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Study of Lutetium-177 and Yttrium-90 DOTATATE combination therapy for patients with inoperable gastrointestinal neuroendocrine tumors

Fast replyInvestigationalNo 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 focuses on treating patients with neuroendocrine tumors of the gastrointestinal tract using a combination therapy called DuoNEN. The treatment consists of two radioactive substances: Lutetium-177 and Yttrium-90, which are combined with a special molecule called DOTATATE. These substances are designed to target and treat tumors that cannot be removed by surgery.

The purpose of this study is to develop a personalized treatment approach for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs) using a mixture of radioactive medications. The treatment will be administered through injection, and patients will receive carefully calculated doses of the medication based on their individual needs.

During the study, participants will receive the combination therapy and undergo regular medical examinations. The treatment effectiveness will be monitored through various imaging tests, including CT (computed tomography) or MRI (magnetic resonance imaging) scans. Regular blood tests will also be performed to ensure patient safety throughout the treatment period.

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 evaluation

    Your eligibility for the study will be confirmed based on your medical imaging results from the past 12 weeks, including PET/CT scan showing somatostatin receptors.

    Laboratory tests will be reviewed, including blood count, kidney function (creatinine), and liver tests (ALT, AspAT, bilirubin).

    Your overall physical condition will be assessed using the Karnofsky score, which must be 60% or higher.

  2. Step 2

    Treatment administration

    You will receive DuoNEN treatment through injection.

    The treatment contains two active substances: lutetium-177 DOTATATE and yttrium-90 DOTATATE.

    The dose will be personalized based on your individual needs.

  3. Step 3

    Monitoring during treatment

    Blood tests will be performed during the first visit and during hospital stays.

    The total amount of blood collected at each test will be 6.8 ml.

    Tests will check your blood count, kidney function, and liver function.

  4. Step 4

    Follow-up evaluations

    You will undergo regular imaging tests (CT or MRI) at 3, 6, 12, 24, 36, 48, and 60 months after completing therapy.

    Blood tests will continue every 3 months during the observation period.

    The study will continue monitoring your condition until September 2027.

Who can join the trial?

15 criteria

  • Confirmed diagnosis of neuroendocrine tumor (a type of tumor that cannot be surgically removed) in the digestive system that is either spread out or located in one area
  • Presence of tumor that:
    • Cannot be removed by surgery
    • Shows high levels of specific receptors on special imaging tests (performed within 12 weeks before treatment)
    • Shows growth in size within the last 18 months on CT or MRI scans
    • Blood test results showing:
      • Hemoglobin above 9g/dl
      • Blood platelets above 100,000/μl
      • White blood cells above 3,000/μl
      • Neutrophils (type of white blood cells) above 1,500/μl
      • Kidney function test showing:
        • Creatinine less than 120 μmol/l
        • Or kidney filtration rate (eGFR) above 45 ml/min
        • Liver function tests (ALT, AspAT, bilirubin) not exceeding 3 times the normal range
        • Karnofsky score (measure of patient's ability to perform daily activities) of 60% or higher
        • Life expectancy of more than 6 months
        • Age 18 or older
        • Ability to understand and sign informed consent form

Who cannot join the trial?

14 criteria

  • Age below 18 years old
  • Pregnancy or breastfeeding
  • Previous treatment with peptide receptor radionuclide therapy (PRRT) - a type of radiation therapy that targets specific receptors on tumor cells
  • Severe kidney dysfunction (creatinine clearance less than 40 mL/min)
  • Severe liver dysfunction
  • Bone marrow dysfunction, including:
    • Low white blood cell count (less than 2.0 × 10^9/L)
    • Low platelet count (less than 70 × 10^9/L)
    • Low hemoglobin level (less than 8.0 g/dL)
    • Life expectancy less than 3 months
    • Inability to comply with treatment and follow-up schedule
    • Active participation in other clinical trials
    • Lack of written informed consent
    • Mental conditions that prevent understanding of the study procedures
    • Known hypersensitivity to study medications or their components
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Investigated drugs

LutaPol (Lutetium-177 DOTATATE) is a radioactive medication used to treat neuroendocrine tumors. It works by attaching to specific receptors on tumor cells and delivering targeted radiation to destroy cancer cells. ItraPol (Yttrium-90 DOTATATE) is also a radioactive treatment for neuroendocrine tumors. Like LutaPol, it targets specific receptors on tumor cells, but it uses a different type of radiation to kill cancer cells. These medications are used together as a combination therapy (tandem therapy) to provide more effective treatment for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The combination approach allows for personalized treatment based on each patient's specific condition.

What is already known about the treatment

  • LutaPol (177Lu-DOTATATE)

    A radiopharmaceutical medication administered intravenously for the treatment of neuroendocrine tumors of the gastrointestinal tract. This targeted therapy uses lutetium-177 labeled peptides that bind specifically to somatostatin receptors on tumor cells, delivering localized radiation to destroy cancer cells while minimizing damage to healthy tissue. It belongs to the class of peptide receptor radionuclide therapy (PRRT) agents and is used when tumors are inoperable or widely spread.

  • ItraPol (90Y-DOTATATE)

    A radiopharmaceutical treatment delivered through intravenous infusion, specifically designed for treating well-differentiated and intermediate-differentiated neuroendocrine tumors. The medication uses yttrium-90 labeled peptides that target somatostatin receptors expressed on tumor cells, delivering precise radiation therapy to cancer cells. It is classified as a peptide receptor radionuclide therapy (PRRT) agent and is often used in combination with other treatments for managing inoperable or metastatic neuroendocrine tumors.

Investigated diseases

Neuroendocrine Tumors of the Gastrointestinal Tract (GEP-NETs) - A rare type of tumor that develops from specialized cells called neuroendocrine cells in the digestive tract. These tumors can form in different parts of the gastrointestinal system, including the stomach, small intestine, pancreas, and large intestine. GEP-NETs are characterized by their ability to grow either in a concentrated area or spread diffusely throughout the digestive system. They can be classified as well-differentiated or intermediately differentiated, which refers to how closely the tumor cells resemble normal neuroendocrine cells. These tumors typically grow slowly compared to other types of cancer.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516503-17-01Protocol codeDuoNen2020Estimated enrolment92 patientsSponsorNarodowe Centrum Badan Jadrowych

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