Melanoma Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Patients must have a stage II primary invasive cutaneous melanoma with Breslow thickness >2mm without ulceration), or >1mm (with ulceration only) (pT2b-pT4b, AJCC 8th edition) as determined by diagnostic biopsy (narrow excision, incision 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.
Surgery (which refers to the staging sentinel node biopsy and wide local excision as these are both to be done on the same day) must be completed within 120 days of the original diagnosis.
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.

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 (except for successfully treated cervical or non-melanoma skin cancer 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:

Uncertain diagnosis of melanoma i.e. so-called 'melanocytic lesion of unknown malignant potential'.
Patient has already undergone wide local excision at the site of the primary index lesion.
Patient unable or ineligible to undergo staging sentinel lymph node biopsy of the primary index lesion.
Desmoplastic or neurotropic 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 other desmoplasia or mixed subtypes are eligible unless there is neurotropism present (peri-neural invasion).Peri-neural invasion does not include entrapment of nerves within the main primary tumour mass. Microsatellitosis as per AJCC 8th edition definition
Subungual melanoma
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.
History of previous or concurrent (i.e., second primary) invasive melanoma.
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.
Physical, clinical, radiographic or pathologic evidence of satellite, in-transit, regional, or distant metastatic melanoma.
Patient has undergone surgery on a separate occasion to clear the lymph nodes of the probable draining lymphatic field, including sentinel lymph node biopsy, of the index melanoma.
Any additional solid tumour or hematologic malignancy during the past 5 years except T1 skin lesions of squamous cell carcinoma, basal cell carcinoma, or uterine/cervical cancer.
Melanoma-related operative procedures not corresponding to criteria described in the protocol.
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.
History of organ transplantation.
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 sentinel node biopsy until the pregnancy has been completed, which is likely to 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 is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

2998

Study ID:

NCT03860883

Recruitment Status:

Recruiting

Sponsor:

Melanoma and Skin Cancer Trials Limited

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There are 86 Locations for this study

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University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States More Info
Michail Mavros
Contact
[email protected]
Michail Mavros
Principal Investigator
The Angeles (Cedars-Sinai Medical Center and its Affiliates)
Los Angeles California, 90048, United States More Info
Dr Mark Faries
Contact
Dr Mark Faries
Principal Investigator
Smilow Hospital Care Center, Guilford
Guilford Connecticut, 06437, United States More Info
James Clune
Contact
[email protected]
James Clune
Principal Investigator
Yale University
New Haven Connecticut, 06520, United States More Info
James Clune
Contact
[email protected]
James Clune
Principal Investigator
MedStar Georgetown University Hospital
Washington District of Columbia, 20007, United States More Info
Geoffrey T Gibney
Contact
[email protected]
Geoffrey T Gibney
Principal Investigator
Baptist MD Anderson Cancer Center
Jacksonville Florida, 32207, United States More Info
Konstantinos Chouliaras
Contact
[email protected]
Konstantinos Chouliaras
Principal Investigator
Mayo Clinic in Florida
Jacksonville Florida, 32224, United States More Info
James W Jakub
Contact
[email protected]
James W Jakub
Principal Investigator
Lakeland Regional Health Hollis Cancer Center
Lakeland Florida, 33805, United States More Info
Manuel Molina
Contact
[email protected]
Manuel Molina
Principal Investigator
Moffitt Cancer Center - McKinley Campus
Tampa Florida, 33612, United States More Info
Jonathan Zager
Contact
[email protected]
Jonathan Zager
Principal Investigator
Moffitt Cancer Center, Magnolia Campus
Tampa Florida, 33612, United States More Info
Jonathan Zager
Contact
[email protected]
Jonathan Zager
Principal Investigator
Emory University
Atlanta Georgia, 30322, United States More Info
Dr Michael Lowe
Contact
Dr Michael Lowe
Principal Investigator
Professor Keith Delman
Principal Investigator
Northside Hospital Atlanta
Atlanta Georgia, 30342, United States More Info
Nicole Kounalakis
Contact
[email protected]
Nicole Kounalakis
Principal Investigator
Northside Hospital Cancer Institute
Atlanta Georgia, 30342, United States More Info
Margaret Ferreira
Contact
Dr. Nicole Kounalakis
Contact
Dr. Nicole Kounalakis
Principal Investigator
Northwestern Medicine Cancer Center Kishwaukee
DeKalb Illinois, 60115, United States More Info
Jeffrey Wayne
Contact
[email protected]
Jeffrey Wayne
Principal Investigator
Northwestern University
Evanston Illinois, 60208, United States More Info
Jeffrey Wayne
Contact
[email protected]
Jeffrey Wayne
Principal Investigator
Northwestern Medicine Cancer Center Delnor
Geneva Illinois, 60134, United States More Info
Jeffrey Wayne
Contact
[email protected]
Jeffrey Wayne
Principal Investigator
Northwestern Medicine Cancer Center Lake Forest Hospital
Lake Forest Illinois, 60045, United States More Info
Jeffrey Wayne
Contact
[email protected]
Jeffrey Wayne
Principal Investigator
Northwestern Medicine Cancer Center Warrenville
Warrenville Illinois, 60555, United States More Info
Jeffrey Wayne
Contact
[email protected]
Jeffrey Wayne
Principal Investigator
University of Kansas Hospital - Indian Creek Campus
Overland Park Kansas, 66211, United States More Info
Luke Selby
Contact
[email protected]
Luke Selby
Principal Investigator
University of Kansas Hospital- Westwood Cancer Center
Westwood Kansas, 66205, United States More Info
Luke Selby
Contact
[email protected]
Luke Selby
Principal Investigator
University of Kentucky
Lexington Kentucky, 40506, United States More Info
Erin Burke
Contact
[email protected]
Erin Burke
Principal Investigator
MedStar Franklin Square Medical Center
Baltimore Maryland, 21237, United States More Info
Edward McCarron
Contact
[email protected]
Edward McCarron
Principal Investigator
Spectrum Health at Butterworth Campus
Grand Rapids Michigan, 49503, United States More Info
Kathleen Yost
Contact
[email protected]
Kathleen Yost
Principal Investigator
West Michigan Cancer Centre
Kalamazoo Michigan, 49007, United States More Info
Kathleen Yost
Contact
[email protected]
Kathleen Yost
Principal Investigator
Siteman Cancer Centre, Barnes Jewish West County
Creve Coeur Missouri, 63141, United States More Info
Ryan Fields
Contact
[email protected]
Ryan Fields
Principal Investigator
University of Kansas Cancer Center
Kansas City Missouri, 64154, United States More Info
Luke Selby
Contact
[email protected]
Luke Selby
Principal Investigator
Cox South Hospital
Springfield Missouri, 65807, United States More Info
Srikant Nannapaneni
Contact
Srikant Nannapaneni
Principal Investigator
University of Nebraska Medicine
Omaha Nebraska, 68198, United States More Info
Bradley Reames
Contact
[email protected]
Bradley Reames
Principal Investigator
Cooperman Barnabas Medical Center
Livingston New Jersey, 07039, United States More Info
Adam Berger
Contact
[email protected]
Adam Berger
Principal Investigator
Rutgers Cancer Institute of New Jersey
Piscataway New Jersey, 08854, United States More Info
Professor Adam Berger
Contact
Professor Adam Berger
Principal Investigator
Roswell Park Cancer Institute
Buffalo New York, 14203, United States More Info
Shalana O'Brien
Contact
[email protected]
Shalana O'Brien
Principal Investigator
NYU Langone Medical Center (Winthrop Hospital)
Mineola New York, 11501, United States More Info
Erica Friedman
Contact
mailto:[email protected]
Erica Friedman
Principal Investigator
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York New York, 10016, United States More Info
Erica Friedman
Contact
mailto:[email protected]
Erica Friedman
Principal Investigator
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Associate Professor Danielle Bello
Contact
Associate Professor Danielle Bello
Principal Investigator
Sanford Broadway Medical Centre
Fargo North Dakota, 58102, United States More Info
Preston Steen
Contact
[email protected]
Preston Steen
Principal Investigator
Sanford Roger Maris Cancer Centre
Fargo North Dakota, 58102, United States More Info
Preston Steen
Contact
[email protected]
Preston Steen
Principal Investigator
Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States More Info
Joal Joal
Contact
[email protected]
Joal Joal
Principal Investigator
OUHSC Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States More Info
William Dooley
Contact
[email protected]
William Dooley
Principal Investigator
St Luke's University Health Network, Bethlehem Campus
Bethlehem Pennsylvania, 18015, United States More Info
Darius Desai
Contact
[email protected]
Darius Desai
Principal Investigator
St Luke's University Health Network, Anderson Campus
Easton Pennsylvania, 18045, United States More Info
Darius Desai
Contact
[email protected]
Darius Desai
Principal Investigator
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States More Info
Dr Stephanie Greco
Contact
Dr Stephanie Greco
Principal Investigator
Medical University of South Carolina
Charleston South Carolina, 29425, United States More Info
Andrea Abbott
Contact
[email protected]
Andrea Abbott
Principal Investigator
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Jeffrey Gershenwald
Contact
[email protected]
Jeffrey Gershenwald
Principal Investigator
Huntsman Cancer Institute (The University of Utah)
Salt Lake City Utah, 84112, United States More Info
Professor John Hynstrom
Contact
Professor John Hynstrom
Principal Investigator
VCU Massey Cancer Center Peninsula Cancer Institute
Newport News Virginia, 23601, United States More Info
Giao Phan
Contact
[email protected]
Giao Phan
Principal Investigator
VCU Massey Cancer Center
Richmond Virginia, 23298, United States More Info
Giao Phan
Contact
[email protected]
Giao Phan
Principal Investigator
VCU Massey Cancer Center Affiliate Valley Health
Winchester Virginia, 22601, United States More Info
Giao Phan
Contact
[email protected]
Giao Phan
Principal Investigator
Marshfield Medical Center - Marshfield
Marshfield Wisconsin, 54449, United States More Info
Rohit Sharma
Contact
[email protected]
Rohit Sharma
Principal Investigator
Aurora St Luke's Medical Center
Milwaukee Wisconsin, 53215, United States More Info
Sigrun Hallmeyer
Contact
[email protected]
Sigrun Hallmeyer
Principal Investigator
Calvary Public Hospital Bruce
Bruce Australian Capital Territory, 2617, Australia More Info
Dr Rebecca Read
Contact
Dr Rebecca Read
Principal Investigator
The Canberra Hospital
Garran Australian Capital Territory, 2605, Australia More Info
Emily Baxter
Contact
Dr Krishna Rao
Principal Investigator
Westmead Hospital
Sydney New South Wales, 2145, Australia More Info
Pablo Fernandez-Peñas
Contact
[email protected]
Prof Pablo Fernandez-Peñas
Principal Investigator
Melanoma Institute Australia
Sydney New South Wales, , Australia More Info
Andrew Spillane
Contact
Prof Andrew Spillane
Principal Investigator
Royal Prince Alfred Hospital
Sydney New South Wales, , Australia More Info
Robyn Saw
Contact
A/Prof Robyn Saw
Principal Investigator
Princess Alexandra Hospital
Brisbane Queensland, 4102, Australia More Info
Prof Mark Smithers
Contact
Prof Mark Smithers
Principal Investigator
Robina Hospital
Gold Coast Queensland, 4226, Australia More Info
Dr Jennifer Chang
Contact
Dr Jennifer Chang
Principal Investigator
Peter MacCallum Cancer Centre
Melbourne Victoria, , Australia More Info
Michael Henderson
Contact
Prof Michael Henderson
Principal Investigator
A/Prof David Gyorki
Sub-Investigator
The Alfred Hospital
Melbourne Victoria, , Australia More Info
Dr Frank Bruscino-Raiola
Contact
Dr Frank Bruscino-Raiola
Principal Investigator
Tom Baker Cancer Centre
Calgary Alberta, T2N 4, Canada
BCCA - Cancer Centre for the Southern Interior
Kelowna British Columbia, V1Y 5, Canada More Info
Christopher Baliski
Contact
[email protected]
Christopher Baliski
Principal Investigator
CancerCare Manitoba
Winnipeg Manitoba, R3E 0, Canada
Royal Victoria Regional Health Centre
Barrie Ontario, L4M 6, Canada More Info
Kelly Cruise
Contact
705-728-9090
[email protected]
Dr. Renee Hanrahan
Contact
Dr. Renee Hanrahan
Principal Investigator
Hamilton Health Sciences Centre
Hamilton Ontario, L8V 1, Canada More Info
Dr. Valerie Francescutti
Contact
905-387-9495
Dr. Valerie Francescutti
Principal Investigator
Ottawa Hospital Research Institute
Ottawa Ontario, K1Y 4, Canada More Info
Dr. Carolyn Nessim
Contact
[email protected]
Dr. Carolyn Nessim
Principal Investigator
Sunnybrook Health Sciences Centre
Toronto Ontario, M4N 3, Canada More Info
Dr Frances Wright
Contact
416-480-4210
Dr Frances Wright
Principal Investigator
UHN - Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada More Info
Alexandra Easson, Dr
Contact
[email protected]
Hopital Maisonneuve-Rosemont
Montreal Quebec, H1T 2, Canada More Info
Audrey Lamoureux
Contact
514-252-3400
Leïla Idrissi Kaïtouni
Contact
514-252-3400
Dr. Mai-Kim Gervais
Principal Investigator
Hotel-Dieu de Quebec
Québec City Quebec, G1R2J, Canada More Info
Dr Cindy Boulanger-Gobeil
Contact
[email protected]
Dr Cindy Boulanger-Gobeil
Principal Investigator
IOV Istituto Oncologico Veneto IRCCS-Padova
Padova , 35128, Italy More Info
Romina Spina
Contact
Dr Simone Mocellin
Principal Investigator
Fondazione IRCCS Policlinico San Matteo
Pavia , 27100, Italy More Info
Alessandra Ferrari
Contact
Prof Alessandro Testori
Principal Investigator
AOU Città della Salute e della Scienza di Torino
Torino , 10126, Italy More Info
Valentina Pala
Contact
Dr. Franco Picciotto
Principal Investigator
Flevo Hospital
Almere Flevoland, , Netherlands More Info
Gwen Diepenhorst
Contact
Gwen Diepenhorst
Principal Investigator
Ziekenhuis Gelderse Vallei
Ede Gelderland, 6716 , Netherlands More Info
Miriam L Hoven-Gondrie
Contact
[email protected]
Miriam L Hoven-Gondrie
Principal Investigator
University Medical Centre Groningen
Groningen , 9713, Netherlands More Info
Barbara Leeuwen
Contact
[email protected]
Barbara Leeuwen
Principal Investigator
Zuyderland Medical Center
Heerlen , 6419, Netherlands More Info
James van Bastelaar, Dr
Contact
Maastricht University Medical Center
Maastricht , 6229 , Netherlands More Info
Kevin Wevers
Contact
[email protected]
Kevin Wevers
Principal Investigator
North Shore Hospital
Auckland , 0620, New Zealand More Info
Dr Richard Martin
Contact
Dr Richard Martin
Principal Investigator
Sahlgrenska University Hospital
Gothenburg , , Sweden More Info
Roger Olofsson Bagge
Contact
(0)31-3428207
[email protected]
Prof Roger Olofsson Bagge
Principal Investigator
Central Hospital Kristianstad
Kristianstad , 29133, Sweden More Info
Dr Karolin Isaksson
Contact
[email protected]
Dr Karolin Isaksson
Principal Investigator
University Hospitals Birmingham NHS Foundation Trust
Edgbaston Birmingham, B15 2, United Kingdom More Info
Agustin Martin-Clavijo
Contact
[email protected]
Agustin Martin-Clavijo
Principal Investigator
Royal Cornwall Hospital NHS Trust
Truro Cornwall, TR1 3, United Kingdom More Info
Polly King
Contact
[email protected]
Polly King
Principal Investigator
Hull University Teaching Hospitals NHS Trust
Hull East Yorkshire, HU3 2, United Kingdom More Info
Paolo Matteucci
Contact
[email protected]
Paolo Matteucci
Principal Investigator
MID & South Essex NHS Foundation Trust
Westcliff on Sea Essex, SS0 0, United Kingdom More Info
Prof Peter Dziewulski
Contact
[email protected]
Peter Dziewulski
Principal Investigator
Oxford University Hospitals NHS Foundation Trust
Headington Oxford, OX3 9, United Kingdom More Info
oliver cassell
Contact
oliver cassell
Principal Investigator
Queen Victoria Hospital NHS Foundation Trust
East Grinstead West Sussex, RH19 , United Kingdom More Info
Siva Kumar
Contact
[email protected]
Siva Kumar
Principal Investigator
North Bristol NHS Trust
Bristol , BS10 , United Kingdom More Info
Ewan Wilson, Mr
Contact
[email protected]
Cambridge University Hospitals NHS Foundation Trust
Cambridge , CB2 0, United Kingdom More Info
Amit Roshan
Contact
[email protected]
The Royal Marsden Hospital NHS Foundation Trust
London, , SW3 6, United Kingdom More Info
Myles Smith
Contact
[email protected]
Myles Smith
Principal Investigator
Royal Free London NHS Foundation Trust
London , NW3 2, United Kingdom More Info
Steven Hamilton
Contact
[email protected]
Steven Hamilton
Principal Investigator
Guy's and St Thomas's NHS Foundation Trust, of St Thomas' Hospital
London , SE1 7, United Kingdom More Info
Jenny Geh, Ms
Contact
[email protected]
St George's University Hospitals NHS Foundation Trust
London , SW17 , United Kingdom More Info
Joy Odili, Ms
Contact
[email protected]
South Tees Hospitals NHS Foundation Trust of The James Cook University Hospital
Middlesbrough , TS4 3, United Kingdom More Info
Oliver Bassett, Mr
Contact
[email protected]
Norfolk and Norwich University Hospital NHS Trust
Norwich , NR47U, United Kingdom More Info
Professor Marc Moncrieff
Contact
Professor Marc Moncrieff
Principal Investigator
Nottingham University Hospitals, NHS Trust, Trust HQ, City Hospital
Nottingham , NG5 1, United Kingdom More Info
Mr Jonathon Pollock
Contact
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

2998

Study ID:

NCT03860883

Recruitment Status:

Recruiting

Sponsor:


Melanoma and Skin Cancer Trials Limited

How clear is this clinincal trial information?

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