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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Index lymph node resection
Procedure/SurgeryThe largest lymph node affected with melanoma
Therapeutic lymph node dissection
Procedure/SurgeryRemoval of all nodes in the melanoma affected lymph node basin
Treatment groups
1,500 Participants
are divided into 2 treatment groupsGroup A: Index Lymph NodeExperimental treatment 1 intervention
Group B: Therapeutic lymph node dissectionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Recurrence free survival
The proportion of patients with a major pathological response (MPR) alive and disease-free from the time of surgery to the end of 2 years follow up
Time frame
2 yearsSecondary outcomes
1
The rate of escalation to a therapeutic lymph node dissection (TLND) in the ILN arm due to isolated nodal recurrence in the ILN nodal basin
Proportion of patients with a major pathological response (complete pathological response or near complete pathological response) in the index lymph node arm who have disease recurrence involving the same lymph node basin requiring complete dissection
Time frame
2 years2
The salvage rate with surgery, radiotherapy or new systemic therapy post operatively for disease recurrence in each surgical arm with a major pathological response (complete pathological response or near complete pathological response)
Proportion of patients requiring any additional treatment for any disease recurrence following a complete or near complete pathological response
Time frame
2 years3
Distant metastasis free-survival
Proportion of patients with distant metastases from randomisation to the date of first distant metastases diagnosis in each surgical arm, following a major pathological response (complete pathological response or near complete pathological response)
Time frame
2 years4
Overall survival
Proportion of patients who die, from the date of randomisation to the date of death from any cause
Time frame
10 yearsOther outcomes
1
To identify prognostic and predictive biomarkers for recurrence
Comparison of multi-omic biomarkers from baseline with clinical outcomes
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov