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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.
Please contact your study doctor to learn more about the inclusion and exclusion criteria and to check if you meet all requirements.
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.
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.
Your study team will conduct tests to ensure that you are ready for the treatment.
The tests may include but not conclusive of:
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 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:
Possible very common side effects of CAPTEM include among others:
Possible very common side effects of everolimus include among others:
Possible very common side effects of FOLFOX 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:
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.
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.