Temozolomide and Radiation Therapy With or Without Bevacizumab in Treating Patients With Newly Diagnosed Glioblastoma
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
6 other identifiers
interventional
637
3 countries
330
Brief Summary
This randomized phase III trial studies temozolomide (TMZ) and radiation therapy (RT) to compare how well they work with or without bevacizumab in treating patients with newly diagnosed glioblastoma or gliosarcoma. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2009
Typical duration for phase_3
330 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 15, 2009
CompletedFirst Submitted
Initial submission to the registry
April 18, 2009
CompletedFirst Posted
Study publicly available on registry
April 21, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 17, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 17, 2013
CompletedResults Posted
Study results publicly available
October 12, 2016
CompletedJuly 24, 2019
July 1, 2019
3.9 years
April 18, 2009
December 18, 2015
July 22, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Overall Survival (OS)
Survival time was defined as time from randomization to date of death from any cause and was estimated by the Kaplan-Meier method. Patients last known to be alive were censored at the date of last contact. This analysis was planned to occur when 390 deaths had been reported.
From randomization to date of death or last follow-up. Analysis occurs after all 390 deaths have been reported.
Progression-free Survival (PFS)
Progression-free survival was defined as time from randomization to date of progression, death, or last follow-up, and was estimated by the Kaplan-Meier method. Patients last known to be alive were censored at the date of last contact. This analysis was planned to occur when 390 deaths had been reported.
From randomization to date of progression, death, or last follow-up for progression-free survival. Analysis occurs after all 390 deaths have been reported.
Secondary Outcomes (1)
Incidence of Grade 3 and Higher Treatment-related Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (AEs) Version 3.0
Up to 30 days
Other Outcomes (2)
Quality of Life Measured by the M.D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT Tool) and EORTC Quality of Life Questionnaire-Core/Brain Cancer Module( QLQ-C30/BCM20)
Analysis can occur at or after time of primary outcome measure analysis.
Neurocognitive Function Measured by the Hopkins Verbal Learning Test-Revised(HVLT-R), Trail Making Test Part A, Trail Making Test Part B, Controlled Oral Word Association Test (COWAT)
Analysis can occur at or after time of primary outcome measure analysis.
Study Arms (2)
Arm I (radiation therapy, temozolomide, placebo)
ACTIVE COMPARATORPatients 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.
Arm II (radiation therapy, temozolomide, bevacizumab)
EXPERIMENTALPatients 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.
Interventions
Undergo 3-dimentional conformal radiation therapy
Given IV
Undergo intensity-modulated radiation therapy
Correlative studies
Given IV
Ancillary studies
Given orally
Eligibility Criteria
You may qualify if:
- 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 fir central review 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
- +17 more criteria
You may not qualify if:
- 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
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Institute (NCI)lead
- Radiation Therapy Oncology Groupcollaborator
- NRG Oncologycollaborator
Study Sites (330)
Providence Hospital
Mobile, Alabama, 36608, United States
Providence Alaska Medical Center
Anchorage, Alaska, 99508, United States
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
Arizona Oncology Services Foundation
Scottsdale, Arizona, 85260, United States
Arizona Oncology Associates-West Orange Grove
Tucson, Arizona, 85704, United States
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, 95603, United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, 94704, United States
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, 95682, United States
Mercy San Juan Medical Center
Carmichael, California, 95608, United States
John Muir Medical Center-Concord Campus
Concord, California, 94520, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
California Cancer Center - North Fresno
Fresno, California, 93720, United States
Cancer Care Associates of Fresno Medical Group Inc
Fresno, California, 93720, United States
Saint Jude Medical Center
Fullerton, California, 92835, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Memorial Medical Center
Modesto, California, 95355, United States
Bay Area Tumor Institute
Oakland, California, 94609, United States
Kaiser Permanente Oakland-Broadway
Oakland, California, 94611, United States
Saint Joseph Hospital - Orange
Orange, California, 92868, United States
Pomona Valley Hospital Medical Center
Pomona, California, 91767, United States
Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova, California, 95670, United States
Rohnert Park Cancer Center
Rohnert Park, California, 94928, United States
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, 95661, United States
The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California, 95678, United States
Sutter Medical Center Sacramento
Sacramento, California, 95816, United States
Mercy General Hospital Radiation Oncology Center
Sacramento, California, 95819, United States
South Sacramento Cancer Center
Sacramento, California, 95823, United States
University of California San Diego
San Diego, California, 92103, United States
California Pacific Medical Center-Pacific Campus
San Francisco, California, 94115, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051, United States
Kaiser Permanente Cancer Treatment Center
South San Francisco, California, 94080, United States
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Vacaville, California, 95687, United States
John Muir Medical Center-Walnut Creek
Walnut Creek, California, 94598, United States
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, 80012, United States
Boulder Community Hospital
Boulder, Colorado, 80301, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907, United States
Porter Adventist Hospital
Denver, Colorado, 80210, United States
Swedish Medical Center
Englewood, Colorado, 80113, United States
Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, 80120, United States
North Suburban Medical Center
Thornton, Colorado, 80229, United States
SCL Health Lutheran Medical Center
Wheat Ridge, Colorado, 80033, United States
Saint Vincent's Medical Center
Bridgeport, Connecticut, 06606, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
The Hospital of Central Connecticut
New Britain, Connecticut, 06050, United States
Yale University
New Haven, Connecticut, 06520, United States
William Backus Hospital
Norwich, Connecticut, 06360, United States
Broward Health Medical Center
Fort Lauderdale, Florida, 33316, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207, United States
Integrated Community Oncology Network-Southside Cancer Center
Jacksonville, Florida, 32207, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
Baptist Medical Center South
Jacksonville, Florida, 32258, United States
Integrated Community Oncology Network-Florida Cancer Center Beaches
Jacksonville Beach, Florida, 32250, United States
Baptist Hospital of Miami
Miami, Florida, 33176, United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
21st Century Oncology-Orange Park
Orange Park, Florida, 32073, United States
Florida Hospital Orlando
Orlando, Florida, 32803, United States
UF Cancer Center at Orlando Health
Orlando, Florida, 32806, United States
21st Century Oncology-Palatka
Palatka, Florida, 32177, United States
Sacred Heart Hospital
Pensacola, Florida, 32504, United States
Integrated Community Oncology Network-Flager Cancer Center
Saint Augustine, Florida, 32086, United States
Robert and Carol Weissman Cancer Center at Martin Health
Stuart, Florida, 34994, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
John B Amos Cancer Center
Columbus, Georgia, 31904, United States
Dekalb Medical Center
Decatur, Georgia, 30033, United States
Northeast Georgia Medical Center-Gainesville
Gainesville, Georgia, 30501, United States
Southern Regional Medical Center
Riverdale, Georgia, 30274, United States
Memorial University Medical Center
Savannah, Georgia, 31404, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, United States
Northwest Community Hospital
Arlington Heights, Illinois, 60005, United States
Northwestern University
Chicago, Illinois, 60611, United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Trinity Medical Center
Moline, Illinois, 61265, United States
Edward Hospital/Cancer Center
Naperville, Illinois, 60540, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61603, United States
Memorial Medical Center
Springfield, Illinois, 62781, United States
IU Health Bloomington
Bloomington, Indiana, 47403, United States
Radiation Oncology Associates PC
Fort Wayne, Indiana, 46804, United States
Parkview Hospital Randallia
Fort Wayne, Indiana, 46805, United States
IU Health Methodist Hospital
Indianapolis, Indiana, 46202, United States
Community Cancer Center East
Indianapolis, Indiana, 46219, United States
IU Health Central Indiana Cancer Centers-East
Indianapolis, Indiana, 46219, United States
Community Cancer Center North
Indianapolis, Indiana, 46256, United States
Saint Vincent Hospital and Health Care Center
Indianapolis, Indiana, 46260, United States
IU Health Ball Memorial Hospital
Muncie, Indiana, 47303, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46628, United States
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, 50010, United States
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa, 52402, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
Mercy Medical Center - North Iowa
Mason City, Iowa, 50401, United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, 66210, United States
Kansas City NCI Community Oncology Research Program
Prairie Village, Kansas, 66208, United States
Via Christi Regional Medical Center
Wichita, Kansas, 67214, United States
Wesley Medical Center
Wichita, Kansas, 67214, United States
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, 40202, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121, United States
Louisiana State University Health Sciences Center Shreveport
Shreveport, Louisiana, 71103, United States
Central Maine Medical Center
Lewiston, Maine, 04240, United States
Maine Medical Center- Scarborough Campus
Scarborough, Maine, 04074, United States
Anne Arundel Medical Center
Annapolis, Maryland, 21401, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Saint Agnes Hospital
Baltimore, Maryland, 21229, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Saint Anne's Hospital
Fall River, Massachusetts, 02721, United States
Cape Cod Hospital
Hyannis, Massachusetts, 02601, United States
Lowell General Hospital
Lowell, Massachusetts, 01854, United States
D'Amour Center for Cancer Care
Springfield, Massachusetts, 01107, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106, United States
Beaumont Hospital-Dearborn
Dearborn, Michigan, 48124, United States
Saint John Hospital and Medical Center
Detroit, Michigan, 48236, United States
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, 48532, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Sparrow Hospital
Lansing, Michigan, 48912, United States
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, 48073, United States
Saint Mary's of Michigan
Saginaw, Michigan, 48601, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, 48093, United States
Sanford Clinic North-Bemidgi
Bemidji, Minnesota, 56601, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Saint Luke's Hospital of Duluth
Duluth, Minnesota, 55805, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, 56303, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Singing River Hospital
Pascagoula, Mississippi, 39581, United States
Cape Radiation Oncology
Cape Girardeau, Missouri, 63703, United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376, United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141, United States
Truman Medical Center
Kansas City, Missouri, 64108, United States
The University of Kansas Cancer Center-South
Kansas City, Missouri, 64131, United States
The University of Kansas Cancer Center-North
Kansas City, Missouri, 64154, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
CHI Health Good Samaritan
Kearney, Nebraska, 68847, United States
Saint Elizabeth Regional Medical Center
Lincoln, Nebraska, 68510, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Alegent Health Immanuel Medical Center
Omaha, Nebraska, 68122, United States
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, 68124, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, 89106, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
Concord Hospital
Concord, New Hampshire, 03301, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Elliot Hospital
Manchester, New Hampshire, 03103, United States
Saint Barnabas Medical Center
Livingston, New Jersey, 07039, United States
Monmouth Medical Center
Long Branch, New Jersey, 07740, United States
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903, United States
Riverview Medical Center/Booker Cancer Center
Red Bank, New Jersey, 07701, United States
Sparta Cancer Treatment Center
Sparta, New Jersey, 07871, United States
Lovelace Medical Center-Downtown
Albuquerque, New Mexico, 87102, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102, United States
New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico, 87109, United States
New York Oncology Hematology PC - Albany
Albany, New York, 12206, United States
Maimonides Medical Center
Brooklyn, New York, 11219, United States
Sands Cancer Center
Canandaigua, New York, 14424, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
South Nassau Communities
Oceanside, New York, 11572, United States
Hudson Valley Oncology Associates
Poughkeepsie, New York, 12601, United States
Highland Hospital
Rochester, New York, 14620, United States
University Radiation Oncology
Rochester, New York, 14626, United States
University of Rochester
Rochester, New York, 14642, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467-2490, United States
Mission Hospital-Memorial Campus
Asheville, North Carolina, 28801, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204, United States
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, 28791, United States
FirstHealth of the Carolinas-Moore Regional Hosiptal
Pinehurst, North Carolina, 28374, United States
Duke Women's Cancer Care Raleigh
Raleigh, North Carolina, 27607, United States
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
Southeast Clinical Oncology Research (SCOR) Consortium NCORP
Winston-Salem, North Carolina, 27104, United States
Sanford Broadway Medical Center
Fargo, North Dakota, 58122, United States
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, 44304, United States
Akron General Medical Center
Akron, Ohio, 44307, United States
Summa Barberton Hospital
Barberton, Ohio, 44203, United States
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, 44122, United States
Mercy Medical Center
Canton, Ohio, 44708, United States
Aultman Health Foundation
Canton, Ohio, 44710, United States
University of Cincinnati/Barrett Cancer Center
Cincinnati, Ohio, 45219, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, 44111, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Grant Medical Center
Columbus, Ohio, 43215, United States
The Mark H Zangmeister Center
Columbus, Ohio, 43219, United States
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, 43537, United States
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, 44124, United States
Lake University Ireland Cancer Center
Mentor, Ohio, 44060, United States
Southwest General Health Center Ireland Cancer Center
Middleburg Heights, Ohio, 44130, United States
Saint Charles Hospital
Oregon, Ohio, 43616, United States
Cancer Care Center, Incorporated
Salem, Ohio, 44460, United States
North Coast Cancer Care
Sandusky, Ohio, 44870, United States
Trinity's Tony Teramana Cancer Center
Steubenville, Ohio, 43952, United States
Flower Hospital
Sylvania, Ohio, 43560, United States
Mercy Saint Anne Hospital
Toledo, Ohio, 43623, United States
University Pointe
West Chester, Ohio, 45069, United States
UHHS-Westlake Medical Center
Westlake, Ohio, 44145, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Natalie Warren Bryant Cancer Center at Saint Francis
Tulsa, Oklahoma, 74136, United States
Willamette Valley Cancer Center
Eugene, Oregon, 97401, United States
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, 97210, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Providence Saint Vincent Medical Center
Portland, Oregon, 97225, United States
Salem Hospital
Salem, Oregon, 97301, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103, United States
UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania, 15009, United States
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania, 18015, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Northeast Radiation Oncology Center
Dunmore, Pennsylvania, 18512, United States
Pocono Medical Center
East Stroudsburg, Pennsylvania, 18301, United States
The Regional Cancer Center
Erie, Pennsylvania, 16505, United States
Fox Chase Cancer Center Buckingham
Furlong, Pennsylvania, 18925, United States
Adams Cancer Center
Gettysburg, Pennsylvania, 17325, United States
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, 15601, United States
Cherry Tree Cancer Center
Hanover, Pennsylvania, 17331, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
UPMC-Johnstown/John P. Murtha Regional Cancer Center
Johnstown, Pennsylvania, 15901, United States
Armstrong Center for Medicine and Health
Kittanning, Pennsylvania, 16201, United States
Lancaster General Hospital
Lancaster, Pennsylvania, 17604, United States
UPMC Cancer Center at UPMC McKeesport
McKeesport, Pennsylvania, 15132, United States
Intercommunity Cancer Center
Monroeville, Pennsylvania, 15146, United States
Allegheny Valley Hospital
Natrona Heights, Pennsylvania, 15065, United States
UPMC Jameson
New Castle, Pennsylvania, 16105, United States
Paoli Memorial Hospital
Paoli, Pennsylvania, 19301, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Aria Health-Torresdale Campus
Philadelphia, Pennsylvania, 19114, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, 15232, United States
UPMC Jefferson Regional Radiation Oncology
Pittsburgh, Pennsylvania, 15236, United States
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania, 15237, United States
UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania, 16346, United States
UPMC Washington Hospital Radiation Oncology
Washington, Pennsylvania, 15301, United States
Reading Hospital
West Reading, Pennsylvania, 19611, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096, United States
WellSpan Health-York Hospital
York, Pennsylvania, 17403, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57701, United States
Sanford Cancer Center-Oncology Clinic
Sioux Falls, South Dakota, 57104, United States
Erlanger Medical Center
Chattanooga, Tennessee, 37403, United States
Jackson-Madison County General Hospital
Jackson, Tennessee, 38301, United States
Thompson Cancer Survival Center
Knoxville, Tennessee, 37916, United States
Texas Oncology-Arlington South
Arlington, Texas, 76014, United States
Texas Oncology Bedford
Bedford, Texas, 76022, United States
Saint Joseph Regional Cancer Center
Bryan, Texas, 77802, United States
Texas Oncology Methodist Charlton Cancer Center
Dallas, Texas, 75237, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
Texas Oncology-Denton South
Denton, Texas, 76210, United States
The Klabzuba Cancer Center
Fort Worth, Texas, 76104, United States
University of Texas Medical Branch
Galveston, Texas, 77555-0565, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Texas Oncology-Longview Cancer Center
Longview, Texas, 75601, United States
Covenant Medical Center-Lakeside
Lubbock, Texas, 79410, United States
West Texas Cancer Center
Odessa, Texas, 79761, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Texas Cancer Center-Sherman
Sherman, Texas, 75090, United States
Texas Oncology Cancer Center Sugar Land
Sugar Land, Texas, 77479, United States
Tyler Cancer Center
Tyler, Texas, 75702, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
McKay-Dee Hospital Center
Ogden, Utah, 84403, United States
Utah Valley Regional Medical Center
Provo, Utah, 84604, United States
Utah Cancer Specialists-Salt Lake City
Salt Lake City, Utah, 84106, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
LDS Hospital
Salt Lake City, Utah, 84143, United States
Dixie Medical Center Regional Cancer Center
St. George, Utah, 84770, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
Inova Alexandria Hospital
Alexandria, Virginia, 22304, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
Naval Medical Center - Portsmouth
Portsmouth, Virginia, 23708-2197, United States
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225, United States
Harrison Medical Center
Bremerton, Washington, 98310, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Swedish Medical Center-First Hill
Seattle, Washington, 98122-4307, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, 99202, United States
PeaceHealth Southwest Medical Center
Vancouver, Washington, 98664, United States
Compass Oncology Vancouver
Vancouver, Washington, 98684, United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, 98902, United States
Wheeling Hospital/Schiffler Cancer Center
Wheeling, West Virginia, 26003, United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin, 54409, United States
Radiology Associates of Appleton/ThedaCare Regional Medical Center
Appleton, Wisconsin, 54911, United States
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, 54701, United States
Sacred Heart Hospital
Eau Claire, Wisconsin, 54701, United States
Bellin Memorial Hospital
Green Bay, Wisconsin, 54301, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303, United States
UW Cancer Center Johnson Creek
Johnson Creek, Wisconsin, 53038, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
Dean Hematology and Oncology Clinic
Madison, Wisconsin, 53717, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Bay Area Medical Center
Marinette, Wisconsin, 54143, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
Marshfield Medical Center
Marshfield, Wisconsin, 54449, United States
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, 54548, United States
Saint Michael's Hospital
Stevens Point, Wisconsin, 54481, United States
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401, United States
Diagnostic and Treatment Center
Weston, Wisconsin, 54476, United States
Marshfield Clinic - Weston Center
Weston, Wisconsin, 54476, United States
Aspirus UW Cancer Center
Wisconsin Rapids, Wisconsin, 54494, United States
Doctor H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Health Sciences North
Greater Sudbury, Ontario, P3E 5J1, Canada
CHUM - Hopital Notre-Dame
Montreal, Quebec, H2L 4M1, Canada
McGill University Department of Oncology
Montreal, Quebec, H2W 1S6, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1, Canada
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Related Publications (1)
Gilbert MR, Dignam JJ, Armstrong TS, Wefel JS, Blumenthal DT, Vogelbaum MA, Colman H, Chakravarti A, Pugh S, Won M, Jeraj R, Brown PD, Jaeckle KA, Schiff D, Stieber VW, Brachman DG, Werner-Wasik M, Tremont-Lukats IW, Sulman EP, Aldape KD, Curran WJ Jr, Mehta MP. A randomized trial of bevacizumab for newly diagnosed glioblastoma. N Engl J Med. 2014 Feb 20;370(8):699-708. doi: 10.1056/NEJMoa1308573.
PMID: 24552317DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Wendy Seiferheld, M.S.
- Organization
- NRG Oncology
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Gilbert
NRG Oncology
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2009
First Posted
April 21, 2009
Study Start
April 15, 2009
Primary Completion
March 17, 2013
Study Completion
March 17, 2013
Last Updated
July 24, 2019
Results First Posted
October 12, 2016
Record last verified: 2019-07