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

1 1 1 1

What is this study about?

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.

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.

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.

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.

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.

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.

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.

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 Study?

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
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
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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Philipps-Universitaet Marburg	Marburg	Germany
Umlmxeecpgdhrhqrrxvkn Eyvbz Avc	Essen	Germany
Uyvdjnlfixsdmvvwfcuye Wfthjsdwu Aca	Wuerzburg	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	15.10.2025

Trial locations

Investigated drugs:

Lutetium (177Lu) Oxodotreotide

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.

Investigated diseases:

Small intestine neuroendocrine tumour

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.

Trial ID:

2024-518236-36-00

Protocol code:

KKS-312

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?