AuthorisedTherapeutic confirmatory (Phase III)Interventional

Tandem therapy LutaPol/ltraPol ( I 77Lu / 90Y-DOTATATE) as an effective method in the treatment of neuroendocrine neoplasmas.

This important study is investigating a new treatment approach called Tandem therapy for people with specific types of neuroendocrine tumours in their digestive system. These are tumours that are either spread out or can't be removed with surgery. The treatment uses a special medicine called DuoNEN, which is given as an injection. The main goal is to see if this new therapy can stop the cancer from getting worse. Doctors will regularly check the tumours using scans like CT or MRI over several years to see if the treatment is effective. They will also be looking closely at any side effects to make sure the treatment is safe for patients.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Narodowe Centrum Badan Jadrowych

Enrolment target

Start

11 Jan 2025

Diagnosed and histopathologically confirmed diffuse or locally unresectable well and intermediate differentiated neuroendocrine tumour of the gastrointestinal tract

What is this study about?

This clinical trial is designed to investigate a new treatment called Tandem therapy for a type of cancer known as neuroendocrine tumours. Specifically, it's for tumours found in the stomach or gut that have either spread widely or can't be completely removed by surgery. These tumours are usually well-controlled but can sometimes grow. The treatment uses a special medicine called DuoNEN, which contains radioactive substances that target the cancer cells. This is a "Phase III" study, which means it's a very advanced stage of testing, comparing the new treatment against existing ones to confirm if it's better or equally good, and safe.

The main aim of this study is to see if Tandem therapy can prevent the cancer from growing or spreading further. Doctors will use regular scans, like CT or MRI, to measure the size of the tumours over several years. They'll perform these scans at specific times after the treatment finishes to track any changes. This is important because it helps them understand if the treatment is successfully keeping the cancer under control.

Beyond checking tumour growth, the researchers will also be carefully monitoring patients' overall health and looking for any side effects. They'll do regular blood tests to check how the body is responding to the treatment and to ensure it's as safe as possible. The study aims to gather lots of information to see if this personalized therapy is both effective and well-tolerated by patients.

Key takeaways

It's a study for specific neuroendocrine tumours in the gut.
It tests a new treatment called Tandem therapy using DuoNEN injections.
The main goal is to see if the treatment stops cancer growth.
You'll have regular scans and blood tests for up to five years.
It's a Phase III study, meaning it's an advanced stage of testing.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you would need to be an adult, 18 years old or older. The study welcomes both men and women.

Crucially, you would need to have specific types of neuroendocrine tumours in your gut. These tumours must have been officially diagnosed and examined under a microscope (histopathology confirmed). They also need to be either spread out in a way that means they can't be removed by surgery, or locally advanced.

Finally, the tumours need to be classified as 'well and intermediate differentiated'. This refers to how the cells look under a microscope and is an important part of determining if this particular treatment is suitable for you.

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.

Are you 18 years old or older?
Have you been diagnosed with a neuroendocrine tumour in your gut?
Is your tumour either spread out or not removable by surgery?
Has your tumour been classified as 'well and intermediate differentiated'?
Are you able to attend regular follow-up appointments for up to five years?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main part of the treatment involves receiving a medicine called DuoNEN, which is given as an injection. After you've completed your course of treatment with DuoNEN, your journey with the study would continue for a long time – up to five years.

Throughout these five years, you would have regular follow-up appointments. The most important part of these check-ups will be imaging scans, like CT or MRI scans. These scans will be done at specific times: 3, 6, 12, 24, 36, 49, and 60 months after your treatment finishes. These scans are crucial for doctors to monitor how the cancer is responding.

You would also have regular blood tests during the study. These tests will check various aspects of your health, including your blood count and kidney function. These blood tests will happen during some visits, during your hospital stay for treatment, and then every three months during the follow-up period. At each blood test, a small amount of blood, about 6.8 ml (just over a teaspoon), will be collected.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as access to a new treatment before it's widely available, which may help control your neuroendocrine tumour. However, like all medical treatments, Tandem therapy might have side effects, some of which are not yet fully known. Researchers will monitor you closely for any changes in your health. It's important to remember that you are free to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (1)

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

—
Unverified
Poland

Common questions

What kind of cancer is this study for?

This study is for specific types of neuroendocrine tumours found in the stomach or gut that are either spread out or can't be removed by surgery.

What is Tandem therapy?

Tandem therapy is the new treatment being tested, using a medicine called DuoNEN, which is given as an injection.

How long will I be in the study if I take part?

You could be followed for up to five years after completing the treatment.

What will I have to do during the study?

You'll receive injections of the study medicine, have regular CT or MRI scans, and get blood tests to monitor your health.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time without it affecting your usual medical care.