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Melanoma Treatment for Older Patients: WLE vs. WLE with SLN Biopsy

This study is for older patients (75 years or older) with primary melanoma. We are comparing two surgical approaches: a wide local excision (WLE), which removes the melanoma and some surrounding tissue, versus WLE combined with a sentinel lymph node (SLN) biopsy. An SLN biopsy removes lymph nodes where cancer cells might spread. The study wants to see if WLE alone is just as effective as WLE with an SLN biopsy for your melanoma, and if it improves your overall well-being. We are looking for 428 participants. We want to understand if a less aggressive treatment can still be effective and improve how patients feel.

Study design
This is a randomized study, meaning participants are assigned by chance to one of the two treatment groups. It aims to enroll 428 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your well-being will be measured at baseline, 4, 8, 12, 16, 20, and 24 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07068074

A Randomized Phase III Study of Management of Treatment Naive Primary Melanoma in Elderly Patients

Not Yet Recruiting
PHASE3Ages 75+InterventionalTreatment
Eastern Cooperative Oncology Group
~428 participants
Updated 2025-11-13 on ClinicalTrials.gov
What's tested:Wide local ExcisionSentinel Lymph Node and Wide Local Excision

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Patient-Reported Outcome (PRO) Component
Measured over (FACT-M) baseline 4 months 8 months 12 months 16 months 20 months 24 months

Conditions

Cutaneous Melanoma

Explore related trials

Cutaneous Melanoma

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Yana Najjar, MD · STUDY_CHAIR · UPMC Hillman Cancer Center

Who to contact

Yana Najjar, MD
[email protected]
215-728-2500
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patient must be ≥ 75 years of age.
Patient must have 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.
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 be English or Spanish speaking to be eligible for this study in order to complete the patient-reported outcomes (PROs). Patients who speak only French can be enrolled in Canada and appropriate documents will be made available by the study team.

Exclusion

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.

What this trial measures

  • Patient-Reported Outcome (PRO) Component(FACT-M) baseline 4 months 8 months 12 months 16 months 20 months 24 months

    The patient reported outcomes (PRO) in this study include a Geriatric Assessment (GA) and the FACT-M Quality of Life (QOL). The National Comprehensive Cancer Network (NCCN) guidelines advocate geriatric assessment (GA) for older patients with cancer to identify health status issues that increase the risk of adverse outcomes. A GA evaluates comorbidity, functional status, physical performance, cognitive ability, psychological status, medications and social support with standardized tools that predict morbidity and mortality in community-dwelling vulnerable older adults. Benefits of GA in community-dwelling vulnerable older adults include prevention of geriatric syndromes, recognition of cognitive deficits, addressing geriatric abnormalities detected by the assessment to prevent hospitalizations and nursing home admissions, and overall improvement of quality of life.