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A neuroendocrine cancer clinical trial - NE2

A study of whether somatostatin analogues are needed after targeted radiotherapy for patients with neuroendocrine tumours
Disease Site
Gastro-Intestinal Clinical Trials
Trial Code
CCTG NE2 (STOPNET) l NCT06345079
Trial Status
Open to patient enrollment

What is the purpose of this study?

The purpose of this study is to compare the usual approach of continuing Somatostatin Analogues (SSA) injections during and after Peptide Receptor Radionuclide Therapy (PRRT) to stopping SSA injections when PRRT begins in patients with neuroendocrine tumours (NET). In this study, participants will be randomized into two groups - one group will continue to receive SSA injections during and after PRRT treatment and the other group will stop taking SSA injections after starting PRRT.

Why is this study important?

Stopping SSA injections could be just as effective at controlling your cancer and it may cause fewer side effects. It is not clear if stopping SSA injections might be better than the standard treatment of continuing the injections.

Who can participate in this study?

This trial is for:

  • Adults over 18 years of age with grade 1 or 2 mid or hindgut NETs or pancreatic NETs
  • People whose NETs cannot be removed by surgery
  • People who been receiving SSA injections for at least 3 months and whose NET has continued to grow, known as “progression”, and who will now be treated with PRRT 

This trial is not for:

  • People with gastric or lung NETs 
  • People who have received PRRT previously
  • People who are pregnant or who are planning to have children soon
  • People who cannot regularly attend appointments
What are the risks?
  • If you choose to take part in this study, there is a risk that the study approach (i.e. to stop monthly SSA injections after PRRT treatment begins) may not be as good as the standard treatment (i.e. to continue monthly SSA injections after PRRT treatment begins). You will find details of all risks in the consent document.
What can I expect?
  • If you choose to take part in this study, you will be randomly placed in one of two groups and you will receive either PRRT but SSA injections will stop or you will receive PRRT as well as SSA injections.
  • In this study, you will also be asked to complete a few questionnaires and diaries at different times to understand your Quality of Life and to record the number of pills you take.

How can I find out more or join the study?

Talk to your cancer doctor if you are considering joining this study. You can share summaries like this with them and ask if they think joining the trial may be a good option for you.

Before you join this study, you will be asked to review an Informed Consent document which will tell you more about why the research is being done and your role as a participant. You will have an opportunity to discuss anything that is not clear and ask any questions you have.

Joining this study is entirely up to you and you can decide to leave at any time without giving a reason. Your decision to join or leave the trial will not affect your standard medical care.

The NE2 study is currently enrolling patients at cancer centres in Canada. For a full list of participating cancer centres please visit www.clinicaltrials.gov and search using NCT06345079.

Use this trial information for your conversation with your health care team

Participating centres

Information coming soon.