Study of Lutetium (177Lu) Edotreotide compared to standard treatment in patients with aggressive Grade 2 and Grade 3 gastroenteropancreatic neuroendocrine tumors (GEP-NETs)

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What is this study about?

This study focuses on patients with Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs), which are rare tumors that develop in the digestive system or pancreas. The main treatment being tested is Lutetium-177 Edotreotide, a radioactive medication that specifically targets tumor cells. This treatment, also known as Peptide Receptor Radionuclide Therapy (PRRT), will be compared to standard cancer treatments to determine if it works better.

The study includes several standard cancer treatments that may be used as comparison: Everolimus, Temozolomide, Capecitabine, Oxaliplatin, and Fluorouracil. Some patients will also receive supportive medications like Calcium Folinate and an amino acid solution to protect their kidneys during treatment. The purpose is to determine if the radioactive treatment is more effective than current standard treatments for these types of tumors.

During the study, patients will be randomly assigned to receive either the radioactive treatment or one of the standard treatments. The doctors will monitor how well the treatments work by taking regular scans and checking patients’ overall health. They will also track how the treatments affect patients’ quality of life using questionnaires.

1 Initial treatment assignment

You will be randomly assigned to one of two treatment groups: either lutetium (177Lu) edotreotide therapy or best standard of care treatment.

The assignment is done through a computerized system to ensure fairness in group distribution.

2 Medical imaging

You will undergo CT scan or MRI imaging to measure your tumor(s).

These scans will be used to track changes in your condition throughout the study.

3 Treatment administration

If assigned to the lutetium group: You will receive lutetium (177Lu) edotreotide through intravenous infusion.

If assigned to standard care group: You may receive one or more of the following medications:

Oxaliplatin (intravenous)

Everolimus (oral tablets)

Folinic acid or calcium folinate (intravenous)

Fluorouracil (intravenous)

Temozolomide (oral tablets)

Capecitabine (oral tablets)

4 Regular assessments

Your condition will be monitored through regular medical examinations.

You will complete two quality of life questionnaires: EORTC QLQ-C30 and GI.NET21.

Laboratory tests and vital signs will be checked regularly.

Imaging scans will be performed to assess tumor response.

5 Study duration

The study runs from December 2021 to June 2030.

Your participation duration will depend on your response to treatment and overall health status.

Who Can Join the Study?

  • Must be 18 years of age or older
  • Must have confirmed GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) that cannot be surgically removed. These are tumors that occur in the digestive system or pancreas
  • Must have tumors that can be measured using special imaging tests (CT scan or MRI)
  • Must have tumors that are somatostatin receptor-positive (SSTR+), which means the tumors have specific proteins on their surface that can be targeted by treatment
  • Both men and women can participate in the study
  • Must have tumors that are classified as either:
    • Grade 2 with Ki67 between 15 and 20%, or
    • Grade 3 with Ki67 above 20% up to 55%

    (Ki67 is a marker that shows how fast tumor cells are growing)

Who Cannot Join the Study?

  • Prior treatment with Peptide Receptor Radionuclide Therapy (PRRT) – a type of targeted radiation therapy
  • Presence of tumors that do not show positive results for somatostatin receptors (special proteins on tumor cells)
  • Ki-67 index (a measure of tumor growth) less than 15% or greater than 55%
  • Tumors originating from areas other than the digestive system or pancreas
  • Severe kidney or liver problems that could interfere with treatment
  • Pregnancy or breastfeeding
  • Serious heart conditions or uncontrolled high blood pressure
  • Active infections requiring treatment
  • Other types of cancer that require immediate treatment
  • Unable to undergo required imaging procedures
  • Participation in other clinical trials within the past 30 days
  • Mental conditions that prevent understanding of trial requirements
  • Life expectancy less than 6 months

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Edouard Herriot Lyon France
Hospital Universitario 12 De Octubre Madrid Spain
Universitaetsklinikum Erlangen AöR Erlangen Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Universidade De Santiago De Compostela Santiago De Compostela Spain
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Centre Hospitalier Universitaire De Nantes Nantes France
A.O.U. Policlinico G. Martino Di Messina Messina Italy
Udelnrvigxapvqujglpbo Ejuvz Apk Essen Germany
Ihzkfkuj Csqdkw Dogvvdpgfpsommhuw L'hospitalet De Llobregat Spain
Aqlsldjbk Uwa Amsterdam The Netherlands
Ekkezgi Uivoqlotgepw Mvtjhge Ckkgqcj Rhkwncrxt (cjpltiw Mvw Rotterdam The Netherlands
Hlbqovbj Vzua dedadwor Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
21.12.2021
Germany Germany
Not recruiting
21.12.2021
Italy Italy
Not recruiting
21.12.2021
Spain Spain
Not recruiting
21.12.2021
The Netherlands The Netherlands
Not recruiting
21.12.2021

Trial locations

Lutetium (177Lu) edotreotide
This is a peptide receptor radionuclide therapy (PRRT) medication used to treat certain types of neuroendocrine tumors. It works by delivering targeted radiation therapy to cancer cells that have specific receptors called somatostatin receptors. The medication consists of a radioactive substance (lutetium) attached to a molecule that binds to these specific receptors on tumor cells.

Best Standard of Care
This refers to the currently accepted and widely used treatments that doctors would typically prescribe for patients with neuroendocrine tumors. The specific treatment is chosen by the doctor from an approved list of treatment options based on what they believe would work best for each individual patient.

Neuroendocrine Tumors of GastroEnteric or Pancreatic Origin (GEP-NET) – A rare type of cancer that develops in specialized cells called neuroendocrine cells, which are found throughout the digestive system and pancreas. These tumors can form in the stomach, intestines, pancreas, or other parts of the digestive system. GEP-NETs can be categorized into different grades based on how quickly the cells divide, with Grade 2 and Grade 3 representing more aggressive forms of the disease. These tumors often produce excess hormones that can affect various body functions. The disease typically progresses gradually, though the rate varies depending on the tumor grade.

Trial ID:
2024-510812-64-00
Protocol code:
DP-1111-02CT
NCT ID:
NCT04919226
Trial Phase:
Therapeutic confirmatory (Phase III)

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