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Study on Personalized vs Non-Personalized Radionuclide Therapy with 177Lu-Edotreotide and Capecitabine for Patients with Neuroendocrine Tumors

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer known as neuroendocrine tumors. These tumors can occur in various parts of the body and are often difficult to treat. The study is testing a treatment called 177Lu-Edotreotide, which is a solution used for injection or infusion. This treatment is a form of targeted therapy that uses a radioactive substance to attack cancer cells. Another medication involved in the study is Capecitabine, which is taken orally in the form of a tablet. Capecitabine is a chemotherapy drug that helps to stop the growth of cancer cells.

The purpose of the study is to compare the effectiveness and safety of personalized versus non-personalized radionuclide therapy using 177Lu-Edotreotide in patients with neuroendocrine tumors. Participants in the study will receive either a personalized or non-personalized treatment plan. The study will monitor the progress of the disease and any side effects experienced by the participants. The treatment period can last up to 36 months for 177Lu-Edotreotide and up to 48 months for Capecitabine.

Throughout the study, participants will undergo regular assessments to track the progression of their disease and to evaluate the impact of the treatment. These assessments may include imaging tests like MRI or CT scans to visualize the tumors. The study aims to provide valuable information on how these treatments can be used to improve outcomes for patients with neuroendocrine tumors.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, written informed consent is required. This confirms understanding and agreement to participate in the trial.

    Eligibility is confirmed based on specific health criteria, including adequate kidney, blood, and liver function, as well as a confirmed diagnosis of advanced neuroendocrine tumors.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two treatment groups: personalized or non-personalized therapy. This process is essential to compare the effectiveness of the two approaches.

  3. Step 3

    Treatment initiation

    Treatment begins with the administration of 177Lu-Edotreotide, a solution given through an intravenous infusion. The dosage and frequency are determined by the assigned treatment group.

    In addition, capecitabine is taken orally. The specific dosage and schedule are provided by the healthcare team.

  4. Step 4

    Ongoing treatment and monitoring

    Regular monitoring is conducted to assess the response to treatment and manage any side effects. This includes blood tests, imaging studies, and health assessments.

    Participants are required to attend scheduled visits for these evaluations throughout the trial duration.

  5. Step 5

    End of treatment

    The treatment phase concludes as per the trial protocol or if significant side effects occur. Participants are informed about the next steps and any follow-up care needed.

  6. Step 6

    Follow-up

    After completing the treatment, follow-up visits are scheduled to monitor long-term health and any delayed effects of the treatment.

    Participants are encouraged to report any new symptoms or health concerns during this period.

Who can join the trial?

15 criteria

  • The patient has given written informed consent to participate in the study.
  • The doctor believes that PRRT is the best treatment option for the patient, considering other available treatments and the patient's specific situation.
  • The patient has a glomerular filtration rate (GFR) greater than 50 ml/min/1.73 m², which is a measure of kidney function.
  • The patient has adequate blood health, with hemoglobin levels above 90 g/L, platelets above 100 x 109/L, white blood cells above 3.0 x 109/L, and neutrophils above 1.5 x 109/L.
  • The patient has adequate liver function, with ASAT/ALAT levels less than 3 times the upper limit of normal (ULN), bilirubin levels less than 2 times the ULN, and albumin levels above 25 g/L.
  • Women who can become pregnant must use highly effective birth control from the start of the study until at least six months after the end of treatment.
  • Men living with women who can become pregnant must use effective birth control methods, such as vasectomy, surgical or medical castration, or condoms, from the start of the study until at least six months after the end of treatment.
  • The patient is 18 years of age or older.
  • The patient has an ECOG performance status of 0-1, which means they are fully active or have some symptoms but do not need bed rest during the day.
  • The patient has a life expectancy of more than 3 months.
  • The patient has advanced, well-differentiated, inoperable neuroendocrine tumors (NETs) confirmed by a tissue sample, except for pheochromocytoma and paraganglioma, with a Ki67 index of 50% or less, which is a measure of how fast the tumor cells are growing.
  • The patient's tumor shows SSTR-expression (a specific protein on the tumor) that is at least twice as high as in normal liver tissue, as seen on a special scan called 68Ga-DOTA-PET, done within 3 months before starting the study.
  • The patient has shown tumor growth on scans within the last 1-24 months, confirmed by a team of specialists.
  • All previous anti-tumor treatments, except for SSA, must have been stopped at least 4 weeks before starting the study treatment.
  • The patient has measurable disease according to RECIST v 1.1, which is a standard way to measure tumor size and response to treatment.

Who cannot join the trial?

9 criteria

  • Patients with other types of cancer that are not neuroendocrine tumors.
  • Patients who have not tested positive for SSTR (a specific receptor related to the tumor).
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to give informed consent or understand the study requirements.
  • Patients who are pregnant or breastfeeding.
  • Patients with severe medical conditions that could interfere with the study.
  • Patients who have participated in another clinical trial recently.
  • Patients with allergies to the study medication or its components.
  • Patients with a history of non-compliance with medical treatments.
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Investigated drugs

177Lu-DOTATOC is a type of targeted therapy used in the treatment of certain types of tumors known as neuroendocrine tumors. This therapy involves using a radioactive substance, which is attached to a molecule that specifically targets the tumor cells. Once the therapy is administered, the radioactive substance travels to the tumor cells and delivers radiation directly to them. This helps to destroy the tumor cells while minimizing damage to the surrounding healthy tissue. In this clinical trial, the effectiveness and safety of personalized versus non-personalized treatment with 177Lu-DOTATOC are being compared to see which approach works better for patients with specific types of neuroendocrine tumors.

What is already known about the treatment

177Lu-DOTATOC – This medication is administered through an injection, specifically designed for treating neuroendocrine tumors. It is currently being studied in clinical trials to determine its safety and effectiveness, particularly in a personalized versus non-personalized approach. The main use of 177Lu-DOTATOC is to target and treat tumors that have specific receptors, known as SSTR-positive NET G1-G3. At the molecular level, it works by delivering targeted radiation to the tumor cells, which helps to destroy them while minimizing damage to surrounding healthy tissue. This medication falls under the category of targeted radionuclide therapy, a type of treatment that uses radioactive substances to target cancer cells.

Investigated diseases

Neuroendocrine Tumors – Neuroendocrine tumors are a diverse group of growths that originate from neuroendocrine cells, which have traits similar to nerve cells and hormone-producing cells. These tumors can develop in various parts of the body, including the gastrointestinal tract, pancreas, and lungs. They often grow slowly and may not cause symptoms initially, but as they progress, they can lead to hormonal imbalances and related symptoms. Over time, neuroendocrine tumors can increase in size and potentially spread to other parts of the body. The progression of these tumors can vary significantly depending on their location, size, and grade. They are classified into different grades based on how quickly the tumor cells are dividing and how abnormal they appear under a microscope.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508572-11-00Estimated enrolment300 patientsSponsorRegion Skane

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