Melanoma (Skin Cancer)

EA6244


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

STATUS: Active


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.
  • 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.

United States
AK
Fairbanks
Fairbanks Memorial Hospital
Contact: Site Public Contact
Email: [email protected]

AL
Birmingham
University of Alabama at Birmingham Cancer Center
Contact: Site Public Contact
Email: [email protected]

Daphne
Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis
Contact: Site Public Contact
Email: [email protected]

Fairhope
Thomas Hospital
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Mobile
Mobile Infirmary Medical Center
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Saraland
Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland
Contact: Site Public Contact
Email: [email protected]

AZ
Phoenix
Cancer Center at Saint Joseph's
Contact: Site Public Contact
Email: [email protected]

CA
Arroyo Grande
Mission Hope Medical Oncology - Arroyo Grande
Contact: Site Public Contact
Email: [email protected]

Carmichael
Mercy Cancer Center - Carmichael
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Email: [email protected]

Mercy San Juan Medical Center
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Email: [email protected]

Elk Grove
Mercy Cancer Center - Elk Grove
Contact: Site Public Contact
Email: [email protected]

Irvine
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Contact: Site Public Contact
Email: [email protected]

La Jolla
UC San Diego Moores Cancer Center
Contact: Site Public Contact
Email: [email protected]

Loma Linda
Veterans Affairs Loma Linda Healthcare System
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Los Angeles
Los Angeles General Medical Center
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Email: [email protected]

USC / Norris Comprehensive Cancer Center
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Merced
Mercy Cancer Center
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Email: [email protected]

Orange
UC Irvine Health/Chao Family Comprehensive Cancer Center
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Email: [email protected]

Rocklin
Mercy Cancer Center - Rocklin
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Email: [email protected]

Sacramento
Mercy Cancer Center - Sacramento
Contact: Site Public Contact
Email: [email protected]

San Luis Obispo
Pacific Central Coast Health Center-San Luis Obispo
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Email: [email protected]

Santa Maria
Mission Hope Medical Oncology - Santa Maria
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Email: [email protected]

Stockton
Saint Joseph's Medical Center
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Woodland
Woodland Memorial Hospital
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Email: [email protected]

CO
Aurora
UCHealth University of Colorado Hospital
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Colorado Springs
Penrose-Saint Francis Healthcare
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Email: [email protected]

Rocky Mountain Cancer Centers-Penrose
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Saint Francis Cancer Center
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Durango
CommonSpirit Cancer Center Mercy
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Email: [email protected]

Mercy Medical Center
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Lakewood
CommonSpirit Saint Anthony Hospital Cancer Center
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Email: [email protected]

Longmont
Longmont United Hospital
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Email: [email protected]

Pueblo
Saint Mary Corwin Medical Center
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Email: [email protected]

Westminster
Saint Anthony North Hospital
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DE
Lewes
Beebe Medical Center
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Email: [email protected]

Millville
Beebe South Coastal Health Campus
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Email: [email protected]

Newark
Christiana Care Health System-Christiana Hospital
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Email: [email protected]

Helen F Graham Cancer Center
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Email: [email protected]

Medical Oncology Hematology Consultants PA
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Email: [email protected]

Rehoboth Beach
Beebe Health Campus
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Email: [email protected]

Wilmington
Christiana Care Health System-Wilmington Hospital
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Email: [email protected]

FL
Lake Mary
Orlando Health Cancer Institute - Lake Mary
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Email: [email protected]

Lakeland
Lakeland Regional Health Hollis Cancer Center
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Ocoee
Health Central
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Email: [email protected]

Orlando
Orlando Health Cancer Institute
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Email: [email protected]

GA
Atlanta
Emory Saint Joseph's Hospital
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Emory University Hospital/Winship Cancer Institute
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ID
Coeur D'Alene
Kootenai Health - Coeur d'Alene
Contact: Site Public Contact
Email: [email protected]

Post Falls
Kootenai Clinic Cancer Services - Post Falls
Contact: Site Public Contact
Email: [email protected]

Sandpoint
Kootenai Clinic Cancer Services - Sandpoint
Contact: Site Public Contact
Email: [email protected]

IL
Burr Ridge
Loyola Center for Health at Burr Ridge
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Chicago
Northwestern University
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Email: [email protected]

Swedish Covenant Hospital
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Evanston
NorthShore University HealthSystem-Evanston Hospital
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Glenview
NorthShore University HealthSystem-Glenbrook Hospital
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Highland Park
NorthShore University HealthSystem-Highland Park Hospital
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Homer Glen
Loyola Medicine Homer Glen
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Lake Forest
Northwestern Medicine Lake Forest Hospital
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Email: [email protected]

Maywood
Loyola University Medical Center
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Melrose Park
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
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Orland Park
Northwestern Medicine Orland Park
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Email: [email protected]

KS
Kansas City
University of Kansas Cancer Center
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Email: [email protected]

Overland Park
University of Kansas Cancer Center-Overland Park
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Email: [email protected]

University of Kansas Hospital-Indian Creek Campus
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Email: [email protected]

Westwood
University of Kansas Hospital-Westwood Cancer Center
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Email: [email protected]

KY
Bardstown
CommonSpirit Saint Joseph Hospital - Bardstown
Contact: Site Public Contact
Email: [email protected]

Corbin
Commonwealth Cancer Center-Corbin
Contact: Site Public Contact
Email: [email protected]

Lexington
CommonSpirit Saint Joseph Hospital - Lexington
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Email: [email protected]

CommonSpirit Saint Joseph Medical Center - East Lexington
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Email: [email protected]

Saint Joseph Radiation Oncology Resource Center
Contact: Site Public Contact
Email: [email protected]

University of Kentucky/Markey Cancer Center
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London
CommonSpirit Saint Joseph Hospital London
Contact: Site Public Contact
Email: [email protected]

Mount Sterling
CommonSpirit Saint Joseph Hospital Mount Sterling
Contact: Site Public Contact
Email: [email protected]

LA
Baton Rouge
LSU Health Baton Rouge-North Clinic
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Email: [email protected]

Our Lady of the Lake Physician Group
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Email: [email protected]

MD
Elkton
Christiana Care - Union Hospital
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Email: [email protected]

MI
Battle Creek
Bronson Battle Creek
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Email: [email protected]

Grand Rapids
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
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Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
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Email: [email protected]

Trinity Health Grand Rapids Hospital
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Kalamazoo
Beacon Kalamazoo
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Beacon Kalamazoo Cancer Center
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Bronson Methodist Hospital
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Email: [email protected]

West Michigan Cancer Center
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Email: [email protected]

Muskegon
Trinity Health Muskegon Hospital
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Email: [email protected]

Niles
Corewell Health Lakeland Hospitals - Niles Hospital
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Norton Shores
Cancer and Hematology Centers of Western Michigan - Norton Shores
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Email: [email protected]

Reed City
Corewell Health Reed City Hospital
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Email: [email protected]

Saint Joseph
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
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Email: [email protected]

Corewell Health Lakeland Hospitals - Saint Joseph Hospital
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Email: [email protected]

Traverse City
Munson Medical Center
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Email: [email protected]

Wyoming
University of Michigan Health - West
Contact: Site Public Contact
Email: [email protected]

MN
Bemidji
Sanford Joe Lueken Cancer Center
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Email: [email protected]

Thief River Falls
Sanford Thief River Falls Medical Center
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MO
Kansas City
University of Kansas Cancer Center - Briarcliff
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University of Kansas Cancer Center - North
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Email: [email protected]

Lee's Summit
University of Kansas Cancer Center - Lee's Summit
Contact: Site Public Contact
Email: [email protected]

MT
Anaconda
Community Hospital of Anaconda
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Email: [email protected]

Billings
Billings Clinic Cancer Center
Contact: Site Public Contact
Email: [email protected]

Bozeman
Bozeman Health Deaconess Hospital
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Email: [email protected]

Great Falls
Benefis Sletten Cancer Institute
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Email: [email protected]

Great Falls Clinic
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Email: [email protected]

Havre
Hi-Line Sletten Cancer Center
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Email: [email protected]

Helena
Benefis Helena Specialty Center
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Email: [email protected]

Kalispell
Logan Health Medical Center
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Email: [email protected]

Missoula
Community Medical Center
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Email: [email protected]

NC
Cary
Duke Cancer Center Cary
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Email: [email protected]

Durham
Duke University Medical Center
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Raleigh
Duke Cancer Center Raleigh
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Email: [email protected]

ND
Bismarck
Sanford Bismarck Medical Center
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Email: [email protected]

Fargo
Sanford Broadway Medical Center
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Email: [email protected]

Sanford Medical Center Fargo
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Sanford Roger Maris Cancer Center
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Email: [email protected]

Sanford South University Medical Center
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Southpointe-Sanford Medical Center Fargo
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NE
Grand Island
CHI Health Saint Francis
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Email: [email protected]

Kearney
CHI Health Good Samaritan
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Email: [email protected]

Omaha
Alegent Health Bergan Mercy Medical Center
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Email: [email protected]

Alegent Health Immanuel Medical Center
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Alegent Health Lakeside Hospital
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Email: [email protected]

NJ
Hackensack
Hackensack University Medical Center
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Hackettstown
Hackettstown Medical Center
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Long Branch
Monmouth Medical Center
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Email: [email protected]

Morristown
Morristown Medical Center
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New Brunswick
Rutgers Cancer Institute of New Jersey
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Newton
Newton Medical Center
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Paramus
John Theurer Cancer Center at From Road
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Pompton
Chilton Medical Center
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Summit
Overlook Hospital
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Toms River
Community Medical Center
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Email: [email protected]

NM
Albuquerque
Lovelace Women's Hospital
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Email: [email protected]

University of New Mexico Cancer Center
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Email: [email protected]

NV
Reno
Renown Regional Medical Center
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Email: [email protected]

NY
Bronx
Montefiore Medical Center-Einstein Campus
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Email: [email protected]

Glens Falls
Glens Falls Hospital
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Mineola
NYU Langone Hospital - Long Island
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Email: [email protected]

New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Contact: Site Public Contact
Email: [email protected]

Patchogue
NYU Langone Hospital - Suffolk
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Email: [email protected]

Stony Brook
Stony Brook University Medical Center
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OH
Avon
UH Seidman Cancer Center at UH Avon Health Center
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Beachwood
UHHS-Chagrin Highlands Medical Center
Contact: Site Public Contact
Email: [email protected]

Cincinnati
Bethesda North Hospital
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Email: [email protected]

Good Samaritan Hospital - Cincinnati
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Email: [email protected]

TriHealth Cancer Institute-Anderson
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Email: [email protected]

TriHealth Cancer Institute-Westside
Contact: Site Public Contact
Email: [email protected]

Cleveland
Case Western Reserve University
Contact: Site Public Contact
Email: [email protected]

Columbus
Ohio State University Comprehensive Cancer Center
Contact: Site Public Contact
Email: [email protected]

OK
Oklahoma City
University of Oklahoma Health Sciences Center
Contact: Site Public Contact
Email: [email protected]

PA
Chadds Ford
Christiana Care Health System-Concord Health Center
Contact: Site Public Contact
Email: [email protected]

East Norriton
Fox Chase Cancer Center - East Norriton Hospital Outpatient Center
Contact: Site Public Contact
Email: [email protected]

Erie
UPMC Hillman Cancer Center Erie
Contact: Site Public Contact
Email: [email protected]

Philadelphia
Fox Chase Cancer Center
Contact: Site Public Contact

Thomas Jefferson University Hospital
Contact: Site Public Contact
Email: [email protected]

Pittsburgh
UPMC Hillman Cancer Center
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Willow Grove
Asplundh Cancer Pavilion
Contact: Site Public Contact
Email: [email protected]

SC
Charleston
Medical University of South Carolina
Contact: Site Public Contact
Email: [email protected]

TN
Nashville
Vanderbilt University/Ingram Cancer Center
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VA
Charlottesville
University of Virginia Cancer Center
Contact: Site Public Contact
Email: [email protected]

Richmond
VCU Massey Cancer Center at Stony Point
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Email: [email protected]

VCU Massey Comprehensive Cancer Center
Contact: Site Public Contact
Email: [email protected]

VT
Berlin
Central Vermont Medical Center/National Life Cancer Treatment
Contact: Site Public Contact

Burlington
University of Vermont Medical Center
Contact: Site Public Contact
Email: [email protected]

University of Vermont and State Agricultural College
Contact: Site Public Contact
Email: [email protected]

WI
Marshfield
Marshfield Medical Center-Marshfield
Contact: Site Public Contact
Email: [email protected]

Menomonee Falls
Froedtert Menomonee Falls Hospital
Contact: Site Public Contact

Milwaukee
Medical College of Wisconsin
Contact: Site Public Contact

New Berlin
Froedtert and MCW Moorland Reserve Health Center
Contact: Site Public Contact

Oak Creek
Drexel Town Square Health Center
Contact: Site Public Contact

West Bend
Froedtert West Bend Hospital/Kraemer Cancer Center
Contact: Site Public Contact

Weston
Marshfield Medical Center - Weston
Contact: Site Public Contact
Email: [email protected]

WV
Bridgeport
United Hospital Center
Contact: Site Public Contact
Email: [email protected]

Martinsburg
WVUH-Berkely Medical Center
Contact: Site Public Contact
Email: [email protected]

Morgantown
West Virginia University Healthcare
Contact: Site Public Contact
Email: [email protected]

Parkersburg
Camden Clark Medical Center
Contact: Site Public Contact
Email: [email protected]

Princeton
Princeton Community Hospital
Contact: Site Public Contact

WY
Cheyenne
Memorial Hospital of Laramie County
Contact: Site Public Contact
Email: [email protected]

Cody
Billings Clinic-Cody
Contact: Site Public Contact
Email: [email protected]

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.

Interactive content above is from the official study record on the National Cancer Institute website, cancer.gov.


The ECOG-ACRIN Cancer Research Group designed this trial and is conducting it with funding from the National Cancer Institute through its National Clinical Trials Network.