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Closed (no longer recruiting)Last updated: 20 December 2023

EAGLE FM: This phase III trial is evaluating two surgical procedures (Inguinal or Ilio-inguinal Lymphadenectomy) for the removal of metastatic melanoma in the lymph nodes of the groinInguinal 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 to evaluate survival, morbidity, and quality of life.

Clinical summary

Summary

This study aims to determine optimum surgical management of patients with melanoma spread to their groin lymph nodes. Who is it for? You may be eligible to join this study if you are aged 15 years or above and have been diagnosed with primary cutaneous melanoma or stage III melanoma with metastases (i.e. tumour spread) in the groin area. Study details Participants in this study will be randomly (by chance) allocated to one of two surgery types. Participants in one group will be undergo Inguinal Lymphadenectomy (IL), which is removal of the easily accessible superficial groin lymph nodes (LNs) and has a median LN retrieval of 11. Participants in the other group will undergo Ilio-inguinal Lymphadenectomy (I-IL) which involves removal of the same superficial groin LNs 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. Currently surgeons have polarized opinions as to whether to perform a limited or more extensive lymphadenectomy and there is no evidence of which is the best option. Participants will be followed-up for a period of up to 10 years in order to evaluate disease response, survival and quality of life outcomes. The results of this study may standardise care globally, lead to better cancer outcomes, reduce surgical morbidity and reduce economic burden for the health sector.

Conditions

This trial is treating patients with Melanoma.

Cancer

Skin Cancers Skin

Age

People15+

Phase

III

Trial Acronym

EAGLE FM

More information

Trial Identifiers

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Trial sponsor

Australia and New Zealand Melanoma Trials Group (ANZMTG)

Scientific Title

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 to evaluate survival, morbidity, and quality of life.

Eligibility

Inclusion

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

  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)

Inclusion

  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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