
"I am glad that taking part in a trial might help others on their own cancer journey.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is for people with a neuroendocrine tumour that started in the pancreas or small bowel (duodenum) and cannot be removed with surgery.
Neuroendocrine tumours (NET’s) are rare tumours that develop in the nerve or gland cells that make up the neuroendocrine system. They are normally found in all the body but are most common in the .
If the first treatment you have for your NET helps control the growth of the tumour, you don’t usually have more treatment straight away.
You are followed up at regular hospital appointments and only have further treatment if the tumour starts to grow again.
In this study, doctors want to see if a drug called lanreotide can help:
This is called maintenance treatment.
Lanreotide is a man made form of a drug called . It is already used to treat NET’s of the bowel and pancreas. It reduces the secretions of hormones in the cells and also slows the tumour growth.
The aims of the study are to:
The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.
You may be able to join this study if all of the following apply.
You cannot join this study if any of these apply.
This phase 2/3 study is being run in the UK and Europe. It is in 2 parts. The study team need 118 people to join part 1.
If results from part 1 suggest that lanreotide is a useful maintenance treatment, the study will continue in a part 2 to confirm these results. This is the phase 3 part of the study.
It is a randomised study. You are put into 1 of 2 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 treatment you are having. This is called a double blind study.
You have lanreotide or the dummy drug as an injection into your bottom cheek (buttock) once a month.
You have treatment for as long as it works and the side effects aren’t too bad.
You see the study doctors and have some tests before you start treatment. These include:
You go to hospital to have the injections. You see the study doctors once a month for a check up. You have some blood tests and a CT or MRI scan every 3 months.
If the tumour gets worse you stop treatment. You then see the study team every 6 months for check up. Your doctor will talk to you about other treatment options.
If you stop treatment for any other reason, you see the study team every 3 months.
The study team will ask you to fill out some questionnaires before you start treatment and then every 3 months. The questionnaires will ask about side effects and how you’ve been feeling. This is called a quality of life study.
Research samples
The researchers will ask for samples of your cancer that were removed when you previously had surgery or a .
They will also ask for 3 extra blood samples. Where possible, you have these at the same time as your routine blood tests.
All these samples are used to look for substances called . Biomarkers help to predict who is most likely to benefit from this treatment and also help us to better understand neuroendocrine tumours.
You don’t have to give these samples if you don’t want to. You can still take part in the study.
The side effects of lanreotide are quite mild. They most common include
The only side effect of the dummy drug injection is a slight risk of some swelling around the injection site.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Juan Valle
Federation Francophone de Cancerologie Digestive (FFCD)
Ipsen
NIHR Clinical Research Network: Cancer
Freephone 0808 800 4040
"I am glad that taking part in a trial might help others on their own cancer journey.”