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Study Design COMPOSEFAQs COMPOSEParticipating Sites COMPOSE

FAQs COMPOSE

Important questions about COMPOSE

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

Where will the study be conducted?

COMPOSE will be conducted in approximately 40 specialist centers across 10 countries (Australia, France, Germany, India, Italy, Netherlands, Spain, Sweden, UK and USA).

How can I participate?

If you are interested in taking part in the COMPOSE 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.