A trial looking at temozolomide and PCV for people with glioma that has come back after treatment (BR12)

Cancer type:

Brain (and spinal cord) tumours

Status:

Results

Phase:

Phase 3

This trial compared temozolomide (Temodal) with PCV for a type of brain tumour called glioma. This trial was open to people whose glioma had come back after treatment. This trial was supported by Cancer Research UK.

More about this trial

Doctors often treat glioma with surgery and radiotherapy, and sometimes chemotherapy. The treatment they use depends on where in the brain the tumour is and how fast it is growing.

When glioma comes back doctors often used chemotherapy to treat it. One combination of chemotherapy was procarbazine, lomustine (CCNU) and vincristine. This combination is called PCV. Another chemotherapy they could have used was temozolomide. Doctors usually used PCV first. If it didn’t work very well, then they would use temozolomide. But doctors were not sure which of the two was better for treating glioma that had come back. They had not been directly compared before.

This trial compared the two treatments to see which worked best. It also compared having 1 week of temozolomide each month with having it for 3 weeks at a lower daily dose.

Summary of results

The trial team found that having PCV or temozolomide to treat glioma that had come back did not make a difference to how long people lived after treatment. However they did find that to slow down the time that the tumour started to grow again having temozolomide for 1week each month was better than having it for 3 weeks each month or having PCV.

This trial recruited 447 people. Sadly, a few people died before they started treatment. Those taking part in the trial were put into 1 of 3 treatment groups

221 people had PCV
110 people had temozolomide for 1 week
110 people had temozolomide at a lower dose for 3 weeks

The researchers combined the 2 temozolomide groups to compare them with the PCV group. Overall from the start of the trial, the people in both groups lived on average for about 7 months. When the researchers compared the average time people in the different groups lived it was

Just over 6 and a half months for those who had PCV
Just over 7 months for those who had temozolomide

On average the time it took for the tumour to start growing again was

Just over 3 and a half months for those who had PCV
Just over 4 months for those who had temozolomide for 3 weeks
Around 5 months for those who had temozolomide for 1 week

The researchers concluded that the amount of time people lived after having treatment for glioma that had come back was about the same for temozolomide and PCV. However they also found that having temozolomide for 1 week each month was better at slowing down the time it took for the tumour to start growing again than having it for 3 weeks or having PCV. They say that future trials using temozolomide should look at this in more detail.

We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item ) and published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.