
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at Lutathera to treat carcinoid tumours of the small bowel.
Carcinoid tumours are rare and mostly slow growing tumours. They are a type of tumour of the neuroendocrine system. The neuroendocrine system is made up of nerve and gland cells that make hormones and release them into the bloodstream. There are neuroendocrine cells in the gut, lungs and pancreas. One of the most common places for carcinoid tumours to develop is the small bowel.
Doctors can treat carcinoid tumours of the small bowel with surgery. If you can’t have your tumour completely removed with surgery, doctors may use a drug called octreotide. Octreotide is type of drug called a somatostatin analogue. It works by stopping the cells in the gut producing too many hormones and changing the way the body reacts to hormones. It can control the growth of carcinoid tumours and their symptoms.
Lutathera is a targeted radiotherapy treatment. It is also called peptide receptor radionuclide therapy (PRRT). Lutathera is a somatostatin analogue with a radioactive part attached. It works by delivering the radioactive part directly to the carcinoid cells. The radioactive part then kills the cells.
We know from research that Lutathera may help people with carcinoid tumours of the gut and pancreas. The researchers think it may help people with carcinoid tumours of the small bowel.
The aim of this trial is to compare Lutathera with octreotide to find out which treatment is best for people with carcinoid tumours of the small bowel. They also want to find out more about the safety and side effects of Lutathera.
You may be able to enter this trial if
You cannot enter this trial if
This is a phase 3 trial. This international trial will recruit 230 people. It is a randomised trial. The people taking part 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.
The 2 groups are
You have Lutathera as an injection into a vein. People having Lutathera will also have a protein solution as an injection into a vein. This is to protect your kidneys. It takes a total of 4 hours to have Lutathera and the protein solution. You have Lutathera and the protein solution every 2 months for 8 months. After this you have octreotide every month.
You have octreotide as an injection into a muscle. You have high dose octreotide every month.
You have treatment for about 1½ years.
The trial team will ask you to fill out a questionnaire before you start treatment and then every 3 months during your treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
To take part in this trial the trial team need a small piece of tissue (a biopsy) of your tumour. You must agree to this. If a tissue sample is not available from earlier surgery or biopsy, your doctor will talk to you about the possibility of taking a sample for this trial.
You see the doctor and have some tests before taking part in this trial.
These tests include
During treatment you see the doctor regularly for the same tests. Your doctor will tell you how often this is depending on which group you are in.
After treatment you see the doctor every 6 months for 3 years to see how you are.
The most common side effects of Lutathera include
The most common side effects of octreotide are
Your doctor will talk to you about possible side effects of treatment before you agree to take part in this trial.
We have more information about the side effects of octreotide on our somatostatin analogue page.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Ashley Grossman
Advanced Accelerator Applications
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”