A Study of Bevacizumab (Avastin®) in Combination With Temozolomide and Radiotherapy in Participants With Newly Diagnosed Glioblastoma
Completed · Phase 3 · Has a placebo group
Conditions studied: Glioblastoma
In brief
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 adjuvant temozolomide) as compared to the current standard of care alone. Participants were randomly assigned to either the bevacizumab (10 milligrams per kilogram (mg/kg) intravenously \[IV\] once every 2 week \[q2w\]) or the placebo arm, in combination with radiation therapy (total dose 60 Gray \[Gy\], administered as 2 Gy fractions, 5 days/week) plus temozolomide (75 milligrams per meter squared \[mg/m\^2\] oral administration \[po\] daily) for 6 weeks. After a 4 week treatment break, participants continued to receive bevacizumab (10 mg/kg IV q2w) or placebo, plus temozolomide (150-200 mg/m\^2 po daily on days 1-5 of each 4 week cycle) for 6 cycles of maintenance treatment or until disease progression or unacceptable toxicity, whichever occured first. Following the maintenance phase, bevacizumab (15 mg/kg iv every 3 weeks \[q3w\]) or placebo monotherapy continued. The time on study treatment was until disease progression.
Key facts
- Study ID
- NCT00943826
- Run by
- Hoffmann-La Roche
- People needed
- 921
- Starts
- 2009-06-29
- Expected to finish
- 2015-09-09
- Last updated by the study team
- 2017-09-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- UCLA — Los Angeles, California, United States
- University of Colorado — Aurora, Colorado, United States
- Moffitt Cancer Center — Tampa, Florida, United States
- Oncology-Evanston Nthwest Healthcare Kellogg Cancer Care Ctr — Evanston, Illinois, United States
- Henry Ford Health System — Detroit, Michigan, United States
- Hatton Research Institutes — Cincinnati, Ohio, United States
- Sarah Cannon Cancer Center and Research Institute — Nashville, Tennessee, United States
- University of Virgina — Charlottesville, Virginia, United States
- Prince of Wales Hospital; Department of Medical Oncology — Randwick, New South Wales, Australia
- North Shore Private Hospital; Northern Specialist Centre — St Leonards, New South Wales, Australia
- Royal North Shore Hospital; Department of Medical Oncology — St Leonards, New South Wales, Australia
- Princess AleXandra Hospital; Department of Medical Oncology — Woolloongabba, Queensland, Australia
- Calvary North Adelaide; North Adeliade Oncology Centre — North Adelaide, South Australia, Australia
- Royal Melbourne Hospital; Hematology and Medical Oncology — Parkville, Victoria, Australia
- Sir Charles Gairdner Hospital — Nedlands, Western Australia, Australia
- Clin Univ de Bxl Hôpital Erasme — Brussels, Belgium
- Cliniques Universitaires St-Luc — Brussels, Belgium
- UZ Antwerpen — Edegem, Belgium
- AZ Sint Lucas (Sint Lucas) — Ghent, Belgium
- CHU Sart-Tilman — Liège, Belgium
- AZ Delta (Campus Wilgenstraat) — Roeselare, Belgium
- Tom Baker Cancer Centre-Calgary — Calgary, Alberta, Canada
- Cross Cancer Institute ; Dept of Medical Oncology — Edmonton, Alberta, Canada
- BC Cancer Agency, Vancouver Clinic; Dept. of Medical Oncology — Vancouver, British Columbia, Canada
- University of Alabama At Birmingham; Neuro-Oncology — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.