BR14

Phase III trial on concurrent and adjuvant temozolomide chemotherapy in non-1p/19q deleted anaplastic glioma. The CATNON Intergroup trial

Can a drug called temozolomide help improve survival when given with or after radiotherapy in the treatment of a particular type of brain tumour?

What is this study about?

The aim of this study is to find out what the best treatment is for patients with a type of brain tumour called anaplastic glioma. Doctors usually use radiotherapy to treat tumours like this. We want to find out if it is helpful to add a chemotherapy drug called temozolomide, during and/or after radiotherapy.

People who agree to take part in this study will first have a blood test to see if two of the chromosomes (structures inside cells that contain DNA) in the tumour have changed. If at least one of them has not, patients can enter the treatment part of the study where they will be divided into four groups:

Group 1: radiotherapy alone
Patients in this group will receive radiotherapy on its own. Chemotherapy can be given later if the tumour starts to re-grow.
Group 2: radiotherapy with chemotherapy
Patients in this group will receive radiotherapy and take chemotherapy tablets (called temozolomide) at the same time.
Group 3: radiotherapy followed by chemotherapy
Patients in this group will receive radiotherapy alone, then four weeks afterwards they will receive temozolomide tablets for up to a year.
Group 4: radiotherapy with chemotherapy followed by chemotherapy
Patients in this group will receive radiotherapy and take temozolomide tablets at the same time. Four weeks after the completion of radiotherapy, they will receive more temozolomide for up to a year.

It is important to understand the best ways to treat anaplastic gliomas as currently this is not well understood. Temozolomide is helpful in other types of brain tumours, but we do not know if there will be benefits to patients with anaplastic gliomas, or if any benefits may be outweighed by side effects.

Type of study

Randomised trial

Contact details

mrcctu.br14@ucl.ac.uk

Who is funding the study?

The BR14 trial is being carried out by the European Organisation for Research and Treatment of Cancer (EORTC).The pharmaceutical company Merck provided some funding. In the UK, this trial is funded by the charity Cancer Research UK.

When is it taking place?

The trial will be recruiting patients until late 2015.

Where is it taking place?

This trial is recruiting in the UK, Europe, USA, Canada and Australia.

Who is included?

Around 800 people who have an anaplastic glioma. They will have undergone surgery or a biopsy for this tumour, and need some additional treatment.