We Need a Trial to Evaluate Whether Patients with Involved Inguinal Lymph Nodes Should Have Inguinal or Ilio-Inguinal Lymphadenectomy; an Overview of the Proposed Trial ANZMTG 01.12 EAGLE FM Protocol (#329)
Background: Spread of metastatic melanoma to the groin lymph nodes (LN) is a common event. It has been shown that patients with involved groin LN, without proven pelvic LN disease, receive 1 of 3 management strategies in equal proportions (1) inguinal lymphadenectomy (IL); (2) ilio-inguinal lymphadenectomy (I-IL); (3) variable use of either depending on specific patient / surgeon preferences. This is despite 10-15% of pelvic LN being involved after I-IL for positive sentinel node biopsy and 40% when done for clinical LN disease. The main reasons surgeons do not perform I-IL are linked with unfamiliarlity with the surgical intervention, concerns about worse quality of life (QOL) and a perceived increased rate of lymphoedema despite no evidence supporting this.
Methods: A multi-centre, phase III, non-inferiority, prospective, randomised trial comparing IL and I-IL. Target recruitment is 630 patients over 4 years. There will be an interim analysis at 5 years and final analysis at 10 years.
Aims: To provide a more rational evidence-base for the management of melanoma to groin LNs, by assessing the effect of IL or I-IL on patient disease-free survival (DFS), distant DFS, overall survival, and morbidity. Post-operative complications, QOL and longer-term lymphoedema rates will be evaluated. The study also aims to clarify the reliability of PET/CT scans for staging pelvic LNs, identify biomarkers of recurrence and progression, evaluate a molecular genetic prognostic tool for stage 3 melanoma patients, evaluate any health economic benefits for either intervention and evaluate a lymphoedema prevention intervention as part of an optional second randomisation substudy within the main study.
Progress/Timelines: An international feasibility survey for expressions of interest for investigators was conducted in early 2013. There were positive responses from 45 institutions in 17 countries; including Australia, North and South America, Europe and Asia. The study is expected to commence recruitment in 2014.