A trial looking at radiotherapy and chemotherapy for low grade gliomas (EORTC 22033-26033 Trial/MRC BR13)

Please note this trial is no longer recruiting patients.

This trial is comparing radiotherapy with chemotherapy as the first treatment for low grade gliomas.

A low grade glioma is a type of brain tumour that is usually quite slow growing. Sometimes, if the tumour is very slow growing, you may not need treatment when a low grade glioma is first diagnosed.

When you do need treatment, you may have surgery to remove the tumour. If surgery is not possible, or if your specialist thinks you need additional treatment, they may suggest you have radiotherapy. But doctors don’t really know how helpful radiotherapy is in this situation. And it can make problems such as memory loss worse.

Chemotherapy may help people with low grade gliomas. In this trial, the researchers are looking at a chemotherapy drug called temozolomide. They want to see if this is a better treatment than radiotherapy.

The aims of the trial are to

Find out which treatment works best for low grade gliomas
Learn more about the side effects

Recruitment

Start 01/09/2008

End 26/03/2010

Phase

Phase 3

Who can enter

You can enter this trial if

You have been diagnosed with an astrocytoma or oligodendroglioma that is grade 2
A sample of tissue from your tumour can be sent to the laboratory for tests
You have satisfactory blood test results
You are well enough to take part in the trial
You are willing to use reliable contraception during treatment and for 6 months afterwards if there is any chance you or your partner could become pregnant
You are at least 18 years old

You cannot enter this trial if you

Have a brain tumour in the cerebellum or brain stem (below the tentorium)
Have a brain tumour that your doctors think can be successfully treated with surgery alone
Have had any other type of cancer apart from non melanoma skin cancer or carcinoma in situ of the cervix that has been successfully treated
Have already had chemotherapy or radiotherapy for your brain tumour
Have any condition that makes it difficult for you to take or absorb tablets
Have any other medical condition that could affect your taking part in the trial
Are known to be HIV, hepatitis B or hepatitis C positive
Are pregnant or breastfeeding

Trial design

The trial will recruit about 700 people from across Europe. As part of this trial, the researchers need to look at a sample of tissue taken when you had a biopsy. They will also need an extra blood sample from you. They will study the DNA in these samples to see if it affects the way people respond to different treatments.

They will also ask you if they can keep the tissue and blood samples. These will be stored safely and may be used in the future for research purposes. If you don’t give your permission for the researchers to keep the tissue or blood samples, you can still take part in the trial.

You may not start treatment straight away. Your doctor will monitor you and decide when you do need to start treatment. This may be because scans show that your brain tumour is getting bigger, or any symptoms you have may be getting worse.

You will be put into one of two treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. This is called randomisation.

Half the people taking part will have radiotherapy, and the other half will have chemotherapy.

If you have radiotherapy, you have a series of daily treatments for about 6 weeks.

If you have chemotherapy, you have 4 week (28 day) cycles of treatment. You take temozolomide tablets every day for the first 3 weeks of each cycle. Then you have a week without treatment before starting the next cycle. You have up to 12 cycles of treatment, which takes about a year.

You will be asked to fill in some questionnaires before you start treatment and then every 3 months during and after your treatment. The questionnaires will ask about any side effects you have had and about how you have been feeling. These are called quality of life studies.

Hospital visits

You will see the doctors and have some tests before you start treatment. The tests include

Physical examination
Blood tests
MRI scan

In some hospitals, you may also have a PET scan.

If you have chemotherapy, you will go the hospital to see the doctors and have blood tests once a month during your treatment.

If you have radiotherapy, you will go to the radiotherapy department everyday, apart from weekends, for about 6 weeks.

After you finish your treatment, you will see the trial doctors every 3 months in the first year, then every 6 months after that. You will have scans every 6 months.