Clinical trial · Interventional
Evaluation of Groin Lymphadenectomy Extent For Metastatic Melanoma
Inguinal or Ilio-inguinal Lymphadenectomy for Patients With Metastatic Melanoma to Groin Lymph Nodes and no Evidence of Pelvic Disease on PET/CT Scan - A Randomised Phase III Trial (EAGLE FM)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
BACKGROUND: Spread of metastatic melanoma to the groin lymph nodes (LN) is a common event affecting about 350 people a year in Australia. Globally it has been shown that patients with involved groin LN, without proven pelvic LN disease on imaging receive 1 of 3 management strategies in equal proportions - inguinal lymphadenectomy (IL); ilio-inguinal lymphadenectomy (I-IL); or variable use of either depending on circumstances. Different experts have strong and polarised opinions favouring either IL or more extensive I-IL with existing cases series reporting conflicting data on best cancer outcomes. No high level evidence proves which operation is best. HYPOTHESIS: There will be no significant difference in DFS between patients having IL or I-IL, conditional on PET/CT scan showing no evidence of pelvic disease at the time of diagnosis of groin LN metastatic melanoma. AIMS: To provide a rational evidence base for management for melanoma to the groin LNs by randomly assessing the effect of each operation on DFS, distant DFS, overall survival (OS), morbidity - including early complications and longer-term rates of lymphedema as well as comprehensively assessed QOL. Also to clarify the reliability of PET/CT scans for staging pelvic LNs and evaluate any health economic benefits of I-IL over IL. TARGET POPULATION: To recruit 634 patients in 5 years. DESIGN: An Australian led, international, multi-centre, non-inferiority, phase III, prospective, randomised clinical trial comparing IL or I-IL for patients with metastatic melanoma to groin LNs and no evidence of pelvic disease on PET/CT. ENDPOINTS: DFS, Distant DFS, OS and QOL at 5 years. Accuracy of PET/CT for pelvic LN metastases. OUTCOMES: International standardization of care, improved cancer outcomes, improved QOL for patients with groin metastatic melanoma. Proof of principle about extent of surgery when PET/CT is clear in adjacent LN areas, leading to clinical trials investigating management of other lymph node fields.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Melanoma to the Groin Lymph Nodes | Melanoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ilio-inguinal Lymphadenectomy | Procedure | — | UNRESOLVED |
| Inguinal Lymphadenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Arm 1: Inguinal Lymphadenectomy
- description
- Inguinal Lymphadenectomy (IL) is removal of the easily accessible superficial groin lymph nodes (LNs) and has a median LN retrieval of 11 lymph nodes
- interventionNames
- Procedure: Inguinal Lymphadenectomy
- type
- OTHER
- label
- Arm 2: Ilio-inguinal Lymphadenectomy
- description
- Ilio-inguinal Lymphadenectomy (I-IL) is the removal of the same superficial groin lymp nodes (LN) removed during an IL but also combined with the more surgically complex removal of the ipsilateral pelvic LN. About twice as many LN are removed with I-IL compared to IL.
- interventionNames
- Procedure: Ilio-inguinal Lymphadenectomy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
Inclusion Criteria: Patients may be included in the study only if they meet all of the following criteria: 1. Must be 15 and above. 2. Have primary cutaneous melanoma or if the patient presents with stage III melanoma with no known primary tumour then a thorough search for the primary should be documented (including perineal and perianal areas) 3. Life expectancy of at least 10 years from the time of diagnosis, not considering the melanoma in question, as determined by the PI 4. Must have one or multiple inguinal node(s) involved, histologically or cytologically proven as metastatic melanoma. This can can be detected: * At the time of diagnosis; * Or by Ultrasound detection; * Or later after relapse when no Sentinel Node Biopsy (SNB) was performed at the time of primary tumour management; * Or as a result of SNB; * Or at the time of regional recurrence after "false negative" SNB; 5. Absent distant disease clinically and on PET/CT scan. (Patients must have NO further distant disease or visceral metastases) 6. ECOG performance status must be between 0 to 2 at randomisation 7. Whole body PET/CT scan, specifically stating there is NO evidence of pelvic lymph node involvement prior to randomisation and a CT Brain or MRI Brain scan. Scans must be performed within 6 weeks prior to randomisation. 8. Able to provide written, informed consent 9. Willing to return to the centre for follow up examinations and procedures, as outlined in the protocol. 10. All patients must be randomised and undergo lymphadenectomy surgery no more than 120 days following diagnosis of inguinal LN involvement Exclusion Criteria: 1. Distant metastatic disease on clinical examination or staging imaging (CT/MRI brain or whole body PET/CT scan). Scans must be performed within 6 weeks prior to randomisation 2. Pelvic LN involvement on SNB or PET/CT scan suggestive of metastatic disease in the pelvis - criteria for diagnosis include normal size or enlarged lymph nodes (\> 1 cm) with increased FDG activity on PET (SUV \>3). If there are enlarged, necrotic lymph nodes FDG activity on PET is not required to be present. If unsure central review should be sought. 3. Bilateral inguinal lymph node involvement 4. Patients with a history of major pelvic surgery and / or regional radiotherapy at any time in the past 5. Requiring planned radiotherapy following surgery due to macroscopic, bulky and matted nodes. 6. Unfit for General Anaesthesia 7. Melanoma-related operative procedures not corresponding to criteria described in the protocol 8. Patients with prior cancers, except: * those with a thin \<=1 mm, regionally unrelated melanoma \> 5 years ago * those with a good prognosis regionally unrelated cancer (\>90% probability of 10 years disease specific survival) * other cancers diagnosed more than five years ago with no evidence of disease recurrence within this time * successfully treated basal cell and squamous cell skin carcinoma * carcinoma in-situ of the cervix * 1 episode of in transit melanoma \> 3 years ago 9. A medical or psychiatric condition that compromises ability to give informed consent or complete the protocol 10. Positive urine pregnancy test for women of childbearing potential (+/-7 days of randomisation onto the trial)
References
Publications (1)
- DERIVEDMahumud RA, Law CK, Ospino DA, de Wilt JHW, van Leeuwen BL, Allan C, de Lima Vazquez V, Jones RP, Howle J, Peric B, Spillane AJ, Morton RL. Economic Evaluation of Inguinal Versus Ilio-inguinal Lymphadenectomy for Patients with Stage III Metastatic Melanoma to Groin Lymph Nodes: Evidence from the EAGLE FM Randomized Trial. Ann Surg Oncol. 2025 Jun;32(6):4211-4222. doi: 10.1245/s10434-025-17040-2. Epub 2025 Feb 27. PMID 40016616