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

Launched by EASTERN COOPERATIVE ONCOLOGY GROUP · Jul 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether elderly patients (75 years or older) with early skin melanoma can be safely and effectively treated by just removing the melanoma with surgery, without doing an extra procedure called a sentinel lymph node (SLN) biopsy. Normally, after removing the melanoma (called a wide local excision or WLE), doctors also take out nearby lymph nodes to check if the cancer has spread. This study wants to see if skipping the lymph node biopsy still treats the cancer well and may improve patients’ overall quality of life.

To join this study, patients need to be 75 years or older, have a new diagnosis of primary skin melanoma, and be healthy enough for surgery. They must be able to understand the study and give consent, or have a family member or caregiver help if needed. Participants will have surgery to remove their melanoma, and depending on the group they are assigned to, they may or may not have the lymph node biopsy. The study will then compare how well patients do with or without the biopsy. This trial is not yet recruiting, but it aims to help doctors find the best treatment approach for older patients with melanoma, potentially avoiding extra procedures and their risks.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.