Comparing the Effectiveness of Less Invasive Procedures With the Current Standard of Care for the Treatment of Older Adults With Early-Stage Melanoma
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
Interventions
Adjuvant Therapy
Comprehensive Geriatric Assessment
Computed Tomography
Positron Emission Tomography
Questionnaire Administration
Sentinel Lymph Node Biopsy
Surveillance
Ultrasound Imaging
Wide Local Excision
Conditions
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
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Hi-Line Sletten Cancer Center
Havre, Montana 59501
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Benefis Helena Specialty Center
Helena, Montana 59601
United States
Logan Health Medical Center
Kalispell, Montana 59901
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Community Medical Center
Missoula, Montana 59804
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CHI Health Saint Francis
Grand Island, Nebraska 68803
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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
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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
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Hackettstown Medical Center
Hackettstown, New Jersey 07840
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Monmouth Medical Center
Long Branch, New Jersey 07740
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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
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Sanford Roger Maris Cancer Center
Fargo, North Dakota 58122
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UH Seidman Cancer Center at UH Avon Health Center
Avon, Ohio 44011
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UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio 44122
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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
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Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania 19317
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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
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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
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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