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

November 25, 2024 updated by: Melanoma and Skin Cancer Trials Limited

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

2998

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Melanoma and Skin Cancer Trials Coordinator
  • Phone Number: +61 3 9903 9022
  • Email: melmart@masc.org.au

Study Locations

  • Australia
    • Australian Capital Territory
      • Bruce, Australian Capital Territory, Australia, 2617
        • Recruiting
        • Calvary Public Hospital Bruce
        • Contact:
          • Dr Rebecca Read
        • Principal Investigator:
          • Dr Rebecca Read
      • Garran, Australian Capital Territory, Australia, 2605
        • Not yet recruiting
        • The Canberra Hospital
        • Contact:
          • Emily Baxter
        • Principal Investigator:
          • Dr Krishna Rao
    • New South Wales
      • Sydney, New South Wales, Australia, 2145
      • Sydney, New South Wales, Australia
        • Recruiting
        • Melanoma Institute Australia
        • Contact:
          • Andrew Spillane
        • Principal Investigator:
          • Prof Andrew Spillane
      • Sydney, New South Wales, Australia
        • Recruiting
        • Royal Prince Alfred Hospital
        • Contact:
          • Robyn Saw
        • Principal Investigator:
          • A/Prof Robyn Saw
    • Queensland
      • Brisbane, Queensland, Australia, 4102
        • Not yet recruiting
        • Princess Alexandra Hospital
        • Contact:
          • Prof Mark Smithers
        • Principal Investigator:
          • Prof Mark Smithers
      • Gold Coast, Queensland, Australia, 4226
        • Not yet recruiting
        • Robina Hospital
        • Contact:
          • Dr Jennifer Chang
        • Principal Investigator:
          • Dr Jennifer Chang
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Royal Adelaide Hospital
        • Contact:
        • Principal Investigator:
          • Robert Whitfield, MD
    • Victoria
      • Melbourne, Victoria, Australia
        • Recruiting
        • Peter MacCallum Cancer Centre
        • Contact:
          • Michael Henderson
        • Principal Investigator:
          • Prof Michael Henderson
        • Sub-Investigator:
          • A/Prof David Gyorki
      • Melbourne, Victoria, Australia
        • Recruiting
        • The Alfred Hospital
        • Contact:
          • Dr Frank Bruscino-Raiola
        • Principal Investigator:
          • Dr Frank Bruscino-Raiola
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Recruiting
        • Tom Baker Cancer Centre
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • Recruiting
        • BCCA - Cancer Centre for the Southern Interior
        • Contact:
        • Principal Investigator:
          • Christopher Baliski
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • Recruiting
        • CancerCare Manitoba
        • Contact:
          • Justin Rivard, Dr
          • Phone Number: 204-787-4156
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • Recruiting
        • Royal Victoria Regional Health Centre
        • Contact:
        • Contact:
          • Dr. Renee Hanrahan
        • Principal Investigator:
          • Dr. Renee Hanrahan
      • Hamilton, Ontario, Canada, L8V 1C3
        • Recruiting
        • Hamilton Health Sciences Centre
        • Contact:
          • Dr. Valerie Francescutti
          • Phone Number: 905-387-9495
        • Principal Investigator:
          • Dr. Valerie Francescutti
      • Markham, Ontario, Canada, L3P 7P3
        • Recruiting
        • Oak Valley Health
        • Contact:
        • Principal Investigator:
          • Jennifer Zhirui Li
      • Ottawa, Ontario, Canada, K1Y 4E9
        • Recruiting
        • Ottawa Hospital Research Institute
        • Contact:
        • Principal Investigator:
          • Dr. Carolyn Nessim
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Health Sciences Centre
        • Contact:
          • Dr Frances Wright
          • Phone Number: 416-480-4210
        • Principal Investigator:
          • Dr Frances Wright
      • Toronto, Ontario, Canada, M5G 2C1
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Recruiting
        • Hôpital Maisonneuve-Rosemont
        • Contact:
          • Audrey Lamoureux
          • Phone Number: 6258 514-252-3400
        • Contact:
          • Leïla Idrissi Kaïtouni
          • Phone Number: 5853 514-252-3400
        • Principal Investigator:
          • Dr. Mai-Kim Gervais
      • Montréal, Quebec, Canada, H2X 3E4
        • Recruiting
        • Centre Hospitalier de l'Universite de Montreal (CHUM)
        • Contact:
          • Kerianne Boulva
        • Principal Investigator:
          • Kerianna Boulva
      • Québec City, Quebec, Canada, G1R2J6
  • Ireland
      • Cork, Ireland
        • Recruiting
        • Cork University Hospital
        • Contact:
          • Prof Jim Clover, BMEd Sci,BM BS,MRCS,MD,FFERCS
          • Phone Number: 0214922575
      • Dublin, Ireland, D07 R2WY
        • Recruiting
        • Mater Misericordiae University Hospital
        • Contact:
        • Principal Investigator:
          • Shirley Potter
      • Dublin, Ireland, D08 NHY1
        • Recruiting
        • St James Hospital
        • Contact:
        • Principal Investigator:
          • Marlese Dempsey
  • Italy
      • Padova, Italy, 35128
        • Not yet recruiting
        • IOV Istituto Oncologico Veneto IRCCS-Padova
        • Contact:
          • Romina Spina
        • Principal Investigator:
          • Dr Simone Mocellin
      • Pavia, Italy, 27100
        • Not yet recruiting
        • Fondazione IRCCS Policlinico San Matteo
        • Contact:
          • Alessandra Ferrari
        • Principal Investigator:
          • Prof Alessandro Testori
      • Torino, Italy, 10126
        • Not yet recruiting
        • AOU Città della salute e della scienza di Torino
        • Contact:
          • Valentina Pala
        • Principal Investigator:
          • Dr. Franco Picciotto
  • Netherlands
      • Groningen, Netherlands, 9713
        • Recruiting
        • University Medical Centre Groningen
        • Contact:
        • Principal Investigator:
          • Barbara Leeuwen
      • Heerlen, Netherlands, 6419
        • Recruiting
        • Zuyderland Medical Center
        • Contact:
          • James van Bastelaar, Dr
      • Maastricht, Netherlands, 6229 HX
        • Recruiting
        • Maastricht University Medical Center
        • Contact:
        • Principal Investigator:
          • Kevin Wevers
      • Utrecht, Netherlands, 3582 KE
        • Recruiting
        • Diakonessenhuis
        • Contact:
          • Barbara Molenkamp
        • Principal Investigator:
          • Barbara Molenkamp
      • Veldhoven, Netherlands, 5504
        • Recruiting
        • Maxima Medical Center - Veldhoven
        • Contact:
          • Sabrina Maaskant
        • Principal Investigator:
          • Sabrina Maaskant
      • Zwolle, Netherlands, 8025
        • Recruiting
        • Isala Hospital
        • Contact:
          • Anne-Brecht Francken
        • Principal Investigator:
          • Anne-Brecht Francken
    • Flevoland
      • Almere, Flevoland, Netherlands
    • Gelderland
      • Ede, Gelderland, Netherlands, 6716 RP
        • Recruiting
        • Ziekenhuis Gelderse Vallei
        • Contact:
        • Principal Investigator:
          • Miriam L Hoven-Gondrie
      • Zutphen, Gelderland, Netherlands, 7207 AE
        • Recruiting
        • Gelre Hospital
        • Contact:
        • Principal Investigator:
          • Dominique van Uden, MD
    • Noord-Brabant
      • Eindhoven, Noord-Brabant, Netherlands, 5631
        • Recruiting
        • Maxima Medical Centre, Eindhoven
        • Contact:
          • Sabrina Maaskant
        • Principal Investigator:
          • Sabrina Maaskant
  • New Zealand
      • Auckland, New Zealand, 0620
        • Recruiting
        • North Shore Hospital
        • Contact:
          • Dr Richard Martin
        • Principal Investigator:
          • Dr Richard Martin
  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Recruiting
        • Institute of Oncology Ljubljana
        • Contact:
          • Barbara Peric, MD, PhD
        • Principal Investigator:
          • Barbara Peric, MD, PhD
  • Sweden
      • Gothenburg, Sweden
        • Recruiting
        • Sahlgrenska University Hospital
        • Contact:
        • Principal Investigator:
          • Prof Roger Olofsson Bagge
      • Kristianstad, Sweden, 29133
        • Recruiting
        • Central Hospital Kristianstad
        • Contact:
        • Principal Investigator:
          • Dr Karolin Isaksson
  • United Kingdom
      • Bristol, United Kingdom, BS10 5NB
      • Cambridge, United Kingdom, CB2 0QQ
        • Recruiting
        • Cambridge University Hospitals NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Amit Roshan
      • Leeds, United Kingdom, LS9 7TF
        • Recruiting
        • The Leeds Teaching Hospitals Nhs Trust
        • Contact:
      • Liverpool, United Kingdom
      • London, United Kingdom, NW3 2QG
        • Recruiting
        • Royal Free London NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Steven Hamilton
      • London, United Kingdom, SE1 7EH
        • Recruiting
        • Guy's and St Thomas's NHS Foundation Trust, of St Thomas' Hospital
        • Contact:
      • London, United Kingdom, SW17 0QT
      • London,, United Kingdom, SW3 6JJ
      • Manchester, United Kingdom, M20 4BX
        • Recruiting
        • The Christie NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Deemesh Oudit
      • Middlesbrough, United Kingdom, TS4 3BW
        • Recruiting
        • South Tees Hospitals NHS Foundation Trust of The James Cook University Hospital
        • Contact:
      • Norwich, United Kingdom, NR47UY
        • Recruiting
        • Norfolk and Norwich University Hospital NHS Trust
        • Contact:
          • Professor Marc Moncrieff
        • Principal Investigator:
          • Professor Marc Moncrieff
      • Nottingham, United Kingdom, NG5 1PB
        • Recruiting
        • Nottingham University Hospitals, NHS Trust, Trust HQ, City Hospital
        • Contact:
    • Birmingham
      • Edgbaston, Birmingham, United Kingdom, B15 2TH
        • Recruiting
        • University Hospitals Birmingham NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Agustin Martin-Clavijo
    • Cornwall
      • Truro, Cornwall, United Kingdom, TR1 3LJ
        • Recruiting
        • Royal Cornwall Hospital NHS Trust
        • Contact:
        • Principal Investigator:
          • Polly King
    • East Yorkshire
      • Hull, East Yorkshire, United Kingdom, HU3 2JZ
        • Recruiting
        • Hull University Teaching Hospitals NHS Trust
        • Contact:
        • Principal Investigator:
          • Paolo Matteucci
    • Essex
      • Westcliff on Sea, Essex, United Kingdom, SS0 0RY
        • Recruiting
        • Mid & South Essex NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Peter Dziewulski
    • Lancashire
      • Preston, Lancashire, United Kingdom, PR2 9HT
        • Recruiting
        • Lancashire Teaching Hospitals NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Richard Wain
    • Oxford
      • Headington, Oxford, United Kingdom, OX3 9DU
        • Recruiting
        • Oxford University Hospitals NHS Foundation Trust
        • Contact:
          • oliver cassell
        • Contact:
        • Principal Investigator:
          • oliver cassell
    • The Bays
      • London, The Bays, United Kingdom, W2 1NY
    • West Sussex
      • East Grinstead, West Sussex, United Kingdom, RH19 3DZ
        • Recruiting
        • Queen Victoria Hospital NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Siva Kumar
  • United States
    • Alabama
    • Arizona
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • University of Arkansas for Medical Sciences
        • Principal Investigator:
          • Michail Mavros
        • Contact:
    • California
      • Irvine, California, United States, 92868
        • Recruiting
        • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
        • Contact:
          • Maki Yamamoto, MD
        • Principal Investigator:
          • Maki Yamamoto, MD
      • Los Angeles, California, United States, 90033
        • Recruiting
        • USC Norris Comprehensive Cancer Center
        • Principal Investigator:
          • Gino In, MD
        • Contact:
      • Los Angeles, California, United States, 90048-1804
        • Recruiting
        • The Angeles (Cedars-Sinai Medical Center and its Affiliates)
        • Contact:
          • Dr Mark Faries
        • Principal Investigator:
          • Dr Mark Faries
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Los Angeles General Medical Center
        • Principal Investigator:
          • Gino In, MD
        • Contact:
      • Orange, California, United States, 92868
        • Recruiting
        • UC Irvine Health - Chao Family Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Jeremy Harris
      • Orange, California, United States, 92868
        • Recruiting
        • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
        • Principal Investigator:
          • Maki Yamamoto
        • Contact:
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford Cancer Institute
        • Contact:
        • Contact:
      • Pasadena, California, United States, 91105
      • San Jose, California, United States, 95124
        • Recruiting
        • Stanford Cancer Center South Bay
        • Contact:
          • Amanda Kirane
        • Principal Investigator:
          • Amanda Kirane
      • Vallejo, California, United States, 94589
      • Walnut Creek, California, United States, 94596
    • Connecticut
      • Guilford, Connecticut, United States, 06437
        • Recruiting
        • Smilow Hospital Care Center, Guilford
        • Contact:
        • Principal Investigator:
          • James Clune
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale University
        • Contact:
        • Principal Investigator:
          • James Clune
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
      • Washington, District of Columbia, United States, 20007
    • Florida
      • Aventura, Florida, United States, 33180
        • Recruiting
        • University of Miami Sylvester Comprehensive Cancer Center at Aventura
        • Contact:
        • Principal Investigator:
          • Jessica S Crystal
      • Coral Gables, Florida, United States, 33146
        • Recruiting
        • University of Miami Sylvester Comprehensive Cancer Center at Coral Gables
        • Contact:
        • Principal Investigator:
          • Jessica S Crystal
      • Coral Springs, Florida, United States, 33065
        • Recruiting
        • University of Miami Sylvester Cancer Center at Coral Springs
        • Contact:
        • Principal Investigator:
          • Jessica S Crystal
      • Deerfield Beach, Florida, United States, 33442
        • Recruiting
        • University of Miami Sylvester Comprehensive Center at Deerfield Beach
        • Contact:
        • Principal Investigator:
          • Jessica S Crystal
      • Hollywood, Florida, United States, 33021
        • Recruiting
        • University of Miami Sylvester Comprehensive Center at Hollywood
        • Contact:
        • Principal Investigator:
          • Jessica S Crystal
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic in Florida
        • Contact:
        • Principal Investigator:
          • James W Jakub
      • Jacksonville, Florida, United States, 32207
      • Lakeland, Florida, United States, 33805
        • Recruiting
        • Lakeland Regional Health Hollis Cancer Center
        • Contact:
        • Principal Investigator:
          • Manuel Molina
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Miller School of Medicine-Sylvester Cancer Centre
        • Contact:
        • Principal Investigator:
          • Jessica S Crystal
      • Miami, Florida, United States, 33176
        • Recruiting
        • University of Miami Comprehensive Cancer Center at Kendall
        • Contact:
        • Principal Investigator:
          • Jessica S Crystal
      • Plantation, Florida, United States, 33324
        • Recruiting
        • University of Miami Comprehensive Cancer Center at Plantation
        • Contact:
        • Principal Investigator:
          • Jessica S Crystal
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center - McKinley Campus
        • Contact:
        • Principal Investigator:
          • Jonathan Zager
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center, Magnolia Campus
        • Contact:
        • Principal Investigator:
          • Jonathan Zager
    • Georgia
      • Atlanta, Georgia, United States, 30308
      • Atlanta, Georgia, United States, 30342
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University
        • Contact:
          • Dr Michael Lowe
        • Principal Investigator:
          • Dr Michael Lowe
        • Principal Investigator:
          • Professor Keith Delman
      • Atlanta, Georgia, United States, 30342
      • Atlanta, Georgia, United States, 30342
        • Not yet recruiting
        • Northside Hospital Cancer Institute
        • Contact:
          • Margaret Ferreira
        • Contact:
          • Dr. Nicole Kounalakis
        • Principal Investigator:
          • Dr. Nicole Kounalakis
      • Savannah, Georgia, United States, 31405
        • Recruiting
        • Nancy N and JC Lewis Cancer & Research Pavilion St. Joseph's/Candler
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yana Puckett, MD
    • Illinois
      • Chicago, Illinois, United States, 60657
        • Recruiting
        • Advocate Illinois Masonic Medical Center
        • Principal Investigator:
          • Sigrun Hallmeyer
        • Contact:
      • DeKalb, Illinois, United States, 60115
        • Recruiting
        • Northwestern Medicine Cancer Center Kishwaukee
        • Contact:
        • Principal Investigator:
          • Jeffrey Wayne
      • Evanston, Illinois, United States, 60208
        • Recruiting
        • Northwestern University
        • Contact:
        • Principal Investigator:
          • Jeffrey Wayne
      • Geneva, Illinois, United States, 60134
        • Recruiting
        • Northwestern Medicine Cancer Center Delnor
        • Contact:
        • Principal Investigator:
          • Jeffrey Wayne
      • Lake Forest, Illinois, United States, 60045
        • Recruiting
        • Northwestern Medicine Cancer Center Lake Forest Hospital
        • Contact:
        • Principal Investigator:
          • Jeffrey Wayne
      • Park Ridge, Illinois, United States, 60068
      • Warrenville, Illinois, United States, 60555
        • Recruiting
        • Northwestern Medicine Cancer Center Warrenville
        • Contact:
        • Principal Investigator:
          • Jeffrey Wayne
    • Indiana
      • Indianapolis, Indiana, United States, 46237
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Melvin and Bren Simon Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Karl Bilimoria
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University - Melvin and Bren Simon Cancer Center
        • Contact:
          • Karl Bilimoria, MD
        • Contact:
        • Principal Investigator:
          • Karl Bilimoria, MD
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Recruiting
        • University of Kansas Hospital - Indian Creek Campus
        • Contact:
        • Principal Investigator:
          • Luke Selby
      • Westwood, Kansas, United States, 66205
        • Recruiting
        • University of Kansas Hospital- Westwood Cancer Center
        • Contact:
        • Principal Investigator:
          • Luke Selby
    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • Recruiting
        • University Of Kentucky
        • Contact:
        • Principal Investigator:
          • Erin Burke
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Recruiting
        • MedStar Franklin Square Medical Center
        • Contact:
        • Principal Investigator:
          • Edward McCarron
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Medical Center
        • Contact:
        • Principal Investigator:
          • Christina Angeles
      • Brighton, Michigan, United States, 48116
        • Recruiting
        • University of Michigan - Brighton Center for Specialty Care
        • Contact:
        • Principal Investigator:
          • Christina Angeles
      • Grand Rapids, Michigan, United States, 49503
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Spectrum Health at Butterworth Campus
        • Contact:
        • Principal Investigator:
          • Kathleen Yost
      • Kalamazoo, Michigan, United States, 49007
        • Recruiting
        • West Michigan Cancer Centre
        • Contact:
        • Principal Investigator:
          • Kathleen Yost
    • Missouri
      • Creve Coeur, Missouri, United States, 63141
        • Recruiting
        • Siteman Cancer Centre, Barnes Jewish West County
        • Contact:
        • Principal Investigator:
          • Ryan Fields
      • Kansas City, Missouri, United States, 64154
        • Recruiting
        • University of Kansas Cancer Center
        • Contact:
        • Principal Investigator:
          • Luke Selby
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
        • Principal Investigator:
          • Ryan Fields
      • Springfield, Missouri, United States, 65807
        • Recruiting
        • Cox South Hospital
        • Contact:
          • Srikant Nannapaneni
        • Principal Investigator:
          • Srikant Nannapaneni
    • Nebraska
      • Bellevue, Nebraska, United States, 68123
        • Recruiting
        • Nebraska Medicine - Bellevue
        • Contact:
        • Principal Investigator:
          • Bradley Reames
      • Omaha, Nebraska, United States, 68118
        • Recruiting
        • Nebraska Medicine-Village Pointe
        • Contact:
        • Principal Investigator:
          • Bradley Reames
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska medicine
        • Contact:
        • Principal Investigator:
          • Bradley Reames
    • New Jersey
      • Livingston, New Jersey, United States, 07039
        • Recruiting
        • Cooperman Barnabas Medical Center
        • Contact:
        • Principal Investigator:
          • Adam Berger
      • Piscataway, New Jersey, United States, 08854
        • Recruiting
        • Rutgers Cancer Institute of New Jersey
        • Contact:
          • Professor Adam Berger
        • Principal Investigator:
          • Professor Adam Berger
    • New Mexico
      • Albuquerque, New Mexico, United States, 87110
        • Recruiting
        • Lovelace Medical Centre-Saint Joseph Square
        • Contact:
      • Albuquerque, New Mexico, United States, 87110
        • Recruiting
        • Lovelace Women's Hospital
        • Contact:
        • Principal Investigator:
          • Bridget Fahy, MD
    • New York
      • Bay Shore, New York, United States, 11706
      • Buffalo, New York, United States, 14203
      • Lake Success, New York, United States, 11042
      • Mineola, New York, United States, 11501
      • Mount Kisco, New York, United States, 10549
        • Recruiting
        • Northern Westchester Hospital
        • Contact:
        • Principal Investigator:
          • Alan Kadison
      • New York, New York, United States, 10032
        • Recruiting
        • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
        • Principal Investigator:
          • Bret Taback
        • Contact:
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Associate Professor Danielle Bello
        • Principal Investigator:
          • Associate Professor Danielle Bello
      • New York, New York, United States, 10016
        • Recruiting
        • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
        • Contact:
        • Principal Investigator:
          • Erica Friedman
      • Poughkeepsie, New York, United States, 12601
      • Rochester, New York, United States, 14642
      • Sleepy Hollow, New York, United States, 10591
        • Recruiting
        • Phelps Memorial Hospital Center
        • Contact:
        • Principal Investigator:
          • Alan Kadison
      • Syracuse, New York, United States, 13210
        • Recruiting
        • State University of New York Upstate Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Daniel Thomas, MD
      • Syracuse, New York, United States, 13215
        • Recruiting
        • State University of New York Upstate Medical Center-Community Campus
        • Contact:
        • Contact:
        • Principal Investigator:
          • Daniel Thomas, MD
      • Webster, New York, United States, 14580
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina at Chapel Hill
        • Contact:
        • Principal Investigator:
          • David W Ollila
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Principal Investigator:
          • Jay Lee
        • Contact:
      • Greenville, North Carolina, United States, 27858
        • Recruiting
        • East Carolina University
        • Contact:
        • Principal Investigator:
          • Nasreen Vohra
      • Hillsborough, North Carolina, United States, 27278
        • Recruiting
        • University of North Carolina Hospitals - Hillsborough Campus
        • Contact:
        • Principal Investigator:
          • David Ollila
    • North Dakota
      • Fargo, North Dakota, United States, 58102
      • Fargo, North Dakota, United States, 58102
    • Ohio
      • Avon, Ohio, United States, 44011
        • Recruiting
        • University Hospitals Avon Health Center
        • Contact:
        • Principal Investigator:
          • Luke Rothermel
      • Centerville, Ohio, United States, 45459
        • Recruiting
        • Miami Valley Hospital South
        • Contact:
        • Principal Investigator:
          • James Ouellette
      • Chardon, Ohio, United States, 44024
        • Recruiting
        • University Hospitals Geauga Medical Center
        • Contact:
        • Principal Investigator:
          • Luke Rothermel
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati
        • Contact:
        • Principal Investigator:
          • Jeffrey Sussman
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Centre
        • Contact:
        • Principal Investigator:
          • Luke Rothermel
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Joal Joal
      • Orange Village, Ohio, United States, 44122
        • Recruiting
        • University Hospitals Chagrin Highlands Medical Centre
        • Contact:
        • Principal Investigator:
          • Luke Rothermel
      • West Chester, Ohio, United States, 45069
        • Recruiting
        • West Chester Hospital (OH394)
        • Contact:
        • Principal Investigator:
          • Jeffrey Sussman
      • Westlake, Ohio, United States, 44145
        • Recruiting
        • University Hospitals St. John Medical Center
        • Contact:
        • Principal Investigator:
          • Luke Rothermel
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • OUHSC Stephenson Cancer Center
        • Contact:
        • Principal Investigator:
          • William Dooley
      • Oklahoma City, Oklahoma, United States, 73120-8362
    • Oregon
      • Clackamas, Oregon, United States, 97015
        • Recruiting
        • Kaiser Sunnyside Medical Center
        • Contact:
        • Principal Investigator:
          • Sandeep Mashru
      • Portland, Oregon, United States, 97227
        • Recruiting
        • Kaiser Permanente Northwest - Oncology Clinic
        • Contact:
        • Principal Investigator:
          • Sandeep Mashru
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Recruiting
        • St. Luke's University Health Network - Allentown Cancer Center
        • Principal Investigator:
          • Darius Desai, MD
        • Contact:
        • Contact:
      • Bethlehem, Pennsylvania, United States, 18015
        • Recruiting
        • St Luke's University Health Network, Bethlehem Campus
        • Contact:
        • Principal Investigator:
          • Darius Desai
      • Easton, Pennsylvania, United States, 18045
        • Recruiting
        • St Luke's University Health Network, Anderson Campus
        • Contact:
        • Principal Investigator:
          • Darius Desai
      • Philadelphia, Pennsylvania, United States, 19111
        • Recruiting
        • Fox Chase Cancer Center
        • Contact:
          • Dr Stephanie Greco
        • Principal Investigator:
          • Dr Stephanie Greco
      • Quakertown, Pennsylvania, United States, 18951
        • Recruiting
        • St Luke's University Health Network Quakertown Campus
        • Contact:
        • Principal Investigator:
          • Darius Desai
      • Quakertown, Pennsylvania, United States, 18951
      • Sayre, Pennsylvania, United States, 18840
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • Andrea Abbott
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105,
      • Sioux Falls, South Dakota, United States, 57105,
        • Recruiting
        • Sanford USD Medical Center - Sioux Falls
        • Contact:
        • Principal Investigator:
          • Daniel Almquist, MD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas MD Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Jeffrey Gershenwald
      • San Antonio, Texas, United States, 78284-7884
        • Recruiting
        • University of Texas Health Science Center at San Antonio
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fedrico Tozzi, MD
    • Utah
      • Murray, Utah, United States, 84157
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute (The University of Utah)
        • Contact:
          • Professor John Hynstrom
        • Principal Investigator:
          • Professor John Hynstrom
    • Vermont
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • University of Virginia Health System
        • Contact:
        • Principal Investigator:
          • Lynn Dengel
      • Newport News, Virginia, United States, 23601
        • Recruiting
        • VCU Massey Cancer Center Peninsula Cancer Institute
        • Contact:
        • Principal Investigator:
          • Giao Phan
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Vcu Massey Cancer Center
        • Contact:
        • Principal Investigator:
          • Giao Phan
      • Roanoke, Virginia, United States, 24014
      • Winchester, Virginia, United States, 22601
        • Recruiting
        • VCU Massey Cancer Center Affiliate Valley Health
        • Contact:
        • Principal Investigator:
          • Giao Phan
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin Carbone Cancer Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Heather Neuman
      • Madison, Wisconsin, United States, 53718
        • Recruiting
        • University of Winsconsin Carbone Cancer Center-Eastpark medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Heather Neuman, MD
      • Marshfield, Wisconsin, United States, 54449
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jennifer Bruening
      • Milwaukee, Wisconsin, United States, 53215
        • Recruiting
        • Aurora St Luke's Medical Center
        • Principal Investigator:
          • Sigrun Hallmeyer
        • Contact:
      • Weston, Wisconsin, United States, 54476
        • Recruiting
        • Marshfield Medical Center- Weston
        • Contact:
        • Principal Investigator:
          • Rohit Sharma, sharma.rohit@marshfieldclinic.

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A (Wide Local Excision = 1cm Margin)
1cm Wide Local Excision margin + Sentinel Lymph Node Biopsy +/- Reconstruction
Procedure: Wide 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.
Active Comparator: Arm B (Wide Local Excision = 2cm Margin)
2 cm Wide Local Excision margin + Sentinel Lymph Node Biopsy +/- Reconstruction
Procedure: Wide 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-Free Survival
Time Frame: 0-60 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Melanoma-Specific Survival
Time Frame: Day 0-Trial Completion (max. 120 months)
Time from randomisation to death due to melanoma
Day 0-Trial Completion (max. 120 months)
Overall Survival
Time Frame: Day 0-Trial Completion (max. 120 months)
Time from randomisation to death from any cause
Day 0-Trial Completion (max. 120 months)
Melanoma-specific Quality of Life: FACT-M questionnaire
Time Frame: Baseline, 3, 6, 12 & 24 months
Measured by FACT-M (Functional Assessment of Cancer Therapy - Melanoma) questionnaire - It consists of two subsections: The FACT-G subsection is a 27-item compilation of general questions divided into four primary QOL domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. It is considered appropriate for use with patients with any form of cancer. The Melanoma Surgery Subscale evaluates melanoma-specific symptoms such as surgical morbidity and side effects.
Baseline, 3, 6, 12 & 24 months
Neuropathic Pain: PainDetect questionnaire
Time Frame: Baseline, 3, 6, 12 & 24 months
Measured by PainDetect questionnaire
Baseline, 3, 6, 12 & 24 months
Health-related Quality of Life: EQ-5D-5L questionnaire
Time Frame: Baseline, 3, 6, 12 & 24 months
Measured by EuroQoL EQ-5D-5L questionnaire - This tool contains 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Baseline, 3, 6, 12 & 24 months
Health Economic Evaluation
Time Frame: Baseline, 3, 6, 12 & 24 months
Data collected for economic analysis will be from hospital notes, MBS and PBS data (Australia) and patient reported outcome measures (including an employment questionnaire) at baseline, 3, 6, 12 and 24 months and at melanoma recurrence.
Baseline, 3, 6, 12 & 24 months
Local Recurrence
Time Frame: Day 0-Trial Completion (max. 120 months)
Time from randomisation to any clinically, histologically or radiologically confirmed LR of melanoma including satellite lesions and in transit metastases between the primary site and the regional draining lymph nodes or death from any cause.
Day 0-Trial Completion (max. 120 months)
Distant Disease-Free Survival
Time Frame: Day 0-Trial Completion (max. 120 months)
Time from randomisation to any clinically, histologically or radiologically confirmed distant recurrence of melanoma or death from any cause
Day 0-Trial Completion (max. 120 months)
Surgery Related Adverse Events
Time Frame: Up to 12-months from the date of surgery

The following surgical-related adverse events will be recorded from the time of surgery to 12-months following surgery (inclusive):

  • wound dehiscence
  • seroma/haematoma
  • haemorrhage
  • infection
  • skin graft failure
  • necrosis of flap used for reconstruction
  • deep venous thrombosis
  • urinary tract infection
  • pneumonia
  • cardiac complications
  • lymphoedema
Up to 12-months from the date of surgery
Serious Adverse Events
Time Frame: from randomisation up to 12-months post-surgery
All Serious Adverse events (SAEs), will be recorded from randomisation until 12 months post the surgical intervention or until the patient withdraws or dies.
from randomisation up to 12-months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Melanoma and Skin Cancer Trials Limited

Collaborators

Norfolk and Norwich University Hospitals NHS Foundation Trust
Canadian Cancer Trials Group
Cancer Trials Ireland
Zuyderland Medical Centre

Investigators

  • Study Chair: Michael Henderson, Peter MacCallum Cancer Centre, Australia
  • Study Chair: Marc Moncrieff, 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 Major Dates

Study Start (Actual)

December 17, 2019

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2034

Study Registration Dates

First Submitted

February 7, 2019

First Submitted That Met QC Criteria

March 1, 2019

First Posted (Actual)

March 4, 2019

Study Record Updates

Last Update Posted (Actual)

November 27, 2024

Last Update Submitted That Met QC Criteria

November 25, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02.18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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