Regorafenib in combination with temozolomide with or without radiotherapy in patients with newly diagnosed MGMT-Methylated, IDH wild-type glioblastoma. A phase I dose-finding study (REGOMA-2).
This research study, called REGOMA-2, is a Phase I trial investigating a new way to treat a serious type of brain tumour called glioblastoma. Specifically, it's for patients who have been recently diagnosed with a particular kind of glioblastoma (MGMT-Methylated, IDH wild-type). Researchers want to find the safest and most effective dose of a drug called regorafenib when given alongside a common chemotherapy medicine, temozolomide. For some patients, radiotherapy might also be part of the treatment. The main goal is to understand how these medicines work together, how well patients tolerate them, and to determine the best dosages for future, larger studies. This is an early-stage study focusing on safety.
At a glance
What is this study about?
This study is about finding better treatments for a type of brain tumour called glioblastoma. When someone is diagnosed with glioblastoma, it's a very serious condition. Doctors are always looking for ways to improve how they treat it and help patients live longer and have a better quality of life. This particular study is focusing on a new drug called regorafenib. It's being tested alongside a standard chemotherapy drug, temozolomide, and for some patients, radiotherapy (which uses radiation to kill cancer cells).
Think of this study as a careful exploration. Because regorafenib is a newer treatment for this type of cancer, doctors need to find out the best amount, or 'dose', to give to patients. Giving too little might not be effective, and giving too much could cause more side effects. This study aims to find that 'sweet spot' – the dose that is both safe and has the best chance of helping.
This is an early-stage study, called a Phase I trial. This means the main focus is on safety and finding the right dose, rather than on how well it works on the tumour yet. It's an important step in developing new treatments and could pave the way for bigger studies in the future that look more closely at the treatment's effectiveness.
Key takeaways
- This study is testing a new drug (regorafenib) for glioblastoma.
- It's a Phase I study, focusing on finding a safe dose and side effects.
- It's for newly diagnosed patients with a specific type of glioblastoma.
- The new drug is being combined with standard treatments like temozolomide and sometimes radiotherapy.
- Participation involves regular hospital visits and monitoring.
- Your involvement could help improve treatments for future patients.
Who may be eligible?
This study is open to adults aged 18 and over, with no upper age limit. Both men and women can take part. To be considered, you must have been recently diagnosed with a specific type of brain tumour called glioblastoma. Your doctors will have done tests on the tumour to confirm it has certain features, referred to as 'MGMT-Methylated' and 'IDH wild-type'. These are important details that help doctors understand how your cancer might respond to treatment.
Your doctors will check your overall health to make sure you're well enough to take part in the study and handle the treatments. This involves looking at things like your organ function, making sure you don't have other serious medical conditions, and aren't taking medicines that might interfere with the study drugs. They will also make sure you haven't received certain past treatments for glioblastoma that would prevent you from joining this particular trial.
Ultimately, your medical team will carefully review all of your health information to see if you meet all the requirements for this study. They will explain everything clearly if they think you might be a good fit.
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 recently diagnosed with glioblastoma?
- Has your doctor confirmed your tumour is 'MGMT-Methylated, IDH wild-type'?
- Are you generally well enough to start a new treatment plan?
- Are you able to attend regular hospital appointments?
What does participation involve?
Taking part in this study would involve regular hospital visits for check-ups and to receive your treatment. You would be given the study drug, regorafenib, along with temozolomide, and possibly radiotherapy, as prescribed by the study doctors. You'd have blood tests, scans, and other assessments to monitor your health, check for side effects, and see how the treatment is affecting you. While the total duration isn't specified, studies like this often involve treatment cycles followed by regular follow-up appointments. You will be closely monitored throughout your participation.
Potential risks and benefits
Locations (1)
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Common questions
What is glioblastoma?
Glioblastoma is a serious type of brain tumour that grows quite quickly. Doctors are always looking for better ways to treat it.
What does 'Phase I' mean for a study?
Phase I is an early stage of research. It mainly focuses on finding a safe dose of a new drug and understanding its side effects, rather than how well it cures the disease.
What is regorafenib?
Regorafenib is a medicine being tested to see if it can help treat glioblastoma when given alongside standard treatments.
What is temozolomide?
Temozolomide is a common chemotherapy drug often used to treat glioblastoma.
Who can join this study?
Adults aged 18 or older, diagnosed recently with a specific type of glioblastoma, might be eligible. Your doctor will check if you fit all the requirements.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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