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Study on Continuing Somatostatin Analogues with Sunitinib, Octreotide, and Lutetium (177Lu) Oxodotreotide 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 the effects of continuing treatment with certain medications in patients with neuroendocrine tumors. Neuroendocrine tumors are a type of cancer that can occur in various parts of the body and are known for their slow growth. The study involves several medications, including sunitinib, octreotide, lutetium (177Lu) oxodotreotide, everolimus, and lanreotide. These medications are used in different forms, such as capsules, injections, and infusions, to manage the disease.

The purpose of the study is to understand the benefits of continuing treatment with somatostatin analogues (a type of medication that helps control hormone-related symptoms) when the disease progresses. The study is divided into two parts: one part looks at the effects of continuing or stopping these medications when patients start a second-line treatment called PRRT (Peptide Receptor Radionuclide Therapy), and the other part examines the effects when patients start a different type of second-line treatment known as targeted therapy. The study aims to see if continuing these medications can help delay the worsening of the disease and improve the quality of life for patients.

Participants in the study will receive either the medication or a placebo, and their progress will be monitored over time. The study will assess how long patients can live without their disease getting worse and how long it takes for their overall health to decline. The study will also look at the overall survival rates, response to treatment, quality of life, and any side effects experienced by the participants. This information will help determine the best approach to managing neuroendocrine tumors when the disease progresses.

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, you will be asked to provide written informed consent. This means you agree to participate after understanding the study's purpose and procedures.

    You will need to meet certain criteria, such as being 18 years or older and having a specific type of tumor called a neuroendocrine tumor.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to evaluate your health status. This includes checking your performance status, which is a measure of your ability to perform daily activities.

    Your medical history and current health condition will be reviewed to confirm eligibility for the study.

  3. Step 3

    Treatment assignment

    You will be assigned to one of two substudies based on your specific medical condition and treatment needs.

    If you are in the targeted therapy substudy, you may receive either sunitinib or everolimus as a second-line therapy. These medications are taken orally.

  4. Step 4

    Treatment administration

    For the targeted therapy substudy, you will take sunitinib or everolimus orally as prescribed by your doctor.

    If you are in the PRRT substudy, you will receive lutetium (177lu) oxodotreotide through an intravenous infusion. This is a process where the medication is delivered directly into your bloodstream.

  5. Step 5

    Ongoing monitoring

    Throughout the study, your health will be monitored regularly. This includes imaging tests to assess the progression of your tumor.

    You will also complete questionnaires to evaluate your quality of life and any changes in your health status.

  6. Step 6

    End of study participation

    Your participation in the study will continue until the study ends or until your doctor decides it is best for you to stop.

    At the end of your participation, a final assessment will be conducted to evaluate your overall health and any effects of the treatment.

Who can join the trial?

7 criteria

  • Must be at least 18 years old.
  • Must provide written informed consent before any study-related procedures. This means you agree to participate after being fully informed about the study.
  • Must have an ECOG performance status of 2 or less. This is a scale used to assess how your disease affects your daily living abilities, with 0 being fully active and 5 being deceased.
  • Must have a confirmed diagnosis of locally advanced or metastatic, non-functional, well-differentiated WHO 2019 grade 1-2 GEP NET. This refers to a specific type of neuroendocrine tumor that has spread or is advanced, but not causing symptoms related to hormone production.
  • Must have documented radiological disease progression while on first-line SSA treatment. This means your disease has been shown to progress on imaging tests despite initial treatment.
  • For the targeted therapy substudy: Must have an indication to start with either sunitinib or everolimus as second-line therapy, as determined by your doctor.
  • For the PRRT substudy: Must have an indication to start with PRRT with 177Lu-DOTATATE as second-line therapy, as determined by your doctor.

Who cannot join the trial?

5 criteria

  • Patients with other types of cancer that are not neuroendocrine tumors cannot participate.
  • Patients who have not started second-line therapy, which is the next treatment after the first one doesn't work, are excluded.
  • Patients who are not in the specified age range for the study cannot join. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population, meaning they need special protection, are not eligible.
  • Patients who are not willing or able to follow the study procedures and visits cannot participate.
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Investigated drugs

  • Somatostatin Analogues

    are medications used to treat certain types of tumors, including neuroendocrine tumors. They work by mimicking a natural hormone in the body called somatostatin, which helps to slow down the growth of these tumors. In this trial, the role of somatostatin analogues is to see if continuing their use can help patients live longer without their disease getting worse.

  • PRRT (Peptide Receptor Radionuclide Therapy)

    is a type of targeted therapy used to treat neuroendocrine tumors. It involves using a small amount of radioactive material that is attached to a molecule that specifically targets tumor cells. This allows the radiation to be delivered directly to the tumor, helping to shrink it or slow its growth. In this trial, PRRT is being used as a second-line treatment to see how it affects the progression of the disease.

  • Targeted Therapy

    refers to a group of medications that specifically target certain molecules involved in the growth and spread of cancer cells. These therapies are designed to interfere with the cancer's ability to grow and spread, while causing less harm to normal cells. In this trial, targeted therapy is being used as a second-line treatment to evaluate its effectiveness in slowing down the disease progression in patients with neuroendocrine tumors.

What is already known about the treatment

Somatostatin Analogues – Somatostatin analogues are medications administered through injections, typically under the skin or into a muscle. They are currently used in medicine to manage symptoms and slow the growth of neuroendocrine tumors, as supported by medical literature. These medications work by mimicking the natural hormone somatostatin, which helps regulate the body's hormone levels and inhibits the release of certain substances that can promote tumor growth. They belong to the pharmacological class of hormone analogues and are primarily indicated for treating neuroendocrine tumors.

Investigated diseases

Neuroendocrine Tumors – Neuroendocrine tumors are a diverse group of neoplasms that originate from neuroendocrine cells, which are found throughout the body. These tumors can produce hormones, leading to various symptoms depending on the hormones released. They often grow slowly, but their progression can vary significantly, with some remaining indolent for years while others may grow more rapidly. As they progress, neuroendocrine tumors can metastasize to other parts of the body, most commonly the liver. The symptoms and progression depend on the tumor's location, size, and whether it secretes hormones. Over time, they may cause complications related to hormone overproduction or mass effect on surrounding tissues.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502703-30-00Protocol codeSAUNAEstimated enrolment270 patientsSponsorAntwerp University Hospital

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).