Evaluation of treatment PERSOnalization based on its therapeutic monitoring in patients with metastatic colorectal cancer treated with regorafenib
This research study is for people with advanced bowel cancer that has spread to other parts of the body. It's investigating a medicine called Stivarga (regorafenib). The main goal is to understand if adjusting the dose of Stivarga based on how much of it is in a patient's blood can lead to better outcomes. Doctors will measure the drug levels in the blood to see if being in a certain 'optimal range' helps patients live longer or controls their cancer better. They will also look at side effects. This is a Phase II study, meaning it's an early-stage trial focusing on how well the treatment works and its safety, with the hope of making future treatments more personalised and effective for individual patients.
At a glance
What is this study about?
This research study is about helping people with advanced bowel cancer, which means the cancer has spread to other parts of the body. The study focuses on a specific medicine called Stivarga (regorafenib), which is used to treat this type of cancer. The main idea behind this research is to see if we can make the treatment work better for each patient by giving them just the right amount of medicine.
Think of it like this: just as a tailor makes clothes to fit you perfectly, doctors want to find the perfect dose of medicine for each patient. In this study, they will measure how much Stivarga is in a patient's blood. They want to see if patients who have a certain amount of the drug in their blood (what they call an 'optimal exposure') respond better to the treatment and live longer than those with different levels. This is a ‘Phase II’ study, which means it’s an early step to understand if this way of giving the medicine is effective and safe.
By understanding how different drug levels affect patients, doctors hope to learn how to personalise treatment in the future. This could mean adjusting the dose of Stivarga for each individual to make it as effective as possible while also keeping side effects to a minimum. Ultimately, the goal is to improve how long people live and their quality of life when living with advanced bowel cancer.
Key takeaways
- This study focuses on advanced bowel cancer.
- It investigates the medicine Stivarga (regorafenib).
- Aims to find the best individual dose by checking drug levels in the blood.
- Hopes to improve how long patients live and control their cancer.
- It's an early-stage study (Phase II) looking at effectiveness and safety.
Who may be eligible?
This study is looking for adults who are at least 18 years old and have advanced bowel cancer that has spread to other parts of their body. Both men and women can take part in this research.
To be eligible, you would need to meet certain health criteria that the doctors would check. This is to make sure the study is as safe as possible for you and that the results are clear. Your doctor will be able to tell you if your specific health situation matches what the researchers are looking for.
It's important to remember that not everyone who has advanced bowel cancer will be able to join. There are often other medical factors that researchers consider, but the main criteria are being an adult with this specific type of cancer.
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 bowel cancer that has spread to other parts of your body?
- Are you able to take Stivarga tablets?
- Are you willing to have regular blood tests and scans?
What does participation involve?
If you decide to take part in this study, you'll be taking Stivarga (regorafenib) tablets as prescribed by the study doctors. Throughout the study, you would have regular appointments where blood samples will be taken. These blood tests are important because they help the researchers measure the level of the medicine in your body.
You would also have regular scans and check-ups to see how the cancer is responding to the treatment. The doctors will also keep a close eye on any side effects you might experience. We don't have the exact number of visits or the total length of the study here, but typically, these kinds of studies involve ongoing monitoring as long as the treatment is working and safe for you. Your study doctor would explain the full schedule.
Potential risks and benefits
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Common questions
What is Stivarga (regorafenib)?
Stivarga is a medicine used to treat certain types of cancer, including advanced bowel cancer, by targeting specific processes that help cancer cells grow.
What does 'advanced bowel cancer' mean?
It means the cancer started in the bowel but has spread to other parts of the body, also known as metastatic cancer.
What will happen during the study?
You will take Stivarga tablets, and doctors will take blood samples and perform scans to see how the medicine is working and check for side effects.
Why is measuring drug levels important?
Researchers want to see if having a certain amount of the medicine in your blood helps the treatment work better and personalises your care.
Can I stop participating if I want to?
Yes, you can choose to stop being part of the study at any time, and it will not affect your regular medical care.
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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