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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentActive18 and overNCI, OtherRTOG-1205
NCI-2012-01732, U10CA021661, NCT01730950

Trial Description


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

Further Study Information


I. To establish an improvement in overall survival in recurrent glioblastoma (GBM) patients receiving bevacizumab and re-irradiation compared with patients receiving bevacizumab alone.


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.

Eligibility Criteria

Inclusion Criteria:

  • Histopathologically proven diagnosis of glioblastoma or variants (gliosarcoma, giant cell glioblastoma etc); patients will be eligible if the original histology was lower-grade glioma and a subsequent diagnosis of glioblastoma or gliosarcoma is made
  • Patients who did not have recent surgery for their glioblastoma must have shown unequivocal radiographic evidence for tumor progression by contrast-enhanced magnetic resonance imaging (MRI) scan (or computed tomography [CT] scan for patients with non-compatible devices) CT scan within 21 days prior to registration
  • Patients also must have passed an interval of 6 months or greater between completion of prior radiotherapy and registration; if patients have not passed an interval of at least 6 months, they may still be eligible if they meet one or more of the following criteria:
  • New areas of tumor outside the original radiotherapy fields as determined by the investigator, or
  • Histologic confirmation of tumor through biopsy or resection, or
  • Nuclear medicine imaging, magnetic resonance (MR) spectroscopy, or MR perfusion imaging consistent with true progressive disease, rather than radiation necrosis obtained within 28 days of registration AND an interval of at least 90 days between completion of radiotherapy and registration
  • Patients unable to undergo MR imaging because of non-compatible devices can be enrolled provided CT scans are obtained and are of sufficient quality; patients without non-compatible devices may not use CT scans performed to meet this requirement
  • Prior history of standard dose CNS radiation of 60 Gy in 30 fractions or 59.4 Gy in 1.8 Gy fractions, or equivalent or lower doses
  • Patients who have received prior treatment with non-standard radiation therapy (RT) dose and fractionation, interstitial brachytherapy, stereotactic radiosurgery, etc. are eligible
  • Patients must have recovered from the toxic effects of prior therapy, and there must be a minimum time of 28 days prior to registration from the administration of any investigational agent or prior cytotoxic therapy with the following exceptions:
  • 14 days from administration of vincristine
  • 42 days from administration of nitrosoureas
  • 21 days from administration of procarbazine
  • Patients having undergone recent resection of their glioblastoma (within 5 weeks prior to registration) must have recovered from the effects of surgery; for CNS related core or needle biopsies, a minimum of 7 days must have elapsed prior to registration
  • Residual disease following resection of recurrent glioblastoma is not mandated for eligibility into the study; to best assess the extent of residual disease post-operatively, a post-operative or intra-operative MRI scan (or CT scan for patients with non-compatible devices) must be performed prior to registration and should be within 96 hours post surgery (although 24 hours would be optimum)
  • History/physical examination, including neurologic examination, within 14 days prior to registration
  • Karnofsky performance status >= 60 within 14 days prior to registration
  • Complete blood count (CBC)/differential obtained within 14 days prior to registration, with adequate bone marrow function
  • Absolute neutrophil count (ANC) >= 1,500 cells/mm^3
  • Platelets >= 75,000 cells/mm^3
  • Hemoglobin >= 9.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin (Hgb) >= 9.0 g/dl is acceptable)
  • Total bilirubin =< 2.0 mg/dL
  • Serum glutamic oxaloacetic transaminase (SGOT) or aspartate aminotransferase (AST) =< 2.5 times the upper limit of normal
  • Serum creatinine =< 1.8 mg/dL
  • Urine protein creatinine (UPC) ratio >= 1.0 within 14 days prior to registration OR urine dipstick for proteinuria >= 2+ (patients discovered to have >= 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate =< 1g of protein in 24 hours to be eligible)
  • Note: UPC ratio of spot urine is an estimation of the 24-hour urine protein excretion; a UPC ratio of 1 is roughly equivalent to a 24-hour urine protein of 1 gm; UPC ratio is calculated using one of the following formulas:
  • [urine protein]/[urine creatinine]: if both protein and creatinine are reported in mg/dL
  • [(urine protein) x 0.088]/[urine creatinine]: if urine creatinine is reported in mmol/L
  • Patients must not be pregnant (positive pregnancy test) or breast feeding; pregnancy test must be done within 14 days prior to registration; effective contraception (men and women) must be used in patients of child-bearing potential while on trial and for 6 months after
  • Patients on full-dose anticoagulants (e.g., warfarin or low molecular weigh [LMW] heparin) must meet both of the following criteria:
  • No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
  • In-range international normalized ratio (INR) (usually between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin
  • Patient must be able to provide study-specific informed consent prior to study entry

Exclusion Criteria:

  • More than three relapses
  • Infratentorial or leptomeningeal evidence of recurrent disease
  • Recurrent or persistent tumor greater than 6 cm in maximum diameter
  • Prior therapy with an inhibitor of vascular endothelial growth factor (VEGF) or VEGFR (including bevacizumab)
  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1 year (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
  • Severe, active co-morbidity, defined as follows:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to registration
  • Transmural myocardial infarction within the last 6 months prior to registration
  • History of stroke or transient ischemic attack within 6 months prior to registration
  • Significant vascular disease (e.g., aortic aneurysm, history of aortic dissection) or clinically significant peripheral vascular disease
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function other than screening panel and coagulation parameters are not required for entry into this protocol
  • Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol; the need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive; protocol specific requirements may also exclude immuno-compromised patients
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic
  • Prior allergic reaction to the study drug (bevacizumab)
  • Prior history of hypertensive crisis or hypertensive encephalopathy
  • History of a non-healing wound, ulcer, or bone fracture within 90 days (3 months) prior to registration
  • Gastrointestinal bleeding or any other hemorrhage/bleeding event Common Terminology Criteria for adverse Events (CTCAE), v. 4 grade 3 or greater within 30 days prior to registration
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration (with the exception of craniotomy)

Trial Contact Information

Trial Lead Organizations/Sponsors

Radiation Therapy Oncology Group

National Cancer Institute

Christina TsienPrincipal Investigator

Jeffrey J. RaizerStudy Chair

Adam P. Dicker, MD, PhDStudy Chair

Martha M. Matuszak, PhDStudy Chair

Trial Sites

 UAB Comprehensive Cancer Center
 John Fiveash Ph: 205-934-0309
 Arizona Oncology Services Foundation
 David G. Brachman Ph: 877-602-4111
 Epic Care-Dublin
 James H. Feusner Ph: 510-450-7600
 Fresno Cancer Center
 Samantha A Seaward Ph: 626-564-3455
  Rancho Cardova
 Kaiser Permanente Medical Center - Rancho Cordova
 Samantha A Seaward Ph: 626-564-3455
  Rohnert Park
 Rohnert Park Cancer Center
 Samantha A Seaward Ph: 626-564-3455
 The Permanente Medical Group-Roseville Radiation Oncology
 Samantha A Seaward Ph: 626-564-3455
 South Sacramento Cancer Center
 Samantha A Seaward Ph: 626-564-3455
  Santa Clara
 Kaiser Permanente Medical Center - Santa Clara Homestead Campus
 Samantha A Seaward Ph: 626-564-3455
  South San Francisco
 Kaiser Permanente Cancer Treatment Center
 Samantha A Seaward Ph: 626-564-3455
 Rocky Mountain Cancer Centers-Boulder
 Keren Sturtz Ph: 888-785-6789
  Colorado Springs
 Penrose Cancer Center at Penrose Hospital
 Keren Sturtz Ph: 888-785-6789
 Hope Cancer Care Center at Longmont United Hospital
 Keren Sturtz Ph: 888-785-6789
  Wheat Ridge
 Exempla Lutheran Medical Center
 Keren Sturtz Ph: 888-785-6789
 St. Vincent's Medical Center
 Nicholas A Blondin Ph: 203-576-6329
  Deerfield Beach
 University of Miami/Deerfield Beach
 Fazilat Ishkanian Ph: 866-574-5124
 Baptist Cancer Institute - Jacksonville
 Mark E Augspurger Ph: 904-202-7051
 University of Miami Sylvester Comprehensive Cancer Center - Miami
 Fazilat Ishkanian Ph: 866-574-5124
 Emory University Hospital Midtown
 Ian R Crocker Ph: 404-778-1868
 Winship Cancer Institute of Emory University
 Ian R Crocker Ph: 404-778-1868
 Queen's Cancer Institute at Queen's Medical Center
 Paul A. DeMare Ph: 808-545-8548
 Robert H. Lurie Comprehensive Cancer Center at Northwestern University
 Jeffrey J. Raizer Ph: 312-695-1301
 University of Chicago Cancer Research Center
 Steven J Chmura Ph: 773-834-7424
 Central Dupage Cancer Center
 Vinai Gondi Ph: 630-352-5300
 Methodist Cancer Center at Methodist Hospital
 Mark P Langer Ph: 317-274-2552
  South Bend
 Memorial Hospital of South Bend
 David A. Hornback Ph: 800-284-7370
 Central Baptist Hospital
 Marta S Hayne Ph: 859-260-6425
 Louisville Oncology at Norton Cancer Institute - Louisville
 Aaron C Spalding Ph: 502-629-2500
 Maine Medical Center- Scarborough Campus
 Ian J Bristol Ph: 207-396-8090
 Greenebaum Cancer Center at University of Maryland Medical Center
 Young Kwok Ph: 800-888-8823
  Bel Air
 Upper Chesapeake Medical Center
 Young Kwok Ph: 800-888-8823
 Dana-Farber/Brigham and Women's Cancer Center
 Kevin S Oh Ph: 877-726-5130
 Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
 Kevin S Oh Ph: 877-726-5130
 Massachusetts General Hospital
 Kevin S Oh Ph: 877-726-5130
 Baystate Medical Center
 Seth A Kaufman Ph: 413-794-9338
  Ann Arbor
 University of Michigan Comprehensive Cancer Center
 Daniel A Hamstra Ph: 800-865-1125
 Christina I. Tsien Ph: 734-936-4307
  Royal Oak
 William Beaumont Hospital - Royal Oak Campus
 Inga S Grills Ph: 248-551-7695
 William Beaumont Hospital - Troy Campus
 Inga S Grills Ph: 248-551-7695
 Phelps County Regional Medical Center
 Jay W Carlson Ph: 800-821-7532
  Saint Louis
 Barnes-Jewish West County Hospital
 Jiayi Huang Ph: 800-600-3606
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 Jiayi Huang Ph: 800-600-3606
 Billings Clinic Cancer Center - 801 N 29th Street
 Benjamin Thomas Marchello Ph: 800-648-6274
 Methodist Estabrook Cancer Center
 Tien-Shew W Huang Ph: 402-354-5144
 Comprehensive Cancer Centers of Nevada - Henderson
 John Allan Ellerton Ph: 702-384-0013
  Las Vegas
 Cancer Institute of Nevada at Summerlin Hospital Medical Center
 John Allan Ellerton Ph: 702-384-0013
 Comprehensive Cancer Centers of Nevada - Central Valley
 John Allan Ellerton Ph: 702-384-0013
 Comprehensive Cancer Centers of Nevada - Northwest
 John Allan Ellerton Ph: 702-384-0013
 Comprehensive Cancer Centers of Nevada - Southwest
 John Allan Ellerton Ph: 702-384-0013
New Jersey
  Mount Holly
 Virtua Fox Chase Health Cancer Program at Virtua Memorial Hospital Burlington County
 Lemuel S. Ariaratnam Ph: 888-847-8823
 Fox Chase Virtua Health Cancer Program at Virtua West Jersey
 Lemuel S. Ariaratnam Ph: 888-847-8823
New York
  Bay Shore
 Southside Hospital
 Jonathan P. S. Knisely Ph: 516-562-3467
 Montefiore Medical Center
 Mary R Welch Ph: 718-904-2730
  New Hyde Park
 Monter Cancer Center of the North Shore-LIJ Health System
 Jonathan P. S. Knisely Ph: 516-562-3467
  New York
 St. Luke's - Roosevelt Hospital Center - St.Luke's Division
 Rahul R Parikh Ph: 212-824-7320
North Carolina
 CaroMont Cancer Center at Gaston Memorial Hospital
 Charles J. Meakin Ph: 704-834-2932
 Moses Cone Regional Cancer Center at Wesley Long Community Hospital
 Matthew A Manning Ph: 336-832-0821
 McDowell Cancer Center at Akron General Medical Center
 Mitchell Lee Fromm Ph: 330-344-6348
 Summa Center for Cancer Care at Akron City Hospital
 Charles A Kunos Ph: 330-375-6101
 Barberton Citizens Hospital
 Charles A Kunos Ph: 330-375-6101
 Case Comprehensive Cancer Center
 Simon Shek-Man Lo Ph: 800-641-2422
 Riverside Methodist Hospital Cancer Care
 J. Philip Kuebler Ph: 614-566-3275
 Charles F. Kettering Memorial Hospital
 Howard M. Gross Ph: 937-775-1350
  Oklahoma City
 Stephenson Cancer Center at the University of Oklahoma
 Terence S. Herman Ph: 405-271-4272
 Clackamas Radiation Oncology Center
 Matthew C Solhjem Ph: 503-215-6412
 Legacy Good Samaritan Hospital & Comprehensive Cancer Center
 Andrew Y Kee Ph: 507-538-7623
 Providence Cancer Center at Providence Portland Medical Center
 Matthew C Solhjem Ph: 503-215-6412
 Providence St. Vincent Medical Center
 Matthew C Solhjem Ph: 503-215-6412
 UPMC Cancer Center at Beaver Medical Center
 John C Flickinger Ph: 412-647-2811
 St. Luke's Cancer Network at St. Luke's Hospital
 Nimisha Deb Ph: 610-954-3582
 Geisinger Cancer Institute at Geisinger Health
 Thomas J Gergel Ph: 570-271-5251
 UPMC Cancer Center - Arnold Palmer Pavilion
 John C Flickinger Ph: 412-647-2811
 UPMC Cancer Center at UPMC McKeesport
 John C Flickinger Ph: 412-647-2811
  Moon Township
 UPMC - Moon
 John C Flickinger Ph: 412-647-2811
 Frankford Hospital Cancer Center - Torresdale Campus
 Maria Werner-Wasik Ph: 215-955-6084
 Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
 Maria Werner-Wasik Ph: 215-955-6084
 Allegheny Cancer Center at Allegheny General Hospital
 Stephen M Karlovits Ph: 877-284-2000
 St. Clair Memorial Hospital Cancer Center
 John C Flickinger Ph: 412-647-2811
 UPMC - Shadyside
 John C Flickinger Ph: 412-647-2811
 UPMC Cancer Center at UPMC Passavant
 John C Flickinger Ph: 412-647-2811
 UPMC Cancer Center at UPMC St. Margaret
 John C Flickinger Ph: 412-647-2811
  West Reading
 McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
 Albert Yuen Ph: 610-988-9323
 Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
 Thomas J Gergel Ph: 570-271-5251
South Carolina
 Cancer Centers of the Carolinas - Faris Road
 David L Grisell Ph: 864-241-6251
 CCOP - Greenville
 David L Grisell Ph: 864-241-6251
 Cancer Centers of the Carolinas - Greer Radiation Oncology
 David L Grisell Ph: 864-241-6251
 Cancer Centers of the Carolinas - Seneca
 David L Grisell Ph: 864-241-6251
 Cancer Centers of the Carolinas - Spartanburg
 David L Grisell Ph: 864-241-6251
 Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
 Patricia C Griffin Ph: 800-486-5941
South Dakota
  Rapid City
 Rapid City Regional Hospital
 Michael J Swartz Ph: 605-716-3982
 Thompson Cancer Survival Center
 Daniel D Scaperoth Ph: 865-541-1812
 University of Texas Medical Branch
 Martin Colman Ph: 409-772-1950
  League City
 UTMB Cancer Center at Victory Lakes
 Martin Colman Ph: 409-772-1950
 Covenant Medical Center
 Paul Joseph Anderson Ph: 806-725-8000
 Lower Columbia Regional Cancer Center at PeaceHealth-St. John Medical Center
 Matthew C Solhjem Ph: 503-215-6412
 Southwest Washington Medical Center Cancer Center
 Matthew C Solhjem Ph: 503-215-6412
 North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
 Sean F. Cleary Ph: 877-902-3324
  Green Bay
 St. Mary's Hospital Medical Center - Green Bay
 Gregory M. Cooley Ph: 920-433-8889
 St. Vincent Hospital Regional Cancer Center
 Gregory M. Cooley Ph: 920-433-8889
 Bay Area Cancer Care Center at Bay Area Medical Center
 Gregory M. Cooley Ph: 920-433-8889
 D.N. Greenwald Center
 Wingate F. Clapper Ph: 262-928-7632
 Regional Cancer Center at Oconomowoc Memorial Hospital
 Wingate F. Clapper Ph: 262-928-7632
  Sturgeon Bay
 Door County Cancer Center at Door County Memorial Hospital
 Gregory M. Cooley Ph: 920-433-8889
 Waukesha Memorial Hospital Regional Cancer Center
 Wingate F. Clapper Ph: 262-928-7632
 Allan Blair Cancer Centre at Pasqua Hospital
 Rashmi Koul Ph: 866-561-1026
  Tel Aviv
 Tel-Aviv Sourasky Medical Center
 Felix Bokstein Ph: 011-972-3-6974761

Link to the current record.
NLM Identifer NCT01730950 processed this data on February 27, 2015

Note: Information about this trial is from the database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the record to standardize the names of study sponsors, sites, and contacts. only lists sites that are recruiting patients for active trials, whereas lists all sites for all trials. Questions and comments regarding the presented information should be directed to

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