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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02166788




Registration number
NCT02166788
Ethics application status
Date submitted
15/06/2014
Date registered
18/06/2014
Date last updated
7/04/2022

Titles & IDs
Public title
Evaluation of Groin Lymphadenectomy Extent For Metastatic Melanoma
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 (EAGLE FM)
Secondary ID [1] 0 0
01.12
Universal Trial Number (UTN)
Trial acronym
EAGLE FM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Melanoma to the Groin Lymph Nodes 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Inguinal Lymphadenectomy
Treatment: Surgery - Ilio-inguinal Lymphadenectomy

Other: 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

Other: 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.


Treatment: Surgery: Inguinal Lymphadenectomy


Treatment: Surgery: Ilio-inguinal Lymphadenectomy
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary endpoint of the study will be Disease Free Survival following lymphadenectomy, assessed after 60 months of follow-up.
Timepoint [1] 0 0
60 Months
Secondary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
0 - 120 months
Secondary outcome [2] 0 0
Distant Disease Free Survival
Timepoint [2] 0 0
0 - 120 Months
Secondary outcome [3] 0 0
Regional Recurrence Free Survival
Timepoint [3] 0 0
0 - 120 Months
Secondary outcome [4] 0 0
Morbidity differences
Timepoint [4] 0 0
Up to 120 days from lymphadenectomy, and from 0 - 120 months
Secondary outcome [5] 0 0
Quality Of Life
Timepoint [5] 0 0
0 - 120 Months
Secondary outcome [6] 0 0
Sensitivity / specificity and positive predictive value and negative predictive value of PET/CT for pelvic disease at diagnosis of groin LN involvement by melanoma.
Timepoint [6] 0 0
0 - 120 Months
Secondary outcome [7] 0 0
Resource use and utility based Quality Of Life
Timepoint [7] 0 0
0 - 60 Months

Eligibility
Key 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
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2030
Actual
Sample size
Target
634
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
Recruitment hospital [1] 0 0
Calvary Public Hospital Bruce - Canberra
Recruitment hospital [2] 0 0
Melanoma Institute Australia - The Poche Centre - North Sydney
Recruitment hospital [3] 0 0
Sydney Adventist Hospital - Sydney
Recruitment hospital [4] 0 0
Westmead Hospital - Sydney
Recruitment hospital [5] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [6] 0 0
Mater Hospital Brisbane - Brisbane
Recruitment hospital [7] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2617 - Canberra
Recruitment postcode(s) [2] 0 0
2060 - North Sydney
Recruitment postcode(s) [3] 0 0
2076 - Sydney
Recruitment postcode(s) [4] 0 0
2145 - Sydney
Recruitment postcode(s) [5] 0 0
- Sydney
Recruitment postcode(s) [6] 0 0
4101 - Brisbane
Recruitment postcode(s) [7] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
SP
Country [2] 0 0
Italy
State/province [2] 0 0
Veneto
Country [3] 0 0
Netherlands
State/province [3] 0 0
Gelderland
Country [4] 0 0
Netherlands
State/province [4] 0 0
Groningen
Country [5] 0 0
Slovenia
State/province [5] 0 0
Ljubljana
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Norfolk
Country [7] 0 0
United Kingdom
State/province [7] 0 0
London
Country [8] 0 0
United Kingdom
State/province [8] 0 0
St Helens

Funding & Sponsors
Primary sponsor type
Other
Name
Melanoma and Skin Cancer Trials Limited
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Cancer Council New South Wales
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Melanoma Institute Australia
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02166788
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Spillane
Address 0 0
The University of Sydney, Northern Clinical School
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02166788