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Trial record 11 of 510 for:    melanoma phase III

Evaluation of Groin Lymphadenectomy Extent For Metastatic Melanoma (EAGLE FM)

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ClinicalTrials.gov Identifier: NCT02166788
Recruitment Status : Recruiting
First Posted : June 18, 2014
Last Update Posted : October 22, 2018
Sponsor:
Collaborators:
Cancer Council New South Wales
Melanoma Institute Australia
Information provided by (Responsible Party):
Australia and New Zealand Melanoma Trials Group

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Metastatic Melanoma to the Groin Lymph Nodes Procedure: Inguinal Lymphadenectomy Procedure: Ilio-inguinal Lymphadenectomy Phase 3

Detailed Description:

Background and Rationale

Spread of metastatic melanoma to the groin lymph nodes (LN) is a common event for patients with melanoma. In melanoma treatment centres around the world, patients without demonstrated pelvic LN disease receive 1 of 3 strategies of management in relatively equal proportions (Pasquali, Spillane et al. 2012):

i. Inguinal Lymphadenectomy (IL) ii. Ilio-inguinal Lymphadenectomy (I-IL) iii. Variable use of either IL or I-IL surgery.

Some larger melanoma centres have an institutional policy that all patients have either IL or I-IL for metastatic inguinal node involvement. Nearly all centres would agree that patients with pelvic LN involvement without distant metastatic disease should have I-IL.

Study Objectives This study aims to provide a more rational evidence base for appropriate management for metastatic melanoma in the groin LNs, through assessing the effect of the addition of ipsilateral pelvic lymphadenectomy on patient disease-free survival (DFS), distant disease-free survival (DDFS), overall survival (OS), morbidity, and quality of life. In addition, the study will clarify the reliability of PET (Positron Emission Tomography) / CT (Computed Tomography) scans for staging pelvic LNs, clarify morbidity differences between the operations in a balanced cohort, evaluate any health economic benefits of I-IL over IL and provide a tissue and serum resource to be used to identify biological markers of recurrence and progression after inguinal metastases.

Study 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.

Study Population The aim is to recruit 634 patients in 5 years who are 15 years or older with cytologically or histologically confirmed metastatic melanoma in inguinal LNs (H&E & IHC); specifically with no evidence of pelvic node involvement or distant spread of melanoma clinically or on PET/CT staging scans. To be eligible patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 at randomisation.

Study Treatments Eligible patients will be randomised 1:1 to undergo an IL or I-IL.

Study Design This is an international, multi-centre, phase III, non-inferiority, prospective, randomised clinical trial.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 634 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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 (EAGLE FM)
Study Start Date : January 2015
Estimated Primary Completion Date : August 2025
Estimated Study Completion Date : August 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Arm 1: Inguinal Lymphadenectomy
Inguinal Lymphadenectomy (IL) is removal of the easily accessible superficial groin lymph nodes (LNs) and has a median LN retrieval of 11 lymph nodes
Procedure: Inguinal Lymphadenectomy
Arm 2: Ilio-inguinal Lymphadenectomy
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.
Procedure: Ilio-inguinal Lymphadenectomy



Primary Outcome Measures :
  1. The primary endpoint of the study will be Disease Free Survival following lymphadenectomy, assessed after 60 months of follow-up. [ Time Frame: 60 Months ]
    The difference between IL and I-IL surgery in DFS 5 years after randomisation


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 0 - 120 months ]
    time from randomisation to death from any cause

  2. Distant Disease Free Survival [ Time Frame: 0 - 120 Months ]
    time to new distant melanoma recurrence

  3. Regional Recurrence Free Survival [ Time Frame: 0 - 120 Months ]
    time to new regional lymph node recurrence

  4. Morbidity differences [ Time Frame: Up to 120 days from lymphadenectomy, and from 0 - 120 months ]
    This includes lymphoedema, wound complications (wound infections, dehiscence/necrosis, and seroma) chronic pain, and restriction in mobility

  5. Quality Of Life [ Time Frame: 0 - 120 Months ]
    Quality Of Life questionnaires completed by patients

  6. Sensitivity / specificity and positive predictive value and negative predictive value of PET/CT for pelvic disease at diagnosis of groin LN involvement by melanoma. [ Time Frame: 0 - 120 Months ]
    The diagnostic accuracy of PET/CT and CT for detecting pelvic lymph nodes positive for metastatic melanoma as confirmed by histopathology will be assessed in the sub-group of patients screened and shown to have a positive pelvic LN on PET/CT and those patients who had negative pelvic LN on PET/CT and randomised for I-IL treatment.

  7. Resource use and utility based Quality Of Life [ Time Frame: 0 - 60 Months ]
    Resource use will be identified from the trial case report forms, and valued according the relevant Australian Refined Diagnosis Related Groups and Medicare Benefits Schedule item numbers.The cost-effectiveness and cost-utility analyses will calculate total costs and mean per patient costs per surgical group allocation, as well as total and mean benefits per group allocation.



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02166788


Contacts
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Contact: Alex Economides + 61 2 9911 7352 eagle.fm@melanoma.org.au

Locations
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Australia, Australian Capital Territory
Calvary Public Hospital Bruce Recruiting
Canberra, Australian Capital Territory, Australia, 2617
Principal Investigator: Rebecca Read         
Australia, New South Wales
Melanoma Institute Australia - The Poche Centre Recruiting
North Sydney, New South Wales, Australia, 2060
Contact: Alex Economides    + 61 2 9911 7352    eagle.fm@melanoma.org.au   
Principal Investigator: Andrew Spillane         
Sydney Adventist Hospital Recruiting
Sydney, New South Wales, Australia, 2076
Contact: Michael Hughes         
Principal Investigator: Michael Hughes         
Westmead Hospital Active, not recruiting
Sydney, New South Wales, Australia, 2145
Royal Prince Alfred Hospital Recruiting
Sydney, New South Wales, Australia
Contact: Robyn Saw         
Principal Investigator: Robyn Saw         
Australia, Queensland
Mater Hospital Brisbane Recruiting
Brisbane, Queensland, Australia, 4101
Contact: Vicky Harvey       vicky.harvey@mater.org.au   
Principal Investigator: Christopher Allan         
Australia, Victoria
Peter MacCallum Cancer Centre Recruiting
Melbourne, Victoria, Australia, 3000
Contact: John Spillane         
Principal Investigator: John Spillane         
Brazil
Hospital de Câncer de Barretos Recruiting
Barretos, SP, Brazil, 14784-400
Contact: Vinicius Vazquez         
Principal Investigator: Vinicius Vazquez         
A.C. Camargo Cancer Center Recruiting
Sao Paulo, SP, Brazil, 01508-010
Contact: Joao Duprat         
Principal Investigator: Joao Duprat         
Italy
Veneto Institute of Oncology - IOV Recruiting
Padova, Veneto, Italy, 35128
Contact: Luca Campana         
Principal Investigator: Luca Campana         
Netherlands
Radboud University Nijmegen Medical Center Recruiting
Nijmegen, Gelderland, Netherlands, 6525
Contact: Hans deWilt         
Principal Investigator: Hans deWilt         
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9713
Contact: Barbara van Leeuwen         
Principal Investigator: Barbara van Leeuwen         
Slovenia
Institute of Oncology Ljubljana Recruiting
Ljubljana, Slovenia, 1000
Contact: Barbara Peric         
Principal Investigator: Marko Hocevar         
United Kingdom
Norfolk and Norwich University Hospital Recruiting
Norwich, Norfolk, United Kingdom, NR4 7UY
Contact: Marc Moncrieff         
Principal Investigator: Marc Moncrieff         
Guy's and St Thomas's Hospitals Recruiting
London, United Kingdom
Contact: Jenny Geh         
Principal Investigator: Jenny Geh         
St George's Hospital Recruiting
London, United Kingdom
Contact: Barry Powell         
Principal Investigator: Barry Powell         
St Helen's and Knowsley Teaching Hospitals Recruiting
St Helens, United Kingdom
Contact: Rowan Pritchard-Jones         
Principal Investigator: Rowan Pritchard-Jones         
Sponsors and Collaborators
Australia and New Zealand Melanoma Trials Group
Cancer Council New South Wales
Melanoma Institute Australia
Investigators
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Principal Investigator: Andrew Spillane The University of Sydney, Northern Clinical School

Additional Information:
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Responsible Party: Australia and New Zealand Melanoma Trials Group
ClinicalTrials.gov Identifier: NCT02166788     History of Changes
Other Study ID Numbers: ANZMTG 01.12
ANZMTG 01.12 ( Other Identifier: ANZMTG )
First Posted: June 18, 2014    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018

Keywords provided by Australia and New Zealand Melanoma Trials Group:
metastatic melanoma
groin lymph nodes
surgery
lymphadenectomy

Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas