A trial looking at treatment to the groin for people with melanoma that has spread (EAGLE FM)

Cancer type:

Melanoma

Status:

Open

Phase:

Phase 3

This trial is for people with melanoma that has spread to the lymph nodes in the area where the leg joins the tummy (groin). 

It is comparing surgery to remove the groin lymph nodes Open a glossary item with surgery to remove the lymph nodes from the groin and the area between the hip bones (pelvis). 

More about this trial

Melanoma can sometimes spread to the lymph nodes. If this happens, you usually have surgery to remove all the lymph nodes in the affected area. This is a lymphadenectomy.   
        
If melanoma spreads to the lymph nodes in the groin, you have surgery to remove all the lymph nodes either:

  • in the groin (an inguinal lymphadenectomy)
  • in the groin and the pelvis (ilio-inguinal lymphadenectomy)

Doctors don’t know whether one type of surgery is better at stopping melanoma from coming back. Or at reducing side effects such as lymphoedema. So in this trial they are comparing both surgeries, to see which treatment is better.  

The main aims of this trial are to: 

  • find out how well both types of surgery work as a treatment
  • look at the side effects of both surgeries such as lymphoedema Open a glossary item 
  • find out more about people’s quality of life Open a glossary item 
  • see if scans such as PET-CT scan and CT scan can give information about melanoma spread in the pelvis (stage Open a glossary item

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you. 

You may be able to join this trial if all of the following apply.

  • Your melanoma started in the skin (cutaneous Open a glossary item melanoma) or your doctor doesn’t know where the melanoma started but it has spread to the skin or nearby lymph nodes (stage 3
  • Your melanoma has spread to at least 1 lymph node in the groin
  • Doctors found out that you have melanoma spread in the groin less than 120 days ago (about 4 months)
  • You have had a PET-CT scan of your whole body and a CT scan or MRI scan of your brain in the past 6 weeks 
  • You are well enough to be up and about for at least half the day (performance status 0, 1 or 2
  • You are at least 18 years old

Who cannot enter

You cannot join this trial if any of these apply.

Cancer related

  • Your melanoma has spread to the lymph nodes in the pelvis or to other parts of the body
  • Your melanoma has spread to the lymph nodes in both sides of the groin 
  • You have had radiotherapy to the pelvis or your doctor thinks you need radiotherapy after surgery 
  • You have had another cancer apart from melanoma that measured less than 1 mm and was successfully treated more than 5 years ago, successfully treated basal or squamous cell skin cancer, an early cancer (carcinoma in situ Open a glossary item) of the cervix, or any other cancer treated with the aim to cure, no signs of it for at least 5 years and a low risk of it coming back

Medical conditions

  • You have had major surgery to the pelvis 
  • Doctors think you are not well enough to have a general anaesthetic Open a glossary item
  • You have any other medical condition or mental health problem that the trial team thinks could affect you taking part in this trial 

 Other

  • You are pregnant 

Trial design

This is an international phase 3 trial. Researchers need about 634 people worldwide and hope that around 50 people from the UK will take part.  

This trial is randomised. The people taking part are put into 1 of the following treatment groups by computer:

  • surgery to remove the lymph nodes in the groin (inguinal lymphadenectomy)
  • surgery to remove the lymph nodes in the groin and pelvis (ilio-inguinal lymphadenectomy) 

Neither you nor your doctor will be able to decide which group you are.  
study diagram

Before surgery your doctor marks the skin with a pen. You have a general anaesthetic during the operation. This means you will be asleep the whole time. 

Inguinal lymphadenectomy 
Your surgeon makes a cut in the groin and removes around 11 lymph nodes. This can take around 1 to 3 hours.  

Ilio-inguinal lymphadenectomy 
You have a larger cut in the groin that can go up to the tummy (abdomen). Doctors remove lymph nodes in the groin and the area above the groin (pelvis). 

You usually have around 22 lymph nodes removed. This can take up to 3 hours. 

Questionnaires
Everyone taking part completes some questionnaires before starting treatment and:

  • 1 to 2 months after surgery 
  • every 3 months for 2 years
  • every 6 months for 3 years 
  • then every year for 5 years

The questionnaires will ask how treatment has affected your daily life (quality of life Open a glossary item) and about your work and finances. 

Checking for lymphoedema
To help the trial team check for lymphoedema you have your leg measured and your mobility checked. You will also be asked to complete a questionnaire about your mobility. The checks on your leg will be done before your surgery and then: 

  • every 6 months for 2 years
  • once a year for the next 3 years

Everyone completes the mobility questionnaire before surgery and then at the first 6 month visit. You only need to carry on doing the questionnaire if you develop lymphoedema. 

Hospital visits

You see a doctor and have some tests before taking part. These tests include: 

  • physical examination
  • blood tests
  • a PET-CT scan of your whole body or a CT scan of your chest, tummy and pelvis
  • a CT scan or MRI scan of your brain 
  • blood tests
  • urine test

After surgery you see the trial doctor for blood tests and a physical examination after 1 or 2 months. Then you see them:

  • every 3 months for 2 years
  • every 6 months for 3 years 
  • every year for 5 years

You also have a PET-CT scan or a CT scan every 6 months for 2 years and every year for 5 years. 

Side effects

The common side effects of surgery to remove the lymph nodes are:

  • infection 
  • pain at the surgery site
  • fluid or blood collection at the surgery site
  • swelling (lymphoedema) 

We have more information about surgery to remove lymph nodes. And information about having a:

Location

London
Norwich

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Mr Marc Moncrieff

Supported by

Australia and New Zealand Melanoma Trials Group (ANZMTG) 
Norfolk & Norwich University Hospitals NHS Foundation Trust

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14632

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Wendy took part in a new trial studying the possible side effect of hearing loss

A picture of Wendy

"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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