RANDOMIZED PHASE II TRIAL OF CONCURRENT BEVACIZUMAB AND RE-IRRADIATION VERSUS BEVACIZUMAB ALONE AS TREATMENT FOR 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.
ARM I: Patients receive bevacizumab intravenously (IV) over 30-90 minutes every 2 weeks.
ARM II: Patients receive bevacizumab as patients 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 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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival
Estimated using the Kaplan-Meier method (Kaplan 1958), and differences between treatment arms will be tested in the log-rank test (Mantel 1966).
From randomization to the date of death or the last follow-up. Analysis occurs after XX deaths have bee reported.
No
Christina Tsien
Principal Investigator
Radiation Therapy Oncology Group
United States: Institutional Review Board
RTOG-1205
NCT01730950
December 2012
Name | Location |
---|---|
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
John Muir Medical Center | Walnut Creek, California 94598 |
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital | Yakima, Washington 98902 |
Lancaster General Hospital | Lancaster, Pennsylvania 17604-3555 |
Allegheny Cancer Center at Allegheny General Hospital | Pittsburgh, Pennsylvania 15212 |
Arizona Oncology Services Foundation | Phoenix, Arizona 85013 |
Lowell General Hospital | Lowell, Massachusetts 01854 |
Queen's Medical Center | Honolulu, Hawaii 96813 |
University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
Nebraska Methodist Hospital | Omaha, Nebraska 68114 |
University of Rochester | Rochester, New York 14642 |
Yale University | New Haven, Connecticut 06520 |
Radiation Therapy Oncology Group | Philadelphia, Pennsylvania 19107 |
Summa Barberton Hospital | Barberton, Ohio 44203 |
Saint Vincent Hospital | Green Bay, Wisconsin 54301 |
Saint Mary's Hospital | Green Bay, Wisconsin 54303 |
Bay Area Medical Center | Marinette, Wisconsin 54143 |
Maine Medical Center- Scarborough Campus | Scarborough, Maine 04074 |
University of Michigan University Hospital | Ann Arbor, Michigan 48109 |
University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami, Florida 33136 |
Norton Health Care Pavilion - Downtown | Louisville, Kentucky 40202 |
Radiation Oncology Associates PC | Fort Wayne, Indiana 46804 |
Summa Akron City Hospital | Akron, Ohio 44304 |
Door County Cancer Center | Sturgeon Bay, Wisconsin 54235-1495 |
Cone Health Cancer Center | Greensboro, North Carolina |
IU Health Methodist Hospital | Indianapolis, Indiana 46202 |
Arizona Oncology-Deer Valley Center | Phoenix, Arizona 85027 |