A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Trial of Bevacizumab, Temozolomide and Radiotherapy, Followed by Bevacizumab and Temozolomide Versus Placebo, Temozolomide and Radiotherapy Followed by Placebo and Temozolomide in Patients With Newly Diagnosed Glioblastoma
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Trial of Bevacizumab, Temozolomide and Radiotherapy, Followed by Bevacizumab and Temozolomide Versus Placebo, Temozolomide and Radiotherapy Followed by Placebo and Temozolomide in Patients With Newly Diagnosed Glioblastoma
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.
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Key Exclusion Criteria:
St Leonards, New South Wales 2065, Australia
St Leonards, New South Wales 2065, Australia
Woolloongabba, Queensland 4102, Australia
North Adelaide, South Australia 5006, Australia
Vancouver, British Columbia V5Z 4E6, Canada
Marseille, 13385, France
Dresden, 01307, Germany
Hamburg, 20246, Germany
Ibbenbühren, 49479, Germany
Mainz, 55131, Germany
München, 81377, Germany
Jerusalem, 91120, Israel
Milan, Lombardy 20133, Italy
Turin, Piedmont 10126, Italy
Saitama, 350-1298, Japan
Auckland, 1023, New Zealand
Lublin, 20-954, Poland
Bucharest, 022328, Romania
Moscow, 115478, Russia
Jeollanam-do, 58128, South Korea
Seoul, 03080, South Korea