A clinical trial to determine if extending temozolomide treatment (chemotherapy) after radiation improves survival in patients with newly diagnosed glioblastoma.
About this study
Patients diagnosed with glioblastoma are treated with a combination of chemotherapy and radiation, followed by six months of temozolomide (chemotherapy). However, even with the best treatment, the average survival is around 14 months.
Previous research has suggested that an extra six months of temozolomide may improve survival without any impact on quality of life or symptoms related to treatment. However, these studies were small and unable to provide a definitive answer. In some centres, it is standard to use six months of chemotherapy, while in others, the standard is 12 months.
The purpose of this study is to determine if an additional six months of temozolomide will improve the survival of patients with glioblastoma. We will also assess whether an additional six months of temozolomide causes more side effects.
Patients who decide to participate in the trial will be randomly assigned to either receive an additional six months of temozolomide chemotherapy or not and continue with their usual care.
Anticipated enrolment close date: November 2020
Who can take part
- People who have been diagnosed with glioblastoma in the last 9 months
- Aged 18 years and older
- Completed radiation with temozolomide chemotherapy, followed by six months of post-radiation temozolomide chemotherapy
- No evidence of progressive disease on brain imaging.
- Tolerated temozolomide chemotherapy and safe to continue
What's involved
Participants enrolled will undergo routine blood tests before the administration of chemotherapy, which is part of standard hospital care.
Ethics
All research in Australia involving human participants is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by the Royal Melbourne Hospital HREC.
This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement protects the interests of people who agree to participate in human research studies.
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