A trial comparing standard temozolomide with extended temozolomide for newly diagnosed glioblastoma (EORTC 26052-22053/RTOG 0525)

Who can enter

You can enter this trial if

• You have been diagnosed with glioblastoma by open biopsy or during surgery to remove a brain tumour
• There is a sample of tissue from your tumour that can be sent to the laboratory for genetic tests
• You have recovered from your surgery and are well enough to take part in the trial
• You had a CT scan or MRI scan both before and after your operation
• You had your surgery in the last 5 weeks
• You are on a stable dose of steroids or are reducing your dose
• You have satisfactory blood test results
• You are willing to use a reliable form of contraception while you are taking part in the trial if there is any chance that you or your partner could become pregnant
• You are at least 18 years old

You cannot enter this trial if

• Your brain tumour was diagnosed by a stereotactic biopsy
• You have a glioma that has come back after earlier treatment or you have more than one tumour
• Your brain tumour has spread to the part of the brain below the tentorium
• You have had treatment with Gliadel wafers or other chemotherapy for cancer of the head or neck
• You have had radiotherapy to the head or neck before (except radiotherapy for stage T1 larynx cancer in your vocal cords (cancer of the glottis)
• You have had any other invasive cancer in the last 3 years apart from non melanoma skin cancer
• You have had a heart attack in the last 6 months
• You have any other serious medical condition including (but not limited to) unstable angina, heart failure, an infection, respiratory disease or liver disease
• You have Acquired Immune Deficiency Syndrome (AIDS)
• You have had an allergic reaction to temozolomide
• You have taken part in another clinical trial in the last 30 days
• You are pregnant or breastfeeding

Trial design

The trial will recruit 834 people around the world. This includes 35 to 70 people from the UK. At the start of the trial, the trial doctor will ask your permission to get a sample of the tissue taken when you had surgery to remove your brain tumour. The doctor will send the sample to a central laboratory. In the laboratory, a pathologist will look at the sample to check that the tumour is a glioblastoma.

They will also see if there is enough tissue to test how the MGMT gene is working. If there is not enough tissue to do these tests, you will not be able to carry on in the trial and will have the standard treatment.

As well as testing the MGMT gene, the researchers will keep some of the tumour tissue for future research into brain tumours.

If it is possible to study the genetic material in your tissue sample, you will be put into one of 2 treatment groups by a computer. This means that it is a randomised trial. Neither you nor your doctor will be able to decide which group you are in.

Everybody taking part will have radiotherapy treatment for 6 or 7 weeks. And at the same time, you will have temozolomide tablets every day for 7 weeks.

4 weeks after you finish your radiotherapy, the next phase of treatment will start. You will have chemotherapy in 4 week (28 day) cycles of treatment.

Group 1 will have the standard dose of temozolomide. This means you will have temozolomide tablets on the first 5 days of each 28 day cycle.

Group 2 will have temozolomide tablets on the first 21 days of each 28 day cycle.

Both groups will have 6 cycles of treatment, lasting about 6 months.

You will have a blood test before the beginning of each cycle. You will also have blood tests on days 14 and 21 of each cycle. You will have a CT or MRI scan of your brain before the 1st and 4th cycles of chemotherapy.

The doctors will ask you to keep a diary of any other medicines you are taking such as steroids or drugs to help control fits.

If the treatment is helping and you don’t have side effects, your doctor may suggest that you carry on having temozolomide for another 6 cycles - up to a maximum of 12 months treatment in total. If you do carry on with the treatment, you will have 2 more scans before the 7th and 10th cycles.

Hospital visits

You will go the hospital to see the doctors and have some tests before you take part in the trial. These include

• Blood tests
• MRI scan or CT scan

You will go to the hospital every day (Monday to Friday) for 6 or 7 weeks to have your radiotherapy treatment. During your radiotherapy, you will see the doctors and have a blood test every week.

During the 6 months of temozolomide treatment, you will see the doctors before the start of each chemotherapy cycle. They will examine you and ask about any side effects you are having.

After you finish the temozolomide, you will go to see the trial doctors and have a scan every 3 months for the first year, every 4 months in the second year and then every 6 months after that.

Side effects

The most common side effects of temozolomide are

• Feeling or being sick
• Headache
• Constipation
• Tiredness (fatigue)

There is more information about the less common side effects of temozolomide on CancerHelp UK.

Side effects of radiotherapy for brain tumours include

• Red or sore skin
• Hair loss
• Fatigue

There is more information about radiotherapy for brain tumours on CancerHelp UK.