At a glance
ClinicalIndex Comparison Record- ✓Newly diagnosed histologically-confirmed supratentorial WHO grade IV gliomas (glioblastoma multiforme or gliosarcoma)
- ✓Age 18 or older
- ✓Karnofsky performance status ≥70
- ✓Life expectancy of at least 12 weeks
- ✕Recurrent glioma, or tumor involving brainstem or cerebellum
- ✕Prior Gliadel wafers or other intratumoral/intracavitary treatment
- ✕Prior temozolomide or bevacizumab (prior chemotherapy for different cancer otherwise allowed)
- ✕Evidence of cerebrospinal fluid dissemination (positive CSF cytology or MRI findings consistent with CSF dissemination)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Study of High Dose Radiotherapy and Concurrent Temozolomide Using Biologically-Based Target Volume Definition in Patients With Newly Diagnosed Glioblastoma
In Brief
A Phase 2 clinical trial evaluating High Dose Radiation and Temozolomide for Glioma. Completed, enrolled 26 participants across 1 site.
Detailed Summary
This is a study to determine the safety and effectiveness of high-dose radiation therapy (RT) with concurrent temozolomide in patients with newly diagnosed glioblastoma.
Study Details
Timeline
Interventions
Radiation will be delivered once daily for a total of 30 fractions, five days per week.
Patients will receive concurrent temozolomide (75 mg/m\^2 daily for 6 weeks). Adjuvant temozolomide will be given at 150-200 mg/m\^2, D1-5 every 28 days for a minimum of six cycles and will be started approximately four weeks following completion of radiotherapy.