A trial comparing standard temozolomide with intense temozolomide for newly diagnosed glioblastoma (EORTC 26052-22053/RTOG 0525)
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This trial compared different doses of temozolomide after surgery, for a type of brain tumour called glioblastoma multiforme.
Doctors usually treat newly diagnosed brain tumours with surgery and radiotherapy.
We know from research that fitter people who have a brain tumour called a glioblastoma multiforme do better if they have a drug called temozolomide as well as radiotherapy. Temozolomide is a type of chemotherapy.
At the time of this trial, people in clinical trials had taken temozolomide every day during their radiotherapy treatment and on 5 days of each month for the next 6 months. In this trial, the doctors wanted to see if taking a lower dose of temozolomide over a longer period of time would be better.
Researchers also thought that a change in a gene in the tumour called MGMT could make the cancer cells more 
to temozolomide. The doctors hoped that taking the drug at a lower dose but for longer might overcome this resistance. So they wanted to look at the genes in the tumour of the people taking part to see if a change to the MGMT gene affected the response to treatment.
The aims of this study were to
- Compare the standard 5 days of temozolomide with 21 days of temozolomide
- Learn more about the side effects
- Understand more about the MGMT gene
Summary of results
The trial team found that having temozolomide for 21 days did not help people with glioblastoma to live longer.
This international trial recruited 833 people from different countries around the world. Half the people had the standard 5 day dose of temozolomide and the other half had the intensive 21 day dose.
The researchers looked at the 2 groups to find the time at which only half in each group were still alive after treatment. This is called the ‘median survival’.
In the group having standard chemotherapy for 5 days, half the people had died after 16½ months. In the group having chemotherapy for 21 days, half the people had died after 15 months. This means there was no real difference in survival time in the 2 groups as this could have happened by chance (the result was not ).
The researchers also looked at the time it took for the tumour to start growing again after treatment. The time at which half of those in the group have tumours that have started growing is called the median progression free survival.
In the 5 day chemotherapy group, half the tumours had started growing again after 5½ months. In the 21 day group, half the tumours had started growing again after 6½ months. This means there was no real difference in the time it took for the tumours to start growing again (the result was not statistically significant).
They also found that those who had temozolomide 21 days had more side effects. The most significant were tiredness (fatigue) and a drop in blood cells.
The researchers also looked at if the gene MGMT was switched off (methylated) or not. They found that the median survival was
- 21 months for those who MGMT gene was methylated
- 14 months for those whose MGMT gene was not methylated
The researchers concluded that giving temozolomide for 21 days was no better than the standard 5 days for people with newly diagnosed glioblastoma multiforme.
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 () but may not have been published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Dr Sara Erridge
Supported by
Cancer Research UK
European Organisation for Research and Treatment of Cancer (EORTC)
Experimental Cancer Medicine Centre (ECMC)
National Institute for Health Research Cancer Research Network (NCRN)
Other information
This is Cancer Research UK trial number CRUKE/06/036.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
