Cutaneous MelanomaPhase 3NCT07068074
Comparing the Effectiveness of Less Invasive Procedures With the Current Standard of Care for the Treatment of Older Adults With Early-Stage Melanoma
A Phase 3 study testing Adjuvant Therapy, Comprehensive Geriatric Assessment and Computed Tomography in people with Cutaneous Melanoma, run by ECOG-ACRIN Cancer Research Group at 181 sites in United States.
Trial summary
This phase III trial compares the effect of wide local excision (WLE) alone to usual care with WLE plus sentinel lymph node (SLN) biopsy for the treatment of older adults with early-stage melanoma. A WLE is a surgical procedure performed to cut out an abnormal lesion and some surrounding normal tissue. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Cutaneous Melanoma
- What is being tested?
- Adjuvant Therapy, Comprehensive Geriatric Assessment and Computed Tomography
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 428 participants
- Where
- 181 sitesUnited States
- Study dates
- 17 Apr 2026to 1 Jan 2031
- Phase
- Phase 3
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patient must be ≥ 75 years of age.
- Patient must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible.
- Patient must have newly diagnosed primary cutaneous melanoma with wide local excision (WLE) and sentinel lymph node (SLN) biopsy indicated per the treating physician, pending definitive surgical management.
- NOTE: For WLE and SLN to be indicated, the patient must have either:
- Pathologic features that include ≧ Breslow 0.8 mm OR Breslow < 0.8 mm determined at initial biopsy, with a positive margin, ulceration, lymphovascular invasion, perineural invasion or > 1 mitosis/mm^2.
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- OR
- Risk of SLN metastasis of at least 5%, as calculated using the Melanoma Institute of Australia (MIA) Sentinel Node Metastasis Prediction Tool.
- Patient must be eligible for WLE and SLN biopsy. Patients for whom SLN biopsy would be contraindicated, difficult to perform (i.e., after prior surgery in the draining basin) or impossible (i.e., after prior lymphadenectomy for another cause) are not eligible.
- Patient must be eligible for surgery and not have uncontrolled medical condition that in the opinion of the medical or surgical oncologist precludes surgical management.
- Patient must not have an active infection that precludes enrollment to this study in opinion of treating investigator.
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial.
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association functional classification. To be eligible for this trial, patients should be class 2B or better.
- Patient must be English speaking to be eligible for this study in order to complete the patient-reported outcomes (PROs).
- NOTE: Sites cannot translate the associated quality of life (QOL) forms.
Who cannot join
None listed.
Trial locations and contacts
181 sites in 1 country. Contact the study team or a site near you to ask about taking part.
181 sites in 1 country
United States181 sites, 176 recruiting
- Recruiting
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
Site Public Contact, 505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu
David Savage
- Recruiting
Lovelace Women's Hospital
Albuquerque, New Mexico, 87109
Site Public Contact, 505-272-0530, AYost@nmcca.org
David Savage
- Recruiting
Community Hospital of Anaconda
Anaconda, Montana, 59711
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, 93420
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Site Public Contact, 404-778-1868
Michael Lowe
- Recruiting
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
Site Public Contact, 404-851-7115
Michael Lowe
- Recruiting
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045
Site Public Contact, 720-848-0650
Theresa M. Medina
- Recruiting
UH Seidman Cancer Center at UH Avon Health Center
Avon, Ohio, 44011
Site Public Contact, 800-641-2422
Luke D. Rothermel
- Recruiting
CommonSpirit Saint Joseph Hospital - Bardstown
Bardstown, Kentucky, 40004
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, 70805
Site Public Contact, 225-765-7659, research@ololrmc.com
Sagar G. Kansara
- Recruiting
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana, 70808
Site Public Contact, 225-765-7659, research@ololrmc.com
Sagar G. Kansara
- Recruiting
Bronson Battle Creek
Battle Creek, Michigan, 49017
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, 44122
Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org
Luke D. Rothermel
- Recruiting
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
Site Public Contact, 218-333-5000, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, 05602
Site Public Contact, 802-225-5400
Conor H. O'Neill
- Recruiting
Billings Clinic Cancer Center
Billings, Montana, 59101
Site Public Contact, 800-996-2663, research@billingsclinic.org
John M. Schallenkamp
- Recruiting
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
Site Public Contact, gingerreeves@uabmc.edu
Sarah Bateni
- Recruiting
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
United Hospital Center
Bridgeport, West Virginia, 26330
Site Public Contact, 304-293-7374, cancertrialsinfo@hsc.wvu.edu
Joanna A. Kolodney
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
Site Public Contact, 800-767-9355, askroswell@roswellpark.org
Eleanor A. Fallon
- Recruiting
University of Vermont Medical Center
Burlington, Vermont, 05401
Site Public Contact, 802-656-4101, rpo@uvm.edu
Conor H. O'Neill
- Recruiting
University of Vermont and State Agricultural College
Burlington, Vermont, 05405
Site Public Contact, 802-656-8990, rpo@uvm.edu
Conor H. O'Neill
- Recruiting
Loyola Center for Health at Burr Ridge
Burr Ridge, Illinois, 60527
Site Public Contact, 708-216-9000
Joseph I. Clark
- Recruiting
Mercy Cancer Center - Carmichael
Carmichael, California, 95608
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Mercy San Juan Medical Center
Carmichael, California, 95608
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@commonspirit.org
Shahzad Siddique
- Recruiting
Duke Cancer Center Cary
Cary, North Carolina, 27518
Site Public Contact, NCTNStudyTeam@dm.duke.edu
Jay S. Lee
- Recruiting
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Site Public Contact, 843-792-9321, hcc-clinical-trials@musc.edu
Andrea M. Abbott
- Recruiting
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
Site Public Contact, 434-243-6303, uvacancertrials@hscmail.mcc.virginia.edu
Lynn T. Dengel
- Recruiting
Memorial Hospital of Laramie County
Cheyenne, Wyoming, 82001
Site Public Contact, ecog.rss@jimmy.harvard.edu
John M. Schallenkamp
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Site Public Contact, 312-695-1301, cancer@northwestern.edu
Jeffrey D. Wayne
- Recruiting
Swedish Covenant Hospital
Chicago, Illinois, 60625
Site Public Contact, 773-878-8200
Dhruv Bansal
- Recruiting
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Bethesda North Hospital
Cincinnati, Ohio, 45242
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
TriHealth Cancer Institute-Westside
Cincinnati, Ohio, 45247
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
TriHealth Cancer Institute-Anderson
Cincinnati, Ohio, 45255
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Case Western Reserve University
Cleveland, Ohio, 44106
Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org
Luke D. Rothermel
- Recruiting
Billings Clinic-Cody
Cody, Wyoming, 82414
Site Public Contact, 800-996-2663, research@billingsclinic.org
John M. Schallenkamp
- Recruiting
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, 80907
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Saint Francis Cancer Center
Colorado Springs, Colorado, 80923
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Site Public Contact, 800-293-5066, Jamesline@osumc.edu
Joal Beane
- Recruiting
Commonwealth Cancer Center-Corbin
Corbin, Kentucky, 40701
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis
Daphne, Alabama, 36526
Site Public Contact, 251-435-2273, donna.goggins@infirmaryhealth.org
Udai Sibia
- Recruiting
CommonSpirit Cancer Center Mercy
Durango, Colorado, 81301
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Mercy Medical Center
Durango, Colorado, 81301
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Site Public Contact, 888-275-3853
Jay S. Lee
- Recruiting
Fox Chase Cancer Center - East Norriton Hospital Outpatient Center
East Norriton, Pennsylvania, 19401
Site Public Contact, ecog.rss@jimmy.harvard.edu
Maureen Hill
- Recruiting
Mercy Cancer Center - Elk Grove
Elk Grove, California, 95758
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Christiana Care - Union Hospital
Elkton, Maryland, 21921
Site Public Contact, 410-443-1360, frank.crum@christianacare.org
Gregory A. Masters
- Recruiting
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, 16505
Site Public Contact, 412-864-7716, ClinicalResearchServices@upmc.edu
Yana Najjar
- Recruiting
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, 60201
Site Public Contact, 847-570-2109
Dhruv Bansal
- Recruiting
Fairbanks Memorial Hospital
Fairbanks, Alaska, 99701
Site Public Contact, 907-458-3043, Veronica.Stevenson@foundationhealth.org
John M. Schallenkamp
- Recruiting
Thomas Hospital
Fairhope, Alabama, 36532
Site Public Contact, 251-435-4584
Udai Sibia
- Recruiting
Sanford South University Medical Center
Fargo, North Dakota, 58103
Site Public Contact, 701-234-6161
Daniel Almquist
- Recruiting
Southpointe-Sanford Medical Center Fargo
Fargo, North Dakota, 58103
Site Public Contact, 605-312-3320
Daniel Almquist
- Recruiting
Sanford Medical Center Fargo
Fargo, North Dakota, 58104
Site Public Contact, 800-437-4010
Daniel Almquist
- Recruiting
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
Site Public Contact, 701-234-6161, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Glens Falls Hospital
Glens Falls, New York, 12801
Site Public Contact, 518-926-6700
Conor H. O'Neill
- Recruiting
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, 60026
Site Public Contact, 847-570-2109
Dhruv Bansal
- Recruiting
CHI Health Saint Francis
Grand Island, Nebraska, 68803
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Suspended
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503
- Recruiting
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Great Falls Clinic
Great Falls, Montana, 59405
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Site Public Contact, 551-996-2897
Andrew L. Pecora
- Recruiting
Hackettstown Medical Center
Hackettstown, New Jersey, 07840
Site Public Contact, 973-971-5990
Eric D. Whitman
- Recruiting
Hi-Line Sletten Cancer Center
Havre, Montana, 59501
Site Public Contact, ecog.rss@jimmy.harvard.edu
John M. Schallenkamp
- Recruiting
Benefis Helena Specialty Center
Helena, Montana, 59601
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, 60035
Site Public Contact, 847-570-2109
Dhruv Bansal
- Recruiting
Loyola Medicine Homer Glen
Homer Glen, Illinois, 60491
Site Public Contact, 708-216-9000
Joseph I. Clark
- Recruiting
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 92612
Site Public Contact, 877-827-8839, ucstudy@uci.edu
Thuy Tran
- Recruiting
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Suspended
Beacon Kalamazoo Cancer Center
Kalamazoo, Michigan, 49009
- Suspended
Beacon Kalamazoo
Kalamazoo, Michigan, 49048
- Recruiting
Logan Health Medical Center
Kalispell, Montana, 59901
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
University of Kansas Cancer Center
Kansas City, Kansas, 66160
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Luke V. Selby
- Recruiting
University of Kansas Cancer Center - Briarcliff
Kansas City, Missouri, 64116
Site Public Contact, 913-588-3671
Luke V. Selby
- Recruiting
University of Kansas Cancer Center - North
Kansas City, Missouri, 64154
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Luke V. Selby
- Recruiting
CHI Health Good Samaritan
Kearney, Nebraska, 68847
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Site Public Contact, 858-822-5354, cancercto@ucsd.edu
Theresa Guo
- Recruiting
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045
Site Public Contact, cancertrials@northwestern.edu
Jeffrey D. Wayne
- Recruiting
Orlando Health Cancer Institute - Lake Mary
Lake Mary, Florida, 32746
Site Public Contact, r-adultoncnewops@orlandohealth.com
Rajesh M. Nair
- Recruiting
Lakeland Regional Health Hollis Cancer Center
Lakeland, Florida, 33805
Site Public Contact, 863-904-1900
Manuel A. Molina-Vega
- Recruiting
CommonSpirit Saint Anthony Hospital Cancer Center
Lakewood, Colorado, 80228
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, 64064
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Luke V. Selby
- Recruiting
Beebe Medical Center
Lewes, Delaware, 19958
Site Public Contact, 302-291-6730, research@beebehealthcare.org
Gregory A. Masters
- Recruiting
CommonSpirit Saint Joseph Hospital - Lexington
Lexington, Kentucky, 40504
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Saint Joseph Radiation Oncology Resource Center
Lexington, Kentucky, 40504
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
CommonSpirit Saint Joseph Medical Center - East Lexington
Lexington, Kentucky, 40509
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
Site Public Contact, 859-257-3379
Irada Ibrahim-Zada
- Recruiting
Veterans Affairs Loma Linda Healthcare System
Loma Linda, California, 92357
Site Public Contact, 800-741-8387
Mark E. Reeves
- Recruiting
CommonSpirit Saint Joseph Hospital London
London, Kentucky, 40741
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Monmouth Medical Center
Long Branch, New Jersey, 07740
Site Public Contact, 732-923-6564, mary.danish@rwjbh.org
Jessica A. Cintolo-Gonzalez
- Recruiting
Longmont United Hospital
Longmont, Colorado, 80501
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Los Angeles General Medical Center
Los Angeles, California, 90033
Site Public Contact, 323-865-0451, uscnorrisinfo@med.usc.edu
Fumito Ito
- Recruiting
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Site Public Contact, 323-865-0451
Fumito Ito
- Recruiting
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Rohit Sharma
- Recruiting
WVUH-Berkely Medical Center
Martinsburg, West Virginia, 25401
Site Public Contact, 304-293-7374, cancertrialsinfo@hsc.wvu.edu
Joanna A. Kolodney
- Recruiting
Loyola University Medical Center
Maywood, Illinois, 60153
Site Public Contact, 708-226-4357
Joseph I. Clark
- Recruiting
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
Melrose Park, Illinois, 60160
Site Public Contact, 708-450-4554
Joseph I. Clark
- Recruiting
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, 53051
Site Public Contact, 262-257-5100
Callisia N. Clarke
- Recruiting
Mercy Cancer Center
Merced, California, 95340
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Beebe South Coastal Health Campus
Millville, Delaware, 19967
Site Public Contact, 302-291-6730, research@beebehealthcare.org
Gregory A. Masters
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Site Public Contact, 414-805-3666
Callisia N. Clarke
- Recruiting
NYU Langone Hospital - Long Island
Mineola, New York, 11501
Site Public Contact, 212-263-4432, cancertrials@nyulangone.org
Erica B. Friedman
- Recruiting
Community Medical Center
Missoula, Montana, 59804
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Mobile Infirmary Medical Center
Mobile, Alabama, 36607
Site Public Contact, 251-435-3942
Udai Sibia
- Recruiting
West Virginia University Healthcare
Morgantown, West Virginia, 26506
Site Public Contact, 304-293-7374, cancertrialsinfo@hsc.wvu.edu
Joanna A. Kolodney
- Recruiting
Morristown Medical Center
Morristown, New Jersey, 07960
Site Public Contact, 973-971-5900
Eric D. Whitman
- Recruiting
CommonSpirit Saint Joseph Hospital Mount Sterling
Mount Sterling, Kentucky, 40353
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Suspended
Trinity Health Muskegon Hospital
Muskegon, Michigan, 49444
- Recruiting
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
Site Public Contact, 800-811-8480
Cameron E. Schlegel
- Recruiting
Froedtert and MCW Moorland Reserve Health Center
New Berlin, Wisconsin, 53151
Site Public Contact, 414-805-0505
Callisia N. Clarke
- Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Site Public Contact, 732-235-7356
Jessica A. Cintolo-Gonzalez
- Recruiting
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016
Site Public Contact, CancerTrials@nyulangone.org
Erica B. Friedman
- Recruiting
Helen F Graham Cancer Center
Newark, Delaware, 19713
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Newton Medical Center
Newton, New Jersey, 07860
Site Public Contact, 973-971-5990
Eric D. Whitman
- Recruiting
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, 49120
Site Public Contact, 616-391-1230
Kathleen Y. Butler
- Suspended
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan, 49444
- Recruiting
Drexel Town Square Health Center
Oak Creek, Wisconsin, 53154
Site Public Contact, 414-805-0505
Callisia N. Clarke
- Recruiting
Health Central
Ocoee, Florida, 34761
Site Public Contact, 888-823-5923, ctsucontact@westat.com
Rajesh M. Nair
- Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu
Ajay Jain
- Recruiting
Alegent Health Immanuel Medical Center
Omaha, Nebraska, 68122
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, 68124
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Alegent Health Lakeside Hospital
Omaha, Nebraska, 68130
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868
Site Public Contact, 877-827-8839, ucstudy@uci.edu
Thuy Tran
- Recruiting
Northwestern Medicine Orland Park
Orland Park, Illinois, 60462
Site Public Contact, nctnprogram_rhlccc@northwestern.edu
Jeffrey D. Wayne
- Recruiting
Orlando Health Cancer Institute
Orlando, Florida, 32806
Site Public Contact, 321-841-7246, CancerClinicalTrials@orlandohealth.com
Rajesh M. Nair
- Recruiting
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, 66210
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Luke V. Selby
- Recruiting
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas, 66211
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Luke V. Selby
- Recruiting
John Theurer Cancer Center at From Road
Paramus, New Jersey, 07652
Site Public Contact, 551-996-2897
Andrew L. Pecora
- Recruiting
Camden Clark Medical Center
Parkersburg, West Virginia, 26101
Site Public Contact, 304-293-7374, cancertrialsinfo@hsc.wvu.edu
Joanna A. Kolodney
- Recruiting
NYU Langone Hospital - Suffolk
Patchogue, New York, 11772
Site Public Contact, cancertrials@nyulangone.org
Erica B. Friedman
- Recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu
Rino Seedor
- Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Site Public Contact, 215-728-4790
Maureen Hill
- Recruiting
Cancer Center at Saint Joseph's
Phoenix, Arizona, 85004
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Site Public Contact, 412-647-8073
Yana Najjar
- Recruiting
Chilton Medical Center
Pompton, New Jersey, 07444
Site Public Contact, 973-971-5990
Eric D. Whitman
- Recruiting
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Princeton Community Hospital
Princeton, West Virginia, 24740
Site Public Contact, 304-487-7515
Joanna A. Kolodney
- Recruiting
Saint Mary Corwin Medical Center
Pueblo, Colorado, 81004
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Duke Cancer Center Raleigh
Raleigh, North Carolina, 27609
Site Public Contact, NCTNStudyTeam@dm.duke.edu
Jay S. Lee
- Recruiting
Corewell Health Reed City Hospital
Reed City, Michigan, 49677
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Beebe Health Campus
Rehoboth Beach, Delaware, 19971
Site Public Contact, 302-291-6730, research@beebehealthcare.org
Gregory A. Masters
- Recruiting
Renown Regional Medical Center
Reno, Nevada, 89502
Site Public Contact, 775-982-5050, Renown-CRD@renown.org
Alicia Gingrich
- Recruiting
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235
Site Public Contact, ctoclinops@vcu.edu
Benjamin Schmidt
- Recruiting
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298
Site Public Contact, 804-628-6430, CTOclinops@vcu.edu
Benjamin Schmidt
- Recruiting
Mercy Cancer Center - Rocklin
Rocklin, California, 95765
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Mercy Cancer Center - Sacramento
Sacramento, California, 95816
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan, 49085
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California, 93401
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, 83864
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Mission Hope Medical Oncology - Santa Maria
Santa Maria, California, 93444
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland
Saraland, Alabama, 36571
Site Public Contact, 251-435-2273, donna.goggins@infirmaryhealth.org
Udai Sibia
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Site Public Contact, 800-804-8824
Katherine Jackson
- Recruiting
University of Washington Medical Center - Montlake
Seattle, Washington, 98195
Site Public Contact, 800-804-8824
Katherine Jackson
- Recruiting
Saint Joseph Medical Center Hematology and Oncology - Silverdale
Silverdale, Washington, 98383
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Saint Joseph's Medical Center
Stockton, California, 95204
Site Public Contact, 209-461-5257
Shahzad Siddique
- Recruiting
Stony Brook University Medical Center
Stony Brook, New York, 11794
Site Public Contact, 800-862-2215
Tara Huston
- Recruiting
Overlook Hospital
Summit, New Jersey, 07902
Site Public Contact, 908-522-2043
Eric D. Whitman
- Recruiting
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461
Site Public Contact, 718-379-6866, eskwak@montefiore.org
Yvonne Saenger
- Recruiting
Sanford Thief River Falls Medical Center
Thief River Falls, Minnesota, 56701
Site Public Contact, 605-312-3320
Daniel Almquist
- Recruiting
Community Medical Center
Toms River, New Jersey, 08755
Site Public Contact, 732-557-8294, Lennette.Gonzales@rwjbh.org
Jessica A. Cintolo-Gonzalez
- Recruiting
Munson Medical Center
Traverse City, Michigan, 49684
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin, 53095
Site Public Contact, 414-805-0505
Callisia N. Clarke
- Recruiting
Saint Anthony North Hospital
Westminster, Colorado, 80023
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Rohit Sharma
- Recruiting
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Luke V. Selby
- Recruiting
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, 19090
Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu
Rino Seedor
- Recruiting
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, 19801
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Woodland Memorial Hospital
Woodland, California, 95695
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
University of Michigan Health - West
Wyoming, Michigan, 49519
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
About this study
Official title: A Randomized Phase III Study of Management of Treatment Naive Primary Melanoma in Elderly Patients
This phase III trial compares the effect of wide local excision (WLE) alone to usual care with WLE plus sentinel lymph node (SLN) biopsy for the treatment of older adults with early-stage melanoma. A WLE is a surgical procedure performed to cut out an abnormal lesion and some surrounding normal tissue. This is sometimes followed by a SLN biopsy, in which lymph nodes that tumor cells could spread to are removed as well. Using WLE alone may be just as effective as usual care in treating older adults with early-stage melanoma.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate and compare 2-year recurrence-free survival (RFS) rates in both study arms.
II. To evaluate patient-reported outcomes (PRO) at 2 years (as measured by the change in Functional Assessment of Cancer Therapy-Melanoma [FACT-M] total score) in both study arms.
SECONDARY OBJECTIVES:
- To evaluate and compare RFS, overall survival (OS), melanoma-specific survival (MSS), safety and PRO (at various endpoints).
II. To evaluate the correlation between practical geriatric assessment (PGA) findings at baseline by domain and study outcomes including RFS, OS, MSS.
III. To evaluate the correlation between changes in PGA scores over the study period and study outcomes including RFS, OS, MSS.
IV. To use the baseline and follow up geriatric assessment (GA) data to develop an assessment tool to allow for future risk assessment for older adults with early-stage melanoma to guide the decision regarding surgical approach.
- To validate the practical geriatric assessment instrument with data obtained from this study.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients undergo WLE plus SLN biopsy and may undergo surveillance of nodal basin as usual care on study. Patients may receive adjuvant therapy as clinically indicated. Additionally, patients may undergo computed tomography (CT), positron emission tomography (PET)/CT or ultrasound throughout the study.
ARM B: Patients undergo WLE and surveillance of nodal basin on study. Patients may receive adjuvant therapy as clinically indicated. Additionally, patients may undergo CT, PET/CT or ultrasound throughout the study.
After completion of study treatment, patients are followed up every 4 months for 2 years post-randomization and then every 6 months until 5 years post-randomization.
- Conditions
- Cutaneous Melanoma
- Being tested
- Adjuvant Therapy, Comprehensive Geriatric Assessment, Computed Tomography, Positron Emission Tomography, Questionnaire Administration
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvant TherapyProcedure or surgery
Also called adjunct therapy, adjunctive therapy, AJ-Adjuvant Therapy
Receive adjuvant therapy
Comprehensive Geriatric AssessmentOther
Ancillary studies
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)
Undergo PET/CT
Questionnaire AdministrationOther
Ancillary studies
Sentinel Lymph Node BiopsyProcedure or surgery
Also called Sentinel Node Biopsy, Sentinel node biopsy alone, SLNB, SNB
Undergo SLN biopsy
SurveillanceBehavioural
Also called Epidemiology / Surveillance
Undergo surveillance of nodal basin
Ultrasound ImagingProcedure or surgery
Also called 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, Ultrasonography
Undergo ultrasound
Wide Local ExcisionProcedure or surgery
Also called Wide Resection
Undergo WLE
| Study group | Role | What they receive |
|---|---|---|
| Arm A (WLE, SLN biopsy) | Active comparator | Patients undergo WLE plus SLN biopsy and may undergo surveillance of nodal basin as usual care on study. Patients may receive adjuvant therapy as clinically indicated. Additionally, patients may undergo CT, PET/CT or ultrasound throughout the study. Receives: Procedure: Adjuvant Therapy; Other: Comprehensive Geriatric Assessment; Procedure: Computed Tomography; Procedure: Positron Emission Tomography; Other: Questionnaire Administration; Procedure: Sentinel Lymph Node Biopsy; Behavioral: Surveillance; Procedure: Ultrasound Imaging; Procedure: Wide Local Excision |
| Arm B (WLE) | Experimental | Patients undergo WLE and surveillance of nodal basin on study. Patients may receive adjuvant therapy as clinically indicated. Additionally, patients may undergo CT, PET/CT or ultrasound throughout the study. Receives: Procedure: Adjuvant Therapy; Other: Comprehensive Geriatric Assessment; Procedure: Computed Tomography; Procedure: Positron Emission Tomography; Other: Questionnaire Administration; Behavioral: Surveillance; Procedure: Ultrasound Imaging; Procedure: Wide Local Excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence free survival (RFS) rate
Will evaluate RFS rate. Will compare the co-primary endpoints in a hierarchical manner starting with RFS rate. The 2-year RFS rate will be estimated from the Kaplan-Meier curve and compared between treatment arms via two sample binomial test, and the 95% confidence interval (CI) will be provided. Will be measured on the intention-to-treat patient cohort. Patients that have not had an event reported at analysis will be censored at their date of last follow-up. Patients who drop out or are lost to follow up before 2 years will be censored.
Measured: From randomization to recurrence of disease or death from any cause, assessed at 2 years
Patient reported outcome (PRO)
Will compare the co-primary endpoints in a hierarchical manner starting with RFS rate. If RFS rate in non-inferior (wide local incision [WLE] is non-inferior to WLE plus sentinel lymph node biopsy) will proceed to evaluate PRO as a co-primary endpoint. Will measure patients quality of life by Functional Assessment of Cancer Therapy-Melanoma (FACT-M) score. The FACT-M score change will be calculated by FACT-M score at 2 years minus the FACT-M score at baseline. Descriptive analyses will be conducted for baseline scores, 2-year scores and the change. The change scores will be compared between the two study arms with two sample t test. 95% CI will be provided. If RFS rate is inferior will proceed to evaluate PRO as an exploratory endpoint.
Measured: Baseline to 2 years
Secondary outcomes (6)
RFS
Will evaluate RFS. Will be measured on the intention-to-treat patient cohort. Survival analyses will be performed using the Kaplan-Meier curve and compared between the two treatment arms by stratified log-rank test. Estimates at 2 years will be summarized along with median time for those events that reach a median survival at or before 2 years.
Measured: From randomization to recurrence of disease or death from any cause, assessed up to 2 years
Overall Survival (OS)
Will evaluate OS. Will be measured on the intention-to-treat patient cohort. Survival analyses will be performed using the Kaplan-Meier curve and compared between the two treatment arms by stratified log-rank test. Estimates at 2 years will be summarized along with median time for those events that reach a median survival at or before 2 years.
Measured: From randomization to death from any cause, assessed up to 2 years
Melanoma-specific survival (MSS)
Will evaluate MSS. Will be measured on the intention-to-treat patient cohort. Survival analyses will be performed using the Kaplan-Meier curve and compared between the two treatment arms by stratified log-rank test. Estimates at 2 years will be summarized along with median time for those events that reach a median survival at or before 2 years. Patients who have not died will be censored at the date last known to be alive.
Measured: From randomization to death due to melanoma, assessed up to 2 years
Incidence of adverse events (AEs)
Will evaluate AEs. All subjects will be included in the safety analysis, with toxicities graded according to National Cancer Institute Common Terminology Criteria for Adverse Events. Incidence tables will be generated to summarize incidence of patients reporting at least one episode of each specific AE, incidence of AEs causing withdrawals and incidence of serious AEs. Listing of AEs by patients will include the time to onset, the duration of each event, the severity of each event, and the relationship of the event to study therapy, whether it was a serious event, and whether it caused withdrawal.
Measured: Baseline to after surgery
PRO
Will evaluate PRO. Quality of life questionnaires will be scored and summarized at each timepoint within and after 2 years. Parametric assumptions will be assessed using Shapiro-Wilk statistics and qqplots and non-parametric alternatives will be considered when necessary. Scores will be analyzed using an appropriate longitudinal modeling approach (e.g., mixed-effects linear modeling assuming normality of scores) to compare patterns over time between treatment groups.
Measured: Up to 5 years
Geriatric factors
Will analyze geriatric factors evaluated by the baseline practical geriatric assessment domains, to better understand factors affecting older adults diagnosed with localized melanoma. Will investigate the associations of survival outcomes and practical geriatric assessment scores by domains. Will use Cronbach's alpha test to test for an internal consistency for each domain. Will also use the intra-class correlation test to assess the level of agreement of each domain score at different timepoints. Will use Cohen's kappa test to test the agreement over different timepoints for specific items of interest.
Measured: Baseline to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start17 Apr 2026
- Primary completion1 Jan 2031 (estimated)
- Study completion1 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous MelanomaStudies of the same condition, open and under way.
- More trials run by ECOG-ACRIN Cancer Research GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 428 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ECOG-ACRIN Cancer Research Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Yana Najjar, Principal investigator, ECOG-ACRIN Cancer Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07068074
- Sponsor's protocol ID
- EA6244
- Other IDs
- NCI-2025-01931, EA6244, EA6244, U10CA180820
- Status last verified
- Sep 2026
- First submitted
- 17 Jun 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Study of Management of Treatment Naive Primary Melanoma in Elderly Patients
- ClinicalTrials.gov ID
- NCT07068074
- Acronym / sponsor ID
- EA6244
- Conditions
- Cutaneous Melanoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 428 participants (estimated)
- Lead sponsor
- ECOG-ACRIN Cancer Research GroupResearch network
- Study start
- 17 Apr 2026 (actual)
- Primary completion
- 1 Jan 2031 (estimated)
- Study completion
- 1 Jan 2031 (estimated)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase III trial compares the effect of wide local excision (WLE) alone to usual care with WLE plus sentinel lymph node (SLN) biopsy for the treatment of older adults with early-stage melanoma. A WLE is a surgical procedure performed to cut out an abnormal lesion and some surrounding normal tissue. This is sometimes followed by a SLN biopsy, in which lymph nodes that tumor cells could spread to are removed as well. Using WLE alone may be just as effective as usual care in treating older adults with early-stage melanoma.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate and compare 2-year recurrence-free survival (RFS) rates in both study arms.
II. To evaluate patient-reported outcomes (PRO) at 2 years (as measured by the change in Functional Assessment of Cancer Therapy-Melanoma [FACT-M] total score) in both study arms.
SECONDARY OBJECTIVES:
- To evaluate and compare RFS, overall survival (OS), melanoma-specific survival (MSS), safety and PRO (at various endpoints).
II. To evaluate the correlation between practical geriatric assessment (PGA) findings at baseline by domain and study outcomes including RFS, OS, MSS.
III. To evaluate the correlation between changes in PGA scores over the study period and study outcomes including RFS, OS, MSS.
IV. To use the baseline and follow up geriatric assessment (GA) data to develop an assessment tool to allow for future risk assessment for older adults with early-stage melanoma to guide the decision regarding surgical approach.
- To validate the practical geriatric assessment instrument with data obtained from this study.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients undergo WLE plus SLN biopsy and may undergo surveillance of nodal basin as usual care on study. Patients may receive adjuvant therapy as clinically indicated. Additionally, patients may undergo computed tomography (CT), positron emission tomography (PET)/CT or ultrasound throughout the study.
ARM B: Patients undergo WLE and surveillance of nodal basin on study. Patients may receive adjuvant therapy as clinically indicated. Additionally, patients may undergo CT, PET/CT or ultrasound throughout the study.
After completion of study treatment, patients are followed up every 4 months for 2 years post-randomization and then every 6 months until 5 years post-randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (WLE, SLN biopsy) | Active comparator | Procedure: Adjuvant Therapy, Other: Comprehensive Geriatric Assessment, Procedure: Computed Tomography, Procedure: Positron Emission Tomography, Other: Questionnaire Administration, Procedure: Sentinel Lymph Node Biopsy, Behavioral: Surveillance, Procedure: Ultrasound Imaging, Procedure: Wide Local ExcisionPatients undergo WLE plus SLN biopsy and may undergo surveillance of nodal basin as usual care on study. Patients may receive adjuvant therapy as clinically indicated. Additionally, patients may undergo CT, PET/CT or ultrasound throughout the study. |
| Arm B (WLE) | Experimental | Procedure: Adjuvant Therapy, Other: Comprehensive Geriatric Assessment, Procedure: Computed Tomography, Procedure: Positron Emission Tomography, Other: Questionnaire Administration, Behavioral: Surveillance, Procedure: Ultrasound Imaging, Procedure: Wide Local ExcisionPatients undergo WLE and surveillance of nodal basin on study. Patients may receive adjuvant therapy as clinically indicated. Additionally, patients may undergo CT, PET/CT or ultrasound throughout the study. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (16 listed)
- Patient must be ≥ 75 years of age.
- Patient must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible.
- Patient must have newly diagnosed primary cutaneous melanoma with wide local excision (WLE) and sentinel lymph node (SLN) biopsy indicated per the treating physician, pending definitive surgical management.
- OR
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adjuvant TherapyAlso: adjunct therapy, adjunctive therapy, AJ-Adjuvant TherapyReceive adjuvant therapy | Procedure or surgery | Arm A (WLE, SLN biopsy), Arm B (WLE) |
| Comprehensive Geriatric AssessmentAncillary studies | Other | Arm A (WLE, SLN biopsy), Arm B (WLE) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT | Procedure or surgery | Arm A (WLE, SLN biopsy), Arm B (WLE) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)Undergo PET/CT | Procedure or surgery | Arm A (WLE, SLN biopsy), Arm B (WLE) |
| Questionnaire AdministrationAncillary studies | Other | Arm A (WLE, SLN biopsy), Arm B (WLE) |
| Sentinel Lymph Node BiopsyAlso: Sentinel Node Biopsy, Sentinel node biopsy alone, SLNB, SNBUndergo SLN biopsy | Procedure or surgery | Arm A (WLE, SLN biopsy) |
| SurveillanceAlso: Epidemiology / SurveillanceUndergo surveillance of nodal basin | Behavioural | Arm A (WLE, SLN biopsy), Arm B (WLE) |
| Ultrasound ImagingAlso: 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, UltrasonographyUndergo ultrasound | Procedure or surgery | Arm A (WLE, SLN biopsy), Arm B (WLE) |
| Wide Local ExcisionAlso: Wide ResectionUndergo WLE | Procedure or surgery | Arm A (WLE, SLN biopsy), Arm B (WLE) |
Primary outcome
Recurrence free survival (RFS) rate
Time frame: From randomization to recurrence of disease or death from any cause, assessed at 2 years
Will evaluate RFS rate. Will compare the co-primary endpoints in a hierarchical manner starting with RFS rate. The 2-year RFS rate will be estimated from the Kaplan-Meier curve and compared between treatment arms via two sample binomial test, and the 95% confidence interval (CI) will be provided. Will be measured on the intention-to-treat patient cohort. Patients that have not had an event reported at analysis will be censored at their date of last follow-up. Patients who drop out or are lost to follow up before 2 years will be censored.
Patient reported outcome (PRO)
Time frame: Baseline to 2 years
Will compare the co-primary endpoints in a hierarchical manner starting with RFS rate. If RFS rate in non-inferior (wide local incision [WLE] is non-inferior to WLE plus sentinel lymph node biopsy) will proceed to evaluate PRO as a co-primary endpoint. Will measure patients quality of life by Functional Assessment of Cancer Therapy-Melanoma (FACT-M) score. The FACT-M score change will be calculated by FACT-M score at 2 years minus the FACT-M score at baseline. Descriptive analyses will be conducted for baseline scores, 2-year scores and the change. The change scores will be compared between the two study arms with two sample t test. 95% CI will be provided. If RFS rate is inferior will proceed to evaluate PRO as an exploratory endpoint.
6 secondary outcomes
RFS
Time frame: From randomization to recurrence of disease or death from any cause, assessed up to 2 years
Overall Survival (OS)
Time frame: From randomization to death from any cause, assessed up to 2 years
Melanoma-specific survival (MSS)
Time frame: From randomization to death due to melanoma, assessed up to 2 years
Incidence of adverse events (AEs)
Time frame: Baseline to after surgery
PRO
Time frame: Up to 5 years
Geriatric factors
Time frame: Baseline to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis
Daphne, United States
Yana Najjar principal investigator
ECOG-ACRIN Cancer Research Group
181 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adjuvant Therapy, Comprehensive Geriatric Assessment and Computed Tomography in people with Cutaneous Melanoma, run by ECOG-ACRIN Cancer Research Group at 181 sites in United States.
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 16 inclusion and 0 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 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 181 sites in United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence free survival (RFS) rate (time frame: From randomization to recurrence of disease or death from any cause, assessed at 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Sep 2026.