"He went through six operations and was placed on a clinical trial so he could try new treatments.”
A trial looking at radiotherapy with and without temozolomide for anaplastic glioma (BR14 EORTC 26053-22054)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
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. This trial is supported by Cancer Research UK.
More about this trial
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
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
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
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.
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
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.
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
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
Temozolomide can sometimes affect the liver. You will have blood tests before and during treatment to check how well your liver is working.
How to join a clinical trial
Dr Sara Erridge
Cancer Research UK
European Organisation for Research and Treatment of Cancer (EORTC)
Experimental Cancer Medicine Centre (ECMC)
Medical Research Council Clinical Trials Unit at University College London (MRC CTU at UCL)
NIHR Clinical Research Network: Cancer
This is Cancer Research UK trial number CRUK/07/028.