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

NCT07068074 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 428

Last updated 2025-11-13

No results posted yet for this study

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

Interventions

PROCEDURE

Wide local Excision

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

PROCEDURE

Sentinel Lymph Node and Wide Local Excision

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.

Sponsors & Collaborators

  • Eastern Cooperative Oncology Group

    lead NETWORK

Principal Investigators

  • Yana Najjar, MD · UPMC Hillman Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-12
Primary Completion
2031-01-01
Completion
2031-01-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07068074 on ClinicalTrials.gov