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NCT03860883NARecruiting

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

Melanoma and Skin Cancer Trials Limited

Start Date

12/17/2019

Completion Date

12/31/2034

Summary

Patients with a primary invasive melanoma are recommended to undergo excision of the primary lesion with a wide margin. There is evidence that less radical margins of excision may be just as safe. This is a randomised controlled trial of 1 cm versus 2 cm margin of excision of the primary lesion for adult patients with stage II primary invasive cutaneous melanomas (AJCC 8th edition) to determine differences in disease-free survival. A reduction in margins is expected to improve patient quality of life.

Detailed Description

This study will determine whether there is a difference in disease-free survival rates for patients with primary cutaneous melanoma with Breslow thickness \> 2mm or 1-2mm with ulceration (pT2b-pT4b, AJCC 8th edition), treated with either a 1cm excision margin or 2cm margin. The study is designed to be able to prove or disprove that there is no difference in risk of the tumour recurring around the scar or anywhere else in the body between the two groups of patients. If the study shows no risk of tumour recurrence then we will also be able to determine how much of an impact the narrower excision has on patients in terms of improved quality of life and reduced side effects from the surgery and melanoma disease. This trial will also evaluate and determine the economic impact of narrower excision margins on the health services and society in general.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

PROCEDURE

Wide Local Excision = 1cm Margin

PROCEDURE

Wide Local Excision = 2cm Margin

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Conditions

Cutaneous Melanoma, Stage II

Locations

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 D.C., District of Columbia 20007

United States

MedStar Washington Hospital Center

Washington D.C., 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

Cox South Hospital

Springfield, Missouri 65807

United States

Washington University School of Medicine

St Louis, Missouri 63110

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, 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

Calvary Public Hospital Bruce

Bruce, Australian Capital Territory 2617

Australia

The Canberra Hospital

Garran, Australian Capital Territory 2605

Australia

Westmead Hospital

Sydney, New South Wales 2145

Australia

Melanoma Institute Australia

Sydney, New South Wales

Australia

Royal Prince Alfred Hospital

Sydney, New South Wales

Australia

Princess Alexandra Hospital

Brisbane, Queensland 4102

Australia

Robina Hospital

Gold Coast, Queensland 4226

Australia

Royal Adelaide Hospital

Adelaide, South Australia 5000

Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria

Australia

The Alfred Hospital

Melbourne, Victoria

Australia

Tom Baker Cancer Centre

Calgary, Alberta T2N 4N2

Canada

BCCA - Cancer Centre for the Southern Interior

Kelowna, British Columbia V1Y 5L3

Canada

CancerCare Manitoba

Winnipeg, Manitoba R3E 0V9

Canada

Royal Victoria Regional Health Centre

Barrie, Ontario L4M 6M2

Canada

Hamilton Health Sciences Centre

Hamilton, Ontario L8V 1C3

Canada

Oak Valley Health

Markham, Ontario L3P 7P3

Canada

Ottawa Hospital Research Institute

Ottawa, Ontario K1Y 4E9

Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario M4N 3M5

Canada

UHN - Princess Margaret Cancer Centre

Toronto, Ontario M5G 2C1

Canada

Hopital Maisonneuve-Rosemont

Montreal, Quebec H1T 2M4

Canada

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec H2X 3E4

Canada

Hotel-Dieu de Quebec

Québec, Quebec G1R2J6

Canada

Cork University Hospital

Cork,

Ireland

Mater Misericordiae University Hospital

Dublin, D07 R2WY

Ireland

St James Hospital

Dublin, D08 NHY1

Ireland

IOV Istituto Oncologico Veneto IRCCS-Padova

Padova, 35128

Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100

Italy

AOU Città della Salute e della Scienza di Torino

Torino, 10126

Italy

Flevo Hospital

Almere Stad, Flevoland

Netherlands

Ziekenhuis Gelderse Vallei

Ede, Gelderland 6716 RP

Netherlands

Gelre Hospital

Zutphen, Gelderland 7207 AE

Netherlands

Maxima Medical Centre, Eindhoven

Eindhoven, North Brabant 5631

Netherlands

University Medical Centre Groningen

Groningen, 9713

Netherlands

Zuyderland Medical Center

Heerlen, 6419

Netherlands

Maastricht University Medical Center

Maastricht, 6229 HX

Netherlands

Diakonessenhuis

Utrecht, 3582 KE

Netherlands

Maxima Medical Center - Veldhoven

Veldhoven, 5504

Netherlands

Isala Hospital

Zwolle, 8025

Netherlands

North Shore Hospital

Auckland, 0620

New Zealand

Institute of Oncology Ljubljana

Ljubljana, 1000

Slovenia

Sahlgrenska University Hospital

Gothenburg,

Sweden

Central Hospital Kristianstad

Kristianstad, 29133

Sweden

University Hospitals Birmingham NHS Foundation Trust

Edgbaston, Birmingham B15 2TH

United Kingdom

Royal Cornwall Hospital NHS Trust

Truro, Cornwall TR1 3LJ

United Kingdom

Hull University Teaching Hospitals NHS Trust

Hull, East Yorkshire HU3 2JZ

United Kingdom

MID & South Essex NHS Foundation Trust

Westcliff-on-Sea, Essex SS0 0RY

United Kingdom

Lancashire Teaching Hospitals NHS Foundation Trust

Preston, Lancashire PR2 9HT

United Kingdom

Oxford University Hospitals NHS Foundation Trust

Headington, Oxford OX3 9DU

United Kingdom

Imperial College Healthcare NHS Trust

London, The Bays W2 1NY

United Kingdom

Queen Victoria Hospital NHS Foundation Trust

East Grinstead, West Sussex RH19 3DZ

United Kingdom

North Bristol NHS Trust

Bristol, BS10 5NB

United Kingdom

Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB2 0QQ

United Kingdom

The Leeds Teaching Hospitals NHS Trust

Leeds, LS9 7TF

United Kingdom

St. Helens & Knowsley Teaching Hospitals NHS Trust

Liverpool,

United Kingdom

Royal Free London NHS Foundation Trust

London, NW3 2QG

United Kingdom

Guy's and St Thomas's NHS Foundation Trust, of St Thomas' Hospital

London, SE1 7EH

United Kingdom

St George's University Hospitals NHS Foundation Trust

London, SW17 0QT

United Kingdom

The Royal Marsden Hospital NHS Foundation Trust

London, SW3 6JJ

United Kingdom

The Christie NHS Foundation Trust

Manchester, M20 4BX

United Kingdom

South Tees Hospitals NHS Foundation Trust of The James Cook University Hospital

Middlesbrough, TS4 3BW

United Kingdom

Norfolk and Norwich University Hospital NHS Trust

Norwich, NR47UY

United Kingdom

Nottingham University Hospitals, NHS Trust, Trust HQ, City Hospital

Nottingham, NG5 1PB

United Kingdom