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Study on Reducing Side Effects of Lutetium (177Lu) Oxodotreotide in Patients with Advanced Midgut 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 that originate in the midgut, which includes parts of the small intestine and the right side of the colon. These tumors are often slow-growing and can be difficult to treat when they become advanced or spread to other parts of the body. The treatment being tested in this study is called Lu177-Dotatate, a form of targeted therapy that uses a radioactive substance to deliver treatment directly to the cancer cells. This therapy is given as a solution through an infusion into the veins.

The purpose of the study is to see if giving Lu177-Dotatate every 16 weeks, instead of every 8 weeks, can reduce the side effects related to blood health, such as low blood cell counts, in patients with these tumors. Participants in the study will receive the treatment at different intervals, and their health will be monitored over time to assess the impact on their condition and any side effects they experience. The study aims to find a balance between effective treatment and minimizing adverse effects.

Throughout the study, participants will undergo regular health check-ups and assessments to monitor their response to the treatment and any changes in their condition. The study is designed to last for several years, allowing researchers to gather comprehensive data on the long-term effects and benefits of the treatment schedule. The ultimate goal is to improve the quality of life for patients with advanced neuroendocrine tumors by finding a treatment regimen that is both effective and less taxing on the body.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit and consent

    Upon joining the study, the patient will attend an initial visit where detailed information about the trial will be provided. The patient will be required to sign a consent form, which has been approved by an ethics committee, to confirm understanding and willingness to participate.

    The patient must be able and willing to attend all study visits and procedures as required by the trial protocol.

  2. Step 2

    Screening and eligibility confirmation

    The patient will undergo a series of tests to confirm eligibility for the trial. This includes confirming a diagnosis of advanced or metastatic midgut neuroendocrine tumors (NETs) and ensuring the patient meets all health criteria, such as adequate organ function and performance status.

    A negative pregnancy test is required for female patients, and both male and female patients must agree to use effective birth control methods during the study and for 7 months after the final dose.

  3. Step 3

    Treatment initiation

    The patient will begin treatment with Lutathera 370 MBq/mL solution for infusion, which contains the active substance lutetium (177lu) oxodotreotide. This medication is administered through an intravenous infusion.

    The treatment is given every 16 weeks, with the aim of reducing adverse events while managing the patient's condition.

  4. Step 4

    Ongoing assessments

    Throughout the trial, the patient will attend regular assessments to monitor the effects of the treatment. These assessments will include blood tests and imaging studies to evaluate the response of the tumors to the treatment.

    The primary focus is to observe any hematological toxicity, which refers to side effects affecting the blood, over a period of up to 24 months.

  5. Step 5

    End of treatment and follow-up

    After completing the treatment cycle, the patient will continue to be monitored for any long-term effects or changes in their condition. This follow-up period is crucial to ensure the patient's safety and to gather comprehensive data on the treatment's effectiveness.

    The study is expected to conclude by January 31, 2029, with all data collected and analyzed by this date.

Who can join the trial?

15 criteria

  • Patients must have a confirmed diagnosis of **unresectable, advanced, or metastatic midgut neuroendocrine tumors (NETs)**. This means the tumor cannot be removed by surgery and has spread to other parts of the body.
  • Patients must be **18 years or older**.
  • Patients must have recovered to **Grade 1 or lower** from any side effects of previous treatments, except for hair loss or weakness.
  • Patients must have a **life expectancy of at least 12 months**.
  • Patients must have **health coverage** that includes clinical trials.
  • Female patients must have a **negative pregnancy test** and agree to use a highly effective birth control method during the study and for 7 months after the last treatment. Male patients must agree to use a condom during the study and for 7 months after the last treatment.
  • Patients must agree **not to participate in another interventional study** while in this study.
  • The **Ki-67 index** must be **20% or lower**. This is a measure of how quickly cancer cells are growing.
  • The disease must have shown **progression within 36 months** before joining the study, according to specific medical criteria (RECIST v1.1).
  • Patients can be new to treatment or have had previous treatments, except for any type of prior **radioligand therapy (RLT)**.
  • All target and non-target lesions must be **somatostatin receptor positive (SSTR+)** in imaging tests, meaning they show a certain level of uptake in scans.
  • Patients must have **measurable disease** according to specific medical criteria (RECIST v1.1).
  • Patients must have **adequate organ function**, which includes specific blood counts and liver and kidney function tests.
  • Patients must have a **Karnofsky performance status (KPS) of 70% or higher**, which measures their ability to perform daily activities.
  • Patients must provide **informed consent** by signing a consent form approved by an ethics committee, and they must be willing to follow study procedures.

Who cannot join the trial?

7 criteria

  • Patients with other types of cancer that are not **neuroendocrine tumors of midgut origin** cannot participate.
  • Patients who have a fast-growing form of the disease are not eligible.
  • Patients who are not within the age range specified for the study cannot join. The study is open to adults only.
  • Patients who are pregnant or breastfeeding are not allowed to participate.
  • Patients with severe health conditions that could interfere with the study treatment are excluded.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients who cannot follow the study procedures or attend the required visits are not eligible.
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Investigated drugs

Lu177-Dotatate is a type of targeted therapy used in the treatment of certain types of tumors, specifically neuroendocrine tumors. It works by delivering radiation directly to the cancer cells. The medication is designed to attach to specific receptors on the tumor cells, allowing the radioactive component to enter and destroy the cancer cells from the inside. This approach helps to minimize damage to surrounding healthy tissues, potentially reducing side effects compared to traditional radiation therapy. In this clinical trial, the goal is to find out if using Lu177-Dotatate less frequently can lower the risk of serious blood-related side effects while still effectively treating the tumors.

What is already known about the treatment

Lu177-Dotatate – Lu177-Dotatate is administered through an intravenous infusion, meaning it is given directly into the bloodstream through a vein. This medication is currently being studied in clinical trials for its effectiveness in treating neuroendocrine tumors of midgut origin, which are a type of cancer that affects hormone-producing cells in the digestive tract. The main goal of using Lu177-Dotatate is to reduce the growth of these tumors while minimizing side effects, particularly serious blood-related issues. At the molecular level, Lu177-Dotatate works by delivering targeted radiation to the tumor cells, which helps to destroy them. It is classified as a radiopharmaceutical, a type of drug that combines a radioactive substance with a molecule that targets specific cells in the body.

Investigated diseases

Neuroendocrine tumors of midgut origin – Neuroendocrine tumors of midgut origin are a type of cancer that arises from hormone-producing cells in the small intestine, particularly the jejunum and ileum. These tumors can produce hormones that lead to various symptoms, such as flushing or diarrhea, due to hormone release into the bloodstream. They tend to grow slowly and may not cause symptoms until they are advanced. As the disease progresses, the tumors can spread to other parts of the body, including the liver and lymph nodes. The growth rate and behavior of these tumors can vary, with some remaining stable for long periods while others may grow more rapidly. The progression of the disease can lead to complications related to the size and location of the tumors, affecting nearby organs and tissues.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-517921-14-00Protocol codeRLTTio2023Estimated enrolment158 patientsSponsorGrupo Espanol De Tumores Neuroendocrinos

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