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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 often and how long will I need to stay in hospital?

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.

What tests are required before treatment?

Your study team will conduct tests to make ensure that you are ready for the treatment.
The tests may include:

  • a physical examination
  • blood tests and a urine test
  • a pregnancy test
  • a heart trace (ECG)
  • a computerized tomography (CT scan) or a magnetic resonance imaging (MRI scan) for imaging and localization of the diseased tissue
  • a radioactive scan to ensure your tumor has somatostatin receptors on the cell surface (SSTR+)

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.

What are possible side effects of the treatment?

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:

  • reduction of blood cells, which can lead to an increased risk of bleeding
  • faster exhaustion, shortness of breath and infections
  • sickness, vomiting and abdominal pain during drug administration
  • fatigue, changes in appetite afterwards
  • constipation
  • diarrhoea
  • dizziness

Possible very common side effects of everolimus include among others:

  • increased temperature, chills (signs of infection), fever
  • coughing, di¬fficulty breathing, wheezing
  • high level of sugar in the blood (hyperglycemia)
  • loss of appetite
  • disturbed taste (dysgeusia)
  • headache
  • nose bleeds (epistaxis)
  • mouth ulcers
  • upset stomach including feeling sick (nausea) or diarrhea
  • skin rash
  • itching (pruritus)
  • feeling weak or tired
  • tiredness, breathlessness, dizziness, pale skin, signs of low red blood cells (anemia)
  • swelling of arms, hands, feet, ankles or other part of the body (signs of edema)
  • weight loss
  • high level of lipids (fats) in the blood (hypercholesterolemia)

How can the investigational therapy affect me after administration?

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:

  • good hydration is recommended – drink more fluids (water) than you usually do
  • urinate as often as possible and observe rigorous hygiene in order to avoid risk of contamination of others (sitting down to urinate; using toilet paper after urinating; flushing the toilet twice; washing hands thoroughly and having a towel that only you use)

Can I have contact with my family and friends after the treatment?

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:

  • limit the time visitors spend with you to 30-40 minutes per visit for 1 week after treatment.; for prolonged periods visitors should stay more than 2 meters (6 feet) away; visitors under 15 years of age and pregnant visitors should spend less time with you.
  • do not have any physical contact with children or pregnant women for 1 week
  • do not sleep in the same bed as your partner for 1 week
  • avoid crowded public places for 1 week

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 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.

Who pays for the treatment?

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.

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.

Will there be travel assistance and who pays for it?

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.

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.