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

Glioblastoma Clinical Trial

Official title:
Randomized Phase II Trial of Concurrent Bevacizumab and Re-irradiation Versus Bevacizumab Alone as Treatment for Recurrent Glioblastoma

Clinical Trial Summary

This randomized phase II trial studies how well bevacizumab with or without radiation therapy works in treating patients with glioblastoma that has returned after a period of improvement. Monoclonal antibodies, such as bevacizumab, may block tumor growth by targeting certain cells. 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 known whether bevacizumab is more effective with or without radiation therapy in treating patients with recurrent glioblastoma.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To establish an improvement in overall survival in recurrent glioblastoma multiforme (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.

ARM I: Patients receive bevacizumab intravenously (IV) over 30-90 minutes every 2 weeks.

ARM II: Patients receive bevacizumab as in Arm I and undergo radiation therapy using intensity-modulated radiation therapy (IMRT), 3-dimensional conformal radiation therapy (3D-CRT), or proton beam radiation therapy (RT) 5 days a week for 2 weeks.

In both arms, courses with bevacizumab 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02671981
Study type Interventional
Source Radiation Therapy Oncology Group
Contact
Status Active, not recruiting
Phase Phase 2
Start date December 2012
View Details
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