Metastatic Melanoma to the Groin Lymph NodesPhase 3EAGLE FMNCT02166788
Evaluation of Groin Lymphadenectomy Extent For Metastatic Melanoma
A Phase 3 study testing Inguinal Lymphadenectomy and Ilio-inguinal Lymphadenectomy in people with Metastatic Melanoma to the Groin Lymph Nodes, run by Melanoma and Skin Cancer Trials Limited at 17 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Metastatic Melanoma to the Groin Lymph Nodes
- What is being tested?
- Inguinal Lymphadenectomy and Ilio-inguinal Lymphadenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 634 participants
- Where
- 17 sitesin 6 countries
- Study dates
- 2 Mar 2015to 17 Oct 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients may be included in the study only if they meet all of the following criteria:
- Must be 15 and above.
- 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)
- Life expectancy of at least 10 years from the time of diagnosis, not considering the melanoma in question, as determined by the PI
- 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;
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- 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;
- Absent distant disease clinically and on PET/CT scan. (Patients must have NO further distant disease or visceral metastases)
- ECOG performance status must be between 0 to 2 at randomisation
- 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.
- Able to provide written, informed consent
- Willing to return to the centre for follow up examinations and procedures, as outlined in the protocol.
- All patients must be randomised and undergo lymphadenectomy surgery no more than 120 days following diagnosis of inguinal LN involvement
Who cannot join
- 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
- 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.
- Bilateral inguinal lymph node involvement
- Patients with a history of major pelvic surgery and / or regional radiotherapy at any time in the past
- Requiring planned radiotherapy following surgery due to macroscopic, bulky and matted nodes.
- Unfit for General Anaesthesia
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- Melanoma-related operative procedures not corresponding to criteria described in the protocol
- 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
- A medical or psychiatric condition that compromises ability to give informed consent or complete the protocol
- Positive urine pregnancy test for women of childbearing potential (+/-7 days of randomisation onto the trial)
Trial locations and contacts
17 sites in 6 countries.
17 sites in 6 countries
Australia7 sites
Mater Hospital Brisbane
Brisbane, Queensland, 4101
Calvary Public Hospital Bruce
Canberra, Australian Capital Territory, 2617
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Melanoma Institute Australia - The Poche Centre
North Sydney, New South Wales, 2060
Sydney Adventist Hospital
Sydney, New South Wales, 2076
Westmead Hospital
Sydney, New South Wales, 2145
Royal Prince Alfred Hospital
Sydney, New South Wales
United Kingdom4 sites
Guy's and St Thomas's Hospitals
London
St George's Hospital
London
Norfolk and Norwich University Hospital
Norwich, Norfolk, NR4 7UY
St Helen's and Knowsley Teaching Hospitals
St Helens
Brazil2 sites
Hospital de Câncer de Barretos
Barretos, São Paulo, 14784-400
A.C. Camargo Cancer Center
São Paulo, São Paulo, 01508-010
Netherlands2 sites
University Medical Center Groningen
Groningen, Provincie Groningen, 9713
Radboud University Nijmegen Medical Center
Nijmegen, Gelderland, 6525
About this study
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)
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.
Read the 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):
- 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.
- Being tested
- Inguinal Lymphadenectomy, Ilio-inguinal Lymphadenectomy
- Keywords
- metastatic melanoma, groin lymph nodes, surgery, lymphadenectomy
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inguinal LymphadenectomyProcedure or surgery
Ilio-inguinal LymphadenectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Inguinal Lymphadenectomy | Other | Inguinal Lymphadenectomy (IL) is removal of the easily accessible superficial groin lymph nodes (LNs) and has a median LN retrieval of 11 lymph nodes Receives: Procedure: Inguinal Lymphadenectomy |
| Arm 2: Ilio-inguinal Lymphadenectomy | Other | 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. Receives: Procedure: Ilio-inguinal Lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of the study will be Disease Free Survival following lymphadenectomy, assessed after 60 months of follow-up.
The difference between IL and I-IL surgery in DFS 5 years after randomisation
Measured: 60 Months
Secondary outcomes (7)
Overall Survival
time from randomisation to death from any cause
Measured: 0 - 120 months
Distant Disease Free Survival
time to new distant melanoma recurrence
Measured: 0 - 120 Months
Regional Recurrence Free Survival
time to new regional lymph node recurrence
Measured: 0 - 120 Months
Morbidity differences
This includes lymphoedema, wound complications (wound infections, dehiscence/necrosis, and seroma) chronic pain, and restriction in mobility
Measured: Up to 120 days from lymphadenectomy, and from 0 - 120 months
Quality Of Life
Quality Of Life questionnaires completed by patients
Measured: 0 - 120 Months
Sensitivity / specificity and positive predictive value and negative predictive value of PET/CT for pelvic disease at diagnosis of groin LN involvement by melanoma.
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.
Measured: 0 - 120 Months
Resource use and utility based Quality Of Life
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.
Measured: 0 - 60 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study start2 Mar 2015
- Primary completion17 Oct 2024
- Study completion17 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Melanoma to the Groin Lymph NodesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 634 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Melanoma and Skin Cancer Trials Limited
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Council New South Wales, Melanoma Institute Australia
- Responsible party
- Sponsor
- Investigators
- Andrew Spillane, Principal investigator, The University of Sydney, Northern Clinical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02166788
- Sponsor's protocol ID
- 01.12
- Acronym
- EAGLE FM
- Status last verified
- Apr 2022
- First submitted
- 15 Jun 2014
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mahumud 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.
PubMed 40016616
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02166788
- Acronym / sponsor ID
- EAGLE FM / 01.12
- Keywords
- metastatic melanoma, groin lymph nodes, surgery, lymphadenectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 634 participants (estimated)
- Lead sponsor
- Melanoma and Skin Cancer Trials LimitedUniversity, hospital or other
- Collaborators
- Cancer Council New South Wales, Melanoma Institute Australia
- Study start
- 2 Mar 2015 (actual)
- Primary completion
- 17 Oct 2024 (actual)
- Study completion
- 17 Oct 2024 (actual)
- First posted
- 18 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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):
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Inguinal Lymphadenectomy | Other | Procedure: Inguinal LymphadenectomyInguinal Lymphadenectomy (IL) is removal of the easily accessible superficial groin lymph nodes (LNs) and has a median LN retrieval of 11 lymph nodes |
| Arm 2: Ilio-inguinal Lymphadenectomy | Other | Procedure: Ilio-inguinal LymphadenectomyIlio-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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Must be 15 and above.
- 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)
- Life expectancy of at least 10 years from the time of diagnosis, not considering the melanoma in question, as determined by the PI
- Must have one or multiple inguinal node(s) involved, histologically or cytologically proven as metastatic melanoma. This can can be detected:
- Absent distant disease clinically and on PET/CT scan. (Patients must have NO further distant disease or visceral metastases)
Key exclusion criteria (16 listed)
- 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
- 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.
- Bilateral inguinal lymph node involvement
- Patients with a history of major pelvic surgery and / or regional radiotherapy at any time in the past
- Requiring planned radiotherapy following surgery due to macroscopic, bulky and matted nodes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inguinal Lymphadenectomy | Procedure or surgery | Arm 1: Inguinal Lymphadenectomy |
| Ilio-inguinal Lymphadenectomy | Procedure or surgery | Arm 2: Ilio-inguinal Lymphadenectomy |
Primary outcome
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
7 secondary outcomes
Overall Survival
Time frame: 0 - 120 months
Distant Disease Free Survival
Time frame: 0 - 120 Months
Regional Recurrence Free Survival
Time frame: 0 - 120 Months
Morbidity differences
Time frame: Up to 120 days from lymphadenectomy, and from 0 - 120 months
Quality Of Life
Time frame: 0 - 120 Months
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
Resource use and utility based Quality Of Life
Time frame: 0 - 60 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Derived from this study: PubMed 40016616Mahumud 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.
- Trial WebsiteLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Spillane principal investigator
The University of Sydney, Northern Clinical School
17 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Inguinal Lymphadenectomy and Ilio-inguinal Lymphadenectomy in people with Metastatic Melanoma to the Groin Lymph Nodes, run by Melanoma and Skin Cancer Trials Limited at 17 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Australia, United Kingdom, Brazil, Netherlands, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint of the study will be Disease Free Survival following lymphadenectomy, assessed after 60 months of follow-up. (time frame: 60 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02166788, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.