Study on Retreatment with Lutetium (177Lu) Oxodotreotide for Patients with Intestinal Neuroendocrine Tumors

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What is this study about?

This clinical trial is focused on studying a type of cancer known as neuroendocrine tumors, which are growths that can occur in the intestines and other parts of the body. The study is investigating the effects of a treatment called Lutathera, which is a solution given through an infusion into the veins. This treatment contains a substance called lutetium (177Lu) oxodotreotide, which is designed to target and treat these tumors. The trial will also use another solution called LysaKare, which contains L-lysine hydrochloride and L-arginine hydrochloride, to help protect the kidneys during treatment.

The purpose of the study is to evaluate how effective two additional cycles of Lutathera are in patients who have already received a similar treatment in the past and are experiencing new tumor growth. Participants will receive one infusion every two months, and the study will compare this treatment to a period of active monitoring without additional treatment. The study will last for several months, and participants will have regular check-ups to monitor their health and the progress of the treatment.

Throughout the study, participants will undergo various assessments, including imaging tests like MRI or CT scans, to measure the size and growth of the tumors. The study aims to determine the rate of disease control, which includes complete or partial response to the treatment or stable disease. Safety and quality of life will also be evaluated using standard questionnaires. The trial is expected to continue for several years, with the goal of improving treatment options for patients with neuroendocrine tumors.

1 initial treatment phase

The treatment involves the administration of Lutathera, a solution for infusion. This medication is given through an intravenous route, meaning it is delivered directly into the bloodstream.

The treatment consists of two additional cycles of Lutathera. Each cycle includes one injection every two months.

2 supportive care

During the treatment, LysaKare is also administered. This is a solution for infusion containing l-lysine hydrochloride and l-arginine hydrochloride, which helps protect the kidneys during the treatment with Lutathera.

3 monitoring and evaluation

The effectiveness of the treatment is evaluated every two months. This involves assessing the disease control rate, which includes complete response, partial response, and stable disease.

Regular imaging tests, such as CT or MRI scans, are conducted to monitor the progression of the disease.

4 safety and quality of life assessment

Safety is monitored according to established criteria to ensure the treatment is well-tolerated.

Quality of life is assessed using specific questionnaires designed to evaluate the impact of the treatment on daily living.

Who Can Join the Study?

Must be at least 18 years old.
Have a disease that can be measured on scans, with at least one tumor that is 1 cm or larger and at least two tumors in total.
Have enough healthy blood cells: hemoglobin (Hb) greater than 8 g/dl, neutrophils (a type of white blood cell) at least 1500 per mm³, and platelets (cells that help with blood clotting) at least 80,000 per mm³.
Women who can have children must have a negative pregnancy test within 4 days before joining the study. Women who cannot have children include those who are postmenopausal or have had permanent sterilization (like tubal occlusion, hysterectomy, or removal of both fallopian tubes).
Men and women who can have children must use effective birth control during the study and for at least 7 months for women and 4 months for men after the treatment ends.
Must sign a written consent form agreeing to participate in the study.
Must be willing and able to attend scheduled visits, follow the treatment plan, and undergo necessary tests and procedures.
Must be part of the French Social Security System.
Have a confirmed diagnosis of intestinal G1 or G2 neuroendocrine tumors (NET).
Previously treated with 4 cycles of Lutathera® (referred to as “First PRRT”).
Had disease control for at least 12 months after the “First PRRT”.
Show signs of disease progression (clinical, biological, and/or radiological) after the first PRRT.
Decision to retreat with Lutathera® (referred to as “Second PRRT”) must be approved by RENATEN and/or a multidisciplinary tumor board and be part of the French reimbursement process.
Have an ECOG performance status of 0-2, which means the patient is fully active or has some symptoms but can still carry out light work.
Have a life expectancy of at least 6 months as estimated by the doctor.
Have positive somatostatin receptor imaging (SSTRi+) within 4 months before joining the study. This can be PET imaging or other types of scans, and at least 90% of the tumors must show significant uptake (greater than or equal to the liver or surrounding tissue).

Who Cannot Join the Study?

Patients who have a different type of tumor than a neuroendocrine tumor. A neuroendocrine tumor is a type of growth that can occur in hormone-producing cells.
Patients who have not been previously treated with two cycles of Lutathera®. Lutathera® is a medication used to treat certain types of tumors.
Patients who are not within the specified age range for the study.
Patients who are 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
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
Centre Jean Perrin	Clermont Ferrand	France
Centre Hospitalier Universitaire De Lille	Lille	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Centre Hospitalier Universitaire Rouen	Rouen	France
Hopitaux Universitaires Pitie Salpetriere	Paris	France
Hopital Beaujon	Clichy	France
Centre Henri Becquerel	Rouen	France
Centre Hospitalier Metropole Savoie	Chambery	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Centre Francois Baclesse	Caen	France
Iciyjing Rainwejf Dm Cyurfm Da Mgnrtjermzx	Montpellier	France
Cymlev Lffj Bleqyr	Lyon	France
Colzmb Htjctlahygw Uojafjzhspneg Ds Duipb	Dijon	France
Auuqsmbybv Ptkswdvl Hjyklmyj Dw Mafkmbiba	Marseille	France
Cvvc Dc Ndeyi	Vandoeuvre Les Nancy	France
Ilsdipbt dk Cnwaklsuverg Htsuzmlpfnv Uwcrcefbehuwf dm Sqbwm Ezqgghp (zxhtqwu	Saint Priest En Jarez	France
Iyaeiasa Pjyuylyjtcpnmfq Cberip Cyonjq	Marseille	France
Hvilbvyb Uqhbhichlwjtqf Sjiysprtfn &yfkpnn Hxnxhpk du Hjzlklwmxep	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.09.2021

Trial locations

Investigated drugs:

Lutathera is a medication used in this clinical trial. It is designed to treat patients with a specific type of cancer called intestinal well-differentiated neuroendocrine tumors. The treatment involves administering Lutathera in cycles, where patients receive an injection every two months. The trial aims to evaluate the effectiveness of two additional cycles of Lutathera in patients who have already been retreated with two cycles, comparing it to a period of active surveillance.

Neuroendocrine Tumor – Neuroendocrine tumors are a diverse group of growths that originate from neuroendocrine cells, which have traits similar to both nerve cells and hormone-producing cells. These tumors can develop in various parts of the body, including the gastrointestinal tract, pancreas, and lungs. They often grow slowly and may not cause symptoms until they become large or spread to other parts of the body. Symptoms, when present, can vary widely depending on the tumor’s location and the hormones it may produce. Some neuroendocrine tumors can release excess hormones into the bloodstream, leading to symptoms like flushing, diarrhea, or wheezing. The progression of these tumors can be unpredictable, with some remaining stable for years while others may grow or spread more rapidly.

Trial ID:

2024-511001-28-00

Protocol code:

PROICM 2021-04 REL

NCT ID:

NCT04954820

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Retreatment with Lutetium (177Lu) Oxodotreotide for Patients with Intestinal Neuroendocrine Tumors

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