Study on the Effect of Octreotide and Lanreotide in Peptide Receptor Radionuclide Therapy for Adults with Neuroendocrine Tumors

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for patients with a type of cancer known as neuroendocrine tumors. These tumors are graded as I and II, which refers to their growth rate and how they look under a microscope. The treatment being studied involves a combination of medications, including Octreotide, Lanreotide, and Lutetium (177Lu) Oxodotreotide. Octreotide and Lanreotide are known as somatostatin analogs, which are substances that mimic a natural hormone in the body to help control tumor growth. Lutetium (177Lu) Oxodotreotide is a type of targeted therapy that delivers radiation directly to the tumor cells.

The purpose of this study is to understand how the continued use of long-acting somatostatin analogs affects the amount of radiation absorbed by the tumor during a treatment called Peptide Receptor Radionuclide Therapy (PRRT). PRRT is a type of therapy that uses a small amount of radioactive material to target and kill cancer cells. The study will involve administering these medications to patients and monitoring the effects on their tumors over a period of time. The medications will be given through injections, with Octreotide administered intramuscularly, Lanreotide subcutaneously, and Lutetium (177Lu) Oxodotreotide intravenously.

Throughout the study, patients will undergo imaging tests to measure the radiation absorbed by the tumors and other tissues in the body. These tests will help researchers understand how the treatment affects both the cancer and the surrounding healthy tissues. The study aims to provide valuable insights into the effectiveness and safety of using these medications together in treating neuroendocrine tumors.

1 initial assessment

Upon joining the study, you will undergo an initial assessment to confirm eligibility. This includes verifying your age, medical history, and diagnosis of a neuroendocrine tumor. You must be 18 years or older and able to provide informed consent.

A physical examination and imaging tests will be conducted to ensure you meet the criteria, such as having at least one soft tissue lesion greater than 2 cm.

2 treatment planning

A treatment plan will be developed, which includes the administration of lutetium (177lu) oxodotreotide through an intravenous route. The aimed administered activity is 7400 MBq.

You will also continue using long-acting somatostatin analogues, such as octreotide or lanreotide, which are administered via intramuscular injection or subcutaneous routes.

3 treatment administration

The treatment involves receiving the lutetium (177lu) oxodotreotide intravenously. This process will be repeated as per the treatment schedule provided by the medical team.

You will continue receiving the long-acting somatostatin analogues at the prescribed dosage and frequency throughout the trial.

4 monitoring and imaging

Regular monitoring will be conducted to assess the absorbed dose in tumor lesions and normal tissues using SPECT/CT imaging. This helps in evaluating the treatment’s effectiveness and safety.

Blood samples will be taken to determine the bone marrow dose and to assist in pharmacokinetic modeling.

5 follow-up and evaluation

After completing the treatment cycles, follow-up visits will be scheduled to monitor your health and the treatment’s impact on the tumor.

The study aims to continue until November 2026, with regular assessments to ensure your well-being and gather necessary data.

Who Can Join the Study?

Must be 18 years or older.
Must be able to provide spoken and written consent to participate in the trial.
Must have a neuroendocrine tumor confirmed by a tissue examination.
Must meet the clinical criteria for PRRT (a specific type of treatment for certain tumors).
Must have at least one soft tissue lesion that is larger than 2 cm (about 0.8 inches).
The planned treatment involves an administered activity of 7400 MBq (a measure of the amount of radioactive substance used in treatment).
Must have an ECOG score of 0 to 2, which means the patient is fully active or has some symptoms but can still take care of themselves.

Who Cannot Join the Study?

Patients who are under 18 years old cannot participate.
Patients who do not have a neuroendocrine tumor of grade I or II cannot participate. A neuroendocrine tumor is a type of tumor that can occur in hormone-producing cells.
Patients who do not have a clinical indication for PRRT cannot participate. PRRT stands for Peptide Receptor Radionuclide Therapy, a type of treatment for certain tumors.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Netherlands Cancer Institute	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.05.2024

Trial locations

Investigated drugs:

Peptide Receptor Radionuclide Therapy (PRRT) is a type of treatment that uses a small amount of radioactive material to target and kill cancer cells. It works by attaching the radioactive material to a molecule that can find and bind to specific receptors on the surface of cancer cells. This allows the radiation to be delivered directly to the tumor, minimizing damage to healthy tissues. In this trial, PRRT is being used to treat tumors that have specific receptors for somatostatin, a hormone that regulates various bodily functions.

Long-acting Somatostatin Analogues (LA-SSA) are medications that mimic the action of somatostatin, a natural hormone in the body. These analogues are designed to last longer in the body, providing a sustained effect. They work by binding to the same receptors as somatostatin, helping to control the growth of certain types of tumors. In this trial, LA-SSA is used to see how it affects the amount of radiation absorbed by the tumor during PRRT.

Investigated diseases:

Neuroendocrine tumour

Neuroendocrine Tumor – Neuroendocrine tumors are a type of growth that arises from cells of the neuroendocrine system, which is responsible for producing hormones. These tumors can occur in various parts of the body, including the gastrointestinal tract, pancreas, and lungs. They are classified into different grades based on how quickly they grow and spread, with Grade I and II being slower-growing forms. As the tumor progresses, it may cause symptoms related to hormone overproduction or due to its size and location, such as abdominal pain or changes in bowel habits. Over time, these tumors can metastasize, meaning they spread to other parts of the body. The progression of symptoms and tumor growth can vary significantly among individuals.

Trial ID:

2023-505884-35-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effect of Octreotide and Lanreotide in Peptide Receptor Radionuclide Therapy for Adults with Neuroendocrine Tumors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?