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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00884741
First received: April 18, 2009
Last updated: June 9, 2014
Last verified: June 2014
  Purpose

This randomized phase III trial is studying temozolomide and radiation therapy to compare how well they work when given together with or without bevacizumab in treating patients with newly diagnosed glioblastoma. (gliosarcoma closed to accrual as of 07-13-10). Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. 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 tumor-killing substances to them. It is not yet known whether temozolomide and radiation therapy are more effective when given together with or without bevacizumab in treating glioblastoma or gliosarcoma.


Condition Intervention Phase
Adult Giant Cell Glioblastoma
Adult Glioblastoma
Adult Gliosarcoma
Drug: temozolomide
Biological: bevacizumab
Other: placebo
Radiation: radiation therapy
Other: laboratory biomarker analysis
Procedure: quality-of-life assessment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival [ Time Frame: From randomization to the date of death due to any cause or otherwise, the last follow-up date on which the patient was reported alive, assessed up to 2 years ] [ Designated as safety issue: No ]
    Estimated using the Kaplan-Meier method and differences between treatment arms will be tested in the log rank test (Mantel 1966).

  • Progression-free survival [ Time Frame: From randomization to the date of first progression or death or, otherwise, the last follow-up date on which the patient was reported alive, assessed up to 2 years ] [ Designated as safety issue: No ]
    Estimated using the Kaplan-Meier method and differences between treatment arms will be tested in the log rank test (Mantel 1966).


Secondary Outcome Measures:
  • Treatment-related toxicity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 [ Time Frame: Up to 30 days ] [ Designated as safety issue: Yes ]
    Differences in observed severities of toxicities (grade 3+) between groups will be tested using a chi square test.

  • Molecular profile [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    Multivariate analysis will be performed using the Cox proportional hazard model for both outcomes to determine if molecular profile is an independent prognostic factor and possibly a predictive factor for the use of bevacizumab.


Enrollment: 897
Study Start Date: April 2009
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I (radiotherapy, temozolomide, placebo)
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.
Drug: temozolomide
Given orally
Other Names:
  • SCH 52365
  • Temodal
  • Temodar
  • TMZ
Other: placebo
Given IV
Other Name: PLCB
Radiation: radiation therapy
Undergo radiation therapy
Other Names:
  • irradiation
  • radiotherapy
  • therapy, radiation
Other: laboratory biomarker analysis
Correlative studies
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Experimental: Arm II (radiotherapy, temozolomide, bevacizumab)
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.
Drug: temozolomide
Given orally
Other Names:
  • SCH 52365
  • Temodal
  • Temodar
  • TMZ
Biological: bevacizumab
Given IV
Other Names:
  • anti-VEGF humanized monoclonal antibody
  • anti-VEGF monoclonal antibody
  • Avastin
  • rhuMAb VEGF
Other: placebo
Given IV
Other Name: PLCB
Radiation: radiation therapy
Undergo radiation therapy
Other Names:
  • irradiation
  • radiotherapy
  • therapy, radiation
Other: laboratory biomarker analysis
Correlative studies
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed glioblastoma (gliosarcoma closed to accrual as of 07-13-10)

    • 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
  • 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00884741

  Hide Study Locations
Locations
United States, Alabama
Providence Hospital
Mobile, Alabama, United States, 36608
United States, Alaska
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
United States, Arizona
Arizona Oncology Services Foundation
Scottsdale, Arizona, United States, 85260
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Arizona Oncology Associates-West Orange Grove
Tucson, Arizona, United States, 85704
United States, California
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, United States, 95603
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States, 94704
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, United States, 95682
Mercy San Juan Medical Center
Carmichael, California, United States, 95608
John Muir Medical Center-Concord Campus
Concord, California, United States, 94520
City of Hope Medical Center
Duarte, California, United States, 91010
Saint Jude Medical Center
Fullerton, California, United States, 92835
University of Southern California/Norris Cancer Center
Los Angeles, California, United States, 90033
Kaiser Permanente Oakland-Broadway
Oakland, California, United States, 94611
Saint Joseph Hospital - Orange
Orange, California, United States, 92868
Pomona Valley Hospital Medical Center
Pomona, California, United States, 91767
Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cardova, California, United States, 95670
Rohnert Park Cancer Center
Rohnert Park, California, United States, 94928
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, United States, 95661
The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California, United States, 95678
Radiological Associates of Sacramento
Sacramento, California, United States, 95815
South Sacramento Cancer Center
Sacramento, California, United States, 95823
Mercy General Hospital Radiation Oncology Center
Sacramento, California, United States, 95819
University of California At San Diego
San Diego, California, United States, 92103
California Pacific Medical Center
San Francisco, California, United States, 94118
Kaiser Permanente Radiation Oncology Cancer Treatment Center
Santa Clara, California, United States, 95051
Kaiser Permanente Cancer Treatment Center
South San Francisco, California, United States, 94080
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Vacaville, California, United States, 95687
John Muir Medical Center
Walnut Creek, California, United States, 94598
United States, Colorado
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, United States, 80012
Boulder Community Hospital
Boulder, Colorado, United States, 80301
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States, 80907
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Swedish Medical Center
Englewood, Colorado, United States, 80113
Poudre Valley Radiation Oncology
Fort Collins, Colorado, United States, 80528
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, United States, 80120
North Suburban Medical Center
Thornton, Colorado, United States, 80229
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Saint Vincent's Medical Center
Bridgeport, Connecticut, United States, 06606
Hartford Hospital
Hartford, Connecticut, United States, 06102
The Hospital of Central Connecticut
New Britain, Connecticut, United States, 06050
Yale University
New Haven, Connecticut, United States, 06520
William Backus Hospital
Norwich, Connecticut, United States, 06360
United States, Florida
Broward Health Medical Center
Fort Lauderdale, Florida, United States, 33316
Memorial Healthcare System - Joe DiMaggio Children's Hospital
Hollywood, Florida, United States, 33021
Cancer Specialists of North Florida-Southside
Jacksonville, Florida, United States, 32207
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Edna Williams Cancer Center at the Baptist Cancer Institute
Jacksonville, Florida, United States, 32207
Cancer Specialists of North Florida-Beaches
Jacksonville Beach, Florida, United States, 32250
Cancer Specialists of North Florida-Baptist South
Jascksonville, Florida, United States, 32258
Mount Sinai Medical Center CCOP
Miami Beach, Florida, United States, 33140
Cancer Specialists of North Florida-Orange Park
Orange Park, Florida, United States, 32073
Florida Hospital
Orlando, Florida, United States, 32803
UF Cancer Center at Orlando Health
Orlando, Florida, United States, 32806
Cancer Specialists of North Florida-Putnam
Palatka, Florida, United States, 32177
Sacred Heart Hospital
Pensacola, Florida, United States, 32504
Cancer Specialists of North Florida-Saint Augustine
Saint Augustine, Florida, United States, 32086
Robert and Carol Weissman Cancer Center at Martin Health
Stuart, Florida, United States, 34994
United States, Georgia
Piedmont Hospital
Atlanta, Georgia, United States, 30309
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Dekalb Medical Center
Decatur, Georgia, United States, 30033
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
Southern Regional Medical Center
Riverdale, Georgia, United States, 30274
Memorial Health University Medical Center
Savannah, Georgia, United States, 31403
United States, Hawaii
University of Hawaii
Honolulu, Hawaii, United States, 96813
United States, Idaho
Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
United States, Illinois
Northwest Community Hospital
Arlington Heights, Illinois, United States, 60005
Northwestern University
Chicago, Illinois, United States, 60611
University of Chicago
Chicago, Illinois, United States, 60637
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States, 60612-3785
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Edward Hospital/Cancer Center
Naperville, Illinois, United States, 60540
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61603
Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
United States, Indiana
Radiation Oncology Associates PC
Fort Wayne, Indiana, United States, 46804
Parkview Hospital Randallia
Fort Wayne, Indiana, United States, 46805
Community Regional Cancer Care-North
Indianapolis, Indiana, United States, 46256
IU Health Central Indiana Cancer Centers-Indianapolis
Indianapolis, Indiana, United States, 46219
IU Health Methodist Hospital
Indianapolis, Indiana, United States, 46202
Saint Vincent Oncology Center
Indianapolis, Indiana, United States, 46260
Community Regional Cancer Care-East Radiation Oncology
Indianapolis, Indiana, United States, 46219
IU Health Ball Memorial Hospital
Muncie, Indiana, United States, 47303
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States, 46628
United States, Iowa
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, United States, 50010
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa, United States, 52402
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Kansas City Cancer Centers-Southwest
Overland Park, Kansas, United States, 66210
Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Wesley Medical Center
Wichita, Kansas, United States, 67214
United States, Kentucky
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States, 40202
United States, Louisiana
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States, 70809
Ochsner Clinic CCOP
New Orleans, Louisiana, United States, 70121
Louisiana State University Health Sciences Center Shreveport
Shreveport, Louisiana, United States, 71130
United States, Maine
Central Maine Medical Center
Lewiston, Maine, United States, 04240
Maine Medical Center- Scarborough Campus
Scarborough, Maine, United States, 04074
United States, Maryland
Anne Arundel Medical Center
Annapolis, Maryland, United States, 21401
Saint Agnes Hospital
Baltimore, Maryland, United States, 21229
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Lowell General Hospital
Lowell, Massachusetts, United States, 01854
D'Amour Center for Cancer Care
Springfield, Massachusetts, United States, 01107
United States, Michigan
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Oakwood Hospital
Dearborn, Michigan, United States, 48124
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Sparrow Hospital
Lansing, Michigan, United States, 48912
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States, 48073
Saint Mary's of Michigan
Saginaw, Michigan, United States, 48601
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
Sanford Clinic North-Bemidgi
Bemidji, Minnesota, United States, 56601
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States, 55109
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States, 55422
Mayo Clinic
Rochester, Minnesota, United States, 55905
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, United States, 56303
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
United Hospital
Saint Paul, Minnesota, United States, 55102
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
United States, Missouri
Cape Radiation Oncology
Cape Girardeau, Missouri, United States, 63703
Kansas City Cancer Center - South
Kansas City, Missouri, United States, 64131
Kansas City Cancer Centers - North
Kansas City, Missouri, United States, 64154
Truman Medical Center
Kansas City, Missouri, United States, 64108
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Siteman Cancer Center - Saint Peters
Saint Peters, Missouri, United States, 63376
United States, Montana
Billings Clinic
Billings, Montana, United States, 59107-7000
United States, Nebraska
Good Samaritan Hospital
Kearney, Nebraska, United States, 68847
Saint Elizabeth Regional Medical Center
Lincoln, Nebraska, United States, 68510
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
Alegent Health Immanuel Medical Center
Omaha, Nebraska, United States, 68122
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
The Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, Nevada
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, United States, 89106
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Saint Barnabas Medical Center
Livingston, New Jersey, United States, 07039
Riverview Medical Center/Booker Cancer Center
Red Bank, New Jersey, United States, 07701
Sparta Cancer Treatment Center
Sparta, New Jersey, United States, 07871
United States, New Mexico
New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico, United States, 87109
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
United States, New York
New York Oncology Hematology PC - Albany
Albany, New York, United States, 12206
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Sands Cancer Center
Canandiaqua, New York, United States, 14424
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Highland Hospital
Rochester, New York, United States, 14620
University Radiation Oncology
Rochester, New York, United States, 14626
University of Rochester
Rochester, New York, United States, 14642
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
State University of New York Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Mission Hospital-Memorial Campus
Asheville, North Carolina, United States, 28801
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States, 28204
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, United States, 28791
FirstHealth of the Carolinas-Moore Regional Hosiptal
Pinehurst, North Carolina, United States, 28374
Cancer Centers of North Carolina
Raleigh, North Carolina, United States, 27607
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
Sanford Medical Center-Fargo
Fargo, North Dakota, United States, 58122
United States, Ohio
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, United States, 44304
Akron General Medical Center
Akron, Ohio, United States, 44307
Summa Barberton Hospital
Barberton, Ohio, United States, 44203
Aultman Health Foundation
Canton, Ohio, United States, 44710
Mercy Medical Center
Canton, Ohio, United States, 44708
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States, 44111
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Grant Medical Center
Columbus, Ohio, United States, 43215
The Mark H Zangmeister Center
Columbus, Ohio, United States, 43219
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, United States, 43537
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, United States, 44124
Lake University Ireland Cancer Center
Mentor, Ohio, United States, 44060
Southwest General Health Center Ireland Cancer Center
Middleburg Heights, Ohio, United States, 44130
UHHS-Chagrin Highlands Medical Center
Orange Village, Ohio, United States, 44122
Saint Charles Hospital
Oregon, Ohio, United States, 43616
Cancer Care Center, Incorporated
Salem, Ohio, United States, 44460
North Coast Cancer Care
Sandusky, Ohio, United States, 44870
Trinity's Tony Teramana Cancer Center
Steubenville, Ohio, United States, 43952
Flower Hospital
Sylvania, Ohio, United States, 43560
Mercy Saint Anne Hospital
Toledo, Ohio, United States, 43623
University Pointe
West Chester, Ohio, United States, 45069
UHHS-Westlake Medical Center
Westlake, Ohio, United States, 44145
United States, Oklahoma
Natalie Warren Bryant Cancer Center at Saint Francis
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Willamette Valley Cancer Center
Eugene, Oregon, United States, 97401
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Providence Saint Vincent Medical Center
Portland, Oregon, United States, 97225
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, United States, 97210
Salem Hospital
Salem, Oregon, United States, 97301
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18105
UPMC - HVHS Cancer Center at Heritage Valley Beaver
Beaver, Pennsylvania, United States, 15009
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania, United States, 18015
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
UPMC Cancer Center at Jefferson Regional Medical Center
Clairton, Pennsylvania, United States, 15025
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-2001
Northeast Radiation Oncology Center
Dunmore, Pennsylvania, United States, 18512
Pocono Medical Center
East Stroudsburg, Pennsylvania, United States, 18301
The Regional Cancer Center
Erie, Pennsylvania, United States, 16505
Fox Chase Cancer Center Buckingham
Furlong, Pennsylvania, United States, 18925
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, United States, 15601
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
UPMC-Johnstown/John P. Murtha Regional Cancer Center
Johnstown, Pennsylvania, United States, 15901
Armstrong Center for Medicine and Health
Kittanning, Pennsylvania, United States, 16201
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17604
UPMC Cancer Center at UPMC McKeesport
McKeesport, Pennsylvania, United States, 15132
Intercommunity Cancer Center
Monroeville, Pennsylvania, United States, 15146
Alle-Kiski Medical Center
Natrona Heights, Pennsylvania, United States, 15065
Aria Health-Torresdale Campus
Philadelphia, Pennsylvania, United States, 19114
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Radiation Therapy Oncology Group
Philadelphia, Pennsylvania, United States, 19103
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania, United States, 15237
Allegheny Cancer Center at Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, United States, 15232
UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania, United States, 16346
Washington Hospital
Washington, Pennsylvania, United States, 15301
Reading Hospital
West Reading, Pennsylvania, United States, 19611
Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
Upstate Carolina CCOP
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Sanford Cancer Center-Oncology Clinic
Sioux Falls, South Dakota, United States, 57104
United States, Tennessee
Erlanger Medical Center
Chattanooga, Tennessee, United States, 37403
Jackson-Madison County General Hospital
Jackson, Tennessee, United States, 38301
Thompson Cancer Survival Center
Knoxville, Tennessee, United States, 37916
United States, Texas
Texas Oncology-Arlington South
Arlington, Texas, United States, 76014
Texas Oncology PA - Bedford
Bedford, Texas, United States, 76022
Saint Joseph Regional Cancer Center
Bryan, Texas, United States, 77802
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Texas Oncology Methodist Charlton Cancer Center
Dallas, Texas, United States, 75237
Texas Oncology-Denton South
Denton, Texas, United States, 76210
The Klabzuba Cancer Center
Fort Worth, Texas, United States, 76104
University of Texas Medical Branch at Galveston
Galveston, Texas, United States, 77555-0565
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Texas Oncology-Longview Cancer Center
Longview, Texas, United States, 75601
Covenant Medical Center-Lakeside
Lubbock, Texas, United States, 79410
West Texas Cancer Center
Odessa, Texas, United States, 79761
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Texas Cancer Center-Sherman
Sherman, Texas, United States, 75090
Texas Oncology Cancer Center Sugar Land
Sugar Land, Texas, United States, 77479
Tyler Cancer Center
Tyler, Texas, United States, 75702
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84157
McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Utah Valley Regional Medical Center
Provo, Utah, United States, 84604-3337
Dixie Medical Center Regional Cancer Center
Saint George, Utah, United States, 84770
LDS Hospital
Salt Lake City, Utah, United States, 84143
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
Utah Cancer Specialists-Salt Lake City
Salt Lake City, Utah, United States, 84106
United States, Vermont
Fletcher Allen Health Care-Medical Center
Burlington, Vermont, United States, 05401
United States, Virginia
Inova Alexandria Hospital
Alexandria, Virginia, United States, 22304
Sentara Hospitals
Norfolk, Virginia, United States, 23507
Naval Medical Center - Portsmouth
Portsmouth, Virginia, United States, 23708-2197
United States, Washington
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, United States, 98225
Harrison Medical Center
Bremerton, Washington, United States, 98310
Virginia Mason CCOP
Seattle, Washington, United States, 98101
Swedish Medical Center-First Hill
Seattle, Washington, United States, 98122-4307
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
PeaceHealth Southwest Medical Center
Vancouver, Washington, United States, 98664
Compass Oncology Vancouver
Vancouver, Washington, United States, 98684
United States, West Virginia
Wheeling Hospital
Wheeling, West Virginia, United States, 26003
United States, Wisconsin
Langlade Hospital and Cancer Center
Antigo, Wisconsin, United States, 54409
Appleton Medical Center
Appleton, Wisconsin, United States, 54911
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, United States, 54701
Sacred Heart Hospital
Eau Claire, Wisconsin, United States, 54701
Bellin Memorial Hospital
Green Bay, Wisconsin, United States, 54301
Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301
Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
UW Cancer Center Johnson Creek
Johnson Creek, Wisconsin, United States, 53038
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Dean Hematology and Oncology Clinic
Madison, Wisconsin, United States, 53717
Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Saint Joseph's Hospital
Marshfield, Wisconsin, United States, 54449
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, United States, 54548
Saint Michael's Hospital
Stevens Point, Wisconsin, United States, 54481
Aspirus Regional Cancer Center
Wausau, Wisconsin, United States, 54401
Diagnostic and Treatment Center
Weston, Wisconsin, United States, 54476
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States, 54476
Riverview Hospital
Wisconsin Rapids, Wisconsin, United States, 54494
Canada, Newfoundland and Labrador
Doctor H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Ontario
Health Sciences North
Sudbury, Ontario, Canada, P3E 5J1
Canada, Quebec
CHUM - Hopital Notre-Dame
Montreal, Quebec, Canada, H2L 4M1
McGill University Department of Oncology
Montreal, Quebec, Canada, H2W 1S6
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Sponsors and Collaborators
Investigators
Principal Investigator: Mark Gilbert Radiation Therapy Oncology Group
  More Information

No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00884741     History of Changes
Other Study ID Numbers: NCI-2009-01670, NCI-2009-01670, RTOG-0825, CDR0000640428, RTOG 0825, RTOG-0825, U10CA021661
Study First Received: April 18, 2009
Last Updated: June 9, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Glioblastoma
Gliosarcoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antibodies
Antibodies, Monoclonal
Temozolomide
Dacarbazine
Bevacizumab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on August 01, 2014