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.
Please contact your doctor to learn more about the inclusion and exclusion criteria and to check if you meet all requirements.
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.
If you are assigned to the treatment with n.c.a. lutetium-177-edotreotide, you will have an appointment at the clinic for each of the four treatment cycles, administered every three months. This continues for nine months. A short hospital stay (one to three days) might be required for treatment depending on local regulations and your study doctor. After completing the course of treatment, you will be contacted by the study team every six months, for five years.
Your study team will conduct tests to make ensure that you are ready for the treatment.
The tests may include:
In order for the doctors to identify the tumor grade, the study team will ask to use a sample of your tumor taken at the time of your diagnosis. You will need to have a biopsy if a suitable sample is unavailable.
You will need to complete a quality-of-life (QoL) questionnaire before the treatment can start and at set times during the study. The questionnaire will assess how you have been feeling and what side effects, if any, you have been experiencing.
The study team will be monitoring your health during treatment and afterwards and will tell you about possible side effects of your treatment before you start the study. The most frequently reported side effects for the two treatment options are summarized below, without claiming to be complete. Please consult your doctor should you feel sick or experience any other symptoms.
Possible common side effects of Targeted Radionuclide Therapy with n.c.a. lutetium-177-edotreotide include among others:
Possible very common side effects of everolimus include among others:
Medical administration of radionuclide therapies such as n.c.a. lutetium-177-edotreotide is guided by national radiation safety regulations, which differ between countries. As you will be emitting small quantities of the radioactive substance over a seven-day period following the Targeted Radionuclide Therapy, you will be given precautions and recommendations to follow by the study team, such as:
If you are assigned to the treatment with n.c.a. lutetium-177-edotreotide, you will be emitting small quantities of the radioactive substance over a seven-day period following the Targeted Radionuclide Therapy. You will be given precautions and recommendations to follow by the study team, such as:
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.
You may withdraw your consent to treatment at any time; however, follow-up procedures and information will continue to be collected unless you withdraw from the study completely. You are free to withdraw from the study at any time. If you withdraw, your regular medical care will continue unchanged.
All treatment costs will be covered. Should travel be necessary expenses will be covered based on travel distance and country and according to sponsorship regulations.
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.
Should travel be necessary, travel assistance will be offered, and expenses will be covered based on travel distance and country and according to sponsorship regulations.
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.