A trial looking at Lutathera for carcinoid tumours of the small bowel (NETTER)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
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.
Who can enter
You may be able to enter this trial if
- You have a carcinoid tumour of the small bowel that has spread to the surrounding tissue or to another part of your body and can’t be removed with surgery
- Your tumour has a small amount of a protein called Ki67
- All of your carcinoid tumours have somatostatin receptors
- You are having 20 mg or 30 mg of octreotide every 3 or 4 weeks and have had it for at least 3 months
- You have a CT scan or MRI scan that shows your tumour has grown in the past 3 years while having the same dose of octreotide
- You have at least 1 tumour that can be measured on a scan
- You have an octreoscan that shows equal to or greater than normal uptake of octreotide in your liver
- You are well enough to carry out your normal activities but may need help from time to time (Karnofsky performance status 60 and above)
- You have satisfactory blood test results
- You are willing to use 2 reliable forms of contraception during treatment and for 6 months afterwards
- You are at least 18 years old
You cannot enter this trial if
- Your cancer has spread to your brain – if you’ve had treatment for this and haven’t had any symptoms in the past 6 months you may be able to take part
- You are having more than 30mg of octreotide
- You are having targeted radiotherapy treatment
- You have had major surgery,
radioembolisation 
or interferon in the past 6 weeks - You have had any other treatment, including an experimental drug as part of another clinical trial, in the past month
- You are having short acting octreotide and cannot stop having it for short periods of time
- You have had radiotherapy to more than a quarter of your bones that make blood cells
- You have had another cancer apart from non melanoma skin cancer and carcinoma in situ of the cervix or any other cancer that has been successfully treated and there has been no sign of it in the past 5 years
- You have certain heart problems
- You have diabetes that isn’t controlled with medication
- You are not able to control passing urine (urinary incontinence)
- You have any condition that is not controlled by treatment and would affect you taking part in this trial
- Are pregnant or breastfeeding
Trial design
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
- Lutathera followed by octreotide
- High dose octreotide
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.
Hospital visits
You see the doctor and have some tests before taking part in this trial.
These tests include
- A physical examination
- Blood tests
- Urine test
- Heart trace (
ECG ) - CT scan
- MRI scan
- Octeroscan
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.
Side effects
The most common side effects of Lutathera include
- A drop in blood cells causing an increased risk of infection, bruising and bleeding
- Feeling or being sick (nausea)
- Tummy (abdominal) pain
- Tiredness (fatigue)
- Hair loss
The most common side effects of octreotide are
- Stomach pain – can be sudden and severe
- Feeling or being sick
- Feeling restless
- Dizziness
- Yellowing of your skin or the whites of your eyes
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.
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.
Chief Investigator
Professor Ashley Grossman
Supported by
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
