NCT01730950

Bevacizumab With or Without Radiation Therapy in Treating Patients With Recurrent Glioblastoma

Randomized Phase II Trial of Concurrent Bevacizumab and Re-Irradiation Versus Bevacizumab Alone as Treatment for Recurrent Glioblastoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: Radiation Therapy Oncology Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase II trial studies how well bevacizumab with or without radiation therapy works in treating patients with recurrent glioblastoma. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet know whether bevacizumab is more effective with or without radiation therapy in treating patients with recurrent glioblastoma

Detailed description

PRIMARY OBJECTIVES: I. To establish an improvement in overall survival in recurrent glioblastoma (GBM) patients receiving bevacizumab and re-irradiation compared with patients receiving bevacizumab alone. SECONDARY OBJECTIVES: I. To estimate and compare the rate of objective response in patients with measurable disease. II. To estimate and compare the 6-month progression-free survival rate. III. To estimate and compare progression-free survival. IV. To estimate and compare the rate of treatment adverse events. V. To estimate and compare the rate of grade 3+ acute or delayed central nervous system (CNS) toxicity. OUTLINE: Patients are randomized to 1 of 2 treatment arms. In both arms, courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 2 months for 1 year, every 6 months for 1 year and then annually thereafter.

Conditions

• Adult Giant Cell Glioblastoma
• Adult Glioblastoma
• Adult Gliosarcoma
• Recurrent Adult Brain Tumor

Interventions

Type	Name	Description
BIOLOGICAL	bevacizumab	Staring within 14 days of randomization, IV 10mg/kg every two weeks until disease progression.
RADIATION	radiation therapy	Starting with second dose of bevacizumab, 35 Gy in 10 fractions of 3.5 Gy each delivered on consecutive treatment days (typically 5 fractions per week).

Timeline

• Start date: 2012-12-20
• Primary completion: 2018-09-03
• Completion: 2022-12-22
• First posted: 2012-11-21
• Last updated: 2022-12-29
• Results posted: 2020-03-17

Locations

31 sites across 1 country: United States