Timing of Temozolomide for Glioblastoma Treatment
A Randomized, Multicentre Pilot Trial Evaluating the Feasibility and Efficacy of Dose Timing (Morning vs Evening) of Temozolomide in the Treatment of Glioblastoma
NA · Ottawa Hospital Research Institute · NCT06850766
This study is testing whether taking the cancer drug temozolomide in the morning or evening helps people with glioblastoma feel better and have fewer side effects.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ottawa Hospital Research Institute (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (London, Ontario and 1 other locations) |
| Trial ID | NCT06850766 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility and efficacy of administering temozolomide (TMZ) at different times of the day (morning vs evening) for patients with IDH-wildtype glioblastoma. Participants will be randomly assigned to one of the two groups and will take their medication according to their assigned schedule while recording the timing of their doses. The goal is to determine if the timing of TMZ administration can enhance its effectiveness and reduce side effects, based on the body's circadian rhythms. This pilot trial aims to inform future larger studies on the optimal timing for TMZ treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed IDH-wildtype glioblastoma who have completed brain tumor resection and postoperative radiation therapy.
Not a fit: Patients with metastatic or incurable cancers other than IDH-wildtype glioblastoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for glioblastoma patients by optimizing the timing of chemotherapy.
How similar studies have performed: Previous studies have shown success with chronotherapy in other cancer types, suggesting potential for this approach in glioblastoma treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years of age or older * Newly diagnosed IDH-wildtype glioblastoma * Completed maximal safe brain tumor resection * Completed post-operative brain RT * Plan to proceed with up to 6 cycles of adjuvant TMZ within 8 weeks of completing post-operative RT * Able and willing to provide oral informed consent Exclusion Criteria: * Unable or unwilling to complete study questionnaires * Metastatic or incurable cancer other than IDH-wild type glioblastoma
Where this trial is running
London, Ontario and 1 other locations
- London Health Sciences Centre — London, Ontario, Canada (RECRUITING)
- The Ottawa Hospital Cancer Centre — Ottawa, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Terry Ng, MD — The Ottawa Hospital Cancer Centre
- Study coordinator: Lisa Vandermeer, MSc
- Email: lvandermeer@ohri.ca
- Phone: 613-737-7700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: IDH-Wildtype Glioblastoma, Glioblastoma, temozolomide, chronotherapy, dose timing, cancer, oncology, glioblastoma