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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: ECOG-ACRIN Cancer Research Group • ClinicalTrials.gov ID: NCT07068074

Registry updated: 2026-09-24
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Description

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.

Interventions

  • Adjuvant Therapy (Procedure)
    Receive adjuvant therapy
  • Comprehensive Geriatric Assessment (Other)
    Ancillary studies
  • Computed Tomography (Procedure)
    Undergo CT
  • Positron Emission Tomography (Procedure)
    Undergo PET/CT
  • Questionnaire Administration (Other)
    Ancillary studies
  • Sentinel Lymph Node Biopsy (Procedure)
    Undergo SLN biopsy
  • Surveillance (Behavioral)
    Undergo surveillance of nodal basin
  • Ultrasound Imaging (Procedure)
    Undergo ultrasound
  • Wide Local Excision (Procedure)
    Undergo WLE

Eligibility criteria

Inclusion Criteria: * 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.

Conditions

Cutaneous Melanoma

Locations

  • University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States
  • Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis — Daphne, Alabama, United States
  • Thomas Hospital — Fairhope, Alabama, United States
  • Mobile Infirmary Medical Center — Mobile, Alabama, United States
  • Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland — Saraland, Alabama, United States
  • Fairbanks Memorial Hospital — Fairbanks, Alaska, United States
  • Cancer Center at Saint Joseph's — Phoenix, Arizona, United States
  • Mission Hope Medical Oncology - Arroyo Grande — Arroyo Grande, California, United States
  • Mercy Cancer Center - Carmichael — Carmichael, California, United States
  • Mercy San Juan Medical Center — Carmichael, California, United States
  • Mercy Cancer Center - Elk Grove — Elk Grove, California, United States
  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California, United States
  • UC San Diego Moores Cancer Center — La Jolla, California, United States
  • Veterans Affairs Loma Linda Healthcare System — Loma Linda, California, United States
  • Los Angeles General Medical Center — Los Angeles, California, United States
  • USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
  • Mercy Cancer Center — Merced, California, United States
  • UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States
  • Mercy Cancer Center - Rocklin — Rocklin, California, United States
  • Mercy Cancer Center - Sacramento — Sacramento, California, United States
  • Pacific Central Coast Health Center-San Luis Obispo — San Luis Obispo, California, United States
  • Mission Hope Medical Oncology - Santa Maria — Santa Maria, California, United States
  • Saint Joseph's Medical Center — Stockton, California, United States
  • Woodland Memorial Hospital — Woodland, California, United States
  • UCHealth University of Colorado Hospital — Aurora, Colorado, United States
  • Penrose-Saint Francis Healthcare — Colorado Springs, Colorado, United States
  • Rocky Mountain Cancer Centers-Penrose — Colorado Springs, Colorado, United States
  • Saint Francis Cancer Center — Colorado Springs, Colorado, United States
  • CommonSpirit Cancer Center Mercy — Durango, Colorado, United States
  • Mercy Medical Center — Durango, Colorado, United States
  • CommonSpirit Saint Anthony Hospital Cancer Center — Lakewood, Colorado, United States
  • Longmont United Hospital — Longmont, Colorado, United States
  • Saint Mary Corwin Medical Center — Pueblo, Colorado, United States
  • Saint Anthony North Hospital — Westminster, Colorado, United States
  • Beebe Medical Center — Lewes, Delaware, United States
  • Beebe South Coastal Health Campus — Millville, Delaware, United States
  • Helen F Graham Cancer Center — Newark, Delaware, United States
  • Medical Oncology Hematology Consultants PA — Newark, Delaware, United States
  • Christiana Care Health System-Christiana Hospital — Newark, Delaware, United States
  • Beebe Health Campus — Rehoboth Beach, Delaware, United States
  • Christiana Care Health System-Wilmington Hospital — Wilmington, Delaware, United States
  • Orlando Health Cancer Institute - Lake Mary — Lake Mary, Florida, United States
  • Lakeland Regional Health Hollis Cancer Center — Lakeland, Florida, United States
  • Health Central — Ocoee, Florida, United States
  • Orlando Health Cancer Institute — Orlando, Florida, United States
  • Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States
  • Emory Saint Joseph's Hospital — Atlanta, Georgia, United States
  • Kootenai Health - Coeur d'Alene — Coeur d'Alene, Idaho, United States
  • Kootenai Clinic Cancer Services - Post Falls — Post Falls, Idaho, United States
  • Kootenai Clinic Cancer Services - Sandpoint — Sandpoint, Idaho, United States
  • Loyola Center for Health at Burr Ridge — Burr Ridge, Illinois, United States
  • Northwestern University — Chicago, Illinois, United States
  • Swedish Covenant Hospital — Chicago, Illinois, United States
  • NorthShore University HealthSystem-Evanston Hospital — Evanston, Illinois, United States
  • NorthShore University HealthSystem-Glenbrook Hospital — Glenview, Illinois, United States
  • NorthShore University HealthSystem-Highland Park Hospital — Highland Park, Illinois, United States
  • Loyola Medicine Homer Glen — Homer Glen, Illinois, United States
  • Northwestern Medicine Lake Forest Hospital — Lake Forest, Illinois, United States
  • Loyola University Medical Center — Maywood, Illinois, United States
  • Marjorie Weinberg Cancer Center at Loyola-Gottlieb — Melrose Park, Illinois, United States
  • Northwestern Medicine Orland Park — Orland Park, Illinois, United States
  • University of Kansas Cancer Center — Kansas City, Kansas, United States
  • University of Kansas Cancer Center-Overland Park — Overland Park, Kansas, United States
  • University of Kansas Hospital-Indian Creek Campus — Overland Park, Kansas, United States
  • University of Kansas Hospital-Westwood Cancer Center — Westwood, Kansas, United States
  • CommonSpirit Saint Joseph Hospital - Bardstown — Bardstown, Kentucky, United States
  • Commonwealth Cancer Center-Corbin — Corbin, Kentucky, United States
  • CommonSpirit Saint Joseph Hospital - Lexington — Lexington, Kentucky, United States
  • Saint Joseph Radiation Oncology Resource Center — Lexington, Kentucky, United States
  • CommonSpirit Saint Joseph Medical Center - East Lexington — Lexington, Kentucky, United States
  • University of Kentucky/Markey Cancer Center — Lexington, Kentucky, United States
  • CommonSpirit Saint Joseph Hospital London — London, Kentucky, United States
  • CommonSpirit Saint Joseph Hospital Mount Sterling — Mount Sterling, Kentucky, United States
  • LSU Health Baton Rouge-North Clinic — Baton Rouge, Louisiana, United States
  • Our Lady of the Lake Physician Group — Baton Rouge, Louisiana, United States
  • Christiana Care - Union Hospital — Elkton, Maryland, United States
  • Bronson Battle Creek — Battle Creek, Michigan, United States
  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital — Grand Rapids, Michigan, United States
  • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital — Grand Rapids, Michigan, United States
  • Trinity Health Grand Rapids Hospital — Grand Rapids, Michigan, United States
  • Bronson Methodist Hospital — Kalamazoo, Michigan, United States
  • West Michigan Cancer Center — Kalamazoo, Michigan, United States
  • Beacon Kalamazoo Cancer Center — Kalamazoo, Michigan, United States
  • Beacon Kalamazoo — Kalamazoo, Michigan, United States
  • Trinity Health Muskegon Hospital — Muskegon, Michigan, United States
  • Corewell Health Lakeland Hospitals - Niles Hospital — Niles, Michigan, United States
  • Cancer and Hematology Centers of Western Michigan - Norton Shores — Norton Shores, Michigan, United States
  • Corewell Health Reed City Hospital — Reed City, Michigan, United States
  • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center — Saint Joseph, Michigan, United States
  • Corewell Health Lakeland Hospitals - Saint Joseph Hospital — Saint Joseph, Michigan, United States
  • Munson Medical Center — Traverse City, Michigan, United States
  • University of Michigan Health - West — Wyoming, Michigan, United States
  • Sanford Joe Lueken Cancer Center — Bemidji, Minnesota, United States
  • Sanford Thief River Falls Medical Center — Thief River Falls, Minnesota, United States
  • University of Kansas Cancer Center - Briarcliff — Kansas City, Missouri, United States
  • University of Kansas Cancer Center - North — Kansas City, Missouri, United States
  • University of Kansas Cancer Center - Lee's Summit — Lee's Summit, Missouri, United States
  • Community Hospital of Anaconda — Anaconda, Montana, United States
  • Billings Clinic Cancer Center — Billings, Montana, United States
  • Bozeman Health Deaconess Hospital — Bozeman, Montana, United States
  • Benefis Sletten Cancer Institute — Great Falls, Montana, United States
  • Great Falls Clinic — Great Falls, Montana, United States
  • Hi-Line Sletten Cancer Center — Havre, Montana, United States
  • Benefis Helena Specialty Center — Helena, Montana, United States
  • Logan Health Medical Center — Kalispell, Montana, United States
  • Community Medical Center — Missoula, Montana, United States
  • CHI Health Saint Francis — Grand Island, Nebraska, United States
  • CHI Health Good Samaritan — Kearney, Nebraska, United States
  • Alegent Health Immanuel Medical Center — Omaha, Nebraska, United States
  • Alegent Health Bergan Mercy Medical Center — Omaha, Nebraska, United States
  • Alegent Health Lakeside Hospital — Omaha, Nebraska, United States
  • Renown Regional Medical Center — Reno, Nevada, United States
  • Hackensack University Medical Center — Hackensack, New Jersey, United States
  • Hackettstown Medical Center — Hackettstown, New Jersey, United States
  • Monmouth Medical Center — Long Branch, New Jersey, United States
  • Morristown Medical Center — Morristown, New Jersey, United States
  • Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
  • Newton Medical Center — Newton, New Jersey, United States
  • John Theurer Cancer Center at From Road — Paramus, New Jersey, United States
  • Chilton Medical Center — Pompton, New Jersey, United States
  • Overlook Hospital — Summit, New Jersey, United States
  • Community Medical Center — Toms River, New Jersey, United States
  • University of New Mexico Cancer Center — Albuquerque, New Mexico, United States
  • Lovelace Women's Hospital — Albuquerque, New Mexico, United States
  • Roswell Park Cancer Institute — Buffalo, New York, United States
  • Glens Falls Hospital — Glens Falls, New York, United States
  • NYU Langone Hospital - Long Island — Mineola, New York, United States
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone — New York, New York, United States
  • NYU Langone Hospital - Suffolk — Patchogue, New York, United States
  • Stony Brook University Medical Center — Stony Brook, New York, United States
  • Montefiore Medical Center-Einstein Campus — The Bronx, New York, United States
  • Duke Cancer Center Cary — Cary, North Carolina, United States
  • Duke University Medical Center — Durham, North Carolina, United States
  • Duke Cancer Center Raleigh — Raleigh, North Carolina, United States
  • Sanford Bismarck Medical Center — Bismarck, North Dakota, United States
  • Sanford South University Medical Center — Fargo, North Dakota, United States
  • Southpointe-Sanford Medical Center Fargo — Fargo, North Dakota, United States
  • Sanford Medical Center Fargo — Fargo, North Dakota, United States
  • Sanford Broadway Medical Center — Fargo, North Dakota, United States
  • Sanford Roger Maris Cancer Center — Fargo, North Dakota, United States
  • UH Seidman Cancer Center at UH Avon Health Center — Avon, Ohio, United States
  • UHHS-Chagrin Highlands Medical Center — Beachwood, Ohio, United States
  • Good Samaritan Hospital - Cincinnati — Cincinnati, Ohio, United States
  • Bethesda North Hospital — Cincinnati, Ohio, United States
  • TriHealth Cancer Institute-Westside — Cincinnati, Ohio, United States
  • TriHealth Cancer Institute-Anderson — Cincinnati, Ohio, United States
  • Case Western Reserve University — Cleveland, Ohio, United States
  • Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
  • University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
  • Christiana Care Health System-Concord Health Center — Chadds Ford, Pennsylvania, United States
  • Fox Chase Cancer Center - East Norriton Hospital Outpatient Center — East Norriton, Pennsylvania, United States
  • UPMC Hillman Cancer Center Erie — Erie, Pennsylvania, United States
  • Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
  • Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
  • UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
  • Asplundh Cancer Pavilion — Willow Grove, Pennsylvania, United States
  • Medical University of South Carolina — Charleston, South Carolina, United States
  • Vanderbilt University/Ingram Cancer Center — Nashville, Tennessee, United States
  • Central Vermont Medical Center/National Life Cancer Treatment — Berlin Corners, Vermont, United States
  • University of Vermont Medical Center — Burlington, Vermont, United States
  • University of Vermont and State Agricultural College — Burlington, Vermont, United States
  • University of Virginia Cancer Center — Charlottesville, Virginia, United States
  • VCU Massey Cancer Center at Stony Point — Richmond, Virginia, United States
  • VCU Massey Comprehensive Cancer Center — Richmond, Virginia, United States
  • Fred Hutchinson Cancer Center — Seattle, Washington, United States
  • University of Washington Medical Center - Montlake — Seattle, Washington, United States
  • Saint Joseph Medical Center Hematology and Oncology - Silverdale — Silverdale, Washington, United States
  • United Hospital Center — Bridgeport, West Virginia, United States
  • WVUH-Berkely Medical Center — Martinsburg, West Virginia, United States
  • West Virginia University Healthcare — Morgantown, West Virginia, United States
  • Camden Clark Medical Center — Parkersburg, West Virginia, United States
  • Princeton Community Hospital — Princeton, West Virginia, United States
  • Marshfield Medical Center-Marshfield — Marshfield, Wisconsin, United States
  • Froedtert Menomonee Falls Hospital — Menomonee Falls, Wisconsin, United States
  • Medical College of Wisconsin — Milwaukee, Wisconsin, United States
  • Froedtert and MCW Moorland Reserve Health Center — New Berlin, Wisconsin, United States
  • Drexel Town Square Health Center — Oak Creek, Wisconsin, United States
  • Froedtert West Bend Hospital/Kraemer Cancer Center — West Bend, Wisconsin, United States
  • Marshfield Medical Center - Weston — Weston, Wisconsin, United States
  • Memorial Hospital of Laramie County — Cheyenne, Wyoming, United States
  • Billings Clinic-Cody — Cody, Wyoming, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record