Comparing retreatment of Peptide Receptor Radionuclide Therapy versus standard treatment in patients with metastatic midgut neuroendocrine tumours Disease Site Gastro-Intestinal Clinical Trials Trial Code CCTG NE.1 (NET RETREAT) ǀ NCT05773274 Trial Status Open to patient enrollment What is the purpose of this study? The purpose of this study is to compare a retreatment with Peptide Receptor Radionuclide Therapy (PRRT) to the standard treatment for your neuroendocrine cancer. Why is this study important? The drug being studied is a new type of drug approved for the treatment of neuroendocrine tumours (NETs). The new drug has been shown to shrink tumours in many people and seems promising, but it is not clear if receiving this drug again can offer better results than standard treatment. Who can participate in this study? This trial is for: Adults with stage 4 midgut NETs Grade 1-2 well-differentiated NETs Those who had 3-4 doses of PRRT Cancer has gotten worse after PRRT This trial is not for: People with lingering side effects from PRRT Those who are pregnant Anyone planning to have children soon Anyone not willing to regularly attend appointments What are the risks? If you choose to take part in this study, there is a risk that retreatment with PRRT may not be as good as the usual approach with standard treatment. There is also a risk that you could have side effects, the most common are: loss of appetite, bleeding, bruising, and infection. You will find the details of all potential side effects 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 (a drug given in your vein) or the standard treatment that is commonly used to treat this disease (a pill taken at home). You will also be asked to complete a questionnaire at different times, to understand your physical and emotional well-being. 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 NE.1 study is currently enrolling patients at centres in Canada and the U.S. For a full list of participating centres please visit www.clinicaltrials.gov and search using NCT05773274. Printable information sheet (pdf) Fiche d’information imprimable (pdf) Participating centres Ottawa Hospital Research Institute - Ottawa, ON, K1H 8L6 - Contact: Dr. Tim Asmis Odette Cancer Centre Sunnybrook Health Sciences Centre - Toronto, ON, M4N 3M5 - Contact: Dr. Sten Myrehaug CancerCare Manitoba - Winnipeg, MB, R3E 0V9 - Contact: Dr. Hanbo Zhang BCCA - Vancouver - Vancouver, BC, V5Z 4E6 - Contact: Dr. Jonathan M Loree