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Comparing the Effectiveness of Less Invasive Procedures With the Current Standard of Care for the Treatment of Older Adults With Early-Stage Melanoma

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint added 1 → 2 primary endpoints
See other at-risk trials from ECOG-ACRIN Cancer Research Group

Record History

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  1. Notable Primary endpoint(s) modified Show 9 more changesShow less
    • Sponsor changed: Eastern Cooperative Oncology Group to ECOG-ACRIN Cancer Research Group
    • Recruitment opened
    • Start date changed from estimate of Dec 12, 2025 to Apr 17, 2026
    • Trial sites expanded: 1 → 181 locations
    • Interventions modified
    • Eligibility criteria expanded, about 54 words
    • Secondary endpoints: 1 to 6
    • Study description shortened, about 154 words
    • Study title expanded, about 7 words
  2. Minor Re-verified, no change to tracked fieldsv2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase III trial compares the effect of wide local excision (WLE) alone to usual care with WLE plus sentinel lymph node (SLN) biopsy for the treatment of older adults with early-stage melanoma. A WLE is a surgical procedure performed to cut out an abnormal lesion and some surrounding normal tissue. This is sometimes followed by a SLN biopsy, in which lymph nodes that tumor cells could spread to are removed as well. Using WLE alone may be just as effective as usual care in treating older adults with early-stage melanoma.
Trial Details
NCT Number NCT07068074
Lead Sponsor ECOG-ACRIN Cancer Research Group
Conditions
(from sponsor)
Cutaneous Melanoma
Related terms Melanoma
Enrollment 428 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov