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

Verified siteRegistered drugNo placebo
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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 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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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 trial?

16 criteria

  • 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 trial?

4 criteria

  • 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.
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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.

What is already known about the treatment

Lutathera – Lutathera is administered as an intravenous injection, typically given every two months. It is currently being studied in clinical trials for its effectiveness in treating neuroendocrine tumors, particularly those that are well-differentiated and located in the intestines. The medication works by delivering targeted radiation to cancer cells, using a radioactive substance called lutetium-177 attached to a molecule that binds to specific receptors on the tumor cells. This targeted approach helps to destroy cancer cells while minimizing damage to surrounding healthy tissue. Lutathera is classified as a radiopharmaceutical, a type of drug that combines a radioactive element with a pharmaceutical agent to treat certain types of cancer.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511001-28-00Protocol codePROICM 2021-04 RELEstimated enrolment209 patientsSponsorInstitut Regional Du Cancer De Montpellier

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