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)

Who is this study for? Patients with Cutaneous Melanoma
What treatments are being studied? Wide Local Excision
Status: Recruiting
Location: See all (192) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

∙ Patients may be included in the study if they meet ALL of the following criteria:

• 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.

• Must have a primary melanoma that is cutaneous (including head, neck, trunk, extremity, scalp, palm or sole).

• An uninterrupted 2cm margin must be technically feasible around biopsy scar or primary melanoma.

• 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.

• Patients must be 18 years or older at time of consent.

• Patient must be able to give informed consent and comply with the treatment protocol and follow up plan.

• Life expectancy of at least 5 years from the time of diagnosis, not considering the melanoma in question, as determined by the PI.

• Patients must have an ECOG performance score between 0 and 1 at screening.

• A survivor of prior cancer is eligible provided that ALL of the following criteria are met and documented:

‣ The patient has undergone potentially curative therapy for all prior malignancies,

⁃ There has been no evidence of recurrence of any prior malignancies for at least FIVE years (with the exception of successfully treated uterine/cervical or non-melanoma skin cancers (SCCs/BCCs) with no evidence of recurrence), and

⁃ The patient is deemed by their treating physician to be at low risk of recurrence from previous malignancies.

Locations
United States
Alabama
University of South Alabama Mitchell Cancer Institute
RECRUITING
Mobile
Arkansas
University of Arkansas for Medical Sciences
RECRUITING
Little Rock
Arizona
Banner MD Anderson Cancer Center
RECRUITING
Gilbert
Mayo Clinic Phoenix
RECRUITING
Phoenix
California
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
RECRUITING
Irvine
Los Angeles General Medical Center
RECRUITING
Los Angeles
Los Angeles General Medical Center
RECRUITING
Los Angeles
The Angeles (Cedars-Sinai Medical Center and its Affiliates)
RECRUITING
Los Angeles
USC Norris Comprehensive Cancer Center
RECRUITING
Los Angeles
USC Norris Comprehensive Cancer Center
RECRUITING
Los Angeles
UC Irvine Health - Chao Family Comprehensive Cancer Center
RECRUITING
Orange
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
RECRUITING
Orange
Stanford Cancer Institute
RECRUITING
Palo Alto
Huntington Memorial Hospital
RECRUITING
Pasadena
Stanford Cancer Center South Bay
RECRUITING
San Jose
Kaiser Permanente - Vallejo Medical Center
RECRUITING
Vallejo
Kaiser Permanente - Walnut Creek Medical Center
RECRUITING
Walnut Creek
Connecticut
Smilow Hospital Care Center, Guilford
RECRUITING
Guilford
Yale University
RECRUITING
New Haven
Washington, D.c.
MedStar Georgetown University Hospital
RECRUITING
Washington D.c.
MedStar Washington Hospital Center
RECRUITING
Washington D.c.
Florida
University of Miami Sylvester Comprehensive Cancer Center at Aventura
RECRUITING
Aventura
University of Miami Sylvester Comprehensive Cancer Center at Coral Gables
RECRUITING
Coral Gables
University of Miami Sylvester Cancer Center at Coral Springs
RECRUITING
Coral Springs
University of Miami Sylvester Comprehensive Center at Deerfield Beach
RECRUITING
Deerfield Beach
University of Miami Sylvester Comprehensive Center at Hollywood
RECRUITING
Hollywood
Baptist MD Anderson Cancer Center
RECRUITING
Jacksonville
Mayo Clinic in Florida
RECRUITING
Jacksonville
Lakeland Regional Health Hollis Cancer Center
RECRUITING
Lakeland
University of Miami Comprehensive Cancer Center at Kendall
RECRUITING
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Centre
RECRUITING
Miami
University of Miami Comprehensive Cancer Center at Plantation
RECRUITING
Plantation
Moffitt Cancer Center - McKinley Campus
RECRUITING
Tampa
Moffitt Cancer Center, Magnolia Campus
RECRUITING
Tampa
Georgia
Emory Saint Joseph's Hospital
RECRUITING
Atlanta
Emory University
RECRUITING
Atlanta
Emory University Hospital Midtown
RECRUITING
Atlanta
Northside Hospital Atlanta
RECRUITING
Atlanta
Northside Hospital Cancer Institute
NOT_YET_RECRUITING
Atlanta
Nancy N and JC Lewis Cancer & Research Pavilion St. Joseph's/Candler
RECRUITING
Savannah
Illinois
Advocate Illinois Masonic Medical Center
RECRUITING
Chicago
Northwestern Medicine Cancer Center Kishwaukee
RECRUITING
Dekalb
Northwestern University
RECRUITING
Evanston
Northwestern Medicine Cancer Center Delnor
RECRUITING
Geneva
Northwestern Medicine Cancer Center Lake Forest Hospital
RECRUITING
Lake Forest
Advocate Lutheran General Hospital
RECRUITING
Park Ridge
Northwestern Medicine Cancer Center Warrenville
RECRUITING
Warrenville
Indiana
Franciscan Health Indianapolis
RECRUITING
Indianapolis
Indiana University - Melvin and Bren Simon Cancer Center
RECRUITING
Indianapolis
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
RECRUITING
Indianapolis
Kansas
University of Kansas Hospital - Indian Creek Campus
RECRUITING
Overland Park
University of Kansas Hospital- Westwood Cancer Center
RECRUITING
Westwood
Kentucky
University of Kentucky
RECRUITING
Lexington
Maryland
MedStar Franklin Square Medical Center
RECRUITING
Baltimore
Michigan
University of Michigan Medical Center
RECRUITING
Ann Arbor
University of Michigan - Brighton Center for Specialty Care
RECRUITING
Brighton
Mercy Health Saint Mary's
RECRUITING
Grand Rapids
Spectrum Health at Butterworth Campus
RECRUITING
Grand Rapids
West Michigan Cancer Centre
RECRUITING
Kalamazoo
Missouri
Siteman Cancer Centre, Barnes Jewish West County
RECRUITING
Creve Coeur
University of Kansas Cancer Center
RECRUITING
Kansas City
Cox South Hospital
RECRUITING
Springfield
Washington University School of Medicine
RECRUITING
St Louis
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
Duke University Medical Center
RECRUITING
Durham
East Carolina University
RECRUITING
Greenville
University of North Carolina Hospitals - Hillsborough Campus
RECRUITING
Hillsborough
North Dakota
Sanford Broadway Medical Centre
RECRUITING
Fargo
Sanford Roger Maris Cancer Centre
RECRUITING
Fargo
Nebraska
Nebraska Medicine - Bellevue
RECRUITING
Bellevue
Nebraska Medicine-Village Pointe
RECRUITING
Omaha
University of Nebraska Medicine
RECRUITING
Omaha
New Jersey
Cooperman Barnabas Medical Center
RECRUITING
Livingston
Rutgers Cancer Institute of New Jersey
RECRUITING
Piscataway
New Mexico
Lovelace Medical Centre-Saint Joseph Square
RECRUITING
Albuquerque
Lovelace Women's Hospital
RECRUITING
Albuquerque
New York
Northwell Health Imbert Cancer Center
RECRUITING
Bay Shore
Roswell Park Cancer Institute
RECRUITING
Buffalo
Northwell Health/Center for Advanced Medicine
RECRUITING
Lake Success
NYU Langone Medical Center (Winthrop Hospital)
RECRUITING
Mineola
Northern Westchester Hospital
RECRUITING
Mount Kisco
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
RECRUITING
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
RECRUITING
New York
Vassar Brothers Medical Center
RECRUITING
Poughkeepsie
University of Rochester
RECRUITING
Rochester
Phelps Memorial Hospital Center
RECRUITING
Sleepy Hollow
State University of New York Upstate Medical Center-Community Campus
RECRUITING
Syracuse
State University of New York Upstate Medical University
RECRUITING
Syracuse
Wilmont Cancer Institute at Webster
RECRUITING
Webster
Ohio
University Hospitals Avon Health Center
RECRUITING
Avon
Miami Valley Hospital South
RECRUITING
Centerville
University Hospitals Geauga Medical Center
RECRUITING
Chardon
University of Cincinnati
RECRUITING
Cincinnati
University Hospitals Cleveland Medical Centre
RECRUITING
Cleveland
Ohio State University Comprehensive Cancer Center
RECRUITING
Columbus
University Hospitals Chagrin Highlands Medical Centre
RECRUITING
Orange
West Chester Hospital (OH394)
RECRUITING
West Chester
University Hospitals St. John Medical Center
RECRUITING
Westlake
Oklahoma
Mercy Health Center - Oncology Hematology
RECRUITING
Oklahoma City
OUHSC Stephenson Cancer Center
RECRUITING
Oklahoma City
Oregon
Kaiser Sunnyside Medical Center
RECRUITING
Clackamas
Kaiser Permanente Northwest - Oncology Clinic
RECRUITING
Portland
Pennsylvania
St. Luke's University Health Network - Allentown Cancer Center
RECRUITING
Allentown
St Luke's University Health Network, Bethlehem Campus
RECRUITING
Bethlehem
St Luke's University Health Network, Anderson Campus
RECRUITING
Easton
Fox Chase Cancer Center
RECRUITING
Philadelphia
St Luke's University Health Network Quakertown Campus
RECRUITING
Quakertown
St. Luke's University Health Network - Upper Bucks
RECRUITING
Quakertown
Guthrie Medical Group PC-Robert Packer Hospital
RECRUITING
Sayre
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
South Dakota
Sanford Cancer Center Oncology Clinic
RECRUITING
Sioux Falls
Sanford USD Medical Center - Sioux Falls
RECRUITING
Sioux Falls
Texas
The University of Texas MD Anderson Cancer Center
RECRUITING
Houston
University of Texas Health Science Center at San Antonio
RECRUITING
San Antonio
Utah
Intermountain Medical Center
RECRUITING
Murray
Huntsman Cancer Institute (The University of Utah)
RECRUITING
Salt Lake City
Virginia
University of Virginia Health System
RECRUITING
Charlottesville
VCU Massey Cancer Center Peninsula Cancer Institute
RECRUITING
Newport News
VCU Massey Cancer Center
RECRUITING
Richmond
Carilion Roanoke Memorial Hospital
RECRUITING
Roanoke
VCU Massey Cancer Center Affiliate Valley Health
RECRUITING
Winchester
Vermont
University of Vermont Medical Center
RECRUITING
Burlington
University of Vermount and Sate Agricultural College
RECRUITING
Burlington
Wisconsin
University of Winsconsin Carbone Cancer Center-Eastpark medical Center
RECRUITING
Madison
University of Wisconsin Carbone Cancer Center
RECRUITING
Madison
Marshfield Medical Center - Marshfield
RECRUITING
Marshfield
Aurora St Luke's Medical Center
RECRUITING
Milwaukee
Medical College of Wisconsin
RECRUITING
Milwaukee
Marshfield Medical Center- Weston
RECRUITING
Weston
Other Locations
Australia
Royal Adelaide Hospital
RECRUITING
Adelaide
Princess Alexandra Hospital
NOT_YET_RECRUITING
Brisbane
Calvary Public Hospital Bruce
RECRUITING
Bruce
The Canberra Hospital
NOT_YET_RECRUITING
Garran
Robina Hospital
NOT_YET_RECRUITING
Gold Coast
Peter MacCallum Cancer Centre
RECRUITING
Melbourne
The Alfred Hospital
RECRUITING
Melbourne
Melanoma Institute Australia
RECRUITING
Sydney
Royal Prince Alfred Hospital
RECRUITING
Sydney
Westmead Hospital
RECRUITING
Sydney
Canada
Royal Victoria Regional Health Centre
RECRUITING
Barrie
Tom Baker Cancer Centre
RECRUITING
Calgary
Hamilton Health Sciences Centre
RECRUITING
Hamilton
BCCA - Cancer Centre for the Southern Interior
RECRUITING
Kelowna
Oak Valley Health
RECRUITING
Markham
Centre Hospitalier de l'Universite de Montreal (CHUM)
RECRUITING
Montreal
Hopital Maisonneuve-Rosemont
RECRUITING
Montreal
Ottawa Hospital Research Institute
RECRUITING
Ottawa
Hotel-Dieu de Quebec
RECRUITING
Québec
Sunnybrook Health Sciences Centre
RECRUITING
Toronto
UHN - Princess Margaret Cancer Centre
RECRUITING
Toronto
CancerCare Manitoba
RECRUITING
Winnipeg
Ireland
Cork University Hospital
RECRUITING
Cork
Mater Misericordiae University Hospital
RECRUITING
Dublin
St James Hospital
RECRUITING
Dublin
Italy
IOV Istituto Oncologico Veneto IRCCS-Padova
NOT_YET_RECRUITING
Padua
Fondazione IRCCS Policlinico San Matteo
NOT_YET_RECRUITING
Pavia
AOU Città della Salute e della Scienza di Torino
NOT_YET_RECRUITING
Torino
Netherlands
Flevo Hospital
RECRUITING
Almere Stad
Ziekenhuis Gelderse Vallei
RECRUITING
Ede
Maxima Medical Centre, Eindhoven
RECRUITING
Eindhoven
University Medical Centre Groningen
RECRUITING
Groningen
Zuyderland Medical Center
RECRUITING
Heerlen
Maastricht University Medical Center
RECRUITING
Maastricht
Diakonessenhuis
RECRUITING
Utrecht
Maxima Medical Center - Veldhoven
RECRUITING
Veldhoven
Gelre Hospital
RECRUITING
Zutphen
Isala Hospital
RECRUITING
Zwolle
New Zealand
North Shore Hospital
RECRUITING
Auckland
Slovenia
Institute of Oncology Ljubljana
RECRUITING
Ljubljana
Sweden
Sahlgrenska University Hospital
RECRUITING
Gothenburg
Central Hospital Kristianstad
RECRUITING
Kristianstad
United Kingdom
North Bristol NHS Trust
RECRUITING
Bristol
Cambridge University Hospitals NHS Foundation Trust
RECRUITING
Cambridge
Queen Victoria Hospital NHS Foundation Trust
RECRUITING
East Grinstead
University Hospitals Birmingham NHS Foundation Trust
RECRUITING
Edgbaston
Oxford University Hospitals NHS Foundation Trust
RECRUITING
Headington
Hull University Teaching Hospitals NHS Trust
RECRUITING
Hull
The Leeds Teaching Hospitals NHS Trust
RECRUITING
Leeds
St. Helens & Knowsley Teaching Hospitals NHS Trust
RECRUITING
Liverpool
Guy's and St Thomas's NHS Foundation Trust, of St Thomas' Hospital
RECRUITING
London
Imperial College Healthcare NHS Trust
RECRUITING
London
Royal Free London NHS Foundation Trust
RECRUITING
London
St George's University Hospitals NHS Foundation Trust
RECRUITING
London
The Royal Marsden Hospital NHS Foundation Trust
RECRUITING
London
The Christie NHS Foundation Trust
RECRUITING
Manchester
South Tees Hospitals NHS Foundation Trust of The James Cook University Hospital
RECRUITING
Middlesbrough
Norfolk and Norwich University Hospital NHS Trust
RECRUITING
Norwich
Nottingham University Hospitals, NHS Trust, Trust HQ, City Hospital
RECRUITING
Nottingham
Lancashire Teaching Hospitals NHS Foundation Trust
RECRUITING
Preston
Royal Cornwall Hospital NHS Trust
RECRUITING
Truro
MID & South Essex NHS Foundation Trust
RECRUITING
Westcliff-on-sea
Contact Information
Primary
Melanoma and Skin Cancer Trials Coordinator
melmart@masc.org.au
+61 3 9903 9022
Time Frame
Start Date: 2019-12-17
Estimated Completion Date: 2034-12-31
Participants
Target number of participants: 2998
Treatments
Experimental: Arm A (Wide Local Excision = 1cm Margin)
1cm Wide Local Excision margin + Sentinel Lymph Node Biopsy +/- Reconstruction
Active_comparator: Arm B (Wide Local Excision = 2cm Margin)
2 cm Wide Local Excision margin + Sentinel Lymph Node Biopsy +/- Reconstruction
Related Therapeutic Areas
Sponsors
Collaborators: Norfolk and Norwich University Hospitals NHS Foundation Trust, Canadian Cancer Trials Group, Zuyderland Medical Centre, Cancer Trials Ireland
Leads: Melanoma and Skin Cancer Trials Limited

This content was sourced from clinicaltrials.gov