
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DeKalb Illinois, 60115, United States More Info
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Evanston Illinois, 60208, United States More Info
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Geneva Illinois, 60134, United States More Info
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Lake Forest Illinois, 60045, United States More Info
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Park Ridge Illinois, 60068, United States More Info
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Warrenville Illinois, 60555, United States More Info
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Overland Park Kansas, 66211, United States More Info
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Westwood Kansas, 66205, United States More Info
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Lexington Kentucky, 40506, United States More Info
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Baltimore Maryland, 21237, United States More Info
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Grand Rapids Michigan, 49503, United States More Info
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Grand Rapids Michigan, 49503, United States More Info
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Kalamazoo Michigan, 49007, United States More Info
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Creve Coeur Missouri, 63141, United States More Info
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Kansas City Missouri, 64154, United States More Info
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Springfield Missouri, 65807, United States More Info
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Bellevue Nebraska, 68123, United States More Info
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Omaha Nebraska, 68118, United States More Info
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Omaha Nebraska, 68198, United States More Info
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Livingston New Jersey, 07039, United States More Info
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Piscataway New Jersey, 08854, United States More Info
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Bay Shore New York, 11706, United States More Info
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Buffalo New York, 14203, United States More Info
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Lake Success New York, 11042, United States More Info
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Mineola New York, 11501, United States More Info
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New York New York, 10016, United States More Info
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New York New York, 10065, United States More Info
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Poughkeepsie New York, 12601, United States More Info
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Rochester New York, 14642, United States More Info
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Syracuse New York, 13210, United States More Info
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Syracuse New York, 13215, United States More Info
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Webster New York, 14580, United States More Info
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Chapel Hill North Carolina, 27599, United States More Info
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Durham North Carolina, 27710, United States More Info
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Greenville North Carolina, 27858, United States More Info
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Fargo North Dakota, 58102, United States More Info
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Fargo North Dakota, 58102, United States More Info
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Avon Ohio, 44011, United States More Info
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Centerville Ohio, 45459, United States More Info
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Chardon Ohio, 44024, United States More Info
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Cincinnati Ohio, 45219, United States More Info
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Cleveland Ohio, 44106, United States More Info
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Columbus Ohio, 43210, United States More Info
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Orange Village Ohio, 44122, United States More Info
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West Chester Ohio, 45069, United States More Info
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Westlake Ohio, 44145, United States More Info
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Oklahoma City Oklahoma, 73104, United States More Info
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Oklahoma City Oklahoma, 73120, United States More Info
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Clackamas Oregon, 97015, United States More Info
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Portland Oregon, 97227, United States More Info
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Allentown Pennsylvania, 18104, United States More Info
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Bethlehem Pennsylvania, 18015, United States More Info
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Easton Pennsylvania, 18045, United States More Info
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Philadelphia Pennsylvania, 19111, United States More Info
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Quakertown Pennsylvania, 18951, United States More Info
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Quakertown Pennsylvania, 18951, United States More Info
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Sayre Pennsylvania, 18840, United States More Info
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Charleston South Carolina, 29425, United States More Info
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Houston Texas, 77030, United States More Info
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San Antonio Texas, 78284, United States More Info
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Murray Utah, 84157, United States More Info
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Salt Lake City Utah, 84112, United States More Info
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Charlottesville Virginia, 22903, United States More Info
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Newport News Virginia, 23601, United States More Info
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Richmond Virginia, 23298, United States More Info
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Winchester Virginia, 22601, United States More Info
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Madison Wisconsin, 53792, United States More Info
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Marshfield Wisconsin, 54449, United States More Info
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Milwaukee Wisconsin, 53215, United States More Info
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Milwaukee Wisconsin, 53226, United States More Info
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Bruce Australian Capital Territory, 2617, Australia More Info
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Garran Australian Capital Territory, 2605, Australia More Info
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Sydney New South Wales, 2145, Australia More Info
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Sydney New South Wales, , Australia More Info
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Sydney New South Wales, , Australia More Info
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Brisbane Queensland, 4102, Australia More Info
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Gold Coast Queensland, 4226, Australia More Info
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Adelaide South Australia, 5000, Australia More Info
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Melbourne Victoria, , Australia More Info
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Melbourne Victoria, , Australia More Info
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Calgary Alberta, T2N 4, Canada
Kelowna British Columbia, V1Y 5, Canada More Info
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Winnipeg Manitoba, R3E 0, Canada
Barrie Ontario, L4M 6, Canada More Info
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Hamilton Ontario, L8V 1, Canada More Info
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Ottawa Ontario, K1Y 4, Canada More Info
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Toronto Ontario, M4N 3, Canada More Info
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Montreal Quebec, H1T 2, Canada More Info
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Québec City Quebec, G1R2J, Canada More Info
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Padova , 35128, Italy More Info
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Pavia , 27100, Italy More Info
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Torino , 10126, Italy More Info
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Almere Flevoland, , Netherlands More Info
Ede Gelderland, 6716 , Netherlands More Info
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Zutphen Gelderland, 7207 , Netherlands More Info
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Groningen , 9713, Netherlands More Info
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Maastricht , 6229 , Netherlands More Info
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Auckland , 0620, New Zealand More Info
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Gothenburg , , Sweden More Info
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Kristianstad , 29133, Sweden More Info
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Edgbaston Birmingham, B15 2, United Kingdom More Info
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Truro Cornwall, TR1 3, United Kingdom More Info
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Hull East Yorkshire, HU3 2, United Kingdom More Info
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Westcliff on Sea Essex, SS0 0, United Kingdom More Info
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Headington Oxford, OX3 9, United Kingdom More Info
London The Bays, W2 1N, United Kingdom More Info
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East Grinstead West Sussex, RH19 , United Kingdom More Info
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Cambridge , CB2 0, United Kingdom More Info
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London, , SW3 6, United Kingdom More Info
London , NW3 2, United Kingdom More Info
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London , SE1 7, United Kingdom More Info
Manchester , M20 4, United Kingdom More Info
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Middlesbrough , TS4 3, United Kingdom More Info
Norwich , NR47U, United Kingdom More Info
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Nottingham , NG5 1, United Kingdom More Info
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