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Comparing the Effectiveness of Less Invasive Procedures With the Current Standard of Care for the Treatment of Older Adults With Early-Stage Melanoma

RecruitingPhase 3

A Randomized Phase III Study of Management of Treatment Naive Primary Melanoma in Elderly Patients

Who can join

Ages 75 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* 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.

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.

About the study

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.

What is being tested

Sponsor: ECOG-ACRIN Cancer Research Group · Participants: 428 · Started: Apr 17, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07068074

Locations in the U.S.

AlabamaUniversity of Alabama at Birmingham Cancer Center, Birmingham
Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis, Daphne
Thomas Hospital, Fairhope
Mobile Infirmary Medical Center, Mobile
Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland, Saraland
AlaskaFairbanks Memorial Hospital, Fairbanks
ArizonaCancer Center at Saint Joseph's, Phoenix
CaliforniaMission Hope Medical Oncology - Arroyo Grande, Arroyo Grande
Mercy Cancer Center - Carmichael, Carmichael
Mercy San Juan Medical Center, Carmichael
Mercy Cancer Center - Elk Grove, Elk Grove
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care, Irvine
UC San Diego Moores Cancer Center, La Jolla
Veterans Affairs Loma Linda Healthcare System, Loma Linda
Los Angeles General Medical Center, Los Angeles
USC / Norris Comprehensive Cancer Center, Los Angeles
Mercy Cancer Center, Merced
UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange
Mercy Cancer Center - Rocklin, Rocklin
Mercy Cancer Center - Sacramento, Sacramento
Pacific Central Coast Health Center-San Luis Obispo, San Luis Obispo
Mission Hope Medical Oncology - Santa Maria, Santa Maria
Saint Joseph's Medical Center, Stockton
Woodland Memorial Hospital, Woodland
ColoradoUCHealth University of Colorado Hospital, Aurora
Penrose-Saint Francis Healthcare, Colorado Springs
Rocky Mountain Cancer Centers-Penrose, Colorado Springs
Saint Francis Cancer Center, Colorado Springs
CommonSpirit Cancer Center Mercy, Durango
Mercy Medical Center, Durango
CommonSpirit Saint Anthony Hospital Cancer Center, Lakewood
Longmont United Hospital, Longmont
Saint Mary Corwin Medical Center, Pueblo
Saint Anthony North Hospital, Westminster
DelawareBeebe Medical Center, Lewes
Beebe South Coastal Health Campus, Millville
Christiana Care Health System-Christiana Hospital, Newark
Helen F Graham Cancer Center, Newark
Medical Oncology Hematology Consultants PA, Newark
Beebe Health Campus, Rehoboth Beach
Christiana Care Health System-Wilmington Hospital, Wilmington
FloridaOrlando Health Cancer Institute - Lake Mary, Lake Mary
Lakeland Regional Health Hollis Cancer Center, Lakeland
Health Central, Ocoee
Orlando Health Cancer Institute, Orlando
GeorgiaEmory Saint Joseph's Hospital, Atlanta
Emory University Hospital/Winship Cancer Institute, Atlanta
IdahoKootenai Health - Coeur d'Alene, Coeur d'Alene
Kootenai Clinic Cancer Services - Post Falls, Post Falls
Kootenai Clinic Cancer Services - Sandpoint, Sandpoint
IllinoisLoyola Center for Health at Burr Ridge, Burr Ridge
Northwestern University, Chicago
Swedish Covenant Hospital, Chicago
NorthShore University HealthSystem-Evanston Hospital, Evanston
NorthShore University HealthSystem-Glenbrook Hospital, Glenview
NorthShore University HealthSystem-Highland Park Hospital, Highland Park
Loyola Medicine Homer Glen, Homer Glen
Northwestern Medicine Lake Forest Hospital, Lake Forest
Loyola University Medical Center, Maywood
Marjorie Weinberg Cancer Center at Loyola-Gottlieb, Melrose Park
Northwestern Medicine Orland Park, Orland Park
KansasUniversity of Kansas Cancer Center, Kansas City
University of Kansas Cancer Center-Overland Park, Overland Park
University of Kansas Hospital-Indian Creek Campus, Overland Park
University of Kansas Hospital-Westwood Cancer Center, Westwood
KentuckyCommonSpirit Saint Joseph Hospital - Bardstown, Bardstown
Commonwealth Cancer Center-Corbin, Corbin
CommonSpirit Saint Joseph Hospital - Lexington, Lexington
CommonSpirit Saint Joseph Medical Center - East Lexington, Lexington
Saint Joseph Radiation Oncology Resource Center, Lexington
University of Kentucky/Markey Cancer Center, Lexington
CommonSpirit Saint Joseph Hospital London, London
CommonSpirit Saint Joseph Hospital Mount Sterling, Mount Sterling
LouisianaLSU Health Baton Rouge-North Clinic, Baton Rouge
Our Lady of the Lake Physician Group, Baton Rouge
MarylandChristiana Care - Union Hospital, Elkton
MichiganBronson Battle Creek, Battle Creek
Corewell Health Grand Rapids Hospitals - Butterworth Hospital, Grand Rapids
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital, Grand Rapids
Bronson Methodist Hospital, Kalamazoo
West Michigan Cancer Center, Kalamazoo
Corewell Health Lakeland Hospitals - Niles Hospital, Niles
Corewell Health Reed City Hospital, Reed City
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center, Saint Joseph
Corewell Health Lakeland Hospitals - Saint Joseph Hospital, Saint Joseph
Munson Medical Center, Traverse City
University of Michigan Health - West, Wyoming
MinnesotaSanford Joe Lueken Cancer Center, Bemidji
Sanford Thief River Falls Medical Center, Thief River Falls
MissouriUniversity of Kansas Cancer Center - Briarcliff, Kansas City
University of Kansas Cancer Center - North, Kansas City
University of Kansas Cancer Center - Lee's Summit, Lee's Summit
MontanaCommunity Hospital of Anaconda, Anaconda
Billings Clinic Cancer Center, Billings
Bozeman Health Deaconess Hospital, Bozeman
Benefis Sletten Cancer Institute, Great Falls
Great Falls Clinic, Great Falls
Hi-Line Sletten Cancer Center, Havre
Benefis Helena Specialty Center, Helena
Logan Health Medical Center, Kalispell
Community Medical Center, Missoula
NebraskaCHI Health Saint Francis, Grand Island
CHI Health Good Samaritan, Kearney
Alegent Health Bergan Mercy Medical Center, Omaha
Alegent Health Immanuel Medical Center, Omaha
Alegent Health Lakeside Hospital, Omaha
NevadaRenown Regional Medical Center, Reno
New JerseyHackensack University Medical Center, Hackensack
Hackettstown Medical Center, Hackettstown
Monmouth Medical Center, Long Branch
Morristown Medical Center, Morristown
Rutgers Cancer Institute of New Jersey, New Brunswick
Newton Medical Center, Newton
John Theurer Cancer Center at From Road, Paramus
Chilton Medical Center, Pompton
Overlook Hospital, Summit
Community Medical Center, Toms River
New MexicoLovelace Women's Hospital, Albuquerque
University of New Mexico Cancer Center, Albuquerque
New YorkRoswell Park Cancer Institute, Buffalo
Glens Falls Hospital, Glens Falls
NYU Langone Hospital - Long Island, Mineola
Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York
NYU Langone Hospital - Suffolk, Patchogue
Stony Brook University Medical Center, Stony Brook
Montefiore Medical Center-Einstein Campus, The Bronx
North CarolinaDuke Cancer Center Cary, Cary
Duke University Medical Center, Durham
Duke Cancer Center Raleigh, Raleigh
North DakotaSanford Bismarck Medical Center, Bismarck
Sanford Broadway Medical Center, Fargo
Sanford Medical Center Fargo, Fargo
Sanford Roger Maris Cancer Center, Fargo
Sanford South University Medical Center, Fargo
Southpointe-Sanford Medical Center Fargo, Fargo
OhioUH Seidman Cancer Center at UH Avon Health Center, Avon
UHHS-Chagrin Highlands Medical Center, Beachwood
Bethesda North Hospital, Cincinnati
Good Samaritan Hospital - Cincinnati, Cincinnati
TriHealth Cancer Institute-Anderson, Cincinnati
TriHealth Cancer Institute-Westside, Cincinnati
Case Western Reserve University, Cleveland
Ohio State University Comprehensive Cancer Center, Columbus
OklahomaUniversity of Oklahoma Health Sciences Center, Oklahoma City
PennsylvaniaChristiana Care Health System-Concord Health Center, Chadds Ford
Fox Chase Cancer Center - East Norriton Hospital Outpatient Center, East Norriton
UPMC Hillman Cancer Center Erie, Erie
Fox Chase Cancer Center, Philadelphia
Thomas Jefferson University Hospital, Philadelphia
UPMC Hillman Cancer Center, Pittsburgh
Asplundh Cancer Pavilion, Willow Grove
South CarolinaMedical University of South Carolina, Charleston
TennesseeVanderbilt University/Ingram Cancer Center, Nashville
VermontCentral Vermont Medical Center/National Life Cancer Treatment, Berlin Corners
University of Vermont Medical Center, Burlington
University of Vermont and State Agricultural College, Burlington
VirginiaUniversity of Virginia Cancer Center, Charlottesville
VCU Massey Cancer Center at Stony Point, Richmond
VCU Massey Comprehensive Cancer Center, Richmond
WashingtonFred Hutchinson Cancer Center, Seattle
University of Washington Medical Center - Montlake, Seattle
Saint Joseph Medical Center Hematology and Oncology - Silverdale, Silverdale
West VirginiaUnited Hospital Center, Bridgeport
WVUH-Berkely Medical Center, Martinsburg
West Virginia University Healthcare, Morgantown
Camden Clark Medical Center, Parkersburg
Princeton Community Hospital, Princeton
WisconsinMarshfield Medical Center-Marshfield, Marshfield
Froedtert Menomonee Falls Hospital, Menomonee Falls
Medical College of Wisconsin, Milwaukee
Froedtert and MCW Moorland Reserve Health Center, New Berlin
Drexel Town Square Health Center, Oak Creek
Froedtert West Bend Hospital/Kraemer Cancer Center, West Bend
Marshfield Medical Center - Weston, Weston
WyomingMemorial Hospital of Laramie County, Cheyenne
Billings Clinic-Cody, Cody

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.