A Phase 2, randomised, open label, multicentre study to evaluate efficacy and safety of an intraperitoneal α-emitting radionuclide therapy (Radspherin®) in patients with peritoneal carcinomatosis from colorectal carcinoma following cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC)
This study is a research trial for people with bowel cancer that has spread to the lining of the tummy, a condition called peritoneal carcinomatosis. These patients have already had a big operation to remove as much cancer as possible, followed by a special type of chemotherapy aimed directly at the tummy lining. The trial is looking at a new treatment called Radspherin. It's a 'Phase 2' study, which means researchers are trying to find out how well Radspherin works and if it's safe, by comparing it to standard care. They are particularly interested in how long people stay free from their cancer growing back.
At a glance
What is this study about?
This research study is for people who have been diagnosed with bowel cancer that has spread to the lining of their tummy, often called peritoneal carcinomatosis. This type of cancer spread can be difficult to treat. Patients who are invited to take part in this study have already undergone a major operation to remove the visible cancer, alongside a special type of chemotherapy given directly into the tummy during surgery, called hyperthermic intraperitoneal chemotherapy (HIPEC).
The study is investigating a new treatment called Radspherin. This is a special type of medicine containing a very small amount of radiation, designed to target any remaining cancer cells in the tummy lining after surgery and chemotherapy. The main goal of this study is to see how effective Radspherin is at stopping the cancer from growing back, and for how long. We will also be looking closely at any side effects to understand how safe it is.
Being a 'Phase 2' trial means this is an important step in developing new treatments. Researchers want to gather more information on its benefits and risks before it can go on to larger studies. This study is 'randomised', meaning participants will be put into different treatment groups by chance, to compare Radspherin with standard care. It's also 'open-label', meaning both the patient and the doctors will know which treatment is being given.
Key takeaways
- This study is for bowel cancer that has spread to the tummy lining.
- It tests a new treatment called Radspherin after surgery and special chemotherapy.
- The main goal is to see if Radspherin stops cancer from growing back and if it's safe.
- Participants will be closely checked with scans, blood tests, and questionnaires.
- You will know which treatment you are receiving.
- You can leave the study at any time.
Who may be eligible?
This study is looking for adults, aged 18 or older. Both men and women can take part. Everyone in the study will have a specific type of bowel cancer that has spread to the lining of the tummy (peritoneal carcinomatosis).
To be considered for this study, you must have recently had a big operation to remove as much of the cancer as possible, followed by a special type of chemotherapy given directly into your tummy during the surgery (HIPEC). There will be other specific medical checks to make sure this study is right for you and that taking part would be safe. These will be explained by your medical team.
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 over?
- Do you have bowel cancer that has spread to your tummy lining?
- Have you recently had surgery to remove the cancer?
- Have you had HIPEC (hot chemotherapy in your tummy) recently?
- Are you able to attend regular hospital appointments?
What does participation involve?
If you decide to join this study, you would first have a number of checks to make sure it's safe for you. The treatment involves receiving Radspherin, which will be given directly into your tummy. You would have regular appointments for scans (like CT or MRI) to see how the treatment is working and where your cancer is. You'll also have blood tests and other checks to monitor your general health and any side effects.
Throughout the study, you'll be asked to fill out questionnaires about how you're feeling and your quality of life. The doctors will also closely track any side effects. These visits and checks will continue for a period after the main treatment is finished, to properly monitor your health and the cancer over time. The total duration of participation will depend on how your treatment progresses, but involves regular follow-ups for a certain period.
Potential risks and benefits
Locations (3)
- —UnverifiedNetherlands
- —UnverifiedNorway
- —UnverifiedSweden
Common questions
What is peritoneal carcinomatosis?
It means bowel cancer cells have spread to the thin lining of your tummy (peritoneum).
What is Radspherin?
It's a new treatment being tested, a special medicine with radiation that's put directly into the tummy to target cancer cells.
What does 'randomised' mean in a study?
It means you will be put into a treatment group by chance, like flipping a coin, to ensure fair comparison.
Will I know if I'm getting Radspherin?
Yes, in this 'open-label' study, you and your doctors will know which treatment you are receiving.
How long will I be in the study?
You'll have treatment and then be followed up regularly for up to a year, with ongoing checks depending on your progress.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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