The Multicentre Selective Lymphadenectomy Trial - 3

Part of paid clinical trials in Los Angeles, California.

Sponsor
Melanoma Institute Australia
Study ID
NCT07049276
Status
Recruiting
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Conditions

  • Cutaneous Melanoma, Stage III

Eligibility Criteria

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

Interventions

  • Index lymph node resection — PROCEDURE
    The largest lymph node affected with melanoma
  • Therapeutic lymph node dissection — PROCEDURE
    Removal of all nodes in the melanoma affected lymph node basin

Study Details

The goal of this clinical trial is to demonstrate that there is no difference (non-inferiorty) in the 2 year recurrence-free survival (RFS) between 2 different surgical approaches for clinical Stage III melanoma. Following 6 weeks of standard neaodjuvant immunotherapy, patients will undergo either selective index lymph node resection (ILN) (identified at baseline as the largest affected lymph node) or the standard of care therapeutic lymph node dissection (TLND). The secondary aims are to assess if patients who are managed without TLND will have a reduction in surgical complications (less wound problems \& lymphoedema), an improved quality of life, at a lower healthcare utilisation.

Key Dates

Start date
Oct 1, 2025
Status verified
Apr 2026
Primary completion
Aug 31, 2030
Completion
Aug 31, 2040

Study Design

Enrollment
1,500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Index Lymph Node
    The largest affected (index) lymph node marked with a clip under ultrasound or X-ray guidance and then removed after neoadjuvant therapy for the pathological response to be determined. The response then dictates the next step of management
  • Active Comparator: Therapeutic lymph node dissection
    Complete removal of all nodes in the regional lymph node basin

Primary Outcome Measure

Recurrence free survival [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CentreLos AngelesCalifornia90025
Mark Faries

Find similar trials in Los Angeles, CA

By research site
Cedars-Sinai Medical Centre· Los Angeles, CA

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