Study on Continuing Somatostatin Analogues with Sunitinib, Octreotide, and Lutetium (177Lu) Oxodotreotide for Patients with Neuroendocrine Tumors

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What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Maastricht Maastricht The Netherlands
Katholieke Universiteit te Leuven Leuven Belgium
Algemeen Stedelijk Ziekenhuis Campus Aalst Aalst Belgium

Other Sites

Site Name City Country Status
Universitair Medisch Centrum Groningen Groningen The Netherlands
CHR Verviers Verviers Belgium
Grand Hopital De Charleroi Charleroi Belgium
Institut Jules Bordet Anderlecht Belgium
Gasthuiszusters Antwerpen Antwerp Belgium
Centre hospitalier universitaire de Liege Liege Belgium
Universitair Ziekenhuis Gent Gent Belgium
Algemeen Ziekenhuis Klina Brasschaat Belgium
Vitaz Sint-Niklaas Belgium
Maxima Medisch Centrum Veldhoven The Netherlands
AZ Rivierenland Rumst Belgium
AZ Delta uw Ziekenhuis Campus Rumbeke, campus Brugsesteenweg Roeselare Roeselare Belgium
A Z Monica Antwerp Belgium
Ejybacu Mechelen Belgium
Cjopgvyrc Uhocemqlehmetk Sagjkvzxu Woluwe-Saint-Lambert Belgium
Afasfbvsn Upq Amsterdam The Netherlands
Exxninr Ulfyuulttsze Mcewukr Cmxnkup Rghgvvnbt (typnlca Mea Rotterdam The Netherlands
Uvlsjzwmlu Om Avgnlpz Edegem Belgium
Rajpmidkz Zbwxivmbrv Sgywksony Arnhem The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
30.04.2023
The Netherlands The Netherlands
Recruiting
30.04.2023

Trial locations

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.

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 ID:
2022-502703-30-00
Protocol code:
SAUNA
NCT ID:
NCT05701241
Trial Phase:
Therapeutic confirmatory (Phase III)

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