Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial looking at everolimus for neuroendocrine tumours (RADIANT 4)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at everolimus (Afinitor) to treat neuroendocrine tumours (NETs) of the digestive system or lungs.
Neuroendocrine tumours (NETs) are a rare group of cancers that develop in the neuroendocrine system. Some make extra
Doctors can help control the growth and improve the symptoms of NETs with
- Drugs called somatostatin analogues
- Cutting off the blood supply to the tumour (
- Radiotherapy that is targeted directly to the tumour (radionuclide targeted therapy)
- A drug called interferon
Everolimus is a biological therapy. It works by stopping a protein called mTOR from working properly. mTOR controls other proteins that trigger cancer cells to grow. So by blocking it, everolimus helps to stop the cancer growing. We know from research that everolimus may help treat NETs.
The aim of this trial is to find out if everolimus can help people with non functioning NETs of the digestive system or lungs.
Who can enter
You may be able to enter this trial if
- You have a non functioning neuroendocrine tumour (NF-NET) of the digestive system or lungs
- Your tumour cannot be removed with surgery, has spread to another part of your body or has continued to grow during or after treatment
- You have had a scan that shows your tumour has grown in the past 6 months
- Your tumour can be measured on a scan
- You have satisfactory blood test results
- You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- You are willing to use reliable contraception during treatment if there is any chance you or your partner could become pregnant
- You are at least 18 years old
You cannot enter this trial if you
- Have carcinoid syndrome
- Have had a somatostatin analogue, interferon or chemotherapy in the past month
- Have had a radiolabelled somatostatin analogue in the past 6 months
- Have had more than 1 course of chemotherapy
- Have already had another biological therapy
- Have had treatment aimed at blocking blood vessels in your liver (hepatic artery embolisation) in the past 6 months
- Have had your tumour treated by freezing it (cryoablation or cryotherapy) or heating it with radiowaves (radiofrequency ablation) in the past 2 months
- Have already had everolimus or a similar drug such as sirolimus, temsirolimus or deforolimus
- Are known to be sensitive to everolimus or similar drugs and their ingredients
- Are having ongoing treatment with steroids or any other drug that can suppress your
- Have had an experimental drug as part of another clinical trial in the past month
- Have diabetes that is not well controlled
- Have had a heart attack in the past 6 months or any other serious heart problem
- Have an infection
- Have a problem with your liver such as cirrhosis
- Have severe breathing problems
- Have bleeding problems
- Have any condition where your body cannot properly absorb tablets
- Are known to be HIV, hepatitis B or hepatitis C positive
- Have had another cancer apart from non melanoma skin cancer,
carcinoma in situof the cervix, womb (uterus) or breast that has been successfully treated and there has been no sign of disease for at least 3 years
- Have had a
live vaccinesuch as the flu vaccine in the past week
- Have any other medical condition that could affect you taking part in this trial
- Are pregnant or breastfeeding
This is a phase 3 international trial. It will recruit 285 people from different countries around the world. This is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in either. This is called a double blind trial.
People in group 1 have everolimus. People in group 2 have a dummy drug (placebo). Both everolimus and the dummy drug are tablets. You take them once a day. You continue taking them as long as they are helping you and the side effects aren’t too bad.
The trial team will ask you to fill out 2 questionnaires before you start treatment, every 2 months for a year and then every 3 months. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
If you agree to take part in this study, the researchers will also ask for a sample of tissue taken from when you had your biopsy or surgery to remove your tumour.
You will see the doctor and have some tests before taking part in this trial. These tests include
During treatment you see the doctor every month for a physical examination, blood and urine tests.
After treatment your doctor will see you in clinic or contact you every 3 months to see how you are.
The most common side effects of everolimus are
- Sore mouth or throat
- Tiredness (fatigue)
- Feeling or being sick (nausea)
- Dry mouth
- Dry itchy skin or rash
- Loss of appetite or changes in taste
- Tummy (abdominal) pain
- Swelling of the arms and legs
- Nose bleeds
- Change in sleeping patterns
- A drop in the blood cells causing an increased risk of infection, bruising and bleeding
- Shortness of breath
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.
Dr Juan Valle
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer