Active not recruitingPHASE3INTERVENTIONAL

Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients

This research is looking at how well a new type of treatment, called 177Lu-edotreotide PRRT, works for people who have advanced neuroendocrine tumours of the gut or pancreas. These are a type of cancer that starts in hormone-producing cells. The study will compare this new radiation treatment with a commonly used medication called Everolimus. The main goal is to find out if the new treatment is more effective at controlling the cancer and if it's safe to use. This is important for patients whose cancer can't be removed by surgery and has continued to grow. By understanding which treatment option is best, doctors can make more informed decisions for future patients with similar conditions.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

ITM Solucin GmbH

Enrolment target

324

Start

02 Feb 2017

Estimated completion

01 Nov 2029

Neuroendocrine Tumors

Results

Results from this study

Posted April 2026

Results have been published for this study.

Primary outcome

Progression-Free Survival (PFS)

PFS determined as time elapsed between randomization, and the date of first objective report of tumor progression (evaluated by RECIST criteria v1.1) as evaluated by the Blinded Independent Central Review (BICR), or death.

Full results on the registry

What is this study about?

This study is designed to help doctors understand the best way to treat a specific type of cancer called a neuroendocrine tumour, which can start in the gut or pancreas. These tumours are often slow-growing but can sometimes spread. In this particular study, doctors are looking at patients whose tumours have continued to grow despite previous treatments, and cannot be completely removed by surgery.

The study compares two different treatments. One is called 177Lu-edotreotide PRRT. This is a type of 'targeted' radiation treatment that uses a special substance to deliver radiation directly to the cancer cells, aiming to shrink them or stop them from growing. The other treatment is a standard medication called Everolimus, which works by blocking signals that help cancer cells grow and divide. The research aims to see which of these treatments is more effective at controlling the cancer and which has fewer side effects.

This kind of research is really important because it helps improve how we treat cancer. By carefully comparing these two approaches, doctors can learn more about which one might offer the best outcome for patients with these specific types of neuroendocrine tumours. The findings could potentially lead to better treatment options for many people in the future.

Key takeaways

Compares two treatments for gut/pancreatic neuroendocrine tumours.
One treatment is a new type of targeted radiation, the other is a standard drug.
Aims to find out which treatment is safer and more effective for this specific cancer.
Participation involves regular hospital visits for treatment and check-ups.
Offers potential access to new treatment and helps scientific understanding.

Who may be eligible?

To join this study, you would need to have received a clear diagnosis of a well-behaved neuroendocrine tumour that started in your gut or pancreas. Your doctors would need to show that your tumours are growing and that they have something specific called 'somatostatin receptors' on their surface, which helps the special radiation treatment find them. Also, your medical records would need to show that your cancer can be measured accurately using scans.

There are also some reasons why you might not be able to join. For instance, if you are allergic to any of the medicines used in the study, or if you've already had a similar type of radiation treatment before. You also couldn't take part if you've had certain other treatments recently, or if surgery could still remove all of your cancer.

Other reasons for not being able to join include if you have other serious health problems that might make the treatments unsafe, if you are pregnant or breastfeeding, or if you're not able to fully understand and agree to participate in the study on your own.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have a well-diagnosed neuroendocrine tumour of the gut or pancreas?
Has my cancer continued to grow despite previous treatment?
Do scans show that my tumours have special 'somatostatin receptors'?
Am I able to be safely treated with the study medications?
Am I over 18 years old?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to receive one of the two treatments – either the 177Lu-edotreotide PRRT or Everolimus. This is like flipping a coin, so neither you nor your doctor can choose which treatment you get. You would also receive an amino-acid solution during treatment, which helps protect your kidneys.

You would have regular visits to the hospital for treatment, check-ups, and scans to see how you are responding. These visits would involve blood tests, physical examinations, and imaging scans (like CT or MRI). The total time you spend in the study would depend on how your treatment progresses, but there would be follow-up appointments even after active treatment ends to monitor your health. The study would keep track of your health and any side effects you might experience throughout this period.

Potential risks and benefits

Participating in this study might offer you access to a new treatment that might be more effective than standard options for your type of cancer. It also contributes to medical knowledge that could help future patients. However, like all medical treatments, there are potential risks and side effects from both the new radiation treatment and the Everolimus medication. Your doctors will explain these in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (52)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Banner Health d.b.a. Banner MD Anderson Cancer Center
Verified postcode
Gilbert, United States
Stanford University
Verified postcode
Stanford, United States
Moffitt Cancer Center & Research Institute
Verified postcode
Tampa, United States
Northwestern Memorial Hospital
Verified postcode
Chicago, United States
University of Michigan Comprehensive Cancer Center
Verified postcode
Ann Arbor, United States
Excel Diagnostics & Nuclear Oncology Center
Verified postcode
Houston, United States
Royal North Shore Hospital
Unverified
Saint Leonards, Australia
Olivia Newton-John Cancer & Wellness Centre, Austin Hospital
Verified postcode
Heidelberg, Australia
Peter MacCallum Cancer Centre
Verified postcode
Melbourne, Australia
Fiona Stanley Hospital
Verified postcode
Murdoch, Australia
Allgemeines Krankenhaus Wien
Verified postcode
Vienna, Austria
Institut Jules Bordet
Verified postcode
Brussels, Belgium

Common questions

What are neuroendocrine tumours?

Neuroendocrine tumours (NETs) are a type of cancer that forms in cells that release hormones. They can start in various parts of the body, including the gut or pancreas.

What is PRRT?

PRRT (Peptide Receptor Radionuclide Therapy) is a targeted radiation treatment that uses a special substance to deliver radiation directly to certain cancer cells.

What is Everolimus?

Everolimus is a medication that works by blocking signals inside cancer cells that help them grow and divide.

Will I get to choose my treatment?

No, you would be randomly assigned to one of the two treatments, like drawing lots. This helps ensure fair comparison.

How long will the study last?

The length of your participation would depend on your response to treatment, but there will be ongoing follow-up after active treatment ends.