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)
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.
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.
Inclusion Criteria:
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:
Exclusion Criteria:
Patients will be excluded from the study for ANY of the following reasons:
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.
melmart@masc.org.au+61 3 9903 9022
Mobile, Alabama 36604, United States
jhoward@health.southalabama.edu
tfulford@health.southalabama.edu
Irvine, California 92868, United States
Los Angeles, California 90048-1804, United States
Orange, California 92868, United States
Orange, California 92868, United States
Walnut Creek, California 94596, United States
Washington D.C., District of Columbia 20007, United States
Washington D.C., District of Columbia 20010, United States
Aventura, Florida 33180, United States
Coral Gables, Florida 33146, United States
Coral Springs, Florida 33065, United States
Deerfield Beach, Florida 33442, United States
Hollywood, Florida 33021, United States
Miami, Florida 33136, United States
Miami, Florida 33176, United States
Plantation, Florida 33324, United States
Savannah, Georgia 31405, United States
Lake Forest, Illinois 60045, United States
Indianapolis, Indiana 46202, United States
Indianapolis, Indiana 46202, United States
Overland Park, Kansas 66211, United States
Westwood, Kansas 66205, United States
Brighton, Michigan 48116, United States
Creve Coeur, Missouri 63141, United States
New York, New York 10016, United States
New York, New York 10032, United States
Syracuse, New York 13210, United States
Syracuse, New York 13215, United States
Chapel Hill, North Carolina 27599, United States
Hillsborough, North Carolina 27278, United States
Oklahoma City, Oklahoma 73120-8362, United States
Allentown, Pennsylvania 18104, United States
Bethlehem, Pennsylvania 18015, United States
Easton, Pennsylvania 18045, United States
Quakertown, Pennsylvania 18951, United States
Quakertown, Pennsylvania 18951, United States
San Antonio, Texas 78284-7884, United States
Salt Lake City, Utah 84112, United States
Burlington, Vermont 05405, United States
Newport News, Virginia 23601, United States
Madison, Wisconsin 53718, United States
Edgbaston, Birmingham B15 2TH, United Kingdom
Preston, Lancashire PR2 9HT, United Kingdom
Headington, Oxford OX3 9DU, United Kingdom
East Grinstead, West Sussex RH19 3DZ, United Kingdom
London, SE1 7EH, United Kingdom
Middlesbrough, TS4 3BW, United Kingdom
mark.gimbel@bannerhealth.com
sandra.ortega@bannerhealth.com
pockaj.barbara@mayo.edu
Nelson.Courtney4@mayo.edu
MMavros@uams.edu
gino.in@med.usc.edu
gino.in@med.usc.edu
gino.in@med.usc.edu
gino.in@med.usc.edu
jpharris1@hs.uci.edu
myamamot@hs.uci.edu
akirane@stanford.edu650-725-4169
yuanp@stanford.edu+1 650-498-7061
mfaries@theangelesclinic.org
Tatjana.Kolevska@kp.org
desiree.goldstein@kp.org
Tatjana.Kolevska@kp.org
desiree.goldstein@kp.org
james.clune@yale.edu
james.clune@yale.edu
geofrey.t.gibney@gunet.georgetown.edu
Marc.E.Boisvert@medstar.net
Nicolas.Rojas@medstar.net
jxc2521@med.miami.edu
jxc2521@med.miami.edu
jxc2521@med.miami.edu
jxc2521@med.miami.edu
jxc2521@med.miami.edu
Konstantinos.Chouliaras@bmcjax.com
Jakub.James@mayo.edu
manuel.molina@mylrh.org
jxc2521@med.miami.edu
jxc2521@med.miami.edu
jxc2521@med.miami.edu
Jonathan.zager@moffitt.org
Jonathan.zager@moffitt.org
mlowe3@emory.edu
rachel.ashley.mock@emory.edu
mlowe3@emory.edu
chariesse.aliyya.ellis@emory.edu
nicole.kounalakis@northside.com
drpucketty@sjchs.org
smiths1@sjchs.org
sigrun.hallmeyer@aah.org
jeffrey.wayne@nm.org
jeffrey.wayne@nm.org
jeffrey.wayne@nm.org
jeffrey.wayne@nm.org
sigrun.hallmeyer@aah.org
cheryl.korabik@aah.org
jeffrey.wayne@nm.org
karlb@iu.edu
karlb@iu.edu
juliana.meyer@franciscanalliance.org
lselby@kumc.edu
lselby@kumc.edu
erin.burke@uky.edu
edward.mccarron@medstar.net
angelesc@med.umich.edu
angelesc@med.umich.edu
kyost@crcwm.org
renee.porter@crcwm.org
Kyost@chcwm.com
kyost@chcwm.com
rcfields@wustl.edu
lselby@kumc.edu
rcfields@wustl.edu
bradley.reames@unmc.edu
bradley.reames@unmc.edu
bradley.reames@unmc.edu
ab2047@cinj.rutgers.edu
BFahy@salud.unm.edu
BFahy@salud.unm.edu
akadison@northwell.edu
DDellili@northwell.edu
shalana.obrien@roswellpark.org
akadison@northwell.edu
aamoroso1@northwell.edu
mailto:Erica.Friedman@nyulangone.org
Akadison@northwell.edu
mailto:Erica.Friedman@nyulangone.org
bt2160@cumc.columbia.ed
james.nitzkorski@nuvancehealth.org
karley.flinn@nuvancehealth.orgJames
paul_barr@urmc.rochester.edu
akadison@northwell.edu
ThomasDa@upstate.edu
abernatl@upstate.edu
ThomasDa@upstate.edu
abernatl@upstate.edu
paul_barr@urmc.rochester.edu
sarah_cawley@urmc.rochester.edu
david_ollila@med.unc.edu
jay.lee@duke.edu
joynersu@ecu.edu
david_ollila@med.unc.edu
preston.steen@sanfordhealth.org
preston.steen@sanfordhealth.org
Luke.Rothermel@UHhospitals.org
jrouellett@premierhealth.com
Luke.Rothermel@UHhospitals.org
sussmaj@ucmail.uc.edu
Luke.Rothermel@UHhospitals.org
Joal.Beane@osumc.edu
Luke.Rothermel@UHhospitals.org
sussmaj@ucmail.uc.edu
Luke.Rothermel@UHhospitals.org
William-Dooley@ouhsc.edu
christian.ellis@mercy.net
trisha.strubhar@mercy.net
sandeep.h.mashru@kp.org
sandeep.h.mashru@kp.org
Darius.Desai@sluhn.org
Amy.Grossman@sluhn.org
Darius.Desai@sluhn.org
Darius.Desai@sluhn.org
Darius.Desai@sluhn.org
Darius.Desai@sluhn.org
Amy.Grossman@sluhn.org
david.j.bertsch@guthrie.org
susan.hadlock@guthrie.org
abbottan@musc.edu
daniel.almquist@sanfordhealth.org
daniel.almquist@sanfordhealth.org
jgershen@mdanderson.org
tozzi@uthscsa.edu
bankstonsm@uthscsa.edu
tawnya.bowles@imail.org
Kevin.Adams@imail.org
jessica.cintolo-gonzalez@uvmhealth.org
elizabeth.abrecht@uvmhealth.org
jessica.cintolo-gonzalez@uvmhealth.org
elizabeth.abrecht@uvmhealth.org
LTD5B@uvahealth.org
giao.phan@vcuhealth.org
giao.phan@vcuhealth.org
giao.phan@vcuhealth.org
klcampbell@vcu.edu
giao.phan@vcuhealth.org
neuman@surgery.wisc.edu
neuman@surgery.wisc.edu
neuman@surgery.wisc.edu
shhanson@wisc.ed
sharma.rohit@marshfieldclinic.org
sigrun.hallmeyer@aah.org
jbruening@mcw.edu
cpapageorgio@mcw.edu
sharma.rohit@marshfieldclinic.org
pablo.fernandezpenas@sydney.edu.au
Robert.Whitfield@sa.gov.au
cbaliski@bccancer.bc.ca
204-787-4156
cruisek@rvh.on.ca705-728-9090 ext. 45639
905-387-9495
enli@oakvalleyhealth.ca
cnessim@toh.ca
416-480-4210
Alexandra.Easson@uhn.ca
514-252-3400 ext. 6258
514-252-3400 ext. 5853
cindy.boulanger-gobeil@chudequebec.ca
0214922575
shirleypott@gmail.com
marlesedempsey@gmail.com
gdiepenhorst@flevoziekenhuis.nl
HovenM@zgv.nl
d.van.uden@gerle.nl
b.l.van.leeuwen@umcg.nl
Kevin.wevers@mumc.nl
roger.olofsson.bagge@gu.se(0)31-3428207 ext. +46
karolin.isaksson@med.lu.se
Agustin.Martin-Clavijo@uhb.nhs.uk
polly.king1@nhs.net
paolo.matteucci@hey.nhs.uk
peter.dziewulski1@nhs.net
richard.wain@lthtr.nhs.uk
oliver.cassell@ouh.nhs.uk
jonathan.dunne1@nhs.net
mark.cabelles@nhs.net
siva.kumar1@nhs.net
Ewan.Wilson@nbt.nhs.uk
amit.roshan@addenbrookes.nhs.uk
h.peach@nhs.net
Rowan.PritchardJones@sthk.nhs.uk
stephenhamilton@nhs.net
Jenny.Geh@gstt.nhs.uk
Joy.Odili@stgeorges.nhs.uk
Myles.Smith@rmh.nhs.uk
Myles.Smith@rmh.nhs.uk
deemesh.oudit@nhs.net
o.bassett@nhs.net
Jonathan.Pollock@nuh.nhs.uk