Comparing the Effectiveness of Less Invasive Procedures With the Current Standard of Care for the Treatment of Older Adults With Early-Stage Melanoma
A Randomized Phase III Study of Management of Treatment Naive Primary Melanoma in Elderly Patients
- Cutaneous Melanoma
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- ECOG-ACRIN Cancer Research Group
- Enrolment target
- 428
- Started
- 17 April 2026
- Main results due
- 1 January 2031
- Study sites
- 181
- Registry updated
- 24 September 2026
Can you take part?
- Aged 75 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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.What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(181)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Recruiting
Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis
Daphne, Alabama, United States
Recruiting
Thomas Hospital
Fairhope, Alabama, United States
Recruiting
Mobile Infirmary Medical Center
Mobile, Alabama, United States
Recruiting
Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland
Saraland, Alabama, United States
Recruiting
Fairbanks Memorial Hospital
Fairbanks, Alaska, United States
Recruiting
Cancer Center at Saint Joseph's
Phoenix, Arizona, United States
Recruiting
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, United States
Recruiting
Mercy Cancer Center - Carmichael
Carmichael, California, United States
Recruiting
Mercy San Juan Medical Center
Carmichael, California, United States
Recruiting
Mercy Cancer Center - Elk Grove
Elk Grove, California, United States
Recruiting
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States
Recruiting
UC San Diego Moores Cancer Center
La Jolla, California, United States
Recruiting
Veterans Affairs Loma Linda Healthcare System
Loma Linda, California, United States
Recruiting
Los Angeles General Medical Center
Los Angeles, California, United States
Recruiting
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Recruiting
Mercy Cancer Center
Merced, California, United States
Recruiting
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States
Recruiting
Mercy Cancer Center - Rocklin
Rocklin, California, United States
Recruiting
Mercy Cancer Center - Sacramento
Sacramento, California, United States
Recruiting
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California, United States
Recruiting
Mission Hope Medical Oncology - Santa Maria
Santa Maria, California, United States
Recruiting
Saint Joseph's Medical Center
Stockton, California, United States
Recruiting
Woodland Memorial Hospital
Woodland, California, United States
Recruiting
UCHealth University of Colorado Hospital
Aurora, Colorado, United States
Recruiting
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States
Recruiting
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, United States
Recruiting
Saint Francis Cancer Center
Colorado Springs, Colorado, United States
Recruiting
CommonSpirit Cancer Center Mercy
Durango, Colorado, United States
Recruiting
Mercy Medical Center
Durango, Colorado, United States
Recruiting
CommonSpirit Saint Anthony Hospital Cancer Center
Lakewood, Colorado, United States
Recruiting
Longmont United Hospital
Longmont, Colorado, United States
Recruiting
Saint Mary Corwin Medical Center
Pueblo, Colorado, United States
Recruiting
Saint Anthony North Hospital
Westminster, Colorado, United States
Recruiting
Beebe Medical Center
Lewes, Delaware, United States
Recruiting
Beebe South Coastal Health Campus
Millville, Delaware, United States
Recruiting
Helen F Graham Cancer Center
Newark, Delaware, United States
Recruiting
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States
Recruiting
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States
Recruiting
Beebe Health Campus
Rehoboth Beach, Delaware, United States
Recruiting
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, United States
Recruiting
Orlando Health Cancer Institute - Lake Mary
Lake Mary, Florida, United States
Recruiting
Lakeland Regional Health Hollis Cancer Center
Lakeland, Florida, United States
Recruiting
Health Central
Ocoee, Florida, United States
Recruiting
Orlando Health Cancer Institute
Orlando, Florida, United States
Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Recruiting
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States
Recruiting
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, United States
Recruiting
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, United States
Recruiting
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, United States
Recruiting
Loyola Center for Health at Burr Ridge
Burr Ridge, Illinois, United States
Recruiting
Northwestern University
Chicago, Illinois, United States
Recruiting
Swedish Covenant Hospital
Chicago, Illinois, United States
Recruiting
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States
Recruiting
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, United States
Recruiting
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, United States
Recruiting
Loyola Medicine Homer Glen
Homer Glen, Illinois, United States
Recruiting
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, United States
Recruiting
Loyola University Medical Center
Maywood, Illinois, United States
Recruiting
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
Melrose Park, Illinois, United States
Recruiting
Showing 60 of 181 sites — filter to narrow it down. 176 of the 181 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07068074. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
Not the right study?
Answer three questions and see the studies recruiting near you, in plain language.
Find a study for me