Status:
COMPLETED
A Study of Bevacizumab (Avastin®) in Combination With Temozolomide and Radiotherapy in Participants With Newly Diagnosed Glioblastoma
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This 2 arm study investigated the efficacy and safety of the addition of bevacizumab to the current standard of care (multimodality therapy of concurrent radiotherapy plus temozolomide followed by adj...
Eligibility Criteria
Inclusion
- Key
- newly diagnosed glioblastoma
- World Health Organization (WHO) performance status less than or equal to (\<=2)
- stable or decreasing corticosteroid dose within 5 days prior to randomization
- Key
Exclusion
- evidence of recent hemorrhage on postoperative magnetic resonance imaging (MRI) of brain
- any prior chemotherapy or immunotherapy for glioblastomas and low grade astrocytomas
- any prior radiotherapy to brain
- clinically significant cardiovascular disease
- history of greater than or equal to (\>=) grade 2 hemoptysis within 1 month prior to randomization
- previous centralized screening for Methylguanine-DNA methyltransferase (MGMT) status for enrollment into a clinical trial
Key Trial Info
Start Date :
June 29 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2015
Estimated Enrollment :
921 Patients enrolled
Trial Details
Trial ID
NCT00943826
Start Date
June 29 2009
End Date
September 9 2015
Last Update
September 25 2017
Active Locations (133)
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1
University of Alabama At Birmingham; Neuro-Oncology
Birmingham, Alabama, United States, 35294
2
UCLA
Los Angeles, California, United States, 90095
3
University of Colorado
Aurora, Colorado, United States, 80045
4
Moffitt Cancer Center
Tampa, Florida, United States, 33612