TrialPath
← Back to searchRecruiting

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

NCT03860883 · Melanoma and Skin Cancer Trials Limited
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

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)
About this study
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 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
Enrollment target: 2998 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2019-12-17
Estimated completion: 2034-12-31
Last updated: 2024-11-27
Interventions
Procedure: Wide Local Excision = 1cm MarginProcedure: Wide Local Excision = 2cm Margin
Primary outcomes
  • Disease-Free Survival (0-60 months)
Sponsor
Melanoma and Skin Cancer Trials Limited · other
With: Norfolk and Norwich University Hospitals NHS Foundation Trust, Canadian Cancer Trials Group, Cancer Trials Ireland, Zuyderland Medical Centre
Contacts & investigators
ContactMelanoma and Skin Cancer Trials Coordinator · contact · melmart@masc.org.au · +61 3 9903 9022
InvestigatorMichael Henderson · study_chair, Peter MacCallum Cancer Centre, Australia
InvestigatorMarc Moncrieff · study_chair, Norfolk & Norwich University Hospital
All locations (192)
University of South Alabama Mitchell Cancer InstituteRecruiting
Mobile, Alabama, United States
Banner MD Anderson Cancer CenterRecruiting
Gilbert, Arizona, United States
Mayo Clinic PhoenixRecruiting
Phoenix, Arizona, United States
University of Arkansas for Medical SciencesRecruiting
Little Rock, Arkansas, United States
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareRecruiting
Irvine, California, United States
Los Angeles General Medical CenterRecruiting
Los Angeles, California, United States
Los Angeles General Medical CenterRecruiting
Los Angeles, California, United States
USC Norris Comprehensive Cancer CenterRecruiting
Los Angeles, California, United States
USC Norris Comprehensive Cancer CenterRecruiting
Los Angeles, California, United States
The Angeles (Cedars-Sinai Medical Center and its Affiliates)Recruiting
Los Angeles, California, United States
UC Irvine Health - Chao Family Comprehensive Cancer CenterRecruiting
Orange, California, United States
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareRecruiting
Orange, California, United States
Stanford Cancer InstituteRecruiting
Palo Alto, California, United States
Huntington Memorial HospitalRecruiting
Pasadena, California, United States
Stanford Cancer Center South BayRecruiting
San Jose, California, United States
Kaiser Permanente - Vallejo Medical CenterRecruiting
Vallejo, California, United States
Kaiser Permanente - Walnut Creek Medical CenterRecruiting
Walnut Creek, California, United States
Smilow Hospital Care Center, GuilfordRecruiting
Guilford, Connecticut, United States
Yale UniversityRecruiting
New Haven, Connecticut, United States
MedStar Georgetown University HospitalRecruiting
Washington D.C., District of Columbia, United States
MedStar Washington Hospital CenterRecruiting
Washington D.C., District of Columbia, United States
University of Miami Sylvester Comprehensive Cancer Center at AventuraRecruiting
Aventura, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center at Coral GablesRecruiting
Coral Gables, Florida, United States
University of Miami Sylvester Cancer Center at Coral SpringsRecruiting
Coral Springs, Florida, United States
University of Miami Sylvester Comprehensive Center at Deerfield BeachRecruiting
Deerfield Beach, Florida, United States
University of Miami Sylvester Comprehensive Center at HollywoodRecruiting
Hollywood, Florida, United States
Baptist MD Anderson Cancer CenterRecruiting
Jacksonville, Florida, United States
Mayo Clinic in FloridaRecruiting
Jacksonville, Florida, United States
Lakeland Regional Health Hollis Cancer CenterRecruiting
Lakeland, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer CentreRecruiting
Miami, Florida, United States
University of Miami Comprehensive Cancer Center at KendallRecruiting
Miami, Florida, United States
University of Miami Comprehensive Cancer Center at PlantationRecruiting
Plantation, Florida, United States
Moffitt Cancer Center - McKinley CampusRecruiting
Tampa, Florida, United States
Moffitt Cancer Center, Magnolia CampusRecruiting
Tampa, Florida, United States
Emory University Hospital MidtownRecruiting
Atlanta, Georgia, United States
Emory UniversityRecruiting
Atlanta, Georgia, United States
Emory Saint Joseph's HospitalRecruiting
Atlanta, Georgia, United States
Northside Hospital AtlantaRecruiting
Atlanta, Georgia, United States
Northside Hospital Cancer InstituteNot Yet Recruiting
Atlanta, Georgia, United States
Nancy N and JC Lewis Cancer & Research Pavilion St. Joseph's/CandlerRecruiting
Savannah, Georgia, United States
Advocate Illinois Masonic Medical CenterRecruiting
Chicago, Illinois, United States
Northwestern Medicine Cancer Center KishwaukeeRecruiting
DeKalb, Illinois, United States
Northwestern UniversityRecruiting
Evanston, Illinois, United States
Northwestern Medicine Cancer Center DelnorRecruiting
Geneva, Illinois, United States
Northwestern Medicine Cancer Center Lake Forest HospitalRecruiting
Lake Forest, Illinois, United States
Advocate Lutheran General HospitalRecruiting
Park Ridge, Illinois, United States
Northwestern Medicine Cancer Center WarrenvilleRecruiting
Warrenville, Illinois, United States
Indiana University - Melvin and Bren Simon Cancer CenterRecruiting
Indianapolis, Indiana, United States
Indiana University Melvin and Bren Simon Comprehensive Cancer CenterRecruiting
Indianapolis, Indiana, United States
Franciscan Health IndianapolisRecruiting
Indianapolis, Indiana, United States
University of Kansas Hospital - Indian Creek CampusRecruiting
Overland Park, Kansas, United States
University of Kansas Hospital- Westwood Cancer CenterRecruiting
Westwood, Kansas, United States
University of KentuckyRecruiting
Lexington, Kentucky, United States
MedStar Franklin Square Medical CenterRecruiting
Baltimore, Maryland, United States
University of Michigan Medical CenterRecruiting
Ann Arbor, Michigan, United States
University of Michigan - Brighton Center for Specialty CareRecruiting
Brighton, Michigan, United States
Mercy Health Saint Mary'sRecruiting
Grand Rapids, Michigan, United States
Spectrum Health at Butterworth CampusRecruiting
Grand Rapids, Michigan, United States
West Michigan Cancer CentreRecruiting
Kalamazoo, Michigan, United States
Siteman Cancer Centre, Barnes Jewish West CountyRecruiting
Creve Coeur, Missouri, United States
University of Kansas Cancer CenterRecruiting
Kansas City, Missouri, United States
Cox South HospitalRecruiting
Springfield, Missouri, United States
Washington University School of MedicineRecruiting
St Louis, Missouri, United States
Nebraska Medicine - BellevueRecruiting
Bellevue, Nebraska, United States
Nebraska Medicine-Village PointeRecruiting
Omaha, Nebraska, United States
University of Nebraska MedicineRecruiting
Omaha, Nebraska, United States
Cooperman Barnabas Medical CenterRecruiting
Livingston, New Jersey, United States
Rutgers Cancer Institute of New JerseyRecruiting
Piscataway, New Jersey, United States
Lovelace Medical Centre-Saint Joseph SquareRecruiting
Albuquerque, New Mexico, United States
Lovelace Women's HospitalRecruiting
Albuquerque, New Mexico, United States
Northwell Health Imbert Cancer CenterRecruiting
Bay Shore, New York, United States
Roswell Park Cancer InstituteRecruiting
Buffalo, New York, United States
Northwell Health/Center for Advanced MedicineRecruiting
Lake Success, New York, United States
NYU Langone Medical Center (Winthrop Hospital)Recruiting
Mineola, New York, United States
Northern Westchester HospitalRecruiting
Mount Kisco, New York, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone HealthRecruiting
New York, New York, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterRecruiting
New York, New York, United States
Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
Vassar Brothers Medical CenterRecruiting
Poughkeepsie, New York, United States
University of RochesterRecruiting
Rochester, New York, United States
Phelps Memorial Hospital CenterRecruiting
Sleepy Hollow, New York, United States
State University of New York Upstate Medical UniversityRecruiting
Syracuse, New York, United States
State University of New York Upstate Medical Center-Community CampusRecruiting
Syracuse, New York, United States
Wilmont Cancer Institute at WebsterRecruiting
Webster, New York, United States
University of North Carolina at Chapel HillRecruiting
Chapel Hill, North Carolina, United States
Duke University Medical CenterRecruiting
Durham, North Carolina, United States
East Carolina UniversityRecruiting
Greenville, North Carolina, United States
University of North Carolina Hospitals - Hillsborough CampusRecruiting
Hillsborough, North Carolina, United States
Sanford Broadway Medical CentreRecruiting
Fargo, North Dakota, United States
Sanford Roger Maris Cancer CentreRecruiting
Fargo, North Dakota, United States
University Hospitals Avon Health CenterRecruiting
Avon, Ohio, United States
Miami Valley Hospital SouthRecruiting
Centerville, Ohio, United States
University Hospitals Geauga Medical CenterRecruiting
Chardon, Ohio, United States
University of CincinnatiRecruiting
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical CentreRecruiting
Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer CenterRecruiting
Columbus, Ohio, United States
University Hospitals Chagrin Highlands Medical CentreRecruiting
Orange, Ohio, United States
West Chester Hospital (OH394)Recruiting
West Chester, Ohio, United States
University Hospitals St. John Medical CenterRecruiting
Westlake, Ohio, United States
OUHSC Stephenson Cancer CenterRecruiting
Oklahoma City, Oklahoma, United States
Mercy Health Center - Oncology HematologyRecruiting
Oklahoma City, Oklahoma, United States
Kaiser Sunnyside Medical CenterRecruiting
Clackamas, Oregon, United States
Kaiser Permanente Northwest - Oncology ClinicRecruiting
Portland, Oregon, United States
St. Luke's University Health Network - Allentown Cancer CenterRecruiting
Allentown, Pennsylvania, United States
St Luke's University Health Network, Bethlehem CampusRecruiting
Bethlehem, Pennsylvania, United States
St Luke's University Health Network, Anderson CampusRecruiting
Easton, Pennsylvania, United States
Fox Chase Cancer CenterRecruiting
Philadelphia, Pennsylvania, United States
St Luke's University Health Network Quakertown CampusRecruiting
Quakertown, Pennsylvania, United States
St. Luke's University Health Network - Upper BucksRecruiting
Quakertown, Pennsylvania, United States
Guthrie Medical Group PC-Robert Packer HospitalRecruiting
Sayre, Pennsylvania, United States
Medical University of South CarolinaRecruiting
Charleston, South Carolina, United States
Sanford Cancer Center Oncology ClinicRecruiting
Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux FallsRecruiting
Sioux Falls, South Dakota, United States
The University of Texas MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
University of Texas Health Science Center at San AntonioRecruiting
San Antonio, Texas, United States
Intermountain Medical CenterRecruiting
Murray, Utah, United States
Huntsman Cancer Institute (The University of Utah)Recruiting
Salt Lake City, Utah, United States
University of Vermont Medical CenterRecruiting
Burlington, Vermont, United States
University of Vermount and Sate Agricultural CollegeRecruiting
Burlington, Vermont, United States
University of Virginia Health SystemRecruiting
Charlottesville, Virginia, United States
VCU Massey Cancer Center Peninsula Cancer InstituteRecruiting
Newport News, Virginia, United States
VCU Massey Cancer CenterRecruiting
Richmond, Virginia, United States
Carilion Roanoke Memorial HospitalRecruiting
Roanoke, Virginia, United States
VCU Massey Cancer Center Affiliate Valley HealthRecruiting
Winchester, Virginia, United States
University of Winsconsin Carbone Cancer Center-Eastpark medical CenterRecruiting
Madison, Wisconsin, United States
University of Wisconsin Carbone Cancer CenterRecruiting
Madison, Wisconsin, United States
Marshfield Medical Center - MarshfieldRecruiting
Marshfield, Wisconsin, United States
Aurora St Luke's Medical CenterRecruiting
Milwaukee, Wisconsin, United States
Medical College of WisconsinRecruiting
Milwaukee, Wisconsin, United States
Marshfield Medical Center- WestonRecruiting
Weston, Wisconsin, United States
Calvary Public Hospital BruceRecruiting
Bruce, Australian Capital Territory, Australia
The Canberra HospitalNot Yet Recruiting
Garran, Australian Capital Territory, Australia
Westmead HospitalRecruiting
Sydney, New South Wales, Australia
Melanoma Institute AustraliaRecruiting
Sydney, New South Wales, Australia
Royal Prince Alfred HospitalRecruiting
Sydney, New South Wales, Australia
Princess Alexandra HospitalNot Yet Recruiting
Brisbane, Queensland, Australia
Robina HospitalNot Yet Recruiting
Gold Coast, Queensland, Australia
Royal Adelaide HospitalRecruiting
Adelaide, South Australia, Australia
Peter MacCallum Cancer CentreRecruiting
Melbourne, Victoria, Australia
The Alfred HospitalRecruiting
Melbourne, Victoria, Australia
Tom Baker Cancer CentreRecruiting
Calgary, Alberta, Canada
BCCA - Cancer Centre for the Southern InteriorRecruiting
Kelowna, British Columbia, Canada
CancerCare ManitobaRecruiting
Winnipeg, Manitoba, Canada
Royal Victoria Regional Health CentreRecruiting
Barrie, Ontario, Canada
Hamilton Health Sciences CentreRecruiting
Hamilton, Ontario, Canada
Oak Valley HealthRecruiting
Markham, Ontario, Canada
Ottawa Hospital Research InstituteRecruiting
Ottawa, Ontario, Canada
Sunnybrook Health Sciences CentreRecruiting
Toronto, Ontario, Canada
UHN - Princess Margaret Cancer CentreRecruiting
Toronto, Ontario, Canada
Hopital Maisonneuve-RosemontRecruiting
Montreal, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)Recruiting
Montreal, Quebec, Canada
Hotel-Dieu de QuebecRecruiting
Québec, Quebec, Canada
Cork University HospitalRecruiting
Cork, Ireland
Mater Misericordiae University HospitalRecruiting
Dublin, Ireland
St James HospitalRecruiting
Dublin, Ireland
IOV Istituto Oncologico Veneto IRCCS-PadovaNot Yet Recruiting
Padova, Italy
Fondazione IRCCS Policlinico San MatteoNot Yet Recruiting
Pavia, Italy
AOU Città della Salute e della Scienza di TorinoNot Yet Recruiting
Torino, Italy
Flevo HospitalRecruiting
Almere Stad, Flevoland, Netherlands
Ziekenhuis Gelderse ValleiRecruiting
Ede, Gelderland, Netherlands
Gelre HospitalRecruiting
Zutphen, Gelderland, Netherlands
Maxima Medical Centre, EindhovenRecruiting
Eindhoven, North Brabant, Netherlands
University Medical Centre GroningenRecruiting
Groningen, Netherlands
Zuyderland Medical CenterRecruiting
Heerlen, Netherlands
Maastricht University Medical CenterRecruiting
Maastricht, Netherlands
DiakonessenhuisRecruiting
Utrecht, Netherlands
Maxima Medical Center - VeldhovenRecruiting
Veldhoven, Netherlands
Isala HospitalRecruiting
Zwolle, Netherlands
North Shore HospitalRecruiting
Auckland, New Zealand
Institute of Oncology LjubljanaRecruiting
Ljubljana, Slovenia
Sahlgrenska University HospitalRecruiting
Gothenburg, Sweden
Central Hospital KristianstadRecruiting
Kristianstad, Sweden
University Hospitals Birmingham NHS Foundation TrustRecruiting
Edgbaston, Birmingham, United Kingdom
Royal Cornwall Hospital NHS TrustRecruiting
Truro, Cornwall, United Kingdom
Hull University Teaching Hospitals NHS TrustRecruiting
Hull, East Yorkshire, United Kingdom
MID & South Essex NHS Foundation TrustRecruiting
Westcliff-on-Sea, Essex, United Kingdom
Lancashire Teaching Hospitals NHS Foundation TrustRecruiting
Preston, Lancashire, United Kingdom
Oxford University Hospitals NHS Foundation TrustRecruiting
Headington, Oxford, United Kingdom
Imperial College Healthcare NHS TrustRecruiting
London, The Bays, United Kingdom
Queen Victoria Hospital NHS Foundation TrustRecruiting
East Grinstead, West Sussex, United Kingdom
North Bristol NHS TrustRecruiting
Bristol, United Kingdom
Cambridge University Hospitals NHS Foundation TrustRecruiting
Cambridge, United Kingdom
The Leeds Teaching Hospitals NHS TrustRecruiting
Leeds, United Kingdom
St. Helens & Knowsley Teaching Hospitals NHS TrustRecruiting
Liverpool, United Kingdom
Royal Free London NHS Foundation TrustRecruiting
London, United Kingdom
Guy's and St Thomas's NHS Foundation Trust, of St Thomas' HospitalRecruiting
London, United Kingdom
St George's University Hospitals NHS Foundation TrustRecruiting
London, United Kingdom
The Royal Marsden Hospital NHS Foundation TrustRecruiting
London, United Kingdom
The Christie NHS Foundation TrustRecruiting
Manchester, United Kingdom
South Tees Hospitals NHS Foundation Trust of The James Cook University HospitalRecruiting
Middlesbrough, United Kingdom
Norfolk and Norwich University Hospital NHS TrustRecruiting
Norwich, United Kingdom
Nottingham University Hospitals, NHS Trust, Trust HQ, City HospitalRecruiting
Nottingham, United Kingdom
Melanoma Margins Trial-II: 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma · TrialPath