The Multicentre Selective Lymphadenectomy Trial - 3
ConditionCutaneous Melanoma, Stage III
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMelanoma Institute Australia
About this trial
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.
Eligibility criteria
Qualifiers
Male or female patients ≥ 18 years of age at the time of consent
Written informed consent
Cytologically or histologically confirmed, resectable pathological Stage IIIB, C or D (Any T, N1b, N2b, N2c, N3b, or N3c) cutaneous or unknown primary melanoma, with or without primary tumour in situ
A palpable node, confirmed by pathology
Disqualifiers
Uveal or mucosal melanoma.
Isolated satellite or in-transit metastases only (without any cytological or histological proven lymph node involvement).
Involvement of any lymph node basin other than groin, axilla or neck. Concurrent popliteal, epitrochlear or triangular intermuscular space (TIS) nodes permitted, as long as fully resectable.
Clinical or radiographic evidence of distant metastasis (any AJCC 8th ed M Stage).
Trial design
Treatments tested in this trial
- Index lymph node resection
- Therapeutic lymph node dissection
Treatment groups
1,500 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov