Active not recruitingNAINTERVENTIONAL

Stereotactic Body Radiation Therapy (SBRT) Efficiency and Toxicity in Liver Cancer

This national study is looking into a type of targeted radiation treatment called Stereotactic Body Radiation Therapy (SBRT) for people with liver cancer or cancer that has spread to the liver (called liver metastases). Researchers want to understand how effective SBRT is and what side effects it might cause in a wide range of patients. They are making it easy for many people who could benefit from SBRT to take part, especially if they can't join other studies. The study aims to gather information prospectively, meaning they will follow patients from the beginning of their treatment to see how they respond over time.

At a glance

Status

Active not recruiting

Phase

Sponsor

Centre Oscar Lambret

Enrolment target

280

Start

13 Mar 2019

Estimated completion

01 Jan 2027

Liver Cancer Liver Metastases

What is this study about?

This important study is focused on a treatment called Stereotactic Body Radiation Therapy, or SBRT. This isn't a new medicine, but a very precise way of giving radiation. Imagine aiming a very focused beam directly at a cancer in your liver, protecting the healthy parts around it. Doctors use SBRT to treat different kinds of liver cancer, including cancer that started in the liver and cancer that has spread to the liver from another part of the body.

The main goal of this study is to see how well SBRT works for people with these conditions, and to keep an eye on any side effects or problems it might cause. By gathering information from many patients across different hospitals in the UK, researchers can get a much clearer picture of who benefits most from SBRT and what to expect. This information will help doctors make better decisions about using SBRT for liver cancer in the future.

The study is designed to be as open as possible, so that many patients who could be helped by SBRT can take part. This means doctors are keen to include people who might not fit the strict rules of other studies, ensuring the results are useful for a wide range of patients in regular hospital settings.

Key takeaways

Studies a targeted radiation treatment (SBRT) for liver cancer.
Aims to understand how well SBRT works and its side effects.
Open to a wide range of patients, including those not eligible for other studies.
Involves check-ups, 3-6 SBRT sessions, and long-term follow-up.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old. You would have either liver cancer that started in your liver (which could be hepatocellular carcinoma or cholangiocarcinoma) or cancer that has spread to your liver from another part of your body.

Critically, your doctors must agree that SBRT is a suitable treatment option for you after discussing it in a specialist team meeting. For instance, if you have liver cancer, it shouldn't be suitable for surgery. If you have cancer that has spread to your liver, it should usually be a limited number of spots. You also can't be pregnant or breastfeeding, or have a severe liver condition called Cirrhosis Child C. Everyone taking part needs to be able to understand and sign a consent form and be part of the National Social Security System.

Basically, the study is for people who can't have surgery but are otherwise suitable for SBRT, and it's important that you don't have other health issues that would make SBRT unsafe 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?
Do you have liver cancer (either from the liver or spread to it)?
Have your doctors said that SBRT might be an option for your treatment?
Are you not pregnant or breastfeeding?
Are you able to agree to take part and sign a consent form?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a thorough health check-up within 28 days before starting treatment. This includes a discussion about your medical history, any past treatments, and some basic measurements like your weight and height. You'll also have blood tests to check your liver function and general health, and a scan (like a CT or MRI) to look at your cancer.

The SBRT treatment itself typically involves 3 to 6 sessions. The specific way your doctors deliver the radiation treatment can vary slightly depending on their usual practice. After your treatment, you'll have regular follow-up appointments over several years to see how you're doing. These will involve repeat checks of your clinical health, blood tests, scans to monitor your cancer, and discussions about any side effects. These follow-ups will happen at 3, 6, 9, 12, 18, 24, 30, and 36 months, and then once a year until the study finishes for everyone.

Potential risks and benefits

Taking part in any study has potential benefits and risks. The potential benefit here is receiving SBRT, which is a targeted radiation treatment for your liver cancer, with close monitoring of your health and treatment response. However, SBRT, like all cancer treatments, can have side effects, which the study will carefully track. Although the specific techniques for SBRT are left to the doctors' discretion, the overall treatment is a standard approach that is already in use. It's very important to remember that you are free to change your mind and withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (7)

Centre Oscar Lambret
Verified postcode
Lille, France
Centre Léonard de Vinci
Verified postcode
Dechy, France
Institut Régional du Cancer de Montpellier
Verified postcode
Montpellier, France
Institut de Cancérologie Paris Nord
Verified postcode
Sarcelles, France
Centre Paul Strauss
Verified postcode
Strasbourg, France
Institut de Cancérologie de Lorraine
Verified postcode
Vandœuvre-lès-Nancy, France
Institut Gustave Roussy
Verified postcode
Villejuif, France

Common questions

What is SBRT?

SBRT is a type of radiation treatment that uses very focused beams to target cancer cells in your liver, trying to protect the healthy tissue around them.

What kinds of liver cancer can join this study?

This study is for people with primary liver cancer (which started in the liver) or secondary liver cancer (cancer that spread to the liver from somewhere else).

Will I have more hospital visits than usual?

You'll have specific check-ups before treatment, then 3 to 6 treatment sessions, and regular follow-up appointments over several years to monitor your progress and any side effects.

What if I can't take part in other studies?

This study's rules are quite flexible, specifically to include many patients who might not be eligible for other research studies, so it might be suitable for you.

Can I leave the study if I want to?

Yes, absolutely. You can withdraw from the study at any time, for any reason, without it affecting your medical care.