Bevacizumab with or without Radiation Therapy in Treating Patients with Recurrent Glioblastoma

Active:	No
Cancer Type:	Brain & Spinal Cord Tumor	NCT ID:	NCT01730950
Trial Phases:	Phase II	Protocol IDs:	RTOG-1205 (primary) NCI-2012-01732 U10CA021661
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	NRG Oncology
NCI Full Details:	http://clinicaltrials.gov/show/NCT01730950

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.

Objectives

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.