NCT01985087

A Study Using Radiation Therapy and Temozolomide to Treat Glioblastoma in Patients Over 70

A Phase I/ II Study of Hypofractionated Radiotherapy With Concurrent Temozolomide Followed by Adjuvant Temozolomide in Patients Over 70 Years Old With Newly Diagnosed Glioblastoma

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: University of Louisville · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

In this study we propose to determine outcomes of patients age 70 or older treated with radiation over 2 weeks given with temozolomide 75 mg/m2 daily during radiotherapy and as a post radiation treatment of 150 mg/m2 - 200 mg /m2 for 6 cycles or until the disease progresses.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
RADIATION	Hypofractionated radiotherapy	Treatment of 3.4 Gy will be given daily 5 days per week over 2 weeks.
DRUG	Temozolomide	During concomitant phase Temozolomide will be administered orally at 75 mg/m2 for 2 weeks concomitant with radiotherapy. During the adjuvant phase Temozolomide will be administered orally at 150 mg/m2 on days 1 through day 5 of each 28 day cycle for a maximum of 6 cycles.

Timeline

• Start date: 2014-09-01
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2013-11-15
• Last updated: 2024-10-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study