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

NCT07068074 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: EA6244
• Study Type: interventional
• Target: 428
• Locations: 1 country
• Sites: 1

Brief Summary

Can we treat your melanoma just as effectively without doing a sentinel lymph node (SLN) biopsy in addition to your wide local excision (WLE) procedure? A wide local excision (WLE) is a surgical procedure performed to cut out an abnormal lesion and some surrounding normal tissue. This is sometimes followed by a sentinel lymph node (SLN) biopsy, in which lymph nodes that cancer cells could spread to are removed as well. We are doing this study because we want to find out if performing the WLE alone is just as effective as the usual approach for your melanoma, and if it leads to improvements in patients' overall well-being. The usual approach is defined as care most people get for the early stage of melanoma that you currently have.

Conditions

Cutaneous Melanoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Patient-Reported Outcome (PRO) Component

  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.

  (FACT-M) baseline 4 months 8 months 12 months 16 months 20 months 24 months

Secondary Outcomes (1)

• Geriatric Assessment (GA)

  Geriatric Assessment (at years 1 and 2 during the surveillance stage and at the time of disease recurrence).

Study Arms (2)

Arm A

ACTIVE COMPARATOR

WLE and SLN biopsy with surveillance of nodal basin

Procedure: Sentinel Lymph Node and Wide Local Excision

Arm B

EXPERIMENTAL

WLE only, with surveillance of nodal basin

Procedure: Wide local Excision

Interventions

Wide local Excision PROCEDURE

A wide local excision (WLE) is a surgical procedure performed to cut out an abnormal lesion and some surrounding normal tissue.

Arm B

Sentinel Lymph Node and Wide Local Excision PROCEDURE

A wide local excision (WLE) is a surgical procedure performed to cut out an abnormal lesion and some surrounding normal tissue. This is sometimes followed by a sentinel lymph node (SLN) biopsy, in which lymph nodes that cancer cells could spread to are removed as well.

Arm A

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eastern Cooperative Oncology Group: lead

Study Sites (1)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Yana Najjar, MD

  UPMC Hillman Cancer Center

  STUDY CHAIR

Central Study Contacts

Yana Najjar, MD

CONTACT

215-728-2500; najjaryg@upmc.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Arm A: WLE and SLN biopsy with surveillance of nodal basin then Surveillance plus Standard of care adjuvant therapy then follow-up Arm B: WLE alone with surveillance of nodal basin then Surveillance plus Standard of care adjuvant therapy then follow-up.

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: July 16, 2025
• Study Start: December 12, 2025
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2031
• Last Updated: November 13, 2025

Record last verified: 2025-11

Locations

US (1)