Study on the Effectiveness of Lutetium (177Lu) Oxodotreotide and Octreotide in Patients with Advanced GEP-NET Tumors (Grade 2 and 3)

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What is this study about?

This clinical trial is focused on studying a type of cancer known as gastroenteropancreatic neuroendocrine tumors (GEP-NETs), specifically those that are advanced and have a high proliferation rate, classified as Grade 2 and Grade 3. The study aims to evaluate the effectiveness and safety of a treatment called Lutathera, which is a solution for infusion containing the active substance lutetium (177Lu) oxodotreotide. This treatment will be compared to another medication called Sandostatin LAR, which contains octreotide and is given as an injection. The purpose of the study is to determine if Lutathera is better at delaying the progression of the disease or death when used as a first-line treatment.

Participants in the study will receive either Lutathera in combination with supportive care or a higher dose of Sandostatin LAR. Lutathera is administered through an intravenous infusion, which means it is given directly into a vein, while Sandostatin LAR is given as an intramuscular injection, meaning it is injected into a muscle. The study will also involve the use of a solution called LysaKare, which contains L-lysine hydrochloride and L-arginine hydrochloride, to help protect the kidneys during treatment. The trial will follow participants over a period to observe the time it takes for the disease to progress or for any other significant health changes to occur.

The study is designed to be open-label, meaning both the participants and the researchers know which treatment is being administered. It is a randomized trial, which means participants are randomly assigned to receive either Lutathera or the higher dose of Sandostatin LAR. The trial will take place across multiple centers, allowing for a diverse group of participants. The ultimate goal is to gather information that could lead to improved treatment options for patients with advanced GEP-NETs.

1 initial treatment phase

The treatment begins with the administration of Lutathera (lutetium (177lu) oxodotreotide) as a solution for infusion. This is given through a vein (intravenous use).

The infusion of Lutathera is accompanied by LysaKare (l-lysine hydrochloride, l-arginine hydrochloride) to protect the kidneys. This is also administered intravenously.

2 supportive care with octreotide

Following the initial treatment, Sandostatin LAR (octreotide) is administered as a suspension for injection. This is given into a muscle (intramuscular use).

The dosage of Sandostatin LAR is 30 mg, and it is administered once every four weeks.

3 monitoring and follow-up

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

The primary goal is to delay the progression of the disease or death, known as progression-free survival (PFS).

4 comparison phase

The effectiveness of Lutathera combined with supportive care is compared to a higher dose of Sandostatin LAR (60 mg) given alone.

This phase helps determine which treatment is more effective in managing the condition.

Who Can Join the Study?

The patient must have a type of tumor called a gastroenteropancreatic neuroendocrine tumor (GEP-NET) that is either metastasized (spread to other parts of the body) or locally advanced (grown in the area where it started) and cannot be removed by surgery.
The tumor must be well-differentiated, which means the cancer cells look somewhat like normal cells, and it should be classified as Grade 2 or Grade 3.
The tumor must have been diagnosed within the last 6 months.
The Ki67 index, a measure of how fast the cancer cells are growing, must be between 10% and 55%.
The patient must be at least 15 years old and weigh more than 40 kg (about 88 pounds).
The tumor must show somatostatin receptors on all target lesions, which are specific proteins that can be seen using special imaging tests like PET/CT or MRI scans.
The tumor must take up more of the imaging substance than the normal liver does during these scans.
The patient must have a Karnofsky Performance Score (KPS) of at least 60, which is a way to measure the patient’s ability to perform daily activities.
There must be at least one site of the disease that can be measured.
The patient must have signed a form agreeing to participate in the study, which is called an informed consent form.

Who Cannot Join the Study?

Patients who do not have a positive result for a test that shows the presence of a specific type of receptor called the somatostatin receptor.
Patients whose tumors are not classified as well-differentiated G2 or G3. This means the tumor cells do not look similar to normal cells under a microscope.
Patients who do not have advanced GEP NETs, which stands for gastroenteropancreatic neuroendocrine tumors. These are rare tumors that can occur in the stomach, intestines, or pancreas.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial group.
Patients who are not male or female, as both genders are included in the study.
Patients who are considered part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France

Other Sites

Site Name	City	Country
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Azienda Ospedaliero-Universitaria Sant Andre	Rome	Italy
Hopital Beaujon	Clichy	France
Hospital Edouard Herriot	Lyon	France
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Ixqklppk Rqavavpm Ds Cgdrah Dj Mbyqsivimwx	Montpellier	France
Ixeqxwhj Rbvkohsel Pal Lt Socheq Dse Tyhraq Dohp Abncuwr Igiu Szliqn	Meldola	Italy
Anbrmcm Ung Imwwe Dq Rmwznn Ecajbc	Reggio Emilia	Italy
Unfzbyrcuphurpfwgvsyv Eauoj Aih	Essen	Germany
Akvwtjs Usabp Svgxnsegg Ldhtzl Dl Bciinjl	Bologna	Italy
Eujwheo Umssjpolwqab Mluggdo Cqgbrrp Rnapziavz (ttavrhz Mqq	Rotterdam	The Netherlands
Hddfaabf Vxre dpursfwb	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	30.09.2019
Germany	Not recruiting	30.09.2019
Italy	Not recruiting	30.09.2019
Spain	Not recruiting	30.09.2019
The Netherlands	Not recruiting	30.09.2019

Trial locations

Investigated drugs:

Lutathera is a medication used in this clinical trial to treat patients with advanced neuroendocrine tumors. It works by delivering targeted radiation to the cancer cells, which helps to slow down or stop their growth. The trial aims to show that Lutathera is more effective than the other treatment option in delaying the progression of the disease or death.

Investigated diseases:

Gastroenteropancreatic Neuroendocrine Tumors (GEP NETs) – These are a group of rare tumors that originate in the neuroendocrine cells of the gastrointestinal tract and pancreas. They are characterized by their ability to produce hormones, which can lead to various symptoms depending on the hormones released. GEP NETs are classified based on their grade, with G2 and G3 indicating a higher degree of abnormality and potential for growth. These tumors can be well-differentiated, meaning they resemble normal cells and tend to grow more slowly. As they progress, they may spread to other parts of the body, leading to more complex symptoms. The presence of somatostatin receptors on these tumors can influence their behavior and response to certain treatments.

Trial ID:

2023-507443-10-00

Protocol code:

CAAA601A22301

NCT ID:

NCT03972488

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness of Lutetium (177Lu) Oxodotreotide and Octreotide in Patients with Advanced GEP-NET Tumors (Grade 2 and 3)

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?