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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Eastern Cooperative Oncology Group
Study ID
NCT07068074
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Cutaneous Melanoma

Eligibility Criteria

Sex
ALL
Age
75 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Dec 12, 2025
Status verified
Nov 2025
Primary completion
Jan 1, 2031
Completion
Jan 1, 2031

Study Design

Enrollment
428 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A
    WLE and SLN biopsy with surveillance of nodal basin
  • Experimental: Arm B
    WLE only, with surveillance of nodal basin

Primary Outcome Measure

Patient-Reported Outcome (PRO) Component [ Time Frame: (FACT-M) baseline 4 months 8 months 12 months 16 months 20 months 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC Hillman Cancer CenterPittsburghPennsylvania15232
Yana Najjar, MD
[email protected]
215-728-2500

Find similar trials in Pittsburgh, PA

By research site
UPMC Hillman Cancer Center· Pittsburgh, PA

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