A trial of everolimus and a type of internal radiotherapy for neuroendocrine tumours (COMPETE)

Cancer type:

Carcinoid
Neuroendocrine tumour (NET)
Secondary cancers

Status:

Open

Phase:

Phase 3

This trial is for people with a neuroendocrine tumour (NET) that started in the pancreas or the gastrointestinal tract. The gastrointestinal tract includes the:

  • food pipe (oesophagus)
  • stomach
  • bowel
  • back passage (rectum)

It is for people who have a NET that has spread to other parts of the body (metastatic) or that cannot be removed with surgery.

Everyone taking part has certain proteins on the surface of their cancer cells called somatostatin receptors.

More about this trial

Neuroendocrine tumours (NETs) are rare cancers that start in neuroendocrine cells. They often develop slowly over some years. Neuroendocrine cells are part of our neuroendocrine system. They make hormones that control how our bodies work.

Surgery is the main treatment for NETs. This is often the only treatment you need. But sometimes NETs can spread to other parts of the body, or your doctor may not be able to completely remove the cancer during surgery. You have other treatments such as targeted drugs if this happens.

Everolimus (Afinitor) is a type of targeted drug called a cancer growth blocker. It stops a protein called mTOR from working properly. Everolimus is already a possible treatment for people with advanced NETs. It can stop the cancer from growing for some time.

In this trial, doctors are looking at a type of internal radiotherapy called peptide receptor radionuclide therapy (PRRT). PRRT uses a radioactive substance (radiopharmaceutical) called Lu-Edotreotide. Some neuroendocrine cells have proteins on the outside of them called somatostatin receptors. The hormone somatostatin attaches to this receptor and slows down the production of hormones by the cell.

By attaching the radioactive substance (Lu) to a man made form of the hormone somatostatin (the somatostatin analogue Edotreotide), the radiopharmaceutical can be given directly inside the neuroendocrine tumour cell. In this way, the cancer cell can be destroyed.

Everyone taking part in this trial has 1 of the following:

  • peptide receptor radionuclide therapy (PRRT) with Lu-Edotreotide
  • standard treatment with everolimus

The main aim of this trial is to find out whether PRRT helps people with NETs that have spread to other parts of the body and cannot be removed with surgery.

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.

Who can take part
You may be able to join this trial if all of the following apply:

  • you have a NET that started in the food pipe, stomach, bowel, pancreas or the back passage (rectum)
  • your NET is likely to grow slowly (grade 1 or grade 2)
  • your cancer has spread to other parts of the body (metastatic) or doctors think they cannot remove the cancer completely with surgery
  • you are willing to have a sample of tissue taken (biopsy Open a glossary item) if there isn’t a suitable sample available
  • you have at least 1 area of cancer that can be seen and measured on a CT scan or an MRI scan
  • you have had a scan in the last 3 months
  • your cancer has proteins called somatostatin receptors on its surface (somatostatin receptor positive)
  • your cancer got worse in the past 3 years
  • you are able to care for yourself but not able to carry on with all your activities or do active work (Karnofsky performance status of 70 or more)
  • your kidneys are working well
  • you have satisfactory blood tests results
  • you are at least 18 years old
  • you are willing to use reliable contraception during treatment and for around 2 months afterwards if there is any possibility that you or your partner could become pregnant

Who can’t take part
You cannot join this trial if any of these apply.

Cancer related

  • your NET has spread to the brain
  • you have a lot of cancer spread in the liver (more than 70%)
  • your NET started in the lungs, testicles or ovaries
  • your NET makes hormones that go into the bloodstream (functioning NET). You can take part if you have a functioning NET that started in the pancreas  
  • doctors don’t know where your cancer started (unknown primary)
  • you have had another cancer in the past 5 years apart from basal cell skin cancer
  • you have had cancer treatments in the past month
  • you are going to have other cancer treatments such as chemotherapy, radiotherapy, chemoembolisation Open a glossary item or immunotherapy Open a glossary item   
  • doctors think you can have surgery to try to cure the NET
  • you still have moderate or serious side effects from previous cancer treatment
  • you have had treatment with everolimus or any other similar drug
  • you have had PRRT

Medical conditions
You:

  • have had an investigational treatment in the past month
  • have any other serious medical condition or mental health problem that the trial team think could affect you taking part
  • have had a live vaccine in the last month
  • are sensitive to any of the treatments used in this trial or anything they contain

Trial design

This is an international phase 3 trial. Researchers need around 300 people to take part.

It is a randomised trial. Everyone taking part is put into 1 of the following treatment groups by a computer:

  • peptide receptor radionuclide therapy (PRRT) with Lu-edotreotide
  • standard treatment with everolimus

Neither you nor your doctor will be able to decide which group you are in. And you are 2 times more likely to have PRRT than everolimus.

PRRT with Lu-edotreotide
You have PRRT as a drip into your bloodstream. It takes up to 20 minutes to have it. You also have a drip with proteins called amino acids Open a glossary item to protect the kidneys. It takes up to an hour to have the amino acids drip.

You have PRRT and the amino acids once every 3 months. This continues for 9 months (up to 4 doses of treatment).

After each treatment you need to stay in hospital for some days. The number of days you stay in hospital depends on where you are having treatment. It is usually about 3 days. This is because the treatment is radioactive. Your doctor and nurse will explain the precautions you need to take and for how long.  

Everolimus 
You have everolimus as a tablet that you swallow whole every day. This continues for as long as it is helping you and the side effects aren’t too bad. It can be for up to 2 years.

Doctors will ask you to keep a diary to record each time you take everolimus. This helps your doctor know how many doses of treatment you have had.

After the 2 years, you may be able to have PRRT if your cancer starts to get worse during treatment with everolimus. Your doctor can tell you more about this.

Tissue sample
The trial team will ask to use a sample of your cancer taken at the time of your diagnosis. You need to have a biopsy if there isn’t a suitable sample available.

Doctors want to look at the cancer and the proteins (receptors) on the outside of cancer cells.

Quality of life
You complete a quality of life questionnaire before the start of treatment and at set times during the trial.

The questionnaires ask about how you have been feeling and what side effects you have had.

Hospital visits

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

  • a physical examination
  • blood tests and urine test
  • heart trace (ECG Open a glossary item)
  • CT scan or MRI scan
  • a radioactive scan
  • a kidney scan called renal scintigraphy

During treatment, you see the trial team every month for blood tests and a physical examination. This continues for a year. You then see them every 3 months.

You have a CT scan or MRI scan every 3 months. And you have a kidney scan after 6 months from the start of treatment.

When you finish treatment, you see the trial team every 6 months, for 5 years.

Side effects

The trial team monitor you during treatment and afterwards. You have a phone number to call them if you are worried about anything. The team will tell you about the possible side effects before you start the trial.

The most common side effects of PRRT with Lu-edotreotide are:

PRRT has a small amount of radiation. As a precaution, you should avoid close contact with young children and pregnant women for the first 2 weeks after treatment. Close contact means being within arm’s length.

Your doctor or nurse will tell about all the precautions you need to take before you go home. Most of the radiation will be gone within 2 weeks.

The most common side effects of everolimus are:

We have more information about the potential side effects of everolimus and PRRT.

Location

Birmingham
Liverpool
London
Wirral

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

Prof Dr Shaunak Navalkissoor

Supported by

ITM Solucin

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

15510

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

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

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