Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Temozolomide and Radiation Therapy With or Without Bevacizumab in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Active	18 and over	NCI	RTOG-0825 RTOG 0825, NCT00884741

Objectives

Primary

1. To determine whether the addition of bevacizumab to temozolomide and radiotherapy improves efficacy, as measured by progression-free and/or overall survival, in patients with newly diagnosed glioblastoma or gliosarcoma.
2. To assess the association between overall survival and Ktrans change from T1 to T2.
3. To assess the association between overall survival and spin echo CBV change from T1 to T2.

Secondary

1. To determine whether the tumor molecular profile conferring a mesenchymal/angiogenic phenotype is associated with a selective increase in benefit from the addition of bevacizumab to temozolomide and radiotherapy, as measured by overall or progression-free survival, in these patients.
2. To compare the toxicities of chemoradiotherapy with bevacizumab vs conventional chemoradiotherapy in these patients.
3. To assess the association between progression-free survival and Ktrans change from T1 to T2.
4. To assess the association between progression-free survival and spin echo CBV change from T1 to T2.
5. To assess the association between values of Ktrans and spin echo CBV measured separately at T0 and at T1, and overall and progression-free survival.
6. To assess the association between overall survival and Ktrans changes from T0 to T1 and from T2 to T3.
7. To assess the association between overall survival and spin echo CBV changes from T0 to T1 and from T2 to T3.
8. To assess the association between overall survival and apparent diffusion coefficient (ADC) change from T0 to T1.
9. To assess the association between overall survival and ADC change from T1 to T2.
10. To assess the association between progression-free survival and ADC change from T0 to T1.
11. To assess the association between progression-free survival and ADC change from T1 to T2.
12. To assess the association between T1 values of ADC and overall and progression-free survival.
13. To assess the association between change in lesion size between T1 and T3, as measured by advanced MRI, and overall and progression-free survival.

Entry Criteria

Disease Characteristics:

• Histologically confirmed glioblastoma or gliosarcoma
  • WHO grade IV disease
  • Tumor must have a supratentorial component
• Has undergone partial or complete surgical resection of tumor within the past 3-5 weeks
  • Diagnosis must be made by surgical excision (not by stereotactic biopsy)
  • No significant postoperative hemorrhage, defined as > 1 cm diameter of blood in the tumor cavity by MRI or CT scan
• Has ≥ 1 block of tumor tissue of sufficient size available for analysis of MGMT status and determination of molecular profile
  • At least 1 cm³ of tissue composed primarily of tumor must be present
  • No CUSA (Cavitron ultrasonic aspirator)-derived material
• No recurrent or multifocal malignant glioma
• No metastases detected below the tentorium or beyond the cranial vault

Prior/Concurrent Therapy:

• Recovered from prior surgery
• No prior chemotherapy or radiosensitizers for cancer of the head and neck region
  • Prior chemotherapy for a different cancer is allowed
• No prior temozolomide or bevacizumab
• No prior Gliadel wafers or any other intratumoral or intracavitary treatment
• No prior radiotherapy to the head and neck (except for T1 glottic cancer) resulting in overlap of radiotherapy fields
• More than 28 days since prior major surgical procedure or open biopsy other than craniotomy for tumor resection
• More than 30 days since prior and no concurrent treatment on another therapeutic clinical trial
• No concurrent growth factors to induce elevations in neutrophil count for the purposes of administration of temozolomide on the scheduled dosing interval; to allow treatment with temozolomide at a higher dose; or to avoid interruption of the treatment during concurrent radiotherapy
• No concurrent erythropoietin
• No concurrent tumor debulking surgery, other chemotherapy, immunotherapy, biologic therapy, or additional stereotactic boost radiotherapy
• No other concurrent investigational drugs during the "blinded phase” of the study
• Concurrent full-dose anticoagulants (e.g., warfarin or low molecular weight heparin) allowed provided both of the following criteria are met:
  • No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
  • In-range INR (between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin

Patient Characteristics:

• Karnofsky performance status 70-100%
• Absolute neutrophil count ≥ 1,800/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 10.0 g/dL (transfusion or other intervention allowed)
• ALT and AST ≤ 3 times normal
• Bilirubin ≤ 2.0 mg/dL
• PT/INR < 1.4 (for patients not on warfarin)
• Creatinine ≤ 1.7 mg/dL
• Urine protein:creatinine ratio < 0.5 OR 24-hour urine protein < 1,000 mg
• BUN ≤ 30 mg/dL
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
• Systolic blood pressure (BP) ≤ 160 mm Hg or diastolic BP ≤ 90 mm Hg
• No evidence of acute cardiac ischemia by electrocardiogram
• No other invasive malignancy within the past 3 years, except for nonmelanomatous skin cancer or carcinoma in situ of the breast, oral cavity, or cervix
• No severe, active comorbidity, including any of the following:
  • Unstable angina and/or congestive heart failure within the past 6 months
  • Transmural myocardial infarction within the past 6 months
  • Evidence of recent myocardial infarction or ischemia as indicated by ST elevations of ≥ 2 mm by EKG
  • New York Heart Association class II-IV congestive heart failure requiring hospitalization within the past 12 months
  • Stroke, cerebral vascular accident, or transient ischemic attack within the past 6 months
  • Serious, inadequately controlled cardiac arrhythmia
  • Significant vascular disease (e.g., aortic aneurysm or history of aortic dissection) or clinically significant peripheral vascular disease
  • Evidence of bleeding diathesis or coagulopathy
  • Serious or non-healing wound, ulcer, or bone fracture
  • Abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, or significant traumatic injury within the past 28 days
  • Acute bacterial or fungal infection requiring IV antibiotics
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
  • AIDS based on current CDC definition
  • Active connective tissue disorders (e.g., lupus or scleroderma) that, in the opinion of the treating physician, may place the patient at high risk for radiation toxicity
  • Any other major medical illness or psychiatric impairment that, in the opinion of the investigator, would preclude study drug administration or completion of study therapy

Expected Enrollment

Outcomes

Overall survival
Progression-free survival

Treatment-related toxicity as assessed by NCI CTCAE v3.0

Outline

This is a multicenter study. Patients are stratified according to MGMT methylation status (methylated vs unmethylated vs invalid) and tumor molecular profile metagene score (favorable vs unfavorable vs undetermined). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo radiotherapy (intensity-modulated radiotherapy or 3-dimensional conformal radiotherapy) once daily 5 days a week for 6 weeks and receive concurrent oral temozolomide once daily for up to 7 weeks. Beginning 4 weeks after completion of chemoradiotherapy, patients receive adjuvant oral temozolomide once daily on days 1-5. Treatment with adjuvant temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive placebo IV over 30-90 minutes once every 2 weeks beginning in week 4 of chemoradiotherapy and continuing until the completion of adjuvant temozolomide.
• Arm II: Patients undergo chemoradiotherapy and receive adjuvant temozolomide as in arm I. Patients also receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning in week 4 of chemoradiotherapy and continuing until the completion of adjuvant temozolomide.

Some patients may undergo Dynamic Susceptibility-Contrast MRI (DSC-MRI) and Dynamic Contrast-Enhanced (DCE-MRI) imaging at baseline, periodically during the study, and after completion of treatment.

After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months thereafter.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

Mark Gilbert, MD, Protocol chair		Ph: 713-792-4008; 800-392-1611 Email: mrgilbert@mdanderson.org

U.S.A.
Alaska
	Anchorage
	Providence Cancer Center
		Clinical Trials Office - Providence Cancer Center	Ph:  907-261-3109
Arizona
	Phoenix
	Arizona Oncology Services Foundation
		David Brachman, MD, FACRO	Ph:  602-274-4484
	Tucson
	Arizona Oncology - Tucson
		Vivek Kavadi	Ph:  520-797-4468
California
	Auburn
	Auburn Radiation Oncology
		Christopher Jones, MD	Ph:  916-646-6600
	Berkeley
	Alta Bates Summit Comprehensive Cancer Center
		Clinical Trials Office - Alta Bates Summit Comprehensive Cancer Center	Ph:  510-204-3428
	Cameron Park
	Radiation Oncology Centers - Cameron Park
		Christopher Jones, MD	Ph:  916-646-6600
	Carmichael
	Mercy Cancer Center at Mercy San Juan Medical Center
		Christopher Jones, MD	Ph:  916-646-6600
	Concord
	Cancer Care Center at John Muir Health - Concord Campus
		Clinical Trials Office - Cancer Care Center at John Muir Health - Concord Campus	Ph:  925-674-2580
	Duarte
	City of Hope Comprehensive Cancer Center
		Clinical Trials Office - City of Hope Comprehensive Cancer Center	Ph:  800-826-4673
			Email: becomingapatient@coh.org
	Modesto
	Memorial Medical Center
		Clinical Trials Office - Memorial Medical Center	Ph:  209-572-7116
	Rancho Cardova
	Kaiser Permanente Medical Center - Rancho Cordova
		Louis Fehrenbacher, MD	Ph:  707-651-2577
	Rohnert Park
	Rohnert Park Cancer Center
		Louis Fehrenbacher, MD	Ph:  707-651-2577
	Roseville
	Kaiser Permanente Medical Center - Roseville
		Louis Fehrenbacher, MD	Ph:  707-651-2577
	Radiation Oncology Center - Roseville
		Christopher Jones, MD	Ph:  916-646-6600
	Sacramento
	Mercy General Hospital
		Christopher Jones, MD	Ph:  916-646-6600
	Radiological Associates of Sacramento Medical Group, Incorporated
		Christopher Jones, MD	Ph:  916-646-6600
	South Sacramento Cancer Center
		Louis Fehrenbacher, MD	Ph:  707-651-2577
	San Francisco
	California Pacific Medical Center - California Campus
		David Irwin, MD	Ph:  510-204-1591
	Santa Clara
		Louis Fehrenbacher, MD	Ph:  707-651-2577
	Vacaville
	Solano Radiation Oncology Center
		Christopher Jones, MD	Ph:  916-646-6600
	Walnut Creek
	John Muir/Mt. Diablo Comprehensive Cancer Center
		Clinical Trials Office - John Muir/Mt. Diablo Comprehensive Cancer Center	Ph:  925-941-4246
Colorado
	Colorado Springs
	Penrose Cancer Center at Penrose Hospital
		Clinical Trials Office - Penrose Cancer Center	Ph:  719-776-5275
	Fort Collins
	Poudre Valley Radiation Oncology
		C. Kelley Simpson, MD	Ph:  970-482-3328
Connecticut
	New Haven
	Yale Cancer Center
		Clinical Trials Office - Yale Cancer Center	Ph:  203-785-5702
Florida
	Jacksonville
	Baptist Cancer Institute - Jacksonville
		Clinical Trials Office - Baptist Cancer Institute - Jacksonville	Ph:  904-202-7051
	Integrated Community Oncology Network at Southside Cancer Center
		Douglas Johnson, MD	Ph:  904-202-2273
	Jacksonville Beach
	Integrated Community Oncology Network
		Douglas Johnson, MD	Ph:  904-202-2273
	Jascksonville
	Baptist Medical Center South
		Douglas Johnson, MD	Ph:  904-202-2273
	Orange Park
	Integrated Community Oncology Network - Orange Park
		Douglas Johnson, MD	Ph:  904-202-2273
	Palatka
	Florida Cancer Center - Palatka
		Douglas Johnson, MD	Ph:  904-202-2273
	Saint Augustine
	Flagler Cancer Center
		Douglas Johnson, MD	Ph:  904-202-2273
	Stuart
	Robert and Carol Weissman Cancer Center at Martin Memorial
		Jorge Castillo-Perez	Ph:  772-288-5858
Georgia
	Altanta
	Winship Cancer Institute of Emory University
		Ian Crocker	Ph:  404-778-5180 888-946-7447
	Atlanta
	Piedmont Hospital
		Adam Nowlan	Ph:  404-605-5000 866-605-5111
	Savannah
	Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
		Clinical Trials Office - Curtis and Elizabeth Anderson Cancer Institute	Ph:  912-350-8568
Hawaii
	Honolulu
	Cancer Research Center of Hawaii
		Clinical Trials Office - Cancer Research Center of Hawaii	Ph:  808-586-2979
Idaho
	Boise
	Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
		Clinical Trials Office - Saint Alphonsus Cancer Care Center	Ph:  208-367-7954
Illinois
	Arlington Heights
	Northwest Community Hospital
		Stephen Nigh, MD	Ph:  847-618-6560
	Chicago
	University of Chicago Cancer Research Center
		Clinical Trials Office - University of Chicago Cancer Research Center	Ph:  773-834-7424
	Decatur
	Decatur Memorial Hospital Cancer Care Institute
		Clinical Trials Office - Decatur Memorial Hospital Cancer Care Institute	Ph:  217-876-6601
Indiana
	Fort Wayne
	Parkview Regional Cancer Center at Parkview Health
		Tony Lee	Ph:  260-373-7850
	Radiation Oncology Associates Southwest
		Tony Lee	Ph:  260-373-7850
	Indianapolis
	Central Indiana Cancer Centers - East
		Vivek Kavadi	Ph:  317-964-5200
	Community Regional Cancer Care at Community Hospital East
		Shih Wei	Ph:  317-355-5347
	Community Regional Cancer Care at Community Hospital North
		Shih Wei	Ph:  317-621-4300
	Methodist Cancer Center at Methodist Hospital
		Alexander Yeh, MD	Ph:  317-962-3172
	St. Vincent Oncology Center
		Robert Liebross	Ph:  317-415-6789 888-415-6789
	South Bend
	CCOP - Northern Indiana CR Consortium
		David Hornback, MD	Ph:  574-647-7461
Iowa
	Des Moines
	John Stoddard Cancer Center at Iowa Methodist Medical Center
		Clinical Trials Office - John Stoddard Cancer Center at Iowa Methodist Medical Center	Ph:  515-241-6727
	Mercy Cancer Center at Mercy Medical Center - Des Moines
		Robert Behrens	Ph:  515-643-8206 888-221-4849
Kansas
	Overland Park
	Kansas City Cancer Centers - Southwest
		Vivek Kavadi	Ph:  913-234-0400
Maryland
	Annapolis
	DeCesaris Cancer Institute at Anne Arundel Medical Center
		Peter Graze, MD	Ph:  410-573-5300
Massachusetts
	Fall River
	Hudner Oncology Center at Saint Anne's Hospital - Fall River
		Clinical Trials Office - Hudner Oncology Center at Saint Anne's Hospital - Fall River	Ph:  508-674-5600 ext. 2019
	Hyannis
	Cape Cod Hospital
		Daniel Canaday	Ph:  508-771-1800
Michigan
	Ann Arbor
	Saint Joseph Mercy Cancer Center
		Salam Jafar, MD	Ph:  734-712-3596
	Kalamazoo
	West Michigan Cancer Center
		Clinical Trials Office - West Michigan Cancer Center	Ph:  269-373-7458
	Royal Oak
	William Beaumont Hospital - Royal Oak Campus
		Clinical Trials Office - William Beaumont Hospital - Royal Oak Campus	Ph:  248-551-7695
Minnesota
	Robbinsdale
	Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
		Clinical Trials Office - Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center	Ph:  763-520-1893
	Saint Cloud
	CentraCare Clinic - River Campus
		Barbi Kaplan-Frenkel, DO	Ph:  320-229-4901
	Waconia
	Ridgeview Medical Center
		Patrick Flynn, MD	Ph:  612-863-8585
Missouri
	Cape Girardeau
	Cancer Institute of Cape Girardeau, LLC
		Tapan Roy, MD	Ph:  573-334-2230
	Kansas City
	CCOP - Kansas City
		Rakesh Gaur, MD	Ph:  816-823-0555
	Kansas City Cancer Centers - North
		Vivek Kavadi	Ph:  816-746-4570
	Kansas City Cancer Centers - South
		Vivek Kavadi	Ph:  816-333-1326
Nebraska
	Lincoln
	Saint Elizabeth Cancer Institute at Saint Elizabeth Regional Medical Center
		Clinical Trials Office - Saint Elizabeth Cancer Institute at Saint Elizabeth Regional Medical Center	Ph:  402-483-2827
	Omaha
	Methodist Estabrook Cancer Center
		Tien-Shew Huang	Ph:  402-354-5890 877-850-3212
Nevada
	Las Vegas
	CCOP - Nevada Cancer Research Foundation
		Contact Person	Ph:  702-384-0013
	Reno
	Renown Institute for Cancer at Renown Regional Medical Center
		Lawrence Dardick, MD	Ph:  775-982-5638
New Hampshire
	Concord
	Dartmouth - Hitchcock Concord
		Arul Mahadevan	Ph:  603-230-6100
	Lebanon
	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
		Clinical Trials Office - Norris Cotton Cancer Center	Ph:  603-650-7609
			Email: cancerhelp@dartmouth.edu
	Manchester
	Elliot Regional Cancer Center at Elliot Hospital
		Andrea McKee, MD	Ph:  603-663-1800
New Jersey
	Livingston
	St. Barnabas Medical Center Cancer Center
		Clinical Trials Office - St. Barnabas Medical Center Cancer Center	Ph:  973-322-2470
New Mexico
	Albuquerque
	New Mexico Cancer Center
		Bryan Goss	Ph:  505-842-8171
New York
	Albany
	New York Oncology Hematology, PC at Albany Regional Cancer Care
		Vivek Kavadi	Ph:  518-489-2607
North Carolina
	Asheville
	Mission Hospitals - Memorial Campus
		Clinical Trials Office - Mission Hospitals - Memorial Campus	Ph:  828-213-4150
	Charlotte
	Blumenthal Cancer Center at Carolinas Medical Center
		Clinical Trials Office - Blumenthal Cancer Center at Carolinas Medical Center	Ph:  704-355-2884
	Presbyterian Cancer Center at Presbyterian Hospital
		Clinical Trials Office - Presbyterian Cancer Center at Presbyterian Hospital	Ph:  704-384-5369
	Winston-Salem
	Forsyth Regional Cancer Center at Forsyth Medical Center
		Clinical Trials Office - Forsyth Regional Cancer Center at Forsyth Medical Center	Ph:  336-277-8887
Ohio
	Akron
	McDowell Cancer Center at Akron General Medical Center
		Mitchell Fromm, MD	Ph:  330-344-6448
	Summa Center for Cancer Care at Akron City Hospital
		Clinical Trials Office - Akron City Hospital	Ph:  330-375-6101
	Canton
	Aultman Cancer Center at Aultman Hospital
		Clinical Trials Office - Aultman Cancer Center at Aultman Hospital	Ph:  330-363-6891
	Mercy Cancer Center at Mercy Medical Center
		Mitchell Haut, MD	Ph:  330-453-9993
	Cincinnati
	Charles M. Barrett Cancer Center at University Hospital
		Kevin Redmond, MD	Ph:  513-584-9089
	Cleveland
	Cleveland Clinic Cancer Center at Fairview Hospital
		Clinical Trials Office - Cleveland Clinic Cancer Center at Fairview Hospital	Ph:  216-476-9362
	Cleveland Clinic Taussig Cancer Center
		Clinical Trials Office - Cleveland Clinic Taussig Cancer Center	Ph:  866-223-8100
	Columbus
	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
		Ohio State University Cancer Clinical Trial Matching Service	Ph:  866-627-7616
			Email: osu@emergingmed.com
Oklahoma
	Oklahoma City
	Oklahoma University Cancer Institute
		Terence Herman	Ph:  405-271-6822
Oregon
	Eugene
	Willamette Valley Cancer Center - Eugene
		Vivek Kavadi	Ph:  541-683-5001
Pennsylvania
	Beaver
	UPMC Cancer Center at Beaver Medical Center
		Frank Lieberman, MD	Ph:  412-692-2600
	Bethlehem
	St. Luke's Cancer Network at St. Luke's Hospital
		Nimisha Deb, MD	Ph:  610-954-4300
	Bryn Mawr
	Bryn Mawr Hospital
		Clinical Trials Office - Bryn Mawr Hospital	Ph:  610-645-2680
	Clairton
	UPMC Cancer Center at Jefferson Regional Medical Center
		Frank Lieberman, MD	Ph:  412-692-2600
	Danville
	Geisinger Cancer Institute at Geisinger Health
		Clinical Trials Office - Geisinger Cancer Institute	Ph:  570-271-5251
	Dunmore
	Northeast Radiation Oncology Center
		Maria Werner-Wasik, MD	Ph:  215-955-7679
	Greensburg
	UPMC Cancer Center - Arnold Palmer Pavilion
		Frank Lieberman, MD	Ph:  412-692-2600
	Hershey
	Penn State Cancer Institute at Milton S. Hershey Medical Center
		Clinical Trials Office - Penn State Cancer Institute at Milton S. Hershey Medical Center	Ph:  717-531-3779
			Email: CTO@hmc.psu.edu
	Kittanning
	Richard G. Laube Cancer Center at ACMH
		Diane Buchbarker	Ph:  412-623-3205
	McKeesport
	UPMC Cancer Center at UPMC McKeesport
		Clinical Trials Office - UPMC Cancer Center at UPMC McKeesport	Ph:  412-647-8073
	Monroeville
	Intercommunity Cancer Center
		David Parda	Ph:  412-359-8084
	Natrona Heights
	Alle-Kiski Medical Center
		David Parda	Ph:  412-359-8084
	Philadelphia
	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
		Clinical Trials Office - Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Ph:  215-955-6084
	Pittsburgh
	Allegheny Cancer Center at Allegheny General Hospital
		David Parda	Ph:  412-359-8084
	UPMC - Shadyside
		Clinical Trials Office - UPMC - Shadyside	Ph:  412-621-2334
	UPMC Cancer Center at UPMC Passavant
		Clinical Trials Office - UPMC Cancer Center at UPMC Passavant	Ph:  412-367-6454
	Reading
	McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
		Clinical Trials Office - McGlinn Family Regional Cancer Center	Ph:  610-988-9323
	Seneca
	UPMC Cancer Center at UPMC Northwest
		Frank Lieberman, MD	Ph:  412-692-2600
	Washington
	Washington Hospital Cancer Center
		Frank Lieberman, MD	Ph:  412-692-2600
	Wynnewood
	Lankenau Cancer Center at Lankenau Hospital
		Paul Gilman, MD	Ph:  610-645-2000
South Carolina
	Spartanburg
	CCOP - Upstate Carolina
		Clinical Trials Office - CCOP - Upstate Carolina	Ph:  800-486-5941
Tennessee
	Chattanooga
	Erlanger Cancer Center at Erlanger Hospital - Baroness
		Clinical Trials Office - Erlanger Cancer Center	Ph:  423-778-6947
Texas
	Bedford
	Texas Oncology, PA at Harris Center HEB
		Vivek Kavadi	Ph:  817-359-9000
	Dallas
	Texas Oncology, PA at Texas Cancer Center Dallas Southwest
		Vivek Kavadi	Ph:  972-709-2580
	Fort Worth
	Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital
		Vivek Kavadi	Ph:  817-820-4820
	Houston
	M. D. Anderson Cancer Center at University of Texas
		Clinical Trials Office - M. D. Anderson Cancer Center at the University of Texas	Ph:  713-792-3245
	Odessa
	West Texas Cancer Center
		Vivek Kavadi	Ph:  432-335-8275
	San Antonio
	University of Texas Health Science Center at San Antonio
		Aidnag Diaz, MD	Ph:  210-450-5603
	Sherman
	Texas Oncology, PA at Texas Cancer Center - Sherman
		Vivek Kavadi	Ph:  903-892-9455
	Sugar Land
	Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land
		Vivek Kavadi	Ph:  281-277-5200
Utah
	Murray
	Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
		R. Jeffrey Lee, MD	Ph:  801-408-1146
	Saint George
	Dixie Regional Medical Center - East Campus
		Clinical Trials Office - Dixie Regional Medical Center - East Campus	Ph:  435-688-4167
	Salt Lake City
	Huntsman Cancer Institute at University of Utah
		Clinical Trials Office - Huntsman Cancer Institute at University of Utah	Ph:  801-581-4477
			Email: clinical.trials@hci.utah.edu
Vermont
	Burlington
	Fletcher Allen Health Care - University Health Center Campus
		Clinical Trials Office - Fletcher Allen Health Care	Ph:  802-656-8990
Washington
	Bellingham
	St. Joseph Cancer Center
		Michael Taylor, MD	Ph:  360-715-4144
	Seattle
	CCOP - Virginia Mason Research Center
		Huong Pham, MD	Ph:  206-223-6801
	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
		Vivek Mehta	Ph:  206-386-2323
	Yakima
	North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
		Clinical Trails Office - North Star Lodge Cancer Center	Ph:  509-574-3422
Wisconsin
	Appleton
	Theda Care Cancer Institute
		Clinical Trials Office - Theda Care Cancer Institute	Ph:  920-380-1500
	Green Bay
	St. Vincent Hospital Regional Cancer Center
		Clinical Trials Office - St. Vincent Hospital Regional Cancer Center	Ph:  920-433-8889
	La Crosse
	Gundersen Lutheran Center for Cancer and Blood
		Clinical Trials Office - Gundersen Lutheran Cancer Center	Ph:  608-775-2385
			Email: cancerctr@gundluth.org
	Madison
	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
		Clinical Trials Office - University of Wisconsin Paul P. Carbone Comprehensive Cancer Center	Ph:  608-262-5223
	Marshfield
	Marshfield Clinic - Marshfield Center
		Clinical Trials Office - Marshfield Clinic - Marshfield Center	Ph:  800-782-1581 ext. 94457
	Saint Joseph's Hospital
		Benjamin Lawler	Ph:  715-389-3133
	Milwaukee
	Medical College of Wisconsin Cancer Center
		Clinical Trials Office - Medical College of Wisconsin Cancer Center	Ph:  414-805-4380
	Wausau
	University of Wisconcin Cancer Center at Aspirus Wausau Hospital
		Clinical Trials Office - University of Wisconsin Cancer Center	Ph:  608-262-5223
	Weston
	Diagnostic and Treatment Center
		Benjamin Lawler	Ph:  715-389-3133
	Marshfield Clinic - Weston Center
		Benjamin Lawler	Ph:  715-389-3133
Canada
Quebec
	Montreal
	Hopital Notre-Dame du CHUM
		Carole Lambert	Ph:  514-281-6000
Saskatchewan
	Regina
	Allan Blair Cancer Centre at Pasqua Hospital
		Evgeny Sadikov	Ph:  306-766-2203

Registry Information
Official Title		Phase III Double-Blind Placebo-Controlled Trial of Conventional Concurrent Chemoradiation and Adjuvant Temozolomide Plus Bevacizumab Versus Conventional Concurrent Chemoradiation and Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma
Trial Start Date		2009-04-03
Trial Completion Date		2010-04-01 (estimated)
Registered in ClinicalTrials.gov		NCT00884741
Date Submitted to PDQ		2009-04-08
Information Last Verified		2009-11-25
NCI Grant/Contract Number		CA21661

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