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)
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.
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.
Arms & interventions
- ProcedureWide Local Excision = 1cm Margin
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.
- ProcedureWide Local Excision = 2cm Margin
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.
Outcome measures
Primary
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.
Time frame: 0-60 months
Secondary
Local Recurrence
Time frame: Day 0-Trial Completion (max. 120 months)
Distant Disease-Free Survival
Time frame: Day 0-Trial Completion (max. 120 months)
Melanoma-Specific Survival
Time frame: Day 0-Trial Completion (max. 120 months)
Overall Survival
Time frame: Day 0-Trial Completion (max. 120 months)
Melanoma-specific Quality of Life: FACT-M questionnaire
Time frame: Baseline, 3, 6, 12 & 24 months
Neuropathic Pain: PainDetect questionnaire
Time frame: Baseline, 3, 6, 12 & 24 months
Health-related Quality of Life: EQ-5D-5L questionnaire
Time frame: Baseline, 3, 6, 12 & 24 months
Surgery Related Adverse Events
Time frame: Up to 12-months from the date of surgery
Health Economic Evaluation
Time frame: Baseline, 3, 6, 12 & 24 months
Serious Adverse Events
Time frame: from randomisation up to 12-months post-surgery
Eligibility criteria
Study locations (130)
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, 36604
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Mayo Clinic Phoenix
Phoenix, Arizona, 85054
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 92868
Los Angeles General Medical Center
Los Angeles, California, 90033
Los Angeles General Medical Center
Los Angeles, California, 90033
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
The Angeles (Cedars-Sinai Medical Center and its Affiliates)
Los Angeles, California, 90048-1804
UC Irvine Health - Chao Family Comprehensive Cancer Center
Orange, California, 92868
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Orange, California, 92868
Stanford Cancer Institute
Palo Alto, California, 94304
Huntington Memorial Hospital
Pasadena, California, 91105
Stanford Cancer Center South Bay
San Jose, California, 95124
Kaiser Permanente - Vallejo Medical Center
Vallejo, California, 94589
Kaiser Permanente - Walnut Creek Medical Center
Walnut Creek, California, 94596
Smilow Hospital Care Center, Guilford
Guilford, Connecticut, 06437
Yale University
New Haven, Connecticut, 06520
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
University of Miami Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida, 33180
University of Miami Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, 33146
University of Miami Sylvester Cancer Center at Coral Springs
Coral Springs, Florida, 33065
University of Miami Sylvester Comprehensive Center at Deerfield Beach
Deerfield Beach, Florida, 33442
University of Miami Sylvester Comprehensive Center at Hollywood
Hollywood, Florida, 33021
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Lakeland Regional Health Hollis Cancer Center
Lakeland, Florida, 33805
University of Miami Miller School of Medicine-Sylvester Cancer Centre
Miami, Florida, 33136
University of Miami Comprehensive Cancer Center at Kendall
Miami, Florida, 33176
University of Miami Comprehensive Cancer Center at Plantation
Plantation, Florida, 33324
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, 33612
Moffitt Cancer Center, Magnolia Campus
Tampa, Florida, 33612
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Emory University
Atlanta, Georgia, 30322
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
Northside Hospital Atlanta
Atlanta, Georgia, 30342
Northside Hospital Cancer Institute
Atlanta, Georgia, 30342
Nancy N and JC Lewis Cancer & Research Pavilion St. Joseph's/Candler
Savannah, Georgia, 31405
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115
Northwestern University
Evanston, Illinois, 60208
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134
Northwestern Medicine Cancer Center Lake Forest Hospital
Lake Forest, Illinois, 60045
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555
Indiana University - Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
Franciscan Health Indianapolis
Indianapolis, Indiana, 46237
University of Kansas Hospital - Indian Creek Campus
Overland Park, Kansas, 66211
University of Kansas Hospital- Westwood Cancer Center
Westwood, Kansas, 66205
University of Kentucky
Lexington, Kentucky, 40506
MedStar Franklin Square Medical Center
Baltimore, Maryland, 21237
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
University of Michigan - Brighton Center for Specialty Care
Brighton, Michigan, 48116
Mercy Health Saint Mary's
Grand Rapids, Michigan, 49503
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503
West Michigan Cancer Centre
Kalamazoo, Michigan, 49007
Siteman Cancer Centre, Barnes Jewish West County
Creve Coeur, Missouri, 63141
University of Kansas Cancer Center
Kansas City, Missouri, 64154
Cox South Hospital
Springfield, Missouri, 65807
Washington University School of Medicine
St Louis, Missouri, 63110
Nebraska Medicine - Bellevue
Bellevue, Nebraska, 68123
Nebraska Medicine-Village Pointe
Omaha, Nebraska, 68118
University of Nebraska Medicine
Omaha, Nebraska, 68198
Cooperman Barnabas Medical Center
Livingston, New Jersey, 07039
Rutgers Cancer Institute of New Jersey
Piscataway, New Jersey, 08854
Lovelace Medical Centre-Saint Joseph Square
Albuquerque, New Mexico, 87110
Lovelace Women's Hospital
Albuquerque, New Mexico, 87110
Northwell Health Imbert Cancer Center
Bay Shore, New York, 11706
Roswell Park Cancer Institute
Buffalo, New York, 14203
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042
NYU Langone Medical Center (Winthrop Hospital)
Mineola, New York, 11501
Northern Westchester Hospital
Mount Kisco, New York, 10549
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Vassar Brothers Medical Center
Poughkeepsie, New York, 12601
University of Rochester
Rochester, New York, 14642
Phelps Memorial Hospital Center
Sleepy Hollow, New York, 10591
State University of New York Upstate Medical University
Syracuse, New York, 13210
State University of New York Upstate Medical Center-Community Campus
Syracuse, New York, 13215
Wilmont Cancer Institute at Webster
Webster, New York, 14580
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Duke University Medical Center
Durham, North Carolina, 27710
East Carolina University
Greenville, North Carolina, 27858
University of North Carolina Hospitals - Hillsborough Campus
Hillsborough, North Carolina, 27278
Sanford Broadway Medical Centre
Fargo, North Dakota, 58102
Sanford Roger Maris Cancer Centre
Fargo, North Dakota, 58102
University Hospitals Avon Health Center
Avon, Ohio, 44011
Miami Valley Hospital South
Centerville, Ohio, 45459
University Hospitals Geauga Medical Center
Chardon, Ohio, 44024
University of Cincinnati
Cincinnati, Ohio, 45219
University Hospitals Cleveland Medical Centre
Cleveland, Ohio, 44106
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
University Hospitals Chagrin Highlands Medical Centre
Orange, Ohio, 44122
West Chester Hospital (OH394)
West Chester, Ohio, 45069
University Hospitals St. John Medical Center
Westlake, Ohio, 44145
OUHSC Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
Mercy Health Center - Oncology Hematology
Oklahoma City, Oklahoma, 73120-8362
Kaiser Sunnyside Medical Center
Clackamas, Oregon, 97015
Kaiser Permanente Northwest - Oncology Clinic
Portland, Oregon, 97227
St. Luke's University Health Network - Allentown Cancer Center
Allentown, Pennsylvania, 18104
St Luke's University Health Network, Bethlehem Campus
Bethlehem, Pennsylvania, 18015
St Luke's University Health Network, Anderson Campus
Easton, Pennsylvania, 18045
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
St Luke's University Health Network Quakertown Campus
Quakertown, Pennsylvania, 18951
St. Luke's University Health Network - Upper Bucks
Quakertown, Pennsylvania, 18951
Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania, 18840
Medical University of South Carolina
Charleston, South Carolina, 29425
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57105,
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57105,
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7884
Intermountain Medical Center
Murray, Utah, 84157
Huntsman Cancer Institute (The University of Utah)
Salt Lake City, Utah, 84112
University of Vermont Medical Center
Burlington, Vermont, 05401
University of Vermount and Sate Agricultural College
Burlington, Vermont, 05405
University of Virginia Health System
Charlottesville, Virginia, 22903
VCU Massey Cancer Center Peninsula Cancer Institute
Newport News, Virginia, 23601
VCU Massey Cancer Center
Richmond, Virginia, 23298
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014
VCU Massey Cancer Center Affiliate Valley Health
Winchester, Virginia, 22601
University of Winsconsin Carbone Cancer Center-Eastpark medical Center
Madison, Wisconsin, 53718
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
Marshfield Medical Center - Marshfield
Marshfield, Wisconsin, 54449
Aurora St Luke's Medical Center
Milwaukee, Wisconsin, 53215
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Marshfield Medical Center- Weston
Weston, Wisconsin, 54476