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Efficacy of 177Lu-DOTATATE as Adjuvant Therapy After Surgery for Stage III Small Intestinal Neuroendocrine Tumors

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What is this trial about?

A plain-language summary of the goals, design and what participants do

Small intestinal neuroendocrine neoplasms (SI-NEN) are tumors that develop in the small intestine from cells that release hormones. This study examines whether adding a treatment called peptide receptor radionuclide therapy (PRRT) after surgery can help prevent cancer from returning. PRRT is a type of radioligand therapy that delivers radiation directly to tumor cells by attaching to specific receptors on these cells.

The purpose of this study is to determine if patients who receive PRRT after complete surgical removal of their tumor have a longer time without cancer recurrence compared to patients who only receive standard monitoring. Participants in this study will be randomly assigned to either receive PRRT (experimental group) or undergo regular surveillance with no additional treatment (control group). Both groups will be monitored for at least 60 months (5 years) to track if and when the cancer might return.

Throughout the study, participants will undergo imaging tests called PET-CT scans that use special tracers to detect if there are any new tumors. They will also complete questionnaires about their quality of life. The study will track side effects of the treatment and measure how long participants remain free of disease and their overall survival rates.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomization to Treatment or Control Group
After joining the study, you will be randomly assigned to one of two groups:
Arm A (Experimental Group): You will receive peptide receptor radionuclide therapy (PRRT) with lutetium (177Lu) oxodotreotide (Lutathera).
Arm B (Control Group): You will receive standard care based on close surveillance without additional treatment.
Step 2
Treatment with Lutathera (For Arm A only)
If assigned to the experimental group, you will receive Lutathera 370 MBq/mL solution as an infusion.
Lutathera is a radioactive medication that targets specific receptors found on neuroendocrine tumor cells.
The treatment is administered as an intravenous infusion (through a vein).
The exact schedule of infusions will be explained by your healthcare team.
Step 3
Follow-up Monitoring
Throughout the study, you will undergo regular check-ups to monitor your health status.
These will include imaging scans to check for any signs of cancer returning.
Specifically, you will have Somatostatin receptor imaging by PET-CT (a specialized scan that can detect neuroendocrine tumor cells).
The study team will be looking for any signs of relapse, which means the return of cancer after treatment.
Step 4
Quality of Life Assessments
At various points during the study, you will be asked to complete quality of life questionnaires (EORTC QLQ-C30 and GINET21).
These questionnaires help researchers understand how the treatment affects your daily life and well-being.
Step 5
Monitoring for Side Effects
Throughout the study, any side effects or unexpected health issues will be documented.
These are referred to as Adverse Events (AEs) or Serious Adverse Events (SAEs).
It's important to report any new symptoms or health concerns to the study team promptly.
Step 6
Long-term Follow-up
The study will track your health for up to 60 months (5 years) to measure relapse-free survival.
The study will continue to follow participants until October 15, 2025, with final data collection potentially extending to December 31, 2033.
During this time, you will continue to have regular check-ups to monitor for any signs of cancer returning.
Step 7
Contraception Requirements
If you are a woman who can become pregnant, you must use effective contraception from the start of the study until at least 7 months after your last treatment.
If you are a man with a female partner who can become pregnant, you must use a condom during treatment and for at least 4 months afterward. Your partner must also use effective contraception.
Effective contraception methods include hormonal contraceptives (pills, patches, implants), intrauterine devices (IUDs), or permanent sterilization methods.

Who can join the trial?

14 criteria

You must have a small intestinal neuroendocrine neoplasm (a type of tumor that starts in the small intestine) that is stage III (cancer has spread to nearby tissues but not to distant parts of the body)
You must provide written informed consent to participate in the study
You must be 18 years of age or older
You must have had a positive somatostatin receptor imaging test (a special type of scan that shows these specific tumors) before surgery
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You must have had surgery to remove the tumor completely (R0 resection), which included:
- Examination of your entire small bowel
- Removal of at least 8 lymph nodes
- Your tumor must be classified as grade G1, G2, or G3 based on how the cells look under a microscope
- You must have a negative somatostatin receptor imaging test after surgery (showing no visible remaining tumor)
- If you are a woman who can become pregnant, you must agree to use highly effective contraception during the study and for 7 months after the last treatment
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  If you are a man who can father children and are sexually active with women who can become pregnant, you must:
  - Inform your partner about the study
  - Use a condom during treatment and for 4 months after
  - Ensure your female partner uses highly effective contraception
  - Not donate sperm during this time
  - Highly effective contraception includes: hormonal contraceptives (pills, vaginal rings, patches, or implants), IUDs, IUS systems, bilateral tubal occlusion (tubes tied), having a partner who has had a vasectomy, or sexual abstinence

Who cannot join the trial?

12 criteria

Having any cancer that has spread beyond the local region (not stage III small intestinal neuroendocrine tumors)
Previous treatment with peptide receptor radionuclide therapy (a targeted radiation treatment for neuroendocrine tumors)
Current treatment with other cancer therapies that might interfere with the study treatment
History of other cancers within the past 3 years (except for certain skin cancers or successfully treated cancers)
Severe kidney problems (since the study medication is processed by the kidneys)
Severe liver dysfunction
Inadequate bone marrow function (problems with blood cell production)
Serious heart conditions
Pregnancy or breastfeeding
Not willing to use effective birth control during the study
Unable to follow study procedures or attend required visits
Any medical condition that the doctor believes would make participation unsafe

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Munich, Germany
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Philipps-Universitaet Marburg
Marburg, Germany
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Rheinische Friedrich-Wilhelms-Universitaet Bonn
Bonn, Germany

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Investigated drugs

Peptide Receptor Radionuclide Therapy (PRRT) is a targeted treatment that uses radioactive substances attached to molecules that specifically bind to receptors on neuroendocrine tumor cells. This therapy delivers radiation directly to the cancer cells while limiting damage to surrounding healthy tissue. In this trial, PRRT is being studied as an additional treatment after surgery for small intestine neuroendocrine tumors to see if it can prevent cancer recurrence.

Lutetium (177Lu) Oxodotreotide

What is already known about the treatment

Lutetium-177 DOTATATE – This medication is administered via intravenous infusion as a form of peptide receptor radionuclide therapy (PRRT) for neuroendocrine tumors. It consists of a radioactive isotope (lutetium-177) attached to a molecule (DOTATATE) that specifically binds to somatostatin receptors found in high numbers on neuroendocrine tumor cells. The mechanism of action involves the delivery of targeted radiation directly to tumor cells, causing DNA damage and cell death while minimizing damage to surrounding healthy tissues. Lutetium-177 DOTATATE is classified as a radiopharmaceutical agent and has shown effectiveness in treating various types of neuroendocrine neoplasms, with this trial specifically examining its potential as an adjuvant therapy after surgery for small intestinal neuroendocrine tumors.

Investigated diseases

Small Intestinal Neuroendocrine Neoplasms (SI-NEN) – A type of tumor that develops in the hormone-producing cells of the small intestine. These neoplasms arise from specialized cells called enterochromaffin cells, which are part of the diffuse neuroendocrine system. SI-NENs typically grow slowly but can eventually spread to nearby lymph nodes and to distant organs such as the liver. Stage III (locoregionally restricted) indicates that the cancer has grown into nearby tissues or spread to regional lymph nodes but has not yet metastasized to distant parts of the body. These tumors often produce hormones that can cause symptoms collectively known as carcinoid syndrome, including flushing, diarrhea, and wheezing.