Trials / Completed
CompletedNCT02805179
A Study of High-Dose Chemoradiation Using Biologically-Based Target Volume Definition in Patients With Glioblastoma
Phase II Study of High Dose Radiotherapy and Concurrent Temozolomide Using Biologically-Based Target Volume Definition in Patients With Newly Diagnosed Glioblastoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- University of Michigan Rogel Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
After analysis demonstrated the improved prognostic value of identifying both hypercellular tumor (TVHCV) based on high b-value diffusion-weighted magnetic resonance imaging (DW-MRI) and hyperperfused tumor (TVCBV) based on dynamic contrast-enhanced MRI (DCE-MRI), the study was amended and later-enrolled patients boosted to both TVHCV and TVCBV.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | High Dose Radiation | Radiation will be delivered once daily for a total of 30 fractions, five days per week. |
| DRUG | Temozolomide | 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. |
Timeline
- Start date
- 2016-09-22
- Primary completion
- 2020-02-06
- Completion
- 2020-11-18
- First posted
- 2016-06-17
- Last updated
- 2021-04-15
- Results posted
- 2021-04-15
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02805179. Inclusion in this directory is not an endorsement.