RecruitingOBSERVATIONAL

Observational SIR-Spheres Study for the Treatment of Unresectable Liver Tumors (SIRtain Registry)

This study, called the SIRtain Registry, is looking at a treatment called SIR-Spheres for liver tumours that doctors can't remove with surgery. This includes certain liver cancers (hepatocellular carcinoma) and liver tumours that have spread from bowel cancer, especially if other treatments like chemotherapy haven't worked or can't be used. Instead of testing a new drug, this study simply gathers information from many hospitals around the world about how SIR-Spheres is used in real life. The main goal is to understand how well the treatment helps patients and to confirm it's being used safely and effectively. It’s about watching and learning from patients who are already receiving this treatment as part of their usual care.

At a glance

Status

Recruiting

Sponsor

Sirtex Medical

Enrolment target

845

Start

19 Jun 2023

Estimated completion

01 Jun 2029

Unresectable Hepatocellular Carcinoma (HCC)Liver Metastases From Colorectal Cancer (mCRC)

What is this study about?

This study is gathering information about a treatment for liver tumours called SIR-Spheres. These are tiny radioactive beads that are delivered directly to the liver to treat tumours that can't be removed by surgery. This could be liver cancer that started in the liver (called hepatocellular carcinoma) or tumours that have spread to the liver from bowel cancer.

The study isn't testing a new medicine or asking people to try something experimental. Instead, it's like a big information-gathering project. Doctors from many different hospitals in several countries will share details about patients who are already receiving SIR-Spheres as part of their regular treatment plan. They want to see how the treatment works for these patients in real-world situations, rather than in a special trial setting.

The main aim is to build a clearer picture of how effective SIR-Spheres is and to make sure it's being used correctly and safely for people with these types of liver tumours. By looking at information from a large number of patients, they hope to learn more about the best ways to use this treatment.

Key takeaways

This study collects information about an existing liver tumour treatment called SIR-Spheres.
It's for people with liver tumours that can't be removed by surgery, including some liver cancers or tumours spread from bowel cancer.
The study observes how SIR-Spheres performs in real-world settings, not a new experimental drug.
Participation involves sharing medical information from your regular care; no extra tests or visits.
You must be 18 or older and your doctor must have already decided SIR-Spheres is right for you.
You can withdraw from the study at any time without affecting your medical treatment.

Who may be eligible?

To be part of this study, you need to be at least 18 years old. You must have a confirmed diagnosis of liver cancer that can't be surgically removed, or liver tumours that have spread from bowel cancer and haven't responded well to chemotherapy or you can't have chemotherapy.

Crucially, your doctor must have already decided that SIR-Spheres treatment is the right option for you, and it must be your first time receiving this specific treatment for your liver. You also need to be able to understand the study and agree to take part yourself. If someone else would need to give permission for you, you unfortunately can't join.

You cannot join if you've previously had radiation treatment to your liver or if you're already participating in another clinical trial that involves an experimental medicine or procedure.

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 tumours that doctors can't remove with surgery (either liver cancer or tumours spread from bowel cancer)?
Have other treatments, like chemotherapy, not worked or are not suitable for you?
Has your doctor already recommended SIR-Spheres as your treatment?
Is this your first time receiving SIR-Spheres for your liver?
Have you NOT had radiation treatment to your liver before?

Answer every question to see your result.

What does participation involve?

If you join this study, it means that information about your treatment with SIR-Spheres will be collected. You won't be given any extra medicines or asked to have any additional tests just for the study. Instead, the doctors will simply record details about your health, your treatment, and how you respond to it, as part of your normal medical care. This information will be gathered for research purposes, helping to understand the treatment better. The total duration of your participation will depend on your individual treatment plan and follow-up, as determined by your doctor.

Potential risks and benefits

The potential benefit of taking part is that your information will contribute to a better understanding of SIR-Spheres, which could help future patients. You won't be receiving a new, untested treatment, as SIR-Spheres is already an approved therapy. As this is an observational study, you won't face additional risks beyond those associated with your standard medical care and the SIR-Spheres treatment itself. You are always in control and have the right to withdraw your consent and stop participating in the study at any time, without it affecting your medical care.

Locations (9)

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

Hôpital Beaujon
Verified postcode
Clichy, France· Recruiting
Hopital Henri Mondor
Verified postcode
Créteil, France· Not yet recruiting
Hospices Civils de Lyon HCL Centre Hospitalier Lyon-Sud
Verified postcode
Pierre-Bénite, France· Recruiting
Hospital Universitario Puerta de Hierro - Majadahonda
Verified postcode
Majadahonda, Spain· Not yet recruiting
Hospital General Universitario Gregorio Marañon
Verified postcode
Madrid, Spain· Not yet recruiting
Hospital Clinico Universitario de Valencia
Verified postcode
Valencia, Spain· Not yet recruiting
The Christie Hospital
Verified postcode
Manchester, United Kingdom· Not yet recruiting
Kings College Hospital
Verified postcode
London, United Kingdom· Not yet recruiting
Hammersmith Hospital
Verified postcode
London, United Kingdom· Not yet recruiting

Common questions

What is SIR-Spheres?

SIR-Spheres are tiny radioactive beads that are used to treat liver tumours by delivering radiation directly to the tumour.

Is this a typical clinical trial where I take a new drug?

No, this isn't a trial testing a new drug. It's an 'observational study' which means doctors are simply collecting information about how an existing treatment (SIR-Spheres) works for patients in real life.

Will I have extra doctor visits if I join?

No, you won't need any extra doctor visits or tests specifically for this study. All the information gathered will be from your regular medical appointments.

Who can join this study?

Adults (18+) with certain types of liver tumours that can't be removed by surgery, who are having SIR-Spheres for the first time, and haven't had liver radiation before.

Can I stop being part of the study if I change my mind?

Yes, absolutely. You can decide to stop participating at any time, and it won't affect your medical care.

How to find out more

Janet Bell

jbell@sirtex.com 781-721-3840 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.