NCT07068074 · ECOG-ACRIN Cancer Research Group
Comparing the Effectiveness of Less Invasive Procedures With the Current Standard of Care for the Treatment of Older Adults With Early-Stage Melanoma
What this study is about
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.
View original scientific 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
PROCEDURE
Adjuvant Therapy
Receive adjuvant therapy
OTHER
Comprehensive Geriatric Assessment
Ancillary studies
PROCEDURE
Computed Tomography
Undergo CT
PROCEDURE
Positron Emission Tomography
Undergo PET/CT
OTHER
Questionnaire Administration
Ancillary studies
PROCEDURE
Sentinel Lymph Node Biopsy
Undergo SLN biopsy
BEHAVIORAL
Surveillance
Undergo surveillance of nodal basin
PROCEDURE
Ultrasound Imaging
Undergo ultrasound
PROCEDURE
Wide Local Excision
Undergo WLE
Primary outcome measures
Recurrence free survival (RFS) rate
Time frame: From randomization to recurrence of disease or death from any cause, assessed at 2 years
Will evaluate RFS rate. Will compare the co-primary endpoints in a hierarchical manner starting with RFS rate. The 2-year RFS rate will be estimated from the Kaplan-Meier curve and compared between treatment arms via two sample binomial test, and the 95% confidence interval (CI) will be provided. Will be measured on the intention-to-treat patient cohort. Patients that have not had an event reported at analysis will be censored at their date of last follow-up. Patients who drop out or are lost to follow up before 2 years will be censored.
Patient reported outcome (PRO)
Time frame: Baseline to 2 years
Will compare the co-primary endpoints in a hierarchical manner starting with RFS rate. If RFS rate in non-inferior (wide local incision \[WLE\] is non-inferior to WLE plus sentinel lymph node biopsy) will proceed to evaluate PRO as a co-primary endpoint. Will measure patients quality of life by Functional Assessment of Cancer Therapy-Melanoma (FACT-M) score. The FACT-M score change will be calculated by FACT-M score at 2 years minus the FACT-M score at baseline. Descriptive analyses will be conducted for baseline scores, 2-year scores and the change. The change scores will be compared between the two study arms with two sample t test. 95% CI will be provided. If RFS rate is inferior will proceed to evaluate PRO as an exploratory endpoint.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Birmingham, Alabama
- Daphne, Alabama
- Fairhope, Alabama
- Mobile, Alabama
- Saraland, Alabama
- Fairbanks, Alaska
- Phoenix, Arizona
- Arroyo Grande, California
- Carmichael, California
- Elk Grove, California
- Irvine, California
- La Jolla, California
And 133 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 24, 2026 · Source of record for eligibility and locations