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
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Email: ResearchInstituteInquiries@CommonSpirit.org
CA
Arroyo Grande
Mission Hope Medical Oncology - Arroyo Grande
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Carmichael
Mercy Cancer Center - Carmichael
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Mercy San Juan Medical Center
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Email: ResearchInstituteInquiries@commonspirit.org
Elk Grove
Mercy Cancer Center - Elk Grove
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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
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Email: cancercto@ucsd.edu
Merced
Mercy Cancer Center
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Orange
UC Irvine Health/Chao Family Comprehensive Cancer Center
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Email: ucstudy@uci.edu
Rocklin
Mercy Cancer Center - Rocklin
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Sacramento
Mercy Cancer Center - Sacramento
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San Luis Obispo
Pacific Central Coast Health Center-San Luis Obispo
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Santa Maria
Mission Hope Medical Oncology - Santa Maria
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Stockton
Saint Joseph's Medical Center
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Woodland
Woodland Memorial Hospital
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CO
Colorado Springs
Penrose-Saint Francis Healthcare
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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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Mercy Medical Center
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Lakewood
CommonSpirit Saint Anthony Hospital Cancer Center
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Longmont
Longmont United Hospital
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Pueblo
Saint Mary Corwin Medical Center
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Westminster
Saint Anthony North Hospital
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DE
Lewes
Beebe Medical Center
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Email: research@beebehealthcare.org
Millville
Beebe South Coastal Health Campus
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Email: research@beebehealthcare.org
Newark
Christiana Care Health System-Christiana Hospital
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Email: lbarone@christianacare.org
Helen F Graham Cancer Center
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Email: lbarone@christianacare.org
Medical Oncology Hematology Consultants PA
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Email: lbarone@christianacare.org
Rehoboth Beach
Beebe Health Campus
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Email: research@beebehealthcare.org
Wilmington
Christiana Care Health System-Wilmington Hospital
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Email: lbarone@christianacare.org
FL
Lakeland
Lakeland Regional Health Hollis Cancer Center
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GA
Atlanta
Emory University Hospital/Winship Cancer Institute
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ID
Coeur D'Alene
Kootenai Health - Coeur d'Alene
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Email: mccinfo@mtcancer.org
Post Falls
Kootenai Clinic Cancer Services - Post Falls
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Email: mccinfo@mtcancer.org
Sandpoint
Kootenai Clinic Cancer Services - Sandpoint
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Email: mccinfo@mtcancer.org
IL
Burr Ridge
Loyola Center for Health at Burr Ridge
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Chicago
Northwestern University
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Email: cancer@northwestern.edu
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: cancertrials@northwestern.edu
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: nctnprogram_rhlccc@northwestern.edu
KS
Kansas City
University of Kansas Cancer Center
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Email: KUCC_Navigation@kumc.edu
Overland Park
University of Kansas Cancer Center-Overland Park
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Email: KUCC_Navigation@kumc.edu
University of Kansas Hospital-Indian Creek Campus
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Email: KUCC_Navigation@kumc.edu
Westwood
University of Kansas Hospital-Westwood Cancer Center
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Email: KUCC_Navigation@kumc.edu
KY
Bardstown
Flaget Memorial Hospital
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Corbin
Commonwealth Cancer Center-Corbin
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Lexington
Saint Joseph Hospital
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Saint Joseph Hospital East
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Saint Joseph Radiation Oncology Resource Center
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University of Kentucky/Markey Cancer Center
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London
Saint Joseph London
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Mount Sterling
Saint Joseph Mount Sterling
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LA
Baton Rouge
LSU Health Baton Rouge-North Clinic
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Email: research@ololrmc.com
Our Lady of the Lake Physician Group
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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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Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
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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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West Michigan Cancer Center
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Muskegon
Trinity Health Muskegon Hospital
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Email: crcwm-regulatory@crcwm.org
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: connie.szczepanek@crcwm.org
Reed City
Corewell Health Reed City Hospital
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Email: crcwm-regulatory@crcwm.org
Saint Joseph
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
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Email: crcwm-regulatory@crcwm.org
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
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Traverse City
Munson Medical Center
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Wyoming
University of Michigan Health - West
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Email: crcwm-regulatory@crcwm.org
MN
Bemidji
Sanford Joe Lueken Cancer Center
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Email: OncologyClinicalTrialsFargo@sanfordhealth.org
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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Lee's Summit
University of Kansas Cancer Center - Lee's Summit
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Email: KUCC_Navigation@kumc.edu
MT
Anaconda
Community Hospital of Anaconda
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Email: mccinfo@mtcancer.org
Billings
Billings Clinic Cancer Center
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Email: research@billingsclinic.org
Bozeman
Bozeman Health Deaconess Hospital
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Email: mccinfo@mtcancer.org
Great Falls
Benefis Sletten Cancer Institute
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Email: mccinfo@mtcancer.org
Great Falls Clinic
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Havre
Hi-Line Sletten Cancer Center
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Email: ecog.rss@jimmy.harvard.edu
Helena
Benefis Helena Specialty Center
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Kalispell
Logan Health Medical Center
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Missoula
Community Medical Center
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ND
Bismarck
Sanford Bismarck Medical Center
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Fargo
Sanford Broadway Medical Center
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Sanford Medical Center Fargo
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Sanford Roger Maris Cancer Center
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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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Kearney
CHI Health Good Samaritan
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Omaha
Alegent Health Bergan Mercy Medical Center
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Alegent Health Immanuel Medical Center
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Alegent Health Lakeside Hospital
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Creighton University Medical Center
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NJ
New Brunswick
Rutgers Cancer Institute of New Jersey
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NY
Bronx
Montefiore Medical Center-Einstein Campus
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Email: eskwak@montefiore.org
Glens Falls
Glens Falls Hospital
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Mineola
NYU Langone Hospital - Long Island
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Email: cancertrials@nyulangone.org
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
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Email: CancerTrials@nyulangone.org
OH
Cincinnati
Bethesda North Hospital
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Good Samaritan Hospital - Cincinnati
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TriHealth Cancer Institute-Anderson
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TriHealth Cancer Institute-Westside
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PA
Chadds Ford
Christiana Care Health System-Concord Health Center
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Email: lbarone@christianacare.org
Erie
UPMC Hillman Cancer Center Erie
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Email: ClinicalResearchServices@upmc.edu
Philadelphia
Thomas Jefferson University Hospital
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Email: ONCTrialNow@jefferson.edu
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
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Willow Grove
Asplundh Cancer Pavilion
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Email: ONCTrialNow@jefferson.edu
SC
Charleston
Medical University of South Carolina
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Email: hcc-clinical-trials@musc.edu
VT
Berlin
Central Vermont Medical Center/National Life Cancer Treatment
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Burlington
University of Vermont Medical Center
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Email: rpo@uvm.edu
University of Vermont and State Agricultural College
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Email: rpo@uvm.edu
WA
Silverdale
Saint Joseph Medical Center Hematology and Oncology - Silverdale
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WI
Marshfield
Marshfield Medical Center-Marshfield
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Email: oncology.clinical.trials@marshfieldresearch.org
Menomonee Falls
Froedtert Menomonee Falls Hospital
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Milwaukee
Medical College of Wisconsin
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New Berlin
Froedtert and MCW Moorland Reserve Health Center
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Oak Creek
Drexel Town Square Health Center
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West Bend
Froedtert West Bend Hospital/Kraemer Cancer Center
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Weston
Marshfield Medical Center - Weston
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Email: oncology.clinical.trials@marshfieldresearch.org
WY
Cheyenne
Memorial Hospital of Laramie County
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Email: ecog.rss@jimmy.harvard.edu
Cody
Billings Clinic-Cody
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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.


