Trial record 1 of 1 for:    RTOG 0825
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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: August 4, 2014
Last verified: June 2014
  Purpose

This randomized phase III trial studies temozolomide and radiation therapy to compare how well they work 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, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as bevacizumab, may find tumor cells and help kill 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
Cognitive/Functional Effects
Drug: temozolomide
Biological: bevacizumab
Other: placebo
Radiation: intensity-modulated radiation therapy
Radiation: 3-dimensional conformal radiation therapy
Other: quality-of-life assessment
Other: laboratory biomarker analysis
Procedure: dynamic susceptibility contrast-enhanced magnetic resonance imaging
Procedure: dynamic contrast-enhanced magnetic resonance imaging
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 death due to any cause, assessed up to 4 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 progression or death, whichever occurs first, assessed up to 4 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:
  • Incidence of treatment-related toxicity as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 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.


Other Outcome Measures:
  • Quality of life measured by the MDASI-BT and EORTC QLQ-C30/BCM20 [ Time Frame: Up to 10 weeks after registration ] [ Designated as safety issue: No ]
    The mean scores from different tools will be calculated at baseline, 6 weeks, and 10 weeks after registration; the arms with and without bevacizumab will be compared using the two-sample t-test. If the parametric assumptions are not met, then the Mann-Whitney test will be used. Longitudinal data analysis will also be performed to change trend of scores over time across the two treatment arms using hierarchical formulation of the linear mixed model. The model will include initial performance status, age, and type of surgery.

  • Neurocognitive function measured by the Hopkins Verbal Learning Test-Revised [ Time Frame: Up to 10 weeks after registration ] [ Designated as safety issue: No ]
    The cumulative incidence approach will be used to estimate the median time to neurocognitive failure to account for the competing risks of disease progression and death. Gray's test will be used to test for a statistically significant difference in the distribution of neurocognitive failure times.

  • 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: 978
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 (radiation therapy, temozolomide, placebo)
Patients undergo intensity-modulated radiation therapy or 3-dimensional conformal radiation therapy 5 days a week for 6 weeks and receive temozolomide PO QD for up to 7 weeks. Beginning 4 weeks after completion of chemotherapy and radiation therapy, patients receive temozolomide PO QD on days 1-5. Treatment with 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 chemotherapy and radiation therapy and continuing until the completion of temozolomide.
Drug: temozolomide
Given orally
Other Names:
  • SCH 52365
  • Temodal
  • Temodar
  • TMZ
Other: placebo
Given IV
Other Name: PLCB
Radiation: intensity-modulated radiation therapy
Undergo intensity-modulated radiation therapy
Other Name: IMRT
Radiation: 3-dimensional conformal radiation therapy
Undergo 3-dimentional conformal radiation therapy
Other Names:
  • 3D conformal radiation therapy
  • 3D-CRT
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: laboratory biomarker analysis
Correlative studies
Procedure: dynamic susceptibility contrast-enhanced magnetic resonance imaging
Correlative studies
Other Name: DSC-MRI
Procedure: dynamic contrast-enhanced magnetic resonance imaging
Correlative studies
Other Name: DCE-MRI
Experimental: Arm II (radiation therapy, temozolomide, bevacizumab)
Patients undergo radiation therapy and receive 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
Radiation: intensity-modulated radiation therapy
Undergo intensity-modulated radiation therapy
Other Name: IMRT
Radiation: 3-dimensional conformal radiation therapy
Undergo 3-dimentional conformal radiation therapy
Other Names:
  • 3D conformal radiation therapy
  • 3D-CRT
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: laboratory biomarker analysis
Correlative studies
Procedure: dynamic susceptibility contrast-enhanced magnetic resonance imaging
Correlative studies
Other Name: DSC-MRI
Procedure: dynamic contrast-enhanced magnetic resonance imaging
Correlative studies
Other Name: DCE-MRI

  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 proven diagnosis of glioblastoma or gliosarcoma (World Health Organization [WHO] grade IV) confirmed by central review prior to step 2 registration
  • Tumor tissue that is determined by central pathology review prior to step 2 registration to be of sufficient size for analysis of O-6-methylguanine-DNA methyltransferase (MGMT) and determination of molecular profile

    • Patients must have at least 1 block of tumor tissue; submission of 2 blocks is strongly encouraged to maximize the chances of eligibility; at least 1 cubic centimeter of tissue composed primarily of tumor must be present
    • CUSA (Cavitron ultrasonic aspirator)-derived material is not allowed; fresh frozen tumor tissue acquisition is encouraged
    • Diagnosis must be made by surgical excision, either partial or complete; stereotactic biopsy is not allowed because it will not provide sufficient tissue for MGMT analysis
    • The tumor tissue should be sent as soon as possible to maximize the likelihood of eligibility; tumor tissue should be submitted by 4 weeks after the surgical procedure so that the study registration and treatment can commence by the mandatory 5 week post-surgery outer limit
    • Sites must submit tissue directly to Dr. Aldape in order to obtain the MGMT analysis; patients from sites not following protocol-specified process for obtaining MGMT results will be made ineligible
  • The tumor must have a supratentorial component
  • History/physical examination within 14 days prior to step 2 registration
  • The patient must have recovered from the effects of surgery, postoperative infection, and other complications before step 2 registration
  • A diagnostic contrast-enhanced MRI of the brain must be performed preoperatively and postoperatively prior to the initiation of radiotherapy; the postoperative scan must be performed within 28 days prior to step 1 registration

    • An MRI or computed tomography (CT) scan (potentially in addition to the postoperative scan) must be obtained within 10 days prior to the start of radiation therapy and must not demonstrate significant postoperative hemorrhage defined as > 1 cm diameter of blood; if > 1 cm of acute blood is detected, the patient will be ineligible for this trial; the radiation planning MRI or CT scan may be used to determine presence of hemorrhage
    • Patients unable to undergo MR imaging because of non-compatible devices can be enrolled, provided pre- and postoperative contrast-enhanced CT scans are obtained and are of sufficient quality; preoperative and postoperative scans must be the same type; such patients cannot be enrolled into the advanced imaging component
  • Documentation of steroid doses within 14 days prior to step 2 registration
  • Karnofsky performance status >= 70
  • Absolute neutrophil count (ANC) >= 1,800 cells/mm^3
  • Platelets >= 100,000 cells/mm^3
  • Hemoglobin >= 10.0 g/dL (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 10.0 g/dl is acceptable)
  • Blood urea nitrogen (BUN) =< 30 mg/dL within 14 days prior to step 2 registration
  • Creatinine =< 1.7 mg/dl within 14 days prior to step 2 registration
  • Urine protein screened by urine analysis for urine protein creatinine (UPC) ratio; for UPC ratio > 0.5, 24-hour urine protein should be obtained and the level should be < 1000 mg
  • Bilirubin =< 2.0 mg/dl within 14 days prior to step 2 registration
  • Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =< 3 x normal range within 14 days prior to step 2 registration
  • Systolic blood pressure =< 160 mg Hg or diastolic pressure =< 90 mm Hg within 14 days prior to step 2 registration
  • Electrocardiogram without evidence of acute cardiac ischemia within 14 days prior to step 2 registration
  • Prothrombin time/international normalized ratio (PT INR) < 1.4 for patients not on warfarin confirmed by testing within 14 days prior to step 2 registration
  • Patients on full-dose anticoagulants (e.g., warfarin or 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 INR (between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin
  • Patient must provide study specific informed consent prior to study entry
  • Women of childbearing potential and male participants must practice adequate contraception
  • For females of child-bearing potential, negative serum pregnancy test within 14 days prior to step 2 registration

Exclusion Criteria:

  • Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for >= 3 years; (for example, carcinoma in situ of the breast, oral cavity, and cervix are all permissible)
  • Recurrent or multifocal malignant gliomas
  • Metastases detected below the tentorium or beyond the cranial vault
  • Prior chemotherapy or radiosensitizers for cancers of the head and neck region; note that prior chemotherapy for a different cancer is allowable, except prior temozolomide or bevacizumab; prior use of Gliadel wafers or any other intratumoral or intracavitary treatment are not permitted
  • Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields
  • Severe, active co-morbidity, defined as follows:

    • Unstable angina and/or congestive heart failure within the last 6 months
    • Transmural myocardial infarction within the last 6 months
    • Evidence of recent myocardial infarction or ischemia by the findings of S-T elevations of >= 2 mm using the analysis of an electrocardiogram (EKG) performed within 14 days of step 2 registration
    • New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to step 2 registration
    • History of stroke, cerebral vascular accident (CVA) or transient ischemic attack within 6 months
    • Serious and inadequately controlled cardiac arrhythmia
    • Significant vascular disease (e.g., aortic aneurysm, 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 or history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to step 2 registration, with the exception of the craniotomy for tumor resection
    • 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 step 2 registration
    • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
    • Acquired immune deficiency syndrome (AIDS) based upon current Center for Disease Control (CDC) definition; note, however, that 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
    • Active connective tissue disorders, such as lupus or scleroderma, that in the opinion of the treating physician may put the patient at high risk for radiation toxicity
    • Any other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
  • Pregnant or lactating women
  • Patients treated on any other therapeutic clinical protocols within 30 days prior to study entry or during participation in the study
  • For American College of Radiology Imaging Network (ACRIN) 6686 Advanced Imaging: inability to undergo MRI (e.g., due to safety reasons, such as presence of a pacemaker)
  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
City of Hope
Duarte, California, United States, 91010
Saint Jude Medical Center
Fullerton, California, United States, 92835
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
University of Southern California/Norris Cancer Center
Los Angeles, California, United States, 90033
Kaiser Permanente Oakland-Broadway
Oakland, California, United States, 94611
Bay Area Tumor Institute CCOP
Oakland, California, United States, 94609
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 San Diego
San Diego, California, United States, 92103
California Pacific Medical Center
San Francisco, California, United States, 94118
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States, 95051
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
Baptist Cancer Institute
Jacksonville, Florida, United States, 32207
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Cancer Specialists of North Florida-Southside
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
UF Cancer Center at Orlando Health
Orlando, Florida, United States, 32806
Florida Hospital
Orlando, Florida, United States, 32803
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
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Piedmont Hospital
Atlanta, Georgia, United States, 30309
John B Amos Cancer Center
Columbus, Georgia, United States, 31904
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 Cancer Care Center-Boise
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
Saint Vincent Oncology Center
Indianapolis, Indiana, United States, 46260
IU Health Methodist Hospital
Indianapolis, Indiana, United States, 46202
Community Regional Cancer Care-East Radiation Oncology
Indianapolis, Indiana, United States, 46219
IU Health Central Indiana Cancer Centers-East
Indianapolis, Indiana, United States, 46219
Community Regional Cancer Care-North
Indianapolis, Indiana, United States, 46256
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
Kansas City CCOP
Prairie Village, Kansas, United States, 66208
Wesley Medical Center
Wichita, Kansas, United States, 67214
Via Christi Regional 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 and Medical Center
Dearborn, Michigan, United States, 48124
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, United States, 48532
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
Saint Luke's Hospital of Duluth
Duluth, Minnesota, United States, 55805
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
Regions Hospital
Saint Paul, Minnesota, United States, 55101
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 Centers - North
Kansas City, Missouri, United States, 64154
Truman Medical Center
Kansas City, Missouri, United States, 64108
Kansas City Cancer Center - South
Kansas City, Missouri, United States, 64131
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
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
Alegent Health Immanuel Medical Center
Omaha, Nebraska, United States, 68122
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
UMDNJ - Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08903
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
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
University of New Mexico
Albuquerque, New Mexico, United States, 87106
New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico, United States, 87109
United States, New York
New York Oncology Hematology PC - Albany
Albany, New York, United States, 12206
Montefiore Medical Center - Moses Campus
Bronx, New York, United States, 10467-2490
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
South Nassau Communities
Oceanside, New York, United States, 11572
Hudson Valley Oncology Associates
Poughkeepsie, New York, United States, 12601
University of Rochester
Rochester, New York, United States, 14642
Highland Hospital
Rochester, New York, United States, 14620
University Radiation Oncology
Rochester, New York, United States, 14626
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
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States, 28204
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
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States, 44111
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
The Mark H Zangmeister Center
Columbus, Ohio, United States, 43219
Grant Medical Center
Columbus, Ohio, United States, 43215
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210
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
Jameson Health System North Campus
New Castle, Pennsylvania, United States, 16105
Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Aria Health-Torresdale Campus
Philadelphia, Pennsylvania, United States, 19114
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania, United States, 15237
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, United States, 15232
Allegheny Cancer Center at Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
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
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
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
Texas Oncology Methodist Charlton Cancer Center
Dallas, Texas, United States, 75237
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
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
Utah Cancer Specialists-Salt Lake City
Salt Lake City, Utah, United States, 84106
LDS Hospital
Salt Lake City, Utah, United States, 84143
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
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
Swedish Medical Center-First Hill
Seattle, Washington, United States, 98122-4307
Virginia Mason CCOP
Seattle, Washington, United States, 98101
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
Compass Oncology Vancouver
Vancouver, Washington, United States, 98684
PeaceHealth Southwest Medical Center
Vancouver, Washington, United States, 98664
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
Sacred Heart Hospital
Eau Claire, Wisconsin, United States, 54701
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, United States, 54701
Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301
Bellin Memorial 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
Dean Hematology and Oncology Clinic
Madison, Wisconsin, United States, 53717
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
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
Waukesha Memorial Hospital - ProHealth Care
Waukesha, Wisconsin, United States, 53188
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
McGill University Department of Oncology
Montreal, Quebec, Canada, H2W 1S6
CHUM - Hopital Notre-Dame
Montreal, Quebec, Canada, H2L 4M1
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Sponsors and Collaborators
Investigators
Principal Investigator: Mark Gilbert NRG Oncology
  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, U10CA180868
Study First Received: April 18, 2009
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 23, 2014