RECRUITING

Melanoma Margins Trial-II: 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma

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Conditions

Cutaneous Melanoma, Stage IIMalignantMelanomaCancerSurgery

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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)

Quick Facts

Study Start:2019-12-17
Study Completion:2034-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03860883

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Must have a primary melanoma that is cutaneous (including head, neck, trunk, extremity, scalp, palm or sole).
  3. 3. An uninterrupted 2cm margin must be technically feasible around biopsy scar or primary melanoma.
  4. 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. 5. Patients must be 18 years or older at time of consent.
  6. 6. Patient must be able to give informed consent and comply with the treatment protocol and follow up plan.
  7. 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. 8. Patients must have an ECOG performance score between 0 and 1 at screening.
  9. 9. A survivor of prior cancer is eligible provided that ALL of the following criteria are met and documented:
  10. * The patient has undergone potentially curative therapy for all prior malignancies,
  11. * 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
  12. * The patient is deemed by their treating physician to be at low risk of recurrence from previous malignancies.
  1. 1. Uncertain diagnosis of melanoma i.e., so-called 'melanocytic lesion of unknown malignant potential'.
  2. 2. Patient has already undergone WLE at the site of the primary index lesion.
  3. 3. Patient unable or ineligible to undergo staging SLNB of the primary index lesion.
  4. 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. 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. 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. 7. Subungual melanoma
  8. 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. 9. History of previous or concurrent (i.e. \>1 primary melanoma) invasive melanoma.
  10. 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. 11. Physical, clinical, radiographic or pathologic evidence of satellite, in-transit, regional, or distant metastatic melanoma.
  12. 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. 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. 14. Melanoma-related operative procedures not corresponding to criteria described in the protocol.
  15. 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. 16. History of organ transplantation.
  17. 17. Oral or parenteral immunosuppressive agents (not topical or inhaled steroids) at enrolment or within 6 months prior to enrolment.

Contacts and Locations

Study Contact

Melanoma and Skin Cancer Trials Coordinator
CONTACT
+61 3 9903 9022
melmart@masc.org.au

Principal Investigator

Michael Henderson
STUDY_CHAIR
Peter MacCallum Cancer Centre, Australia
Marc Moncrieff
STUDY_CHAIR
Norfolk & Norwich University Hospital

Study Locations (Sites)

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, District of Columbia, 20007
United States
MedStar Washington Hospital Center
Washington, 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
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Cox South Hospital
Springfield, Missouri, 65807
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 Village, 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

Collaborators and Investigators

Sponsor: Melanoma and Skin Cancer Trials Limited

  • Michael Henderson, STUDY_CHAIR, Peter MacCallum Cancer Centre, Australia
  • Marc Moncrieff, STUDY_CHAIR, Norfolk & Norwich University Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-12-17
Study Completion Date2034-12-31

Study Record Updates

Study Start Date2019-12-17
Study Completion Date2034-12-31

Terms related to this study

Keywords Provided by Researchers

  • Malignant
  • Melanoma
  • Cancer
  • Surgery

Additional Relevant MeSH Terms

  • Cutaneous Melanoma, Stage II