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
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
Contact: Site Public Contact
Mobile
Mobile Infirmary Medical Center
Contact: Site Public Contact
Saraland
Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland
Contact: Site Public Contact
Email: [email protected]
AZ
CA
Arroyo Grande
Mission Hope Medical Oncology - Arroyo Grande
Contact: Site Public Contact
Email: [email protected]
Carmichael
Mercy Cancer Center - Carmichael
Contact: Site Public Contact
Email: [email protected]
Mercy San Juan Medical Center
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]
Loma Linda
Veterans Affairs Loma Linda Healthcare System
Contact: Site Public Contact
Los Angeles
Los Angeles General Medical Center
Contact: Site Public Contact
Email: [email protected]
USC / Norris Comprehensive Cancer Center
Contact: Site Public Contact
Orange
UC Irvine Health/Chao Family Comprehensive Cancer Center
Contact: Site Public Contact
Email: [email protected]
San Luis Obispo
Pacific Central Coast Health Center-San Luis Obispo
Contact: Site Public Contact
Email: [email protected]
Santa Maria
Mission Hope Medical Oncology - Santa Maria
Contact: Site Public Contact
Email: [email protected]
Stockton
Saint Joseph's Medical Center
Contact: Site Public Contact
CO
Aurora
UCHealth University of Colorado Hospital
Contact: Site Public Contact
Colorado Springs
Penrose-Saint Francis Healthcare
Contact: Site Public Contact
Email: [email protected]
Rocky Mountain Cancer Centers-Penrose
Contact: Site Public Contact
Email: [email protected]
Saint Francis Cancer Center
Contact: Site Public Contact
Email: [email protected]
Durango
CommonSpirit Cancer Center Mercy
Contact: Site Public Contact
Email: [email protected]
Mercy Medical Center
Contact: Site Public Contact
Email: [email protected]
Lakewood
CommonSpirit Saint Anthony Hospital Cancer Center
Contact: Site Public Contact
Email: [email protected]
DE
Newark
Christiana Care Health System-Christiana Hospital
Contact: Site Public Contact
Email: [email protected]
Helen F Graham Cancer Center
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Email: [email protected]
Medical Oncology Hematology Consultants PA
Contact: Site Public Contact
Email: [email protected]
Wilmington
Christiana Care Health System-Wilmington Hospital
Contact: Site Public Contact
Email: [email protected]
FL
Lake Mary
Orlando Health Cancer Institute - Lake Mary
Contact: Site Public Contact
Email: [email protected]
Lakeland
Lakeland Regional Health Hollis Cancer Center
Contact: Site Public Contact
GA
Atlanta
Emory Saint Joseph's Hospital
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Emory University Hospital/Winship Cancer Institute
Contact: Site Public Contact
ID
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
Contact: Site Public Contact
Melrose Park
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
Contact: Site Public Contact
KS
Overland Park
University of Kansas Cancer Center-Overland Park
Contact: Site Public Contact
Email: [email protected]
University of Kansas Hospital-Indian Creek Campus
Contact: Site Public Contact
Email: [email protected]
Westwood
University of Kansas Hospital-Westwood Cancer Center
Contact: Site Public Contact
Email: [email protected]
KY
Bardstown
CommonSpirit Saint Joseph Hospital - Bardstown
Contact: Site Public Contact
Email: [email protected]
Lexington
CommonSpirit Saint Joseph Hospital - Lexington
Contact: Site Public Contact
Email: [email protected]
CommonSpirit Saint Joseph Medical Center - East Lexington
Contact: Site Public Contact
Email: [email protected]
Saint Joseph Radiation Oncology Resource Center
Contact: Site Public Contact
Email: [email protected]
University of Kentucky/Markey Cancer Center
Contact: Site Public Contact
Mount Sterling
CommonSpirit Saint Joseph Hospital Mount Sterling
Contact: Site Public Contact
Email: [email protected]
LA
Baton Rouge
LSU Health Baton Rouge-North Clinic
Contact: Site Public Contact
Email: [email protected]
Our Lady of the Lake Physician Group
Contact: Site Public Contact
Email: [email protected]
MD
MI
Grand Rapids
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Contact: Site Public Contact
Email: [email protected]
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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Email: [email protected]
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
Contact: Site Public Contact
Email: [email protected]
Niles
Corewell Health Lakeland Hospitals - Niles Hospital
Contact: Site Public Contact
Norton Shores
Cancer and Hematology Centers of Western Michigan - Norton Shores
Contact: Site Public Contact
Email: [email protected]
Saint Joseph
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Contact: Site Public Contact
Email: [email protected]
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Contact: Site Public Contact
Email: [email protected]
MN
Thief River Falls
Sanford Thief River Falls Medical Center
Contact: Site Public Contact
MO
Kansas City
University of Kansas Cancer Center - Briarcliff
Contact: Site Public Contact
University of Kansas Cancer Center - North
Contact: Site Public Contact
Email: [email protected]
Lee's Summit
University of Kansas Cancer Center - Lee's Summit
Contact: Site Public Contact
Email: [email protected]
MT
Great Falls
Benefis Sletten Cancer Institute
Contact: Site Public Contact
Email: [email protected]
Great Falls Clinic
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NC
Durham
Duke University Medical Center
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ND
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
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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Morristown
Morristown Medical Center
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New Brunswick
Rutgers Cancer Institute of New Jersey
Contact: Site Public Contact
Newton
Newton Medical Center
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Paramus
John Theurer Cancer Center at From Road
Contact: Site Public Contact
Pompton
Chilton Medical Center
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Summit
Overlook Hospital
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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
NY
Glens Falls
Glens Falls Hospital
Contact: Site Public Contact
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Contact: Site Public Contact
Email: [email protected]
Stony Brook
Stony Brook University Medical Center
Contact: Site Public Contact
OH
Avon
UH Seidman Cancer Center at UH Avon Health Center
Contact: Site Public Contact
Cincinnati
Bethesda North Hospital
Contact: Site Public Contact
Email: [email protected]
Good Samaritan Hospital - Cincinnati
Contact: Site Public Contact
Email: [email protected]
TriHealth Cancer Institute-Anderson
Contact: Site Public Contact
Email: [email protected]
TriHealth Cancer Institute-Westside
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]
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
Contact: Site Public Contact
SC
TN
Nashville
Vanderbilt University/Ingram Cancer Center
Contact: Site Public Contact
VA
Charlottesville
University of Virginia Cancer Center
Contact: Site Public Contact
Email: [email protected]
Richmond
VCU Massey Cancer Center at Stony Point
Contact: Site Public Contact
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]
WA
Seattle
Fred Hutchinson Cancer Center
Contact: Site Public Contact
University of Washington Medical Center - Montlake
Contact: Site Public Contact
Silverdale
Saint Joseph Medical Center Hematology and Oncology - Silverdale
Contact: Site Public Contact
Email: [email protected]
WI
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
WV
Princeton
Princeton Community Hospital
Contact: Site Public Contact
WY
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.


