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NCT07068074PHASE3Recruiting

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

ECOG-ACRIN Cancer Research Group

Start Date

4/17/2026

Completion Date

1/1/2031

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. 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: I. 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: I. 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. V. 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.

Eligibility Criteria

Age Range: 75 years to No maximum

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.

Interventions

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

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Conditions

Cutaneous Melanoma

Locations

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama 35233

United States

Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis

Daphne, Alabama 36526

United States

Thomas Hospital

Fairhope, Alabama 36532

United States

Mobile Infirmary Medical Center

Mobile, Alabama 36607

United States

Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland

Saraland, Alabama 36571

United States

Fairbanks Memorial Hospital

Fairbanks, Alaska 99701

United States

Cancer Center at Saint Joseph's

Phoenix, Arizona 85004

United States

Mission Hope Medical Oncology - Arroyo Grande

Arroyo Grande, California 93420

United States

Mercy Cancer Center - Carmichael

Carmichael, California 95608

United States

Mercy San Juan Medical Center

Carmichael, California 95608

United States

Mercy Cancer Center - Elk Grove

Elk Grove, California 95758

United States

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California 92612

United States

UC San Diego Moores Cancer Center

La Jolla, California 92093

United States

Veterans Affairs Loma Linda Healthcare System

Loma Linda, California 92357

United States

Los Angeles General Medical Center

Los Angeles, California 90033

United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California 90033

United States

Mercy Cancer Center

Merced, California 95340

United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California 92868

United States

Mercy Cancer Center - Rocklin

Rocklin, California 95765

United States

Mercy Cancer Center - Sacramento

Sacramento, California 95816

United States

Pacific Central Coast Health Center-San Luis Obispo

San Luis Obispo, California 93401

United States

Mission Hope Medical Oncology - Santa Maria

Santa Maria, California 93444

United States

Saint Joseph's Medical Center

Stockton, California 95204

United States

Woodland Memorial Hospital

Woodland, California 95695

United States

UCHealth University of Colorado Hospital

Aurora, Colorado 80045

United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado 80907

United States

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado 80907

United States

Saint Francis Cancer Center

Colorado Springs, Colorado 80923

United States

CommonSpirit Cancer Center Mercy

Durango, Colorado 81301

United States

Mercy Medical Center

Durango, Colorado 81301

United States

CommonSpirit Saint Anthony Hospital Cancer Center

Lakewood, Colorado 80228

United States

Longmont United Hospital

Longmont, Colorado 80501

United States

Saint Mary Corwin Medical Center

Pueblo, Colorado 81004

United States

Saint Anthony North Hospital

Westminster, Colorado 80023

United States

Beebe Medical Center

Lewes, Delaware 19958

United States

Beebe South Coastal Health Campus

Millville, Delaware 19967

United States

Helen F Graham Cancer Center

Newark, Delaware 19713

United States

Medical Oncology Hematology Consultants PA

Newark, Delaware 19713

United States

Christiana Care Health System-Christiana Hospital

Newark, Delaware 19718

United States

Beebe Health Campus

Rehoboth Beach, Delaware 19971

United States

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware 19801

United States

Orlando Health Cancer Institute - Lake Mary

Lake Mary, Florida 32746

United States

Lakeland Regional Health Hollis Cancer Center

Lakeland, Florida 33805

United States

Health Central

Ocoee, Florida 34761

United States

Orlando Health Cancer Institute

Orlando, Florida 32806

United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia 30322

United States

Emory Saint Joseph's Hospital

Atlanta, Georgia 30342

United States

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho 83814

United States

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho 83854

United States

Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho 83864

United States

Loyola Center for Health at Burr Ridge

Burr Ridge, Illinois 60527

United States

Northwestern University

Chicago, Illinois 60611

United States

Swedish Covenant Hospital

Chicago, Illinois 60625

United States

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois 60201

United States

NorthShore University HealthSystem-Glenbrook Hospital

Glenview, Illinois 60026

United States

NorthShore University HealthSystem-Highland Park Hospital

Highland Park, Illinois 60035

United States

Loyola Medicine Homer Glen

Homer Glen, Illinois 60491

United States

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois 60045

United States

Loyola University Medical Center

Maywood, Illinois 60153

United States

Marjorie Weinberg Cancer Center at Loyola-Gottlieb

Melrose Park, Illinois 60160

United States

Northwestern Medicine Orland Park

Orland Park, Illinois 60462

United States

University of Kansas Cancer Center

Kansas City, Kansas 66160

United States

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas 66210

United States

University of Kansas Hospital-Indian Creek Campus

Overland Park, Kansas 66211

United States

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas 66205

United States

CommonSpirit Saint Joseph Hospital - Bardstown

Bardstown, Kentucky 40004

United States

Commonwealth Cancer Center-Corbin

Corbin, Kentucky 40701

United States

CommonSpirit Saint Joseph Hospital - Lexington

Lexington, Kentucky 40504

United States

Saint Joseph Radiation Oncology Resource Center

Lexington, Kentucky 40504

United States

CommonSpirit Saint Joseph Medical Center - East Lexington

Lexington, Kentucky 40509

United States

University of Kentucky/Markey Cancer Center

Lexington, Kentucky 40536

United States

CommonSpirit Saint Joseph Hospital London

London, Kentucky 40741

United States

CommonSpirit Saint Joseph Hospital Mount Sterling

Mount Sterling, Kentucky 40353

United States

LSU Health Baton Rouge-North Clinic

Baton Rouge, Louisiana 70805

United States

Our Lady of the Lake Physician Group

Baton Rouge, Louisiana 70808

United States

Christiana Care - Union Hospital

Elkton, Maryland 21921

United States

Bronson Battle Creek

Battle Creek, Michigan 49017

United States

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan 49503

United States

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

Grand Rapids, Michigan 49503

United States

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan 49503

United States

Bronson Methodist Hospital

Kalamazoo, Michigan 49007

United States

West Michigan Cancer Center

Kalamazoo, Michigan 49007

United States

Beacon Kalamazoo Cancer Center

Kalamazoo, Michigan 49009

United States

Beacon Kalamazoo

Kalamazoo, Michigan 49048

United States

Trinity Health Muskegon Hospital

Muskegon, Michigan 49444

United States

Corewell Health Lakeland Hospitals - Niles Hospital

Niles, Michigan 49120

United States

Cancer and Hematology Centers of Western Michigan - Norton Shores

Norton Shores, Michigan 49444

United States

Corewell Health Reed City Hospital

Reed City, Michigan 49677

United States

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

Saint Joseph, Michigan 49085

United States

Corewell Health Lakeland Hospitals - Saint Joseph Hospital

Saint Joseph, Michigan 49085

United States

Munson Medical Center

Traverse City, Michigan 49684

United States

University of Michigan Health - West

Wyoming, Michigan 49519

United States

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota 56601

United States

Sanford Thief River Falls Medical Center

Thief River Falls, Minnesota 56701

United States

University of Kansas Cancer Center - Briarcliff

Kansas City, Missouri 64116

United States

University of Kansas Cancer Center - North

Kansas City, Missouri 64154

United States

University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri 64064

United States

Community Hospital of Anaconda

Anaconda, Montana 59711

United States

Billings Clinic Cancer Center

Billings, Montana 59101

United States

Bozeman Health Deaconess Hospital

Bozeman, Montana 59715

United States

Benefis Sletten Cancer Institute

Great Falls, Montana 59405

United States

Great Falls Clinic

Great Falls, Montana 59405

United States

Hi-Line Sletten Cancer Center

Havre, Montana 59501

United States

Benefis Helena Specialty Center

Helena, Montana 59601

United States

Logan Health Medical Center

Kalispell, Montana 59901

United States

Community Medical Center

Missoula, Montana 59804

United States

CHI Health Saint Francis

Grand Island, Nebraska 68803

United States

CHI Health Good Samaritan

Kearney, Nebraska 68847

United States

Alegent Health Immanuel Medical Center

Omaha, Nebraska 68122

United States

Alegent Health Bergan Mercy Medical Center

Omaha, Nebraska 68124

United States

Alegent Health Lakeside Hospital

Omaha, Nebraska 68130

United States

Renown Regional Medical Center

Reno, Nevada 89502

United States

Hackensack University Medical Center

Hackensack, New Jersey 07601

United States

Hackettstown Medical Center

Hackettstown, New Jersey 07840

United States

Monmouth Medical Center

Long Branch, New Jersey 07740

United States

Morristown Medical Center

Morristown, New Jersey 07960

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey 08903

United States

Newton Medical Center

Newton, New Jersey 07860

United States

John Theurer Cancer Center at From Road

Paramus, New Jersey 07652

United States

Chilton Medical Center

Pompton, New Jersey 07444

United States

Overlook Hospital

Summit, New Jersey 07902

United States

Community Medical Center

Toms River, New Jersey 08755

United States

University of New Mexico Cancer Center

Albuquerque, New Mexico 87106

United States

Lovelace Women's Hospital

Albuquerque, New Mexico 87109

United States

Roswell Park Cancer Institute

Buffalo, New York 14263

United States

Glens Falls Hospital

Glens Falls, New York 12801

United States

NYU Langone Hospital - Long Island

Mineola, New York 11501

United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York 10016

United States

NYU Langone Hospital - Suffolk

Patchogue, New York 11772

United States

Stony Brook University Medical Center

Stony Brook, New York 11794

United States

Montefiore Medical Center-Einstein Campus

The Bronx, New York 10461

United States

Duke Cancer Center Cary

Cary, North Carolina 27518

United States

Duke University Medical Center

Durham, North Carolina 27710

United States

Duke Cancer Center Raleigh

Raleigh, North Carolina 27609

United States

Sanford Bismarck Medical Center

Bismarck, North Dakota 58501

United States

Sanford South University Medical Center

Fargo, North Dakota 58103

United States

Southpointe-Sanford Medical Center Fargo

Fargo, North Dakota 58103

United States

Sanford Medical Center Fargo

Fargo, North Dakota 58104

United States

Sanford Broadway Medical Center

Fargo, North Dakota 58122

United States

Sanford Roger Maris Cancer Center

Fargo, North Dakota 58122

United States

UH Seidman Cancer Center at UH Avon Health Center

Avon, Ohio 44011

United States

UHHS-Chagrin Highlands Medical Center

Beachwood, Ohio 44122

United States

Good Samaritan Hospital - Cincinnati

Cincinnati, Ohio 45220

United States

Bethesda North Hospital

Cincinnati, Ohio 45242

United States

TriHealth Cancer Institute-Westside

Cincinnati, Ohio 45247

United States

TriHealth Cancer Institute-Anderson

Cincinnati, Ohio 45255

United States

Case Western Reserve University

Cleveland, Ohio 44106

United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio 43210

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma 73104

United States

Christiana Care Health System-Concord Health Center

Chadds Ford, Pennsylvania 19317

United States

Fox Chase Cancer Center - East Norriton Hospital Outpatient Center

East Norriton, Pennsylvania 19401

United States

UPMC Hillman Cancer Center Erie

Erie, Pennsylvania 16505

United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania 19107

United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania 19111

United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania 15232

United States

Asplundh Cancer Pavilion

Willow Grove, Pennsylvania 19090

United States

Medical University of South Carolina

Charleston, South Carolina 29425

United States

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee 37232

United States

Central Vermont Medical Center/National Life Cancer Treatment

Berlin Corners, Vermont 05602

United States

University of Vermont Medical Center

Burlington, Vermont 05401

United States

University of Vermont and State Agricultural College

Burlington, Vermont 05405

United States

University of Virginia Cancer Center

Charlottesville, Virginia 22908

United States

VCU Massey Cancer Center at Stony Point

Richmond, Virginia 23235

United States

VCU Massey Comprehensive Cancer Center

Richmond, Virginia 23298

United States

Fred Hutchinson Cancer Center

Seattle, Washington 98109

United States

University of Washington Medical Center - Montlake

Seattle, Washington 98195

United States

Saint Joseph Medical Center Hematology and Oncology - Silverdale

Silverdale, Washington 98383

United States

United Hospital Center

Bridgeport, West Virginia 26330

United States

WVUH-Berkely Medical Center

Martinsburg, West Virginia 25401

United States

West Virginia University Healthcare

Morgantown, West Virginia 26506

United States

Camden Clark Medical Center

Parkersburg, West Virginia 26101

United States

Princeton Community Hospital

Princeton, West Virginia 24740

United States

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin 54449

United States

Froedtert Menomonee Falls Hospital

Menomonee Falls, Wisconsin 53051

United States

Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States

Froedtert and MCW Moorland Reserve Health Center

New Berlin, Wisconsin 53151

United States

Drexel Town Square Health Center

Oak Creek, Wisconsin 53154

United States

Froedtert West Bend Hospital/Kraemer Cancer Center

West Bend, Wisconsin 53095

United States

Marshfield Medical Center - Weston

Weston, Wisconsin 54476

United States

Memorial Hospital of Laramie County

Cheyenne, Wyoming 82001

United States

Billings Clinic-Cody

Cody, Wyoming 82414

United States