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Randomized Phase II Trial of Concurrent Bevacizumab and Re-Irradiation Versus Bevacizumab Alone as Treatment for Recurrent Glioblastoma
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
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Alabama at Birmingham
Birmingham, Alabama, United States
Arizona Oncology Services Foundation
Phoenix, Arizona, United States
Arizona Oncology-Deer Valley Center
Phoenix, Arizona, United States
John Muir Medical Center
Walnut Creek, California, United States
Yale University
New Haven, Connecticut, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
Queen's Medical Center
Honolulu, Hawaii, United States
Radiation Oncology Associates PC
Fort Wayne, Indiana, United States
IU Health Methodist Hospital
Indianapolis, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Start Date
December 20, 2012
Primary Completion Date
September 3, 2018
Completion Date
December 22, 2022
Last Updated
December 29, 2022
182
ACTUAL participants
bevacizumab
BIOLOGICAL
radiation therapy
RADIATION
Lead Sponsor
Radiation Therapy Oncology Group
Collaborators
NCT02613988
NCT01894061
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT01062425