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How is the study structured?

202 patients with advanced grade 2 and grade 3 GEP-NETs will be randomized 1:1 by a computerized system. You are equally as likely to receive Targeted Radionuclide Therapy with n.c.a. lutetium-177-edotreotide as you are to receive a standard therapy with CAPTEM, everolimus or FOLFOX. Neither you nor your doctor will be able to choose which group you will be assigned to.

  • 101 patients are planned to receive Targeted Radionuclide Therapy with n.c.a. lutetium-177-edotreotide with six cycles, administered as an infusion (second infusion at six weeks, then subsequent infusions at two-month intervals).
    To protect the kidneys, 30-60 minutes before each cycle with Targeted Radionuclide Therapy, a specific Amino-Acid Solution (AAS) will be given as an infusion over 4-6 hours.
  • 101 patients are planned to receive either CAPTEM or everolimus or FOLFOX. The appropriate standard therapy will be determined by your doctor based on your individual benefit-risk assessment and according to local prescribing information and guidelines.

Who can participate? – Main inclusion criteria:

  • you are at least 18 years old
  • you have a specific advanced Grade 2 or Grade 3 neuroendocrine tumor of gastroenteric or pancreatic origin (G2 or G3 GEP-NET)
  • 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 study 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 average study duration for each patient (treatment and follow-up observation) will be approximately four years but may vary on an individual patient basis. The overall time in the study depends on multiple factors including the individual variability of treatment response and tumor progression.

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 six treatment cycles. A short hospital stay (one to three days) might be required for treatment depending on local regulations and your study doctor.

If you are assigned to a standard therapy, the administration may be conducted at or near your home if recommended by the study doctor. However, the administration and frequency of the standard therapy assigned to you will be determined by your physician based on your individual benefit-risk assessment and will follow local prescribing information and guidelines.

What tests are required before treatment?

Your study team will conduct tests to ensure that you are ready for the treatment.
The tests may include but not conclusive of:

  • a physical examination
  • blood tests and a urine test
  • a pregnancy test
  • a recording of the electrical signals in your heart (ECG)
  • a computerized tomography (CT scan) or a magnetic resonance imaging (MRI scan) for imaging and localization of the diseased tissue
  • radioactive scans to ensure your tumor has somatostatin receptors on the cell surface (SSTR+) and to detect cancer cells with increased glucose consumption

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 treatments?

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 all four 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 CAPTEM include among others:

  • abdominal pain
  • rash, dry or itchy skin
  • hair loss
  • tiredness
  • loss of appetite
  • difficulty speaking
  • headache
  • vomiting, nausea, diarrhea,
  • constipation

Possible very common side effects of everolimus include among others:

  • increased temperature, chills (signs of infection), fever
  • coughing, difficulty 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)

Possible very common side effects of FOLFOX include among others:

  • ischemic heart abnormalities
  • fever
  • nausea, vomiting, diarrhea, malaise, weakness
  • inflammation of rectum or anus
  • delayed wound healing
  • inflammation of lining of the mouth oresophagus, sore lips or mouth ulcers
  • increase in uric acid in the blood
  • blood disorders including low red or white blood cells, low platelets
  • loss of appetite
  • nose bleeds
  • infections
  • hair loss
  • toxic skin reactions, allergies/allergic reactions
  • dry cough, difficulty breathing or crackles

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 – if advised by the study doctor, 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 either CAPTEM or everolimus or FOLFOX work?

The comparator treatments CAPTEM, everolimus or FOLFOX used in this study, are some of the current standard of care treatments. If you are allocated to the standard of care group, you will receive treatment with one of these drugs based on the prior benefit-risk assessment of your study doctor and according to local practice.

  • CAPTEM is a chemotherapy that combines the two orally or intravenous administered active ingredients capecitabine and temozolomide. CAPTEM inhibits the cell division of tumor cells.
  • Everolimus is an orally administered immunosuppressive cancer therapy that affects the division and growth of cancer cells by blocking the enzyme mTOR.
  • FOLFOX is a chemotherapy that contains the active ingredients folinic acid, fluorouracil and oxaliplatin. FOLFOX is given by intravenous infusion and affects the DNA synthesis and tumor cell division.

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.