Melanoma Margins Trial-II: 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma
MelMarT-II
Melanoma Margins Trial-II - A Phase III, Multi-centre Randomised Controlled Trial Investigating 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma (02.18 MelMarT-II)
1 other identifier
interventional
2,998
10 countries
192
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2019
Longer than P75 for not_applicable
192 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2019
CompletedFirst Posted
Study publicly available on registry
March 4, 2019
CompletedStudy Start
First participant enrolled
December 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2034
November 27, 2024
November 1, 2024
10 years
February 7, 2019
November 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease-Free Survival
Time from randomisation until the first clinically, histologically or radiologically confirmed recurrence of melanoma at any body site, or death from any cause.
0-60 months
Secondary Outcomes (10)
Local Recurrence
Day 0-Trial Completion (max. 120 months)
Distant Disease-Free Survival
Day 0-Trial Completion (max. 120 months)
Melanoma-Specific Survival
Day 0-Trial Completion (max. 120 months)
Overall Survival
Day 0-Trial Completion (max. 120 months)
Melanoma-specific Quality of Life: FACT-M questionnaire
Baseline, 3, 6, 12 & 24 months
- +5 more secondary outcomes
Study Arms (2)
Arm A (Wide Local Excision = 1cm Margin)
EXPERIMENTAL1cm Wide Local Excision margin + Sentinel Lymph Node Biopsy +/- Reconstruction
Arm B (Wide Local Excision = 2cm Margin)
ACTIVE COMPARATOR2 cm Wide Local Excision margin + Sentinel Lymph Node Biopsy +/- Reconstruction
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Patients may be included in the study if they meet ALL of the following criteria:
- \. 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.
- 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.
- \. 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.
- 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 at screening.
- 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.
You may not qualify if:
- 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 WLE at the site of the primary index lesion.
- Patient unable or ineligible to undergo staging SLNB of the primary index lesion.
- 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).
- 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. \>1 primary melanoma) 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 -SLNB, of the index melanoma.
- 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).
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Melanoma and Skin Cancer Trials Limitedlead
- Norfolk and Norwich University Hospitals NHS Foundation Trustcollaborator
- Canadian Cancer Trials Groupcollaborator
- Cancer Trials Irelandcollaborator
- Zuyderland Medical Centrecollaborator
Study Sites (192)
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, 36604, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
Mayo Clinic Phoenix
Phoenix, Arizona, 85054, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 92868, United States
Los Angeles General Medical Center
Los Angeles, California, 90033, United States
Los Angeles General Medical Center
Los Angeles, California, 90033, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
The Angeles (Cedars-Sinai Medical Center and its Affiliates)
Los Angeles, California, 90048-1804, United States
UC Irvine Health - Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Orange, California, 92868, United States
Stanford Cancer Institute
Palo Alto, California, 94304, United States
Huntington Memorial Hospital
Pasadena, California, 91105, United States
Stanford Cancer Center South Bay
San Jose, California, 95124, United States
Kaiser Permanente - Vallejo Medical Center
Vallejo, California, 94589, United States
Kaiser Permanente - Walnut Creek Medical Center
Walnut Creek, California, 94596, United States
Smilow Hospital Care Center, Guilford
Guilford, Connecticut, 06437, United States
Yale University
New Haven, Connecticut, 06520, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
University of Miami Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida, 33180, United States
University of Miami Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, 33146, United States
University of Miami Sylvester Cancer Center at Coral Springs
Coral Springs, Florida, 33065, United States
University of Miami Sylvester Comprehensive Center at Deerfield Beach
Deerfield Beach, Florida, 33442, United States
University of Miami Sylvester Comprehensive Center at Hollywood
Hollywood, Florida, 33021, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224, United States
Lakeland Regional Health Hollis Cancer Center
Lakeland, Florida, 33805, United States
University of Miami Miller School of Medicine-Sylvester Cancer Centre
Miami, Florida, 33136, United States
University of Miami Comprehensive Cancer Center at Kendall
Miami, Florida, 33176, United States
University of Miami Comprehensive Cancer Center at Plantation
Plantation, Florida, 33324, United States
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, 33612, United States
Moffitt Cancer Center, Magnolia Campus
Tampa, Florida, 33612, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Emory University
Atlanta, Georgia, 30322, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342, United States
Northside Hospital Atlanta
Atlanta, Georgia, 30342, United States
Northside Hospital Cancer Institute
Atlanta, Georgia, 30342, United States
Nancy N and JC Lewis Cancer & Research Pavilion St. Joseph's/Candler
Savannah, Georgia, 31405, United States
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657, United States
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115, United States
Northwestern University
Evanston, Illinois, 60208, United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134, United States
Northwestern Medicine Cancer Center Lake Forest Hospital
Lake Forest, Illinois, 60045, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555, United States
Indiana University - Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202, United States
Franciscan Health Indianapolis
Indianapolis, Indiana, 46237, United States
University of Kansas Hospital - Indian Creek Campus
Overland Park, Kansas, 66211, United States
University of Kansas Hospital- Westwood Cancer Center
Westwood, Kansas, 66205, United States
University of Kentucky
Lexington, Kentucky, 40506, United States
MedStar Franklin Square Medical Center
Baltimore, Maryland, 21237, United States
University of Michigan Medical Center
Ann Arbor, Michigan, 48109, United States
University of Michigan - Brighton Center for Specialty Care
Brighton, Michigan, 48116, United States
Mercy Health Saint Mary's
Grand Rapids, Michigan, 49503, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503, United States
West Michigan Cancer Centre
Kalamazoo, Michigan, 49007, United States
Siteman Cancer Centre, Barnes Jewish West County
Creve Coeur, Missouri, 63141, United States
University of Kansas Cancer Center
Kansas City, Missouri, 64154, United States
Cox South Hospital
Springfield, Missouri, 65807, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Nebraska Medicine - Bellevue
Bellevue, Nebraska, 68123, United States
Nebraska Medicine-Village Pointe
Omaha, Nebraska, 68118, United States
University of Nebraska Medicine
Omaha, Nebraska, 68198, United States
Cooperman Barnabas Medical Center
Livingston, New Jersey, 07039, United States
Rutgers Cancer Institute of New Jersey
Piscataway, New Jersey, 08854, United States
Lovelace Medical Centre-Saint Joseph Square
Albuquerque, New Mexico, 87110, United States
Lovelace Women's Hospital
Albuquerque, New Mexico, 87110, United States
Northwell Health Imbert Cancer Center
Bay Shore, New York, 11706, United States
Roswell Park Cancer Institute
Buffalo, New York, 14203, United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042, United States
NYU Langone Medical Center (Winthrop Hospital)
Mineola, New York, 11501, United States
Northern Westchester Hospital
Mount Kisco, New York, 10549, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Vassar Brothers Medical Center
Poughkeepsie, New York, 12601, United States
University of Rochester
Rochester, New York, 14642, United States
Phelps Memorial Hospital Center
Sleepy Hollow, New York, 10591, United States
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
State University of New York Upstate Medical Center-Community Campus
Syracuse, New York, 13215, United States
Wilmont Cancer Institute at Webster
Webster, New York, 14580, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
East Carolina University
Greenville, North Carolina, 27858, United States
University of North Carolina Hospitals - Hillsborough Campus
Hillsborough, North Carolina, 27278, United States
Sanford Broadway Medical Centre
Fargo, North Dakota, 58102, United States
Sanford Roger Maris Cancer Centre
Fargo, North Dakota, 58102, United States
University Hospitals Avon Health Center
Avon, Ohio, 44011, United States
Miami Valley Hospital South
Centerville, Ohio, 45459, United States
University Hospitals Geauga Medical Center
Chardon, Ohio, 44024, United States
University of Cincinnati
Cincinnati, Ohio, 45219, United States
University Hospitals Cleveland Medical Centre
Cleveland, Ohio, 44106, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
University Hospitals Chagrin Highlands Medical Centre
Orange, Ohio, 44122, United States
West Chester Hospital (OH394)
West Chester, Ohio, 45069, United States
University Hospitals St. John Medical Center
Westlake, Ohio, 44145, United States
OUHSC Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104, United States
Mercy Health Center - Oncology Hematology
Oklahoma City, Oklahoma, 73120-8362, United States
Kaiser Sunnyside Medical Center
Clackamas, Oregon, 97015, United States
Kaiser Permanente Northwest - Oncology Clinic
Portland, Oregon, 97227, United States
St. Luke's University Health Network - Allentown Cancer Center
Allentown, Pennsylvania, 18104, United States
St Luke's University Health Network, Bethlehem Campus
Bethlehem, Pennsylvania, 18015, United States
St Luke's University Health Network, Anderson Campus
Easton, Pennsylvania, 18045, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
St Luke's University Health Network Quakertown Campus
Quakertown, Pennsylvania, 18951, United States
St. Luke's University Health Network - Upper Bucks
Quakertown, Pennsylvania, 18951, United States
Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania, 18840, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57105,, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57105,, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7884, United States
Intermountain Medical Center
Murray, Utah, 84157, United States
Huntsman Cancer Institute (The University of Utah)
Salt Lake City, Utah, 84112, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
University of Vermount and Sate Agricultural College
Burlington, Vermont, 05405, United States
University of Virginia Health System
Charlottesville, Virginia, 22903, United States
VCU Massey Cancer Center Peninsula Cancer Institute
Newport News, Virginia, 23601, United States
VCU Massey Cancer Center
Richmond, Virginia, 23298, United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014, United States
VCU Massey Cancer Center Affiliate Valley Health
Winchester, Virginia, 22601, United States
University of Winsconsin Carbone Cancer Center-Eastpark medical Center
Madison, Wisconsin, 53718, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792, United States
Marshfield Medical Center - Marshfield
Marshfield, Wisconsin, 54449, United States
Aurora St Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Marshfield Medical Center- Weston
Weston, Wisconsin, 54476, United States
Calvary Public Hospital Bruce
Bruce, Australian Capital Territory, 2617, Australia
The Canberra Hospital
Garran, Australian Capital Territory, 2605, Australia
Westmead Hospital
Sydney, New South Wales, 2145, Australia
Melanoma Institute Australia
Sydney, New South Wales, Australia
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
Princess Alexandra Hospital
Brisbane, Queensland, 4102, Australia
Robina Hospital
Gold Coast, Queensland, 4226, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
BCCA - Cancer Centre for the Southern Interior
Kelowna, British Columbia, V1Y 5L3, Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
Royal Victoria Regional Health Centre
Barrie, Ontario, L4M 6M2, Canada
Hamilton Health Sciences Centre
Hamilton, Ontario, L8V 1C3, Canada
Oak Valley Health
Markham, Ontario, L3P 7P3, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, K1Y 4E9, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
UHN - Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2C1, Canada
Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, H2X 3E4, Canada
Hotel-Dieu de Quebec
Québec, Quebec, G1R2J6, Canada
Cork University Hospital
Cork, Ireland
Mater Misericordiae University Hospital
Dublin, D07 R2WY, Ireland
St James Hospital
Dublin, D08 NHY1, Ireland
IOV Istituto Oncologico Veneto IRCCS-Padova
Padua, 35128, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100, Italy
AOU Città della Salute e della Scienza di Torino
Torino, 10126, Italy
Flevo Hospital
Almere Stad, Flevoland, Netherlands
Ziekenhuis Gelderse Vallei
Ede, Gelderland, 6716 RP, Netherlands
Gelre Hospital
Zutphen, Gelderland, 7207 AE, Netherlands
Maxima Medical Centre, Eindhoven
Eindhoven, North Brabant, 5631, Netherlands
University Medical Centre Groningen
Groningen, 9713, Netherlands
Zuyderland Medical Center
Heerlen, 6419, Netherlands
Maastricht University Medical Center
Maastricht, 6229 HX, Netherlands
Diakonessenhuis
Utrecht, 3582 KE, Netherlands
Maxima Medical Center - Veldhoven
Veldhoven, 5504, Netherlands
Isala Hospital
Zwolle, 8025, Netherlands
North Shore Hospital
Auckland, 0620, New Zealand
Institute of Oncology Ljubljana
Ljubljana, 1000, Slovenia
Sahlgrenska University Hospital
Gothenburg, Sweden
Central Hospital Kristianstad
Kristianstad, 29133, Sweden
University Hospitals Birmingham NHS Foundation Trust
Edgbaston, Birmingham, B15 2TH, United Kingdom
Royal Cornwall Hospital NHS Trust
Truro, Cornwall, TR1 3LJ, United Kingdom
Hull University Teaching Hospitals NHS Trust
Hull, East Yorkshire, HU3 2JZ, United Kingdom
MID & South Essex NHS Foundation Trust
Westcliff-on-Sea, Essex, SS0 0RY, United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust
Preston, Lancashire, PR2 9HT, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Headington, Oxford, OX3 9DU, United Kingdom
Imperial College Healthcare NHS Trust
London, The Bays, W2 1NY, United Kingdom
Queen Victoria Hospital NHS Foundation Trust
East Grinstead, West Sussex, RH19 3DZ, United Kingdom
North Bristol NHS Trust
Bristol, BS10 5NB, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ, United Kingdom
The Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF, United Kingdom
St. Helens & Knowsley Teaching Hospitals NHS Trust
Liverpool, United Kingdom
Royal Free London NHS Foundation Trust
London, NW3 2QG, United Kingdom
Guy's and St Thomas's NHS Foundation Trust, of St Thomas' Hospital
London, SE1 7EH, United Kingdom
St George's University Hospitals NHS Foundation Trust
London, SW17 0QT, United Kingdom
The Royal Marsden Hospital NHS Foundation Trust
London, SW3 6JJ, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
South Tees Hospitals NHS Foundation Trust of The James Cook University Hospital
Middlesbrough, TS4 3BW, United Kingdom
Norfolk and Norwich University Hospital NHS Trust
Norwich, NR47UY, United Kingdom
Nottingham University Hospitals, NHS Trust, Trust HQ, City Hospital
Nottingham, NG5 1PB, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Michael Henderson
Peter MacCallum Cancer Centre, Australia
- STUDY CHAIR
Marc Moncrieff
Norfolk & Norwich University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2019
First Posted
March 4, 2019
Study Start
December 17, 2019
Primary Completion (Estimated)
December 31, 2029
Study Completion (Estimated)
December 31, 2034
Last Updated
November 27, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share