Phase III Trial of Anaplastic Glioma Without 1p/19q Loss of Heterozygosity (LOH)
This study is investigating a type of brain tumour called anaplastic glioma. Doctors want to find the best way to treat it. Currently, people receive radiation therapy, which uses high-energy X-rays to kill cancer cells. This trial is looking at whether adding a chemotherapy drug called temozolomide makes the treatment more effective. Temozolomide works by stopping cancer cells from growing and dividing. Participants will be split into groups: some will have only radiation, and others will have radiation combined with temozolomide, either during radiation, after radiation, or both. The main goals are to see if combining these treatments helps people live longer, keeps the cancer from coming back, and improves their general well-being and health.
At a glance
What is this study about?
This study is for people diagnosed with a specific type of brain tumour called anaplastic glioma. This tumour affects the brain and central nervous system. When someone is diagnosed with a tumour like this, doctors want to find the most effective ways to treat it and help people live as well as possible for as long as possible.
At the moment, a common treatment for anaplastic glioma is radiation therapy. This treatment uses strong X-rays to target and kill cancer cells. However, doctors are always looking for ways to make treatments even better. This is where the drug temozolomide comes in. Temozolomide is a chemotherapy drug, which means it works by stopping cancer cells from growing and dividing. The idea is that using temozolomide alongside radiation therapy might kill more cancer cells than radiation alone.
The main aim of this study is to compare different ways of using temozolomide with radiation therapy. Some people will have only radiation therapy, while others will have radiation therapy plus temozolomide. Temozolomide might be given at the same time as radiation, or after radiation, or both. By comparing these different approaches, researchers hope to find out if adding temozolomide helps people live longer, stops the tumour from getting worse, and improves their overall quality of life. They will also be carefully checking for any side effects and how the treatment affects daily life.
Key takeaways
- This study compares radiation therapy alone with radiation therapy plus temozolomide برای a type of brain tumour.
- It aims to see if adding temozolomide improves survival and prevents the tumour from growing.
- Participants will be randomly assigned to one of four treatment groups.
- The study will also look at how these treatments affect participants' well-being and any side effects.
- You must have a specific type of newly diagnosed anaplastic glioma to be eligible.
Who may be eligible?
To be considered for this study, you must have been recently diagnosed with a specific type of brain tumour called anaplastic oligodendroglioma, anaplastic oligoastrocytoma, or anaplastic astrocytoma. It's important that your tumour has certain genetic features, which doctors will check from a tissue sample.
You should be at least 18 years old. Your general health should be good enough to take part in the study treatments, which doctors will check using various tests. This includes making sure your blood counts and organ functions (like your liver and kidneys) are within a healthy range. You shouldn't be pregnant or breastfeeding, and if you can get pregnant or get someone pregnant, you must use effective contraception during the study.
There are also some things that might mean you can't join. For example, if you have certain other serious medical conditions, or if you've had other cancers recently (with some exceptions like certain skin cancers), you might not be eligible. Also, conditions that might make it hard to take oral medication or attend follow-up appointments could prevent participation.
- I have been newly diagnosed with anaplastic oligodendroglioma, anaplastic oligoastrocytoma, or anaplastic astrocytoma.
- I am at least 18 years old.
- My general health, including blood tests, liver, and kidney function, is within a healthy range.
- I am not pregnant or breastfeeding, and I would use effective contraception if needed.
- I haven't had certain other major cancers within the last five years (excluding specific minor skin or cervix cancers).
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, your treatment will be decided by chance, like flipping a coin. You'll be put into one of four groups: * **Group 1:** You'll receive radiation therapy 5 days a week for about 6 and a half weeks. * **Group 2:** You'll receive radiation therapy 5 days a week for about 6 and a half weeks, and you'll also take oral temozolomide every day during this period. * **Group 3:** You'll receive radiation therapy 5 days a week for about 6 and a half weeks. Then, about a month after radiation finishes, you'll start taking oral temozolomide for 5 days every 28 days. This might continue for up to 12 cycles. * **Group 4:** You'll receive radiation therapy and oral temozolomide every day for about 6 and a half weeks, and then after a break, you'll also receive up to 12 cycles of temozolomide (5 days every 28 days), similar to Group 3.
Throughout the study, you'll have regular hospital visits for assessments such as blood tests, scans, and discussions about your health and any side effects. You'll also be asked to complete questionnaires about your quality of life. These visits will continue for a period after your main treatment ends to monitor your progress. The total duration of your active treatment will depend on which group you are in, but follow-up will last significantly longer.
Potential risks and benefits
Locations (132)
- Arizona Oncology Services FoundationPhoenix, United States
- Cedars-Sinai Medical CenterLos Angeles, United States
- UCSF University of California San Francisco Medical Center-Mount ZionSan Francisco, United States
- University of FloridaGainesville, United States
- Mayo Clinic in FloridaJacksonville, United States
- Florida HospitalOrlando, United States
- Emory UniversityAtlanta, United States
- Memorial Health University Medical CenterSavannah, United States
- Northwestern UniversityChicago, United States
- Loyola University Medical CenterMaywood, United States
- Oncology Associates PCFort Wayne, United States
- Parkview HospitalFort Wayne, United States
+120 more sites — see the official record for the full list.
Common questions
What is anaplastic glioma?
It's a type of brain tumour that affects the brain and spinal cord, growing faster than some other brain tumours.
What is temozolomide?
It's a chemotherapy drug taken as a tablet that helps stop cancer cells from growing and dividing.
What is radiation therapy?
It uses high-energy X-rays to target and kill cancer cells in a specific area of the body.
Will I know which treatment group I'm in?
No, initially you won't know. This helps ensure the study results are fair and unbiased. Your doctor will explain this process fully.
What does 'quality of life assessment' mean?
It means you'll be asked questions about how your health and treatment impact your daily activities, feelings, and general well-being.
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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