A trial looking at radiotherapy with and without temozolomide for anaplastic glioma (BR14; EORTC 26053-22054)

This trial is comparing radiotherapy alone with radiotherapy and temozolomide (Temodal) for a type of brain tumour called anaplastic glioma. ‘Anaplastic’ means that the cancer cells look less like normal glial cells than other gliomas. Anaplastic cancers often grow more quickly than other cancers.

Doctors usually treat brain tumours with surgery and radiotherapy. Some brain tumours also respond well to chemotherapy. But not all of them do.

In this trial, some people won’t have temozolomide. Some will have temozolomide during radiotherapy and some will have it after radiotherapy. Some will have it both during and after radiotherapy.

Some people with a brain tumour have changes in two chromosomes called 1p and 19q in the cell. One or both must be normal in everyone taking part in this trial. Doctors call this ‘non 1p/19q deleted anaplastic glioma’.

The aims of this trial are to find out

If temozolomide during radiotherapy, after radiotherapy or both during and after radiotherapy is better than radiotherapy alone
What the side effects are

Recruitment

Start 01/01/2008

End 01/05/2015

Phase

Phase 3

Who can enter

You can enter this trial if you

Have been diagnosed with anaplastic oligodendroglioma, anaplastic oligoastrocytoma or anaplastic astrocytoma
Do not have changes in both 1p and 19q chromosomes of your cancer cells (at least 1 of the 2 must be unchanged, the research team will test this as part of the trial)
Are up and about and well enough for treatment (performance status 0, 1 or 2)
Are able to take tablets
Are happy for the research team to use a sample of your blood and brain tumour to look for other chromosome changes in the future
Are prepared to use reliable contraception
Are at least 18 years old

You cannot enter this trial if you

Have already had chemotherapy
Have had radiotherapy to your brain
Have any other cancer apart from carcinoma in situ of the cervix or non melanoma skin cancer that has been successfully treated with surgery
Have HIV, Hepatitis B or Hepatitis C
Have any other serious medical condition
Are pregnant or breastfeeding

Trial design

This is a randomised trial. It will recruit about 750 people from around the world, including about 250 from the UK. The people taking part will be put into 1 of 4 groups using a computer. Neither you nor your doctor will be able to decide which group you are in.

Everyone taking part will have radiotherapy. You have 33 treatments (fractions) - one a day (Monday to Friday) for just over 6 weeks. You start radiotherapy within 7 weeks of surgery for your brain tumour.

Whether you have temozolomide or not will depend on which group you are in. Temozolomide is a tablet that you take once a day.

Group 1 will have radiotherapy, and will not have any other treatment unless there are signs that the cancer comes back or starts to grow again.

Group 2 will have temozolomide every day for just over 6 weeks while they are having radiotherapy. This is called concurrent chemotherapy.

Group 3 will start temozolomide 4 weeks after they finish radiotherapy. This is called adjuvant chemotherapy. You take it once a day for 5 days out of every 4 weeks. Each 4 week period is called a cycle of treatment. You will have up to 12 cycles.

Group 4 will have temozolomide both during (concurrent chemotherapy) and after (adjuvant chemotherapy) their radiotherapy.

You fill in a questionnaire before you start treatment, 4 weeks after you finish radiotherapy and then every 3 months after that. It will ask about how you have been feeling and about any side effects you have had. This is called a quality of life study.

Hospital visits

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

The first test is to see if the 1p and 19q chromosomes are changed in your brain tumour cells or not. The doctors will use a small sample of your tumour and blood to do this. If the chromosomes are both changed, you won’t be able to have treatment as part of this trial.

Other tests include

Physical examination
Blood pressure and pulse
Blood tests
MRI scan or CT scan

Some people will also be asked a number of questions to look at their memory and attention.

You go to the hospital every week day for over 6 weeks to have radiotherapy. You have a CT or MRI scan 4 weeks after you finish radiotherapy.

If you are in group 3 or 4 and take temozolomide after you have radiotherapy, you go to the hospital once every 4 weeks. You will see the doctors and have some blood tests.

Everyone taking part will see the doctors once every 3 months after finishing treatment. You have some blood tests and a CT or MRI scan at each appointment.

Side effects

The side effects of radiotherapy vary depending on the part of the body being treated. The most common side effects of radiotherapy for brain tumours are

Hair loss to the area of the head being treated
Sickness
Tiredness

The most common side effects of temozolomide are

A drop in blood cells causing an increased risk of infection, bruising or bleeding problems and shortness of breath
Tiredness (fatigue)
Feeling or being sick
Loss of appetite or changes in taste
Diarrhoea or constipation

There is more information on the side effects of radiotherapy for brain tumours and the side effects of temozolomide on CancerHelp UK.