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
AZ
Phoenix
Cancer Center at Saint Joseph's
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

CA
Arroyo Grande
Mission Hope Medical Oncology - Arroyo Grande
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Carmichael
Mercy Cancer Center - Carmichael
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Mercy San Juan Medical Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@commonspirit.org

Elk Grove
Mercy Cancer Center - Elk Grove
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Irvine
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Contact: Site Public Contact
Email: ucstudy@uci.edu

La Jolla
UC San Diego Moores Cancer Center
Contact: Site Public Contact
Email: cancercto@ucsd.edu

Merced
Mercy Cancer Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Orange
UC Irvine Health/Chao Family Comprehensive Cancer Center
Contact: Site Public Contact
Email: ucstudy@uci.edu

Rocklin
Mercy Cancer Center - Rocklin
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Email: ResearchInstituteInquiries@CommonSpirit.org

Sacramento
Mercy Cancer Center - Sacramento
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

San Luis Obispo
Pacific Central Coast Health Center-San Luis Obispo
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Santa Maria
Mission Hope Medical Oncology - Santa Maria
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Stockton
Saint Joseph's Medical Center
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Woodland
Woodland Memorial Hospital
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Email: ResearchInstituteInquiries@CommonSpirit.org

CO
Colorado Springs
Penrose-Saint Francis Healthcare
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Rocky Mountain Cancer Centers-Penrose
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Email: ResearchInstituteInquiries@CommonSpirit.org

Saint Francis Cancer Center
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Email: ResearchInstituteInquiries@CommonSpirit.org

Durango
CommonSpirit Cancer Center Mercy
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Mercy Medical Center
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Email: ResearchInstituteInquiries@CommonSpirit.org

Lakewood
CommonSpirit Saint Anthony Hospital Cancer Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Longmont
Longmont United Hospital
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Email: ResearchInstituteInquiries@CommonSpirit.org

Pueblo
Saint Mary Corwin Medical Center
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Email: ResearchInstituteInquiries@CommonSpirit.org

Westminster
Saint Anthony North Hospital
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Email: ResearchInstituteInquiries@CommonSpirit.org

DE
Lewes
Beebe Medical Center
Contact: Site Public Contact
Email: research@beebehealthcare.org

Millville
Beebe South Coastal Health Campus
Contact: Site Public Contact
Email: research@beebehealthcare.org

Newark
Christiana Care Health System-Christiana Hospital
Contact: Site Public Contact
Email: lbarone@christianacare.org

Helen F Graham Cancer Center
Contact: Site Public Contact
Email: lbarone@christianacare.org

Medical Oncology Hematology Consultants PA
Contact: Site Public Contact
Email: lbarone@christianacare.org

Rehoboth Beach
Beebe Health Campus
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Email: research@beebehealthcare.org

Wilmington
Christiana Care Health System-Wilmington Hospital
Contact: Site Public Contact
Email: lbarone@christianacare.org

FL
Lakeland
Lakeland Regional Health Hollis Cancer Center
Contact: Site Public Contact

GA
Atlanta
Emory University Hospital/Winship Cancer Institute
Contact: Site Public Contact

ID
Coeur D'Alene
Kootenai Health - Coeur d'Alene
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Post Falls
Kootenai Clinic Cancer Services - Post Falls
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Sandpoint
Kootenai Clinic Cancer Services - Sandpoint
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

IL
Burr Ridge
Loyola Center for Health at Burr Ridge
Contact: Site Public Contact

Chicago
Northwestern University
Contact: Site Public Contact
Email: cancer@northwestern.edu

Swedish Covenant Hospital
Contact: Site Public Contact

Evanston
NorthShore University HealthSystem-Evanston Hospital
Contact: Site Public Contact

Glenview
NorthShore University HealthSystem-Glenbrook Hospital
Contact: Site Public Contact

Highland Park
NorthShore University HealthSystem-Highland Park Hospital
Contact: Site Public Contact

Homer Glen
Loyola Medicine Homer Glen
Contact: Site Public Contact

Lake Forest
Northwestern Medicine Lake Forest Hospital
Contact: Site Public Contact
Email: cancertrials@northwestern.edu

Maywood
Loyola University Medical Center
Contact: Site Public Contact

Melrose Park
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
Contact: Site Public Contact

Orland Park
Northwestern Medicine Orland Park
Contact: Site Public Contact
Email: nctnprogram_rhlccc@northwestern.edu

KS
Kansas City
University of Kansas Cancer Center
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu

Overland Park
University of Kansas Cancer Center-Overland Park
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu

University of Kansas Hospital-Indian Creek Campus
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu

Westwood
University of Kansas Hospital-Westwood Cancer Center
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu

KY
Bardstown
Flaget Memorial Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Corbin
Commonwealth Cancer Center-Corbin
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Lexington
Saint Joseph Hospital
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Email: ResearchInstituteInquiries@CommonSpirit.org

Saint Joseph Hospital East
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Saint Joseph Radiation Oncology Resource Center
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Email: ResearchInstituteInquiries@CommonSpirit.org

University of Kentucky/Markey Cancer Center
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London
Saint Joseph London
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Email: ResearchInstituteInquiries@CommonSpirit.org

Mount Sterling
Saint Joseph Mount Sterling
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Email: ResearchInstituteInquiries@CommonSpirit.org

LA
Baton Rouge
LSU Health Baton Rouge-North Clinic
Contact: Site Public Contact
Email: research@ololrmc.com

Our Lady of the Lake Physician Group
Contact: Site Public Contact
Email: research@ololrmc.com

MD
Elkton
Christiana Care - Union Hospital
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Email: frank.crum@christianacare.org

MI
Battle Creek
Bronson Battle Creek
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Email: crcwm-regulatory@crcwm.org

Grand Rapids
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
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Email: crcwm-regulatory@crcwm.org

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
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Email: crcwm-regulatory@crcwm.org

Trinity Health Grand Rapids Hospital
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Email: crcwm-regulatory@crcwm.org

Kalamazoo
Beacon Kalamazoo
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Beacon Kalamazoo Cancer Center
Contact: Site Public Contact

Bronson Methodist Hospital
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Email: crcwm-regulatory@crcwm.org

West Michigan Cancer Center
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Email: crcwm-regulatory@crcwm.org

Muskegon
Trinity Health Muskegon Hospital
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Email: crcwm-regulatory@crcwm.org

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: connie.szczepanek@crcwm.org

Reed City
Corewell Health Reed City Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Saint Joseph
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Traverse City
Munson Medical Center
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Wyoming
University of Michigan Health - West
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

MN
Bemidji
Sanford Joe Lueken Cancer Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

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: KUCC_Navigation@kumc.edu

Lee's Summit
University of Kansas Cancer Center - Lee's Summit
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu

MT
Anaconda
Community Hospital of Anaconda
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Billings
Billings Clinic Cancer Center
Contact: Site Public Contact
Email: research@billingsclinic.org

Bozeman
Bozeman Health Deaconess Hospital
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Great Falls
Benefis Sletten Cancer Institute
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Great Falls Clinic
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Havre
Hi-Line Sletten Cancer Center
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

Helena
Benefis Helena Specialty Center
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Kalispell
Logan Health Medical Center
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Missoula
Community Medical Center
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

ND
Bismarck
Sanford Bismarck Medical Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Fargo
Sanford Broadway Medical Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Sanford Medical Center Fargo
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Sanford Roger Maris Cancer Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Sanford South University Medical Center
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Southpointe-Sanford Medical Center Fargo
Contact: Site Public Contact

NE
Grand Island
CHI Health Saint Francis
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Kearney
CHI Health Good Samaritan
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Omaha
Alegent Health Bergan Mercy Medical Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Alegent Health Immanuel Medical Center
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Email: ResearchInstituteInquiries@CommonSpirit.org

Alegent Health Lakeside Hospital
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Email: ResearchInstituteInquiries@CommonSpirit.org

Creighton University Medical Center
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Email: ResearchInstituteInquiries@CommonSpirit.org

NJ
New Brunswick
Rutgers Cancer Institute of New Jersey
Contact: Site Public Contact

NY
Bronx
Montefiore Medical Center-Einstein Campus
Contact: Site Public Contact
Email: eskwak@montefiore.org

Glens Falls
Glens Falls Hospital
Contact: Site Public Contact

Mineola
NYU Langone Hospital - Long Island
Contact: Site Public Contact
Email: cancertrials@nyulangone.org

New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Contact: Site Public Contact
Email: CancerTrials@nyulangone.org

OH
Cincinnati
Bethesda North Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Good Samaritan Hospital - Cincinnati
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

TriHealth Cancer Institute-Anderson
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

TriHealth Cancer Institute-Westside
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Email: ResearchInstituteInquiries@CommonSpirit.org

PA
Chadds Ford
Christiana Care Health System-Concord Health Center
Contact: Site Public Contact
Email: lbarone@christianacare.org

Erie
UPMC Hillman Cancer Center Erie
Contact: Site Public Contact
Email: ClinicalResearchServices@upmc.edu

Philadelphia
Thomas Jefferson University Hospital
Contact: Site Public Contact
Email: ONCTrialNow@jefferson.edu

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Contact: Site Public Contact

Willow Grove
Asplundh Cancer Pavilion
Contact: Site Public Contact
Email: ONCTrialNow@jefferson.edu

SC
Charleston
Medical University of South Carolina
Contact: Site Public Contact
Email: hcc-clinical-trials@musc.edu

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: rpo@uvm.edu

University of Vermont and State Agricultural College
Contact: Site Public Contact
Email: rpo@uvm.edu

WI
Marshfield
Marshfield Medical Center-Marshfield
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

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: oncology.clinical.trials@marshfieldresearch.org

WY
Cheyenne
Memorial Hospital of Laramie County
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

Cody
Billings Clinic-Cody
Contact: Site Public Contact
Email: research@billingsclinic.org

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.


EA6244 Home Page
ECOG-ACRIN Cancer Research Group