AzTrials
AzTrials

Cutaneous Melanoma, Stage IIMelMarT-IINCT03860883

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

A study testing Wide Local Excision = 1cm Margin and Wide Local Excision = 2cm Margin in people with Cutaneous Melanoma, Stage II, run by Melanoma and Skin Cancer Trials Limited at 192 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cutaneous Melanoma, Stage II
What is being tested?
Wide Local Excision = 1cm Margin and Wide Local Excision = 2cm Margin
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,998 participants
Where
192 sitesin 10 countries
Study dates
17 Dec 2019to 31 Dec 2034
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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 WLE at the site of the primary index lesion.
  • Patient unable or ineligible to undergo staging SLNB of the primary index lesion.
  • 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.
  • 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).
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  • 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.
  • 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. >1 primary melanoma) 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 -SLNB, of the index melanoma.
  • 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).
  • 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 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.

Trial locations and contacts

192 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

Melanoma and Skin Cancer Trials Coordinator contact

+61 3 9903 9022

melmart@masc.org.au

192 sites in 10 countries

United States130 sites, 130 recruiting

  • Lovelace Medical Centre-Saint Joseph Square

    Albuquerque, New Mexico, 87110

    Bridget Fahy, MD, BFahy@salud.unm.edu

    Recruiting

  • Lovelace Women's Hospital

    Albuquerque, New Mexico, 87110

    Bridget Fahy, MD, BFahy@salud.unm.edu

    Bridget Fahy, MD

    Recruiting

  • St. Luke's University Health Network - Allentown Cancer Center

    Allentown, Pennsylvania, 18104

    Darius Desai, MD, Darius.Desai@sluhn.org

    Amy Grossman, Amy.Grossman@sluhn.org

    Recruiting

  • University of Michigan Medical Center

    Ann Arbor, Michigan, 48109

    Christina Angeles, angelesc@med.umich.edu

    Christina Angeles

    Recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

    Michael Lowe, MD, mlowe3@emory.edu

    Rachel Mock, rachel.ashley.mock@emory.edu

    Recruiting

  • Emory University

    Atlanta, Georgia, 30322

    Dr Michael Lowe

    Dr Michael Lowe

    Recruiting

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

    Michael Lowe, MD, mlowe3@emory.edu

    Charisse Ellis, chariesse.aliyya.ellis@emory.edu

    Recruiting

  • Northside Hospital Atlanta

    Atlanta, Georgia, 30342

    Nicole Kounalakis, nicole.kounalakis@northside.com

    Nicole Kounalakis

    Recruiting

  • Northside Hospital Cancer Institute

    Atlanta, Georgia, 30342

    Margaret Ferreira

    Dr. Nicole Kounalakis

    Not yet recruiting

  • University of Miami Sylvester Comprehensive Cancer Center at Aventura

    Aventura, Florida, 33180

    Jessica S Crystal, jxc2521@med.miami.edu

    Jessica S Crystal

    Recruiting

  • University Hospitals Avon Health Center

    Avon, Ohio, 44011

    Luke Rothermel, Luke.Rothermel@UHhospitals.org

    Luke Rothermel

    Recruiting

  • MedStar Franklin Square Medical Center

    Baltimore, Maryland, 21237

    Edward McCarron, edward.mccarron@medstar.net

    Edward McCarron

    Recruiting

  • Northwell Health Imbert Cancer Center

    Bay Shore, New York, 11706

    Alan Kadison, MD, akadison@northwell.edu

    Diane Delliliune, DDellili@northwell.edu

    Recruiting

  • Nebraska Medicine - Bellevue

    Bellevue, Nebraska, 68123

    Bradley Reames, bradley.reames@unmc.edu

    Bradley Reames

    Recruiting

  • St Luke's University Health Network, Bethlehem Campus

    Bethlehem, Pennsylvania, 18015

    Darius Desai, Darius.Desai@sluhn.org

    Darius Desai

    Recruiting

  • University of Michigan - Brighton Center for Specialty Care

    Brighton, Michigan, 48116

    Christina Angeles, angelesc@med.umich.edu

    Christina Angeles

    Recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14203

    Shalana O'Brien, shalana.obrien@roswellpark.org

    Shalana O'Brien

    Recruiting

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

    Jessica Cintolo-Gonzalez, MD, jessica.cintolo-gonzalez@uvmhealth.org

    Elizabeth Abrecht, elizabeth.abrecht@uvmhealth.org

    Recruiting

  • University of Vermount and Sate Agricultural College

    Burlington, Vermont, 05405

    Jessica Cintolo-Gonzalez, MD, jessica.cintolo-gonzalez@uvmhealth.org

    Elizabeth Abrecht, elizabeth.abrecht@uvmhealth.org

    Recruiting

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

    James Ouellette, jrouellett@premierhealth.com

    James Ouellette

    Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

    David W Ollila, david_ollila@med.unc.edu

    David W Ollila

    Recruiting

  • University Hospitals Geauga Medical Center

    Chardon, Ohio, 44024

    Luke Rothermel, Luke.Rothermel@UHhospitals.org

    Luke Rothermel

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Andrea Abbott, abbottan@musc.edu

    Andrea Abbott

    Recruiting

  • University of Virginia Health System

    Charlottesville, Virginia, 22903

    Lynn Dengel, LTD5B@uvahealth.org

    Lynn Dengel

    Recruiting

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

    Sigrun Hallmeyer, sigrun.hallmeyer@aah.org

    Sigrun Hallmeyer

    Recruiting

  • University of Cincinnati

    Cincinnati, Ohio, 45219

    Jeffrey Sussman, sussmaj@ucmail.uc.edu

    Jeffrey Sussman

    Recruiting

  • Kaiser Sunnyside Medical Center

    Clackamas, Oregon, 97015

    Sandeep Mashru, sandeep.h.mashru@kp.org

    Sandeep Mashru

    Recruiting

  • University Hospitals Cleveland Medical Centre

    Cleveland, Ohio, 44106

    Luke Rothermel, Luke.Rothermel@UHhospitals.org

    Luke Rothermel

    Recruiting

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Joal Joal, Joal.Beane@osumc.edu

    Joal Joal

    Recruiting

  • University of Miami Sylvester Comprehensive Cancer Center at Coral Gables

    Coral Gables, Florida, 33146

    Jessica S Crystal, jxc2521@med.miami.edu

    Jessica S Crystal

    Recruiting

  • University of Miami Sylvester Cancer Center at Coral Springs

    Coral Springs, Florida, 33065

    Jessica S Crystal, jxc2521@med.miami.edu

    Jessica S Crystal

    Recruiting

  • Siteman Cancer Centre, Barnes Jewish West County

    Creve Coeur, Missouri, 63141

    Ryan Fields, rcfields@wustl.edu

    Ryan Fields

    Recruiting

  • University of Miami Sylvester Comprehensive Center at Deerfield Beach

    Deerfield Beach, Florida, 33442

    Jessica S Crystal, jxc2521@med.miami.edu

    Jessica S Crystal

    Recruiting

  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115

    Jeffrey Wayne, jeffrey.wayne@nm.org

    Jeffrey Wayne

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Jay Lee, jay.lee@duke.edu

    Jay Lee

    Recruiting

  • St Luke's University Health Network, Anderson Campus

    Easton, Pennsylvania, 18045

    Darius Desai, Darius.Desai@sluhn.org

    Darius Desai

    Recruiting

  • Northwestern University

    Evanston, Illinois, 60208

    Jeffrey Wayne, jeffrey.wayne@nm.org

    Jeffrey Wayne

    Recruiting

  • Sanford Broadway Medical Centre

    Fargo, North Dakota, 58102

    Preston Steen, preston.steen@sanfordhealth.org

    Preston Steen

    Recruiting

  • Sanford Roger Maris Cancer Centre

    Fargo, North Dakota, 58102

    Preston Steen, preston.steen@sanfordhealth.org

    Preston Steen

    Recruiting

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

    Jeffrey Wayne, jeffrey.wayne@nm.org

    Jeffrey Wayne

    Recruiting

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

    Mark Gimbel, mark.gimbel@bannerhealth.com

    Sandra Ortega, sandra.ortega@bannerhealth.com

    Recruiting

  • Mercy Health Saint Mary's

    Grand Rapids, Michigan, 49503

    Kathleen Yost, kyost@crcwm.org

    Renee Porter, renee.porter@crcwm.org

    Recruiting

  • Spectrum Health at Butterworth Campus

    Grand Rapids, Michigan, 49503

    Kathleen Yost, Kyost@chcwm.com

    Kathleen Yost

    Recruiting

  • East Carolina University

    Greenville, North Carolina, 27858

    Nasreen Vohra, joynersu@ecu.edu

    Nasreen Vohra

    Recruiting

  • Smilow Hospital Care Center, Guilford

    Guilford, Connecticut, 06437

    James Clune, james.clune@yale.edu

    James Clune

    Recruiting

  • University of North Carolina Hospitals - Hillsborough Campus

    Hillsborough, North Carolina, 27278

    David Ollila, david_ollila@med.unc.edu

    David Ollila

    Recruiting

  • University of Miami Sylvester Comprehensive Center at Hollywood

    Hollywood, Florida, 33021

    Jessica S Crystal, jxc2521@med.miami.edu

    Jessica S Crystal

    Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    Jeffrey Gershenwald, jgershen@mdanderson.org

    Jeffrey Gershenwald

    Recruiting

  • Indiana University - Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

    Karl Bilimoria, MD

    karlb@iu.edu

    Recruiting

  • Indiana University Melvin and Bren Simon Comprehensive Cancer Center

    Indianapolis, Indiana, 46202

    Karl Bilimoria, karlb@iu.edu

    Karl Bilimoria

    Recruiting

  • Franciscan Health Indianapolis

    Indianapolis, Indiana, 46237

    Juliana Meyer, juliana.meyer@franciscanalliance.org

    Juliana Meyer

    Recruiting

  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

    Irvine, California, 92868

    Maki Yamamoto, MD

    Maki Yamamoto, MD

    Recruiting

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207

    Konstantinos Chouliaras, Konstantinos.Chouliaras@bmcjax.com

    Konstantinos Chouliaras

    Recruiting

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224

    James W Jakub, Jakub.James@mayo.edu

    James W Jakub

    Recruiting

  • West Michigan Cancer Centre

    Kalamazoo, Michigan, 49007

    Kathleen Yost, kyost@chcwm.com

    Kathleen Yost

    Recruiting

  • University of Kansas Cancer Center

    Kansas City, Missouri, 64154

    Luke Selby, lselby@kumc.edu

    Luke Selby

    Recruiting

  • Northwestern Medicine Cancer Center Lake Forest Hospital

    Lake Forest, Illinois, 60045

    Jeffrey Wayne, jeffrey.wayne@nm.org

    Jeffrey Wayne

    Recruiting

  • Northwell Health/Center for Advanced Medicine

    Lake Success, New York, 11042

    Alan Kadison, MD, akadison@northwell.edu

    Alexa Amoroso, aamoroso1@northwell.edu

    Recruiting

  • Lakeland Regional Health Hollis Cancer Center

    Lakeland, Florida, 33805

    Manuel Molina, manuel.molina@mylrh.org

    Manuel Molina

    Recruiting

  • University of Kentucky

    Lexington, Kentucky, 40506

    Erin Burke, erin.burke@uky.edu

    Erin Burke

    Recruiting

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

    Michail Mavros, MMavros@uams.edu

    Michail Mavros

    Recruiting

  • Cooperman Barnabas Medical Center

    Livingston, New Jersey, 07039

    Adam Berger, ab2047@cinj.rutgers.edu

    Adam Berger

    Recruiting

  • Los Angeles General Medical Center

    Los Angeles, California, 90033

    Gino In, gino.in@med.usc.edu

    Gino In

    Recruiting

  • Los Angeles General Medical Center

    Los Angeles, California, 90033

    Gino In, MD, gino.in@med.usc.edu

    Gino In, MD

    Recruiting

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

    Gino In, gino.in@med.usc.edu

    Gino In

    Recruiting

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

    Gino In, MD, gino.in@med.usc.edu

    Gino In, MD

    Recruiting

  • The Angeles (Cedars-Sinai Medical Center and its Affiliates)

    Los Angeles, California, 90048-1804

    Dr Mark Faries

    Dr Mark Faries

    Recruiting

  • University of Winsconsin Carbone Cancer Center-Eastpark medical Center

    Madison, Wisconsin, 53718

    Heather Neuman, neuman@surgery.wisc.edu

    Heather Neuman, MD, neuman@surgery.wisc.edu

    Recruiting

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53792

    Heather Neuman, neuman@surgery.wisc.edu

    Sam Hanson, shhanson@wisc.ed

    Recruiting

  • Marshfield Medical Center - Marshfield

    Marshfield, Wisconsin, 54449

    Rohit Sharma, sharma.rohit@marshfieldclinic.org

    Rohit Sharma

    Recruiting

  • University of Miami Miller School of Medicine-Sylvester Cancer Centre

    Miami, Florida, 33136

    Jessica S Crystal, jxc2521@med.miami.edu

    Jessica S Crystal

    Recruiting

  • University of Miami Comprehensive Cancer Center at Kendall

    Miami, Florida, 33176

    Jessica S Crystal, jxc2521@med.miami.edu

    Jessica S Crystal

    Recruiting

  • Aurora St Luke's Medical Center

    Milwaukee, Wisconsin, 53215

    Sigrun Hallmeyer, sigrun.hallmeyer@aah.org

    Sigrun Hallmeyer

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Jennifer Bruening, jbruening@mcw.edu

    Chloe Papageorgio, cpapageorgio@mcw.edu

    Recruiting

  • NYU Langone Medical Center (Winthrop Hospital)

    Mineola, New York, 11501

    Erica Friedman, mailto:Erica.Friedman@nyulangone.org

    Erica Friedman

    Recruiting

  • University of South Alabama Mitchell Cancer Institute

    Mobile, Alabama, 36604

    John H Howard, MD, jhoward@health.southalabama.edu

    Tiffany Fulford, tfulford@health.southalabama.edu

    Recruiting

  • Northern Westchester Hospital

    Mount Kisco, New York, 10549

    Alan Kadison, Akadison@northwell.edu

    Alan Kadison

    Recruiting

  • Intermountain Medical Center

    Murray, Utah, 84157

    Tawnya Bowles, tawnya.bowles@imail.org

    Kevin Adams, Kevin.Adams@imail.org

    Recruiting

  • Yale University

    New Haven, Connecticut, 06520

    James Clune, james.clune@yale.edu

    James Clune

    Recruiting

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    New York, New York, 10016

    Erica Friedman, mailto:Erica.Friedman@nyulangone.org

    Erica Friedman

    Recruiting

  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032

    Bret Taback, bt2160@cumc.columbia.ed

    Bret Taback

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Associate Professor Danielle Bello

    Associate Professor Danielle Bello

    Recruiting

  • VCU Massey Cancer Center Peninsula Cancer Institute

    Newport News, Virginia, 23601

    Giao Phan, giao.phan@vcuhealth.org

    Giao Phan

    Recruiting

  • OUHSC Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

    William Dooley, William-Dooley@ouhsc.edu

    William Dooley

    Recruiting

  • Mercy Health Center - Oncology Hematology

    Oklahoma City, Oklahoma, 73120-8362

    Christian Ellis, DO, christian.ellis@mercy.net

    Trisha Strubhar, trisha.strubhar@mercy.net

    Recruiting

  • Nebraska Medicine-Village Pointe

    Omaha, Nebraska, 68118

    Bradley Reames, bradley.reames@unmc.edu

    Bradley Reames

    Recruiting

  • University of Nebraska Medicine

    Omaha, Nebraska, 68198

    Bradley Reames, bradley.reames@unmc.edu

    Bradley Reames

    Recruiting

  • UC Irvine Health - Chao Family Comprehensive Cancer Center

    Orange, California, 92868

    Jeremy Harris, jpharris1@hs.uci.edu

    Jeremy Harris

    Recruiting

  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

    Orange, California, 92868

    Maki Yamamoto, myamamot@hs.uci.edu

    Maki Yamamoto

    Recruiting

  • University Hospitals Chagrin Highlands Medical Centre

    Orange, Ohio, 44122

    Luke Rothermel, Luke.Rothermel@UHhospitals.org

    Luke Rothermel

    Recruiting

  • University of Kansas Hospital - Indian Creek Campus

    Overland Park, Kansas, 66211

    Luke Selby, lselby@kumc.edu

    Luke Selby

    Recruiting

  • Stanford Cancer Institute

    Palo Alto, California, 94304

    Amanda Kirane, MD FACS, 650-725-4169, akirane@stanford.edu

    Patrick Yuan, +1 650-498-7061, yuanp@stanford.edu

    Recruiting

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois, 60068

    Sigrun Hallmeyer, MD, sigrun.hallmeyer@aah.org

    Cheryl Korabik, cheryl.korabik@aah.org

    Recruiting

  • Huntington Memorial Hospital

    Pasadena, California, 91105

    Mark Faries, mfaries@theangelesclinic.org

    Mark Faries

    Recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

    Dr Stephanie Greco

    Dr Stephanie Greco

    Recruiting

  • Mayo Clinic Phoenix

    Phoenix, Arizona, 85054

    Barbara A Pockaj, MD, pockaj.barbara@mayo.edu

    Courtney Nelson, Nelson.Courtney4@mayo.edu

    Recruiting

  • Rutgers Cancer Institute of New Jersey

    Piscataway, New Jersey, 08854

    Professor Adam Berger

    Professor Adam Berger

    Recruiting

  • University of Miami Comprehensive Cancer Center at Plantation

    Plantation, Florida, 33324

    Jessica S Crystal, jxc2521@med.miami.edu

    Jessica S Crystal

    Recruiting

  • Kaiser Permanente Northwest - Oncology Clinic

    Portland, Oregon, 97227

    Sandeep Mashru, sandeep.h.mashru@kp.org

    Sandeep Mashru

    Recruiting

  • Vassar Brothers Medical Center

    Poughkeepsie, New York, 12601

    James Nitzkorski, james.nitzkorski@nuvancehealth.org

    Karley Flinn, James, karley.flinn@nuvancehealth.org

    Recruiting

  • St Luke's University Health Network Quakertown Campus

    Quakertown, Pennsylvania, 18951

    Darius Desai, Darius.Desai@sluhn.org

    Darius Desai

    Recruiting

  • St. Luke's University Health Network - Upper Bucks

    Quakertown, Pennsylvania, 18951

    Darius Desai, MD, Darius.Desai@sluhn.org

    Amy Grossman, Amy.Grossman@sluhn.org

    Recruiting

  • VCU Massey Cancer Center

    Richmond, Virginia, 23298

    Giao Phan, giao.phan@vcuhealth.org

    Giao Phan

    Recruiting

  • Carilion Roanoke Memorial Hospital

    Roanoke, Virginia, 24014

    Giao Phan, giao.phan@vcuhealth.org

    Kristin Campbell, klcampbell@vcu.edu

    Recruiting

  • University of Rochester

    Rochester, New York, 14642

    Paul Barr, paul_barr@urmc.rochester.edu

    Paul Barr

    Recruiting

  • Huntsman Cancer Institute (The University of Utah)

    Salt Lake City, Utah, 84112

    Professor John Hynstrom

    Professor John Hynstrom

    Recruiting

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78284-7884

    Fedrico Tozzi, MD, tozzi@uthscsa.edu

    Samantha Bankston, bankstonsm@uthscsa.edu

    Recruiting

  • Stanford Cancer Center South Bay

    San Jose, California, 95124

    Amanda Kirane

    Amanda Kirane

    Recruiting

  • Nancy N and JC Lewis Cancer & Research Pavilion St. Joseph's/Candler

    Savannah, Georgia, 31405

    Yana Puckett, MD, drpucketty@sjchs.org

    Stephanie Reyes, smiths1@sjchs.org

    Recruiting

  • Guthrie Medical Group PC-Robert Packer Hospital

    Sayre, Pennsylvania, 18840

    David Bertsch, MD, david.j.bertsch@guthrie.org

    Susan Hadlock, susan.hadlock@guthrie.org

    Recruiting

  • Sanford Cancer Center Oncology Clinic

    Sioux Falls, South Dakota, 57105,

    Daniel Almquist, MD, daniel.almquist@sanfordhealth.org

    Daniel Almquist, MD

    Recruiting

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57105,

    Daniel Almquist, MD, daniel.almquist@sanfordhealth.org

    Daniel Almquist, MD

    Recruiting

  • Phelps Memorial Hospital Center

    Sleepy Hollow, New York, 10591

    Alan Kadison, akadison@northwell.edu

    Alan Kadison

    Recruiting

  • Cox South Hospital

    Springfield, Missouri, 65807

    Srikant Nannapaneni

    Srikant Nannapaneni

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Ryan Fields, rcfields@wustl.edu

    Ryan Fields

    Recruiting

  • State University of New York Upstate Medical University

    Syracuse, New York, 13210

    Daniel Thomas, MD, ThomasDa@upstate.edu

    Laine Abernathy, abernatl@upstate.edu

    Recruiting

  • State University of New York Upstate Medical Center-Community Campus

    Syracuse, New York, 13215

    Daniel Thomas, MD, ThomasDa@upstate.edu

    Laine Abernathy, abernatl@upstate.edu

    Recruiting

  • Moffitt Cancer Center - McKinley Campus

    Tampa, Florida, 33612

    Jonathan Zager, Jonathan.zager@moffitt.org

    Jonathan Zager

    Recruiting

  • Moffitt Cancer Center, Magnolia Campus

    Tampa, Florida, 33612

    Jonathan Zager, Jonathan.zager@moffitt.org

    Jonathan Zager

    Recruiting

  • Kaiser Permanente - Vallejo Medical Center

    Vallejo, California, 94589

    Tatjana Kolevska, MD, Tatjana.Kolevska@kp.org

    Desiree Goldstein, desiree.goldstein@kp.org

    Recruiting

  • Kaiser Permanente - Walnut Creek Medical Center

    Walnut Creek, California, 94596

    Tatjana Kolevska, MD, Tatjana.Kolevska@kp.org

    Desiree Goldstein, desiree.goldstein@kp.org

    Recruiting

  • Northwestern Medicine Cancer Center Warrenville

    Warrenville, Illinois, 60555

    Jeffrey Wayne, jeffrey.wayne@nm.org

    Jeffrey Wayne

    Recruiting

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

    Geoffrey T Gibney, geofrey.t.gibney@gunet.georgetown.edu

    Geoffrey T Gibney

    Recruiting

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

    Marc Boisvert, MD, Marc.E.Boisvert@medstar.net

    Nicolas Rojas, Nicolas.Rojas@medstar.net

    Recruiting

  • Wilmont Cancer Institute at Webster

    Webster, New York, 14580

    Paul Barr, MD, paul_barr@urmc.rochester.edu

    Sarah Cawley, sarah_cawley@urmc.rochester.edu

    Recruiting

  • West Chester Hospital (OH394)

    West Chester, Ohio, 45069

    Jeffrey Sussman, sussmaj@ucmail.uc.edu

    Jeffrey Sussman

    Recruiting

  • University Hospitals St. John Medical Center

    Westlake, Ohio, 44145

    Luke Rothermel, Luke.Rothermel@UHhospitals.org

    Luke Rothermel

    Recruiting

  • Marshfield Medical Center- Weston

    Weston, Wisconsin, 54476

    Rohit Sharma, MD, sharma.rohit@marshfieldclinic.org

    Rohit Sharma, sharma.rohit@marshfieldclinic.

    Recruiting

  • University of Kansas Hospital- Westwood Cancer Center

    Westwood, Kansas, 66205

    Luke Selby, lselby@kumc.edu

    Luke Selby

    Recruiting

  • VCU Massey Cancer Center Affiliate Valley Health

    Winchester, Virginia, 22601

    Giao Phan, giao.phan@vcuhealth.org

    Giao Phan

    Recruiting

Other trials in United States

United Kingdom20 sites, 20 recruiting

  • North Bristol NHS Trust

    Bristol, BS10 5NB

    Ewan Wilson, Mr, Ewan.Wilson@nbt.nhs.uk

    Recruiting

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ

    Amit Roshan, amit.roshan@addenbrookes.nhs.uk

    Amit Roshan

    Recruiting

  • Queen Victoria Hospital NHS Foundation Trust

    East Grinstead, West Sussex, RH19 3DZ

    Siva Kumar, siva.kumar1@nhs.net

    Siva Kumar

    Recruiting

  • University Hospitals Birmingham NHS Foundation Trust

    Edgbaston, Birmingham, B15 2TH

    Agustin Martin-Clavijo, Agustin.Martin-Clavijo@uhb.nhs.uk

    Agustin Martin-Clavijo

    Recruiting

  • Oxford University Hospitals NHS Foundation Trust

    Headington, Oxford, OX3 9DU

    oliver cassell

    oliver.cassell@ouh.nhs.uk

    Recruiting

  • Hull University Teaching Hospitals NHS Trust

    Hull, East Yorkshire, HU3 2JZ

    Paolo Matteucci, paolo.matteucci@hey.nhs.uk

    Paolo Matteucci

    Recruiting

  • The Leeds Teaching Hospitals NHS Trust

    Leeds, LS9 7TF

    Howard Peach, Mr, h.peach@nhs.net

    Recruiting

  • St. Helens & Knowsley Teaching Hospitals NHS Trust

    Liverpool

    Rowan Pritchard Jones, Prof, Rowan.PritchardJones@sthk.nhs.uk

    Recruiting

  • Imperial College Healthcare NHS Trust

    London, The Bays, W2 1NY

    Jonathon Dunne, jonathan.dunne1@nhs.net

    Mark Cabelles, mark.cabelles@nhs.net

    Recruiting

  • Royal Free London NHS Foundation Trust

    London, NW3 2QG

    Steven Hamilton, stephenhamilton@nhs.net

    Steven Hamilton

    Recruiting

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

    London, SE1 7EH

    Jenny Geh, Ms, Jenny.Geh@gstt.nhs.uk

    Recruiting

  • St George's University Hospitals NHS Foundation Trust

    London, SW17 0QT

    Joy Odili, Ms, Joy.Odili@stgeorges.nhs.uk

    Recruiting

  • The Royal Marsden Hospital NHS Foundation Trust

    London, SW3 6JJ

    Myles Smith, Myles.Smith@rmh.nhs.uk

    Myles.Smith@rmh.nhs.uk

    Recruiting

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

    Deemesh Oudit, deemesh.oudit@nhs.net

    Deemesh Oudit

    Recruiting

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

    Middlesbrough, TS4 3BW

    Oliver Bassett, Mr, o.bassett@nhs.net

    Recruiting

  • Norfolk and Norwich University Hospital NHS Trust

    Norwich, NR47UY

    Professor Marc Moncrieff

    Professor Marc Moncrieff

    Recruiting

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

    Nottingham, NG5 1PB

    Mr Jonathon Pollock, Jonathan.Pollock@nuh.nhs.uk

    Recruiting

  • Lancashire Teaching Hospitals NHS Foundation Trust

    Preston, Lancashire, PR2 9HT

    Richard Wain, richard.wain@lthtr.nhs.uk

    Richard Wain

    Recruiting

  • Royal Cornwall Hospital NHS Trust

    Truro, Cornwall, TR1 3LJ

    Polly King, polly.king1@nhs.net

    Polly King

    Recruiting

  • MID & South Essex NHS Foundation Trust

    Westcliff-on-Sea, Essex, SS0 0RY

    Prof Peter Dziewulski, peter.dziewulski1@nhs.net

    Peter Dziewulski

    Recruiting

Other trials in United Kingdom

Canada12 sites, 12 recruiting

  • Royal Victoria Regional Health Centre

    Barrie, Ontario, L4M 6M2

    Kelly Cruise, 705-728-9090 ext. 45639, cruisek@rvh.on.ca

    Dr. Renee Hanrahan

    Recruiting

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

    Recruiting

  • Hamilton Health Sciences Centre

    Hamilton, Ontario, L8V 1C3

    Dr. Valerie Francescutti, 905-387-9495

    Dr. Valerie Francescutti

    Recruiting

  • BCCA - Cancer Centre for the Southern Interior

    Kelowna, British Columbia, V1Y 5L3

    Christopher Baliski, cbaliski@bccancer.bc.ca

    Christopher Baliski

    Recruiting

  • Oak Valley Health

    Markham, Ontario, L3P 7P3

    Jennifer Zhirui Li, enli@oakvalleyhealth.ca

    Jennifer Zhirui Li

    Recruiting

  • Hopital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4

    Audrey Lamoureux, 514-252-3400 ext. 6258

    Leïla Idrissi Kaïtouni, 514-252-3400 ext. 5853

    Recruiting

  • Centre Hospitalier de l'Universite de Montreal (CHUM)

    Montreal, Quebec, H2X 3E4

    Kerianne Boulva

    Kerianna Boulva

    Recruiting

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1Y 4E9

    Dr. Carolyn Nessim, cnessim@toh.ca

    Dr. Carolyn Nessim

    Recruiting

  • Hotel-Dieu de Quebec

    Québec, Quebec, G1R2J6

    Dr Cindy Boulanger-Gobeil, cindy.boulanger-gobeil@chudequebec.ca

    Dr Cindy Boulanger-Gobeil

    Recruiting

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

    Dr Frances Wright, 416-480-4210

    Dr Frances Wright

    Recruiting

  • UHN - Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2C1

    Alexandra Easson, Dr, Alexandra.Easson@uhn.ca

    Recruiting

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

    Justin Rivard, Dr, 204-787-4156

    Recruiting

Other trials in Canada

Australia10 sites, 10 recruiting

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

    Robert Whitfield, Robert.Whitfield@sa.gov.au

    Robert Whitfield, MD

    Recruiting

  • Princess Alexandra Hospital

    Brisbane, Queensland, 4102

    Prof Mark Smithers

    Prof Mark Smithers

    Not yet recruiting

  • Calvary Public Hospital Bruce

    Bruce, Australian Capital Territory, 2617

    Dr Rebecca Read

    Dr Rebecca Read

    Recruiting

  • The Canberra Hospital

    Garran, Australian Capital Territory, 2605

    Emily Baxter

    Dr Krishna Rao

    Not yet recruiting

  • Robina Hospital

    Gold Coast, Queensland, 4226

    Dr Jennifer Chang

    Dr Jennifer Chang

    Not yet recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria

    Michael Henderson

    Prof Michael Henderson

    Recruiting

  • The Alfred Hospital

    Melbourne, Victoria

    Dr Frank Bruscino-Raiola

    Dr Frank Bruscino-Raiola

    Recruiting

  • Westmead Hospital

    Sydney, New South Wales, 2145

    Pablo Fernandez-Peñas, pablo.fernandezpenas@sydney.edu.au

    Prof Pablo Fernandez-Peñas

    Recruiting

  • Melanoma Institute Australia

    Sydney, New South Wales

    Andrew Spillane

    Prof Andrew Spillane

    Recruiting

  • Royal Prince Alfred Hospital

    Sydney, New South Wales

    Robyn Saw

    A/Prof Robyn Saw

    Recruiting

Other trials in Australia

Netherlands10 sites, 10 recruiting

  • Flevo Hospital

    Almere Stad, Flevoland

    Gwen Diepenhorst

    gdiepenhorst@flevoziekenhuis.nl

    Recruiting

  • Ziekenhuis Gelderse Vallei

    Ede, Gelderland, 6716 RP

    Miriam L Hoven-Gondrie, HovenM@zgv.nl

    Miriam L Hoven-Gondrie

    Recruiting

  • Maxima Medical Centre, Eindhoven

    Eindhoven, North Brabant, 5631

    Sabrina Maaskant

    Sabrina Maaskant

    Recruiting

  • University Medical Centre Groningen

    Groningen, 9713

    Barbara Leeuwen, b.l.van.leeuwen@umcg.nl

    Barbara Leeuwen

    Recruiting

  • Zuyderland Medical Center

    Heerlen, 6419

    James van Bastelaar, Dr

    Recruiting

  • Maastricht University Medical Center

    Maastricht, 6229 HX

    Kevin Wevers, Kevin.wevers@mumc.nl

    Kevin Wevers

    Recruiting

  • Diakonessenhuis

    Utrecht, 3582 KE

    Barbara Molenkamp

    Barbara Molenkamp

    Recruiting

  • Maxima Medical Center - Veldhoven

    Veldhoven, 5504

    Sabrina Maaskant

    Sabrina Maaskant

    Recruiting

  • Gelre Hospital

    Zutphen, Gelderland, 7207 AE

    Dominique van Uden, MD, d.van.uden@gerle.nl

    Dominique van Uden, MD

    Recruiting

  • Isala Hospital

    Zwolle, 8025

    Anne-Brecht Francken

    Anne-Brecht Francken

    Recruiting

Other trials in Netherlands

Ireland3 sites, 3 recruiting

  • Cork University Hospital

    Cork

    Prof Jim Clover, BMEd Sci,BM BS,MRCS,MD,FFERCS, 0214922575

    Recruiting

  • Mater Misericordiae University Hospital

    Dublin, D07 R2WY

    Shirley Potter, shirleypott@gmail.com

    Shirley Potter

    Recruiting

  • St James Hospital

    Dublin, D08 NHY1

    Marlese Dempsey, marlesedempsey@gmail.com

    Marlese Dempsey

    Recruiting

Other trials in Ireland

Italy3 sites, 3 recruiting

  • IOV Istituto Oncologico Veneto IRCCS-Padova

    Padova, 35128

    Romina Spina

    Dr Simone Mocellin

    Not yet recruiting

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

    Alessandra Ferrari

    Prof Alessandro Testori

    Not yet recruiting

  • AOU Città della Salute e della Scienza di Torino

    Torino, 10126

    Valentina Pala

    Dr. Franco Picciotto

    Not yet recruiting

Other trials in Italy

Sweden2 sites, 2 recruiting

  • Sahlgrenska University Hospital

    Gothenburg

    Roger Olofsson Bagge, (0)31-3428207 ext. +46, roger.olofsson.bagge@gu.se

    Prof Roger Olofsson Bagge

    Recruiting

  • Central Hospital Kristianstad

    Kristianstad, 29133

    Dr Karolin Isaksson, karolin.isaksson@med.lu.se

    Dr Karolin Isaksson

    Recruiting

Other trials in Sweden

New Zealand1 site, 1 recruiting

  • North Shore Hospital

    Auckland, 0620

    Dr Richard Martin

    Dr Richard Martin

    Recruiting

Other trials in New Zealand

Slovenia1 site, 1 recruiting

  • Institute of Oncology Ljubljana

    Ljubljana, 1000

    Barbara Peric, MD, PhD

    Barbara Peric, MD, PhD

    Recruiting

Other trials in Slovenia

About this study

Official title: Melanoma Margins Trial-II - A Phase III, Multi-centre Randomised Controlled Trial Investigating 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma (02.18 MelMarT-II)

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.

Read the 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.

Being tested
Wide Local Excision = 1cm Margin, Wide Local Excision = 2cm Margin
Keywords
Malignant, Melanoma, Cancer, Surgery
Medical subject headings
Melanoma, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Wide Local Excision = 1cm MarginProcedure or surgery

    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.

  • Wide Local Excision = 2cm MarginProcedure or surgery

    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.

Study groups in NCT03860883
Study groupRoleWhat they receive
Arm A (Wide Local Excision = 1cm Margin)Experimental1cm Wide Local Excision margin + Sentinel Lymph Node Biopsy +/- Reconstruction
Receives: Procedure: Wide Local Excision = 1cm Margin
Arm B (Wide Local Excision = 2cm Margin)Active comparator2 cm Wide Local Excision margin + Sentinel Lymph Node Biopsy +/- Reconstruction
Receives: Procedure: Wide Local Excision = 2cm Margin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-Free Survival

    Time from randomisation until the first clinically, histologically or radiologically confirmed recurrence of melanoma at any body site, or death from any cause.

    Measured: 0-60 months

Secondary outcomes (10)

  1. Local Recurrence

    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.

    Measured: Day 0-Trial Completion (max. 120 months)

  2. Distant Disease-Free Survival

    Time from randomisation to any clinically, histologically or radiologically confirmed distant recurrence of melanoma or death from any cause

    Measured: Day 0-Trial Completion (max. 120 months)

  3. Melanoma-Specific Survival

    Time from randomisation to death due to melanoma

    Measured: Day 0-Trial Completion (max. 120 months)

  4. Overall Survival

    Time from randomisation to death from any cause

    Measured: Day 0-Trial Completion (max. 120 months)

  5. Melanoma-specific Quality of Life: FACT-M questionnaire

    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.

    Measured: Baseline, 3, 6, 12 & 24 months

  6. Neuropathic Pain: PainDetect questionnaire

    Measured by PainDetect questionnaire

    Measured: Baseline, 3, 6, 12 & 24 months

  7. Health-related Quality of Life: EQ-5D-5L questionnaire

    Measured by EuroQoL EQ-5D-5L questionnaire - This tool contains 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

    Measured: Baseline, 3, 6, 12 & 24 months

  8. Surgery Related Adverse Events

    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

    Measured: Up to 12-months from the date of surgery

  9. Health Economic Evaluation

    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.

    Measured: Baseline, 3, 6, 12 & 24 months

  10. Serious Adverse Events

    All Serious Adverse events (SAEs), will be recorded from randomisation until 12 months post the surgical intervention or until the patient withdraws or dies.

    Measured: from randomisation up to 12-months post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2019
  2. Study start17 Dec 2019
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completion31 Dec 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,998 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03860883
Sponsor's protocol ID
02.18
Acronym
MelMarT-II
Status last verified
Nov 2024
First submitted
7 Feb 2019
Last updated
27 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Wide Local Excision = 1cm Margin and Wide Local Excision = 2cm Margin in people with Cutaneous Melanoma, Stage II, run by Melanoma and Skin Cancer Trials Limited at 192 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 192 sites in United States, United Kingdom, Canada, Australia, Netherlands and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Melanoma and Skin Cancer Trials Coordinator (+61 3 9903 9022, melmart@masc.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-Free Survival (time frame: 0-60 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03860883.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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