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Study Design COMPETEFAQs COMPETEParticipating Sites COMPETE

FAQs COMPETE

Important questions about COMPETE

How is the study structured?

300 patients with grade 1 or grade 2 GEP-NETs are being randomized 2:1 by a computerized system. This means that you are twice as likely to receive Targeted Radionuclide Therapy with n.c.a. lutetium-177-edotreotide than the standard therapy with everolimus. Neither you nor your doctor is be able to choose which group you are be assigned to.

  • 200 patients are planned to receive Targeted Radionuclide Therapy with n.c.a. lutetium-177-edotreotide with a maximum of 4 cycles, administered as an infusion at 3-monthly intervals for 9 months, or until diagnosis of progression.
    To protect the kidneys, 30-60 minutes before each cycle with Targeted Radionuclide Therapy, an Amino-Acid Solution (AAS) is given as an infusion over 4-6 hours.
  • 100 patients are planned to receive everolimus, 10 mg daily, administered orally as a tablet.

Who can participate? – Main inclusion criteria:

  • you are at least 18 years old
  • you have a neuroendocrine tumor of gastroenteric or pancreatic origin (GEP-NET) that started in the gastrointestinal tract or pancreas
  • your GEP-NET has somatostatin receptors on its surface (SSTR+)
  • your GEP-NET has spread to other parts of the body (metastatic) and cannot be removed completely by surgery

Please contact your doctor to learn more about the inclusion and exclusion criteria and to check if you meet all requirements.

How long will the study run?

The duration of study participation for all patients will be 30 months plus pre-examination, which can be up to 90 days. Information about any other cancer treatments that you receive or any new tumors that may develop will be collected for 5 years (60 months) after the end of the study.

How does the comparator treatment with everolimus work?

Everolimus is an immunosuppressive cancer therapy that affects the division and growth of cancer cells by blocking the enzyme mTOR. You will take everolimus in tablet form that is swallowed whole every day. This can continue for as long as it is helping you and the side effects are not severe, as agreed with your doctor.

The study team will ask you to keep a diary recording each time you take everolimus. This helps your doctor know how many doses of treatment you have had.

What happens if I decide to withdraw my consent?

You are free to withdraw from the study at any time. If you withdraw, your regular medical care will continue unchanged.

Where is the study conducted?

COMPETE is conducted predominantly in Europe, North America, South Africa and Australia, in at least 14 countries and 60 sites. You can find a full list of all participating centers below.

How can I participate?

If you are interested in taking part in the COMPETE study, please contact your attending doctor or reach out to a participating study center nearby. You can find a full list of all participating centers below.