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Trial record 1 of 1 for:    NRG BN-001
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Dose-Escalated Photon IMRT or Proton Beam Radiation Therapy Versus Standard-Dose Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02179086
Recruitment Status : Active, not recruiting
First Posted : July 1, 2014
Last Update Posted : May 19, 2022
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Radiation Therapy Oncology Group
Information provided by (Responsible Party):
NRG Oncology

Brief Summary:
This randomized phase II trial studies how well dose-escalated photon intensity-modulated radiation therapy (IMRT) or proton beam radiation therapy works compared with standard-dose radiation therapy when given with temozolomide in patients with newly diagnosed glioblastoma. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs, such as temozolomide, may make tumor cells more sensitive to radiation therapy. It is not yet known whether dose-escalated photon IMRT or proton beam radiation therapy is more effective than standard-dose radiation therapy with temozolomide in treating glioblastoma.

Condition or disease Intervention/treatment Phase
Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Radiation: 3-dimensional conformal radiation therapy Radiation: intensity-modulated radiation therapy Radiation: photon beam radiation therapy Radiation: proton beam radiation therapy Drug: temozolomide Other: laboratory biomarker analysis Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 624 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of Hypofractionated Dose-Escalated Photon IMRT or Proton Beam Therapy Versus Conventional Photon Irradiation With Concomitant and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma
Actual Study Start Date : October 27, 2014
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : May 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Arm A1 (control)

Patients undergo standard-dose photon irradiation using 3D-CRT or IMRT QD, 5 days a week for 23 fractions plus a boost of 7 additional fractions.

In all treatment arms, patients receive temozolomide PO QD on days 1-49 of radiation therapy. Beginning 4 weeks later, patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Radiation: 3-dimensional conformal radiation therapy
Undergo standard-dose 3D-CRT
Other Names:
  • 3D conformal radiation therapy
  • 3D-CRT

Radiation: intensity-modulated radiation therapy
Undergo standard-dose IMRT
Other Name: IMRT

Drug: temozolomide
Given PO
Other Names:
  • SCH 52365
  • Temodal
  • Temodar
  • TMZ

Other: laboratory biomarker analysis
Correlative studies

Experimental: Arm B (photon IMRT)

Patients undergo dose-escalated and -intensified photon IMRT QD, 5 days a week for a total of 30 fractions.

In all treatment arms, patients receive temozolomide PO QD on days 1-49 of radiation therapy. Beginning 4 weeks later, patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Radiation: photon beam radiation therapy
Undergo dose-escalated and -intensified photon IMRT

Radiation: intensity-modulated radiation therapy
Undergo dose-escalated and -intensified photon IMRT
Other Name: IMRT

Drug: temozolomide
Given PO
Other Names:
  • SCH 52365
  • Temodal
  • Temodar
  • TMZ

Other: laboratory biomarker analysis
Correlative studies

Active Comparator: Arm A2 (control)

Patients undergo standard-dose photon irradiation using 3D-CRT or IMRT as in Arm A1.

In all treatment arms, patients receive temozolomide PO QD on days 1-49 of radiation therapy. Beginning 4 weeks later, patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Radiation: 3-dimensional conformal radiation therapy
Undergo standard-dose 3D-CRT
Other Names:
  • 3D conformal radiation therapy
  • 3D-CRT

Radiation: intensity-modulated radiation therapy
Undergo standard-dose IMRT
Other Name: IMRT

Drug: temozolomide
Given PO
Other Names:
  • SCH 52365
  • Temodal
  • Temodar
  • TMZ

Other: laboratory biomarker analysis
Correlative studies

Experimental: Arm C (proton beam radiation therapy)

Patients undergo dose-escalated and -intensified proton beam therapy QD, 5 days a week for a total of 30 fractions.

In all treatment arms, patients receive temozolomide PO QD on days 1-49 of radiation therapy. Beginning 4 weeks later, patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Radiation: proton beam radiation therapy
Undergo dose-escalated and -intensified proton beam radiation therapy

Drug: temozolomide
Given PO
Other Names:
  • SCH 52365
  • Temodal
  • Temodar
  • TMZ

Other: laboratory biomarker analysis
Correlative studies




Primary Outcome Measures :
  1. Overall survival (OS) compared between dose-escalated and -intensified photon IMRT or proton beam therapy with concomitant and adjuvant temozolomide and the standard-dose photon irradiation with concomitant and adjuvant temozolomide [ Time Frame: Date of randomization to the date of death due to any cause, assessed up to 5 years ]
    OS rate will be estimated using the Kaplan-Meier method, and differences between treatment arms will be tested in a stratified log-rank test, consistent with the stratified randomization. The OS rates by MGMT, recursive partitioning analysis (RPA) class and other prognostic factors will be estimated by Kaplan-Meier methods and compared using the log-rank test. Multivariate analyses with the Cox proportional hazard model for OS will be performed to assess the treatment effect adjusting for patient-specific risk factors.


Secondary Outcome Measures :
  1. OS when compared between dose-escalated and -intensified photon IMRT to dose-escalated and -intensified proton beam therapy [ Time Frame: Date of randomization to the date of death, assessed up to 5 years ]
    If the instrumental variable assumptions hold, OS rate will be estimated using the Kaplan-Meier method, and differences between treatment arms will be tested in the log-rank test.

  2. Progression-free survival (PFS) [ Time Frame: Date of randomization to the date of progression or death, assessed up to 5 years ]
    PFS rates will be estimated using the Kaplan-Meier method and comparisons between treatment arms will be made in the same manner as for OS.

  3. Incidence of treatment-related toxicity, as measured by the Common Terminology Criteria for Adverse Events version 4 [ Time Frame: Up to 5 years ]
    Differences in observed severities of toxicities (grade 3+) between groups will be estimated using an exact binomial distribution together with 95% confidence interval. The difference between the 2 groups will be tested using a chi square test. If the instrumental variable assumptions hold the experimental arms will also be compared.

  4. Change in perceived cognitive function, as measured by M.D. Anderson Symptom Inventory Brain Tumor [ Time Frame: Baseline to up to 60 weeks ]
    The change from baseline to each follow-up time point for the perceived cognitive symptom severity score will each be compared using a t-test with alpha=0.05, or Wilcoxon test if the data is not normally distributed, between treatment arms within each group. If the instrumental variable assumptions hold and the perceived cognitive function is significantly different within both groups, a test will be performed to compare between the 2 experimental arms.

  5. Change in neurocognitive function, as measured by Hopkins' Verbal Learning Test-Revised, Trail Making Test Parts A and B, and Controlled Oral Word Association Test [ Time Frame: Baseline to up to 60 weeks ]
    The change from baseline to each follow-up time point for the perceived Clinical Trial Battery (CTB) composite score will each be compared using a t-test with alpha=0.05, or Wilcoxon test if the data is not normally distributed, between treatment arms within each group. If the instrumental variable assumptions hold and the CTB composite score is significantly different within both groups, a test will be performed to compare between the 2 experimental arms.

  6. Change in CD4 lymphopenia count [ Time Frame: Baseline to up to 5 years ]
    The change from baseline to the completion of radiation will be compared between the control and experimental arms in each group using a t-test. If the instrumental variable assumptions hold, then it will be compared between the experimental arms. A repeated measures analysis, using a mixed effects model, will be used to assess the change of CD4 lymphopenia across time. CD4 count at 2 months after beginning therapy (dichotomized at 200) was shown to be prognostic of OS. This will be assessed here based on the CD4 count at the completion of chemoradiation which matches best to 2-months.

  7. Use of magnetic resonance diffusion and perfusion imaging to differentiate between tumor progression and pseudo-progression [ Time Frame: Up to 5 years ]
    Retrospective analysis will be performed to evaluate and refine the method and the threshold cut-off point determined from our previous single institute data set to determine progression using the first one-third of the patient data collected in this trial. If the initial analysis supports our preliminary results with sufficient high sensitivity and specificity, e.g., 80% specificity and 90% sensitivity or higher, results will be validated using the remaining two-thirds of the imaging data.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • PRIOR TO STEP 1 REGISTRATION
  • A diagnostic contrast-enhanced magnetic resonance imaging (MRI) (no other scan type allowed) of the brain must be performed postoperatively within 72 hours of resection; the enhancing tumor must have a maximal diameter of 5 cm; the tumor diameter will be the greatest diameter as measured on the contrast-enhanced postoperative MRI and will include residual disease and/or the postoperative surgical cavity as appropriate; for cases where residual disease or postoperative surgical cavity is NOT identifiable (e.g., polar glioblastomas [GBMs] where a polar lobectomy is performed), the patient will be excluded from the trial
  • The GBM tumor must be located in the supratentorial compartment only (any component involving the brain stem or cerebellum is not allowed)
  • Patients must provide study-specific informed consent prior to step 1 registration
  • PRIOR TO STEP 2 REGISTRATION
  • Histologically proven diagnosis of glioblastoma (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 quantity for analysis of O6-methylguanin-DNA-methyltransferase (MGMT) status

    • 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
    • Diagnosis must be made by surgical excision, either partial or complete; stereotactic biopsy or cavitron ultrasonic suction aspirator (CUSA) technique are not allowed
  • History/physical examination within 28 days prior to step 2 registration
  • The patient must have recovered from effects of surgery, postoperative infection, and other complications within 28 days prior to step 2 registration
  • Documentation of steroid doses within 28 days prior to step 2 registration
  • Karnofsky performance status >= 70 within 28 days prior to step 2 registration
  • Age >= 18
  • 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)
  • Bilirubin =< 1.5 upper limit of normal (ULN)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN
  • Negative serum pregnancy test obtained for females of child-bearing potential within 28 days prior to step 2 registration

Exclusion Criteria:

  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease-free for a minimum of 3 years; (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
  • Recurrent or multifocal malignant gliomas
  • Any site of distant disease (for example, drop metastases from the GBM tumor site)
  • Prior chemotherapy or radiosensitizers for cancers of the head and neck region; note that prior chemotherapy for a different cancer is allowable (except temozolomide)
  • 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 at step 2 registration
    • Transmural myocardial infarction within the last 6 months prior to step 2 registration
    • 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 28 days prior to step 2 registration
    • New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to step 2 registration
    • Serious and inadequately controlled arrhythmia at step 2 registration
    • Serious or non-healing wound, ulcer or bone fracture or history of abdominal fistula, intra-abdominal abscess requiring major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to step 2 registration, with the exception of the craniotomy for surgical resection
    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 2 registration
    • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of step 2 registration
    • Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol
    • Any other severe immunocompromised condition
    • 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
    • End-stage renal disease (ie, on dialysis or dialysis has been recommended)
    • Any other major medical illnesses or psychiatric treatments 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
  • Patents treated on any other therapeutic clinical protocols within 30 days prior to step 2 registration
  • Inability to undergo MRI (e.g., due to safety reasons, such as presence of a pacemaker, or severe claustrophobia)
  • Postoperative tumor plus surgical bed size exceeds 5 cm in maximum diameter.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02179086


Locations
Hide Hide 240 study locations
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United States, Alabama
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
United States, Arizona
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, United States, 85054
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Arizona Oncology Associates-West Orange Grove
Tucson, Arizona, United States, 85704
Banner University Medical Center - Tucson
Tucson, Arizona, United States, 85719
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, United States, 95603
AIS Cancer Center at San Joaquin Community Hospital
Bakersfield, California, United States, 93301
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
Eden Hospital Medical Center
Castro Valley, California, United States, 94546
Fresno Cancer Center
Fresno, California, United States, 93720
Marin General Hospital
Greenbrae, California, United States, 94904
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Los Angeles County-USC Medical Center
Los Angeles, California, United States, 90033
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Fremont - Rideout Cancer Center
Marysville, California, United States, 95901
Memorial Medical Center
Modesto, California, United States, 95355
Kaiser Permanente Oakland-Broadway
Oakland, California, United States, 94611
Saint Joseph Hospital - Orange
Orange, California, United States, 92868
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Palo Alto Medical Foundation Health Care
Palo Alto, California, United States, 94301
Pomona Valley Hospital Medical Center
Pomona, California, United States, 91767
Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova, 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
Sutter Medical Center Sacramento
Sacramento, California, United States, 95816
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
South Sacramento Cancer Center
Sacramento, California, United States, 95823
California Pacific Medical Center-Pacific Campus
San Francisco, California, United States, 94115
Palo Alto Medical Foundation-Santa Cruz
Santa Cruz, California, United States, 95065
Kaiser Permanente Cancer Treatment Center
South San Francisco, California, United States, 94080
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California, United States, 94086
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Vacaville, California, United States, 95687
John Muir Medical Center-Walnut Creek
Walnut Creek, California, United States, 94598
United States, Colorado
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, United States, 80909
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
United States, Florida
Boca Raton Regional Hospital
Boca Raton, Florida, United States, 33486
University of Florida Health Science Center - Gainesville
Gainesville, Florida, United States, 32610
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States, 32207
University of Florida Health Science Center - Jacksonville
Jacksonville, Florida, United States, 32209
Baptist Medical Center South
Jacksonville, Florida, United States, 32258
Miami Cancer Institute
Miami, Florida, United States, 33176
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
Emory Proton Therapy Center
Atlanta, Georgia, United States, 30308
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, United States, 31405
United States, Idaho
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States, 83706
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States, 60612
Rush University Medical Center
Chicago, Illinois, United States, 60612
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, United States, 60115
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, United States, 60134
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, United States, 60451
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States, 60068
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Memorial Medical Center
Springfield, Illinois, United States, 62781
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States, 60555
United States, Indiana
Radiation Oncology Associates PC
Fort Wayne, Indiana, United States, 46804
Parkview Hospital Randallia
Fort Wayne, Indiana, United States, 46805
Parkview Regional Medical Center
Fort Wayne, Indiana, United States, 46845
IU Health Methodist Hospital
Indianapolis, Indiana, United States, 46202
Community Cancer Center East
Indianapolis, Indiana, United States, 46219
Community Cancer Center South
Indianapolis, Indiana, United States, 46227
Community Cancer Center North
Indianapolis, Indiana, United States, 46256
IU Health Ball Memorial Hospital
Muncie, Indiana, United States, 47303
United States, Iowa
Mercy Hospital
Cedar Rapids, Iowa, United States, 52403
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
United States, Kansas
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, United States, 66210
United States, Kentucky
Norton Hospital Pavilion and Medical Campus
Louisville, Kentucky, United States, 40202
United States, Louisiana
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States, 70121
Willis-Knighton Medical and Cancer Center
Shreveport, Louisiana, United States, 71103
United States, Maryland
Maryland Proton Treatment Center
Baltimore, Maryland, United States, 21201
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
UM Upper Chesapeake Medical Center
Bel Air, Maryland, United States, 21014
Central Maryland Radiation Oncology in Howard County
Columbia, Maryland, United States, 21044
UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland, United States, 21061
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Boston Medical Center
Boston, Massachusetts, United States, 02118
Mass General/North Shore Cancer Center
Danvers, Massachusetts, United States, 01923
Lowell General Hospital
Lowell, Massachusetts, United States, 01854
United States, Michigan
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
McLaren Cancer Institute-Bay City
Bay City, Michigan, United States, 48706
Beaumont Hospital - Dearborn
Dearborn, Michigan, United States, 48124
Henry Ford Hospital
Detroit, Michigan, United States, 48202
McLaren Cancer Institute-Flint
Flint, Michigan, United States, 48532
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States, 49503
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States, 49503
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
McLaren Cancer Institute-Lapeer Region
Lapeer, Michigan, United States, 48446
Saint Mary Mercy Hospital
Livonia, Michigan, United States, 48154
McLaren Cancer Institute-Macomb
Mount Clemens, Michigan, United States, 48043
McLaren Cancer Institute-Central Michigan
Mount Pleasant, Michigan, United States, 48858
McLaren Cancer Institute-Owosso
Owosso, Michigan, United States, 48867
McLaren Cancer Institute-Northern Michigan
Petoskey, Michigan, United States, 49770
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States, 48073
Lakeland Medical Center Saint Joseph
Saint Joseph, Michigan, United States, 49085
William Beaumont Hospital - Troy
Troy, Michigan, United States, 48085
United States, Minnesota
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, United States, 56601
Saint Luke's Hospital of Duluth
Duluth, Minnesota, United States, 55805
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, United States, 56303
Regions Hospital
Saint Paul, Minnesota, United States, 55101
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
North Kansas City Hospital
Kansas City, Missouri, United States, 64116
University of Kansas Cancer Center - North
Kansas City, Missouri, United States, 64154
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Montana
Billings Clinic Cancer Center
Billings, Montana, United States, 59101
United States, Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89148
Renown Regional Medical Center
Reno, Nevada, United States, 89502
Saint Mary's Regional Medical Center
Reno, Nevada, United States, 89503
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08903
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Capital Health Medical Center-Hopewell
Pennington, New Jersey, United States, 08534
ProCure Proton Therapy Center-Somerset
Somerset, New Jersey, United States, 08873
Virtua Voorhees
Voorhees, New Jersey, United States, 08043
United States, New York
Montefiore Medical Center - Moses Campus
Bronx, New York, United States, 10467
New York-Presbyterian/Brooklyn Methodist Hospital
Brooklyn, New York, United States, 11215
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Northwell Health/Center for Advanced Medicine
Lake Success, New York, United States, 11042
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States, 10016
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
Mission Hospital
Asheville, North Carolina, United States, 28801
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, North Dakota
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States, 58501
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States, 58122
United States, Ohio
Cleveland Clinic Akron General
Akron, Ohio, United States, 44307
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, United States, 44122
Geauga Hospital
Chardon, Ohio, United States, 44024
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, United States, 45219
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
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Mercy Cancer Center-Elyria
Elyria, Ohio, United States, 44035
Cleveland Clinic Cancer Center Independence
Independence, Ohio, United States, 44131
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, United States, 44124
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio, United States, 44060
UH Seidman Cancer Center at Southwest General Hospital
Middleburg Heights, Ohio, United States, 44130
University Hospitals Parma Medical Center
Parma, Ohio, United States, 44129
North Coast Cancer Care
Sandusky, Ohio, United States, 44870
UH Seidman Cancer Center at Firelands Regional Medical Center
Sandusky, Ohio, United States, 44870
Cleveland Clinic Cancer Center Strongsville
Strongsville, Ohio, United States, 44136
University of Toledo
Toledo, Ohio, United States, 43614
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, United States, 45069
UHHS-Westlake Medical Center
Westlake, Ohio, United States, 44145
Cleveland Clinic Wooster Family Health and Surgery Center
Wooster, Ohio, United States, 44691
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Willamette Valley Cancer Center
Eugene, Oregon, United States, 97401
Legacy Mount Hood Medical Center
Gresham, Oregon, United States, 97030
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, United States, 97210
United States, Pennsylvania
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania, United States, 18015
Northeast Radiation Oncology Center
Dunmore, Pennsylvania, United States, 18512
Ephrata Cancer Center
Ephrata, Pennsylvania, United States, 17522
Adams Cancer Center
Gettysburg, Pennsylvania, United States, 17325
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, United States, 17109
Sechler Family Cancer Center
Lebanon, Pennsylvania, United States, 17042
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Jefferson Torresdale Hospital
Philadelphia, Pennsylvania, United States, 19114
Reading Hospital
West Reading, Pennsylvania, United States, 19611
WellSpan Health-York Cancer Center
York, Pennsylvania, United States, 17403
United States, South Carolina
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, United States, 29316
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, United States, 29605
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, United States, 29615
Self Regional Healthcare
Greenwood, South Carolina, United States, 29646
Prisma Health Cancer Institute - Greer
Greer, South Carolina, United States, 29650
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, United States, 29672
United States, South Dakota
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
United States, Tennessee
Tennessee Cancer Specialists-Dowell Springs
Knoxville, Tennessee, United States, 37909
United States, Texas
Dell Seton Medical Center at The University of Texas
Austin, Texas, United States, 78701
Austin Cancer Centers-Central Austin
Austin, Texas, United States, 78702
Texas Oncology-Austin Midtown
Austin, Texas, United States, 78705
Texas Oncology - Central Austin Cancer Center
Austin, Texas, United States, 78731
Texas Oncology - South Austin Cancer Center
Austin, Texas, United States, 78745
Austin Cancer Centers-North
Austin, Texas, United States, 78758
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
Texas Oncology - Denison Cancer Center
Denison, Texas, United States, 75020
Texas Oncology-Flower Mound
Flower Mound, Texas, United States, 75028
Texas Oncology - Fort Worth Cancer Center
Fort Worth, Texas, United States, 76104
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0565
Memorial Hermann Memorial City Medical Center
Houston, Texas, United States, 77024
M D Anderson Cancer Center
Houston, Texas, United States, 77030
UTMB Cancer Center at Victory Lakes
League City, Texas, United States, 77573
Covenant Medical Center-Lakeside
Lubbock, Texas, United States, 79410
Texas Oncology-Seton Williamson
Round Rock, Texas, United States, 78665
Texas Oncology - Round Rock Cancer Center
Round Rock, Texas, United States, 78681
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Texas Oncology Cancer Center Sugar Land
Sugar Land, Texas, United States, 77479
Tyler Cancer Center
Tyler, Texas, United States, 75702
United States, Utah
Logan Regional Hospital
Logan, Utah, United States, 84321
Intermountain Medical Center
Murray, Utah, United States, 84107
McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Utah Valley Regional Medical Center
Provo, Utah, United States, 84604
Dixie Medical Center Regional Cancer Center
Saint George, Utah, United States, 84770
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
United States, Vermont
Central Vermont Medical Center/National Life Cancer Treatment
Berlin, Vermont, United States, 05602
University of Vermont Medical Center
Burlington, Vermont, United States, 05401
Norris Cotton Cancer Center-North
Saint Johnsbury, Vermont, United States, 05819
United States, Virginia
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States, 23298
United States, Washington
SCCA Proton Therapy Center
Seattle, Washington, United States, 98133
Seattle Cancer Care Alliance at Northwest Hospital
Seattle, Washington, United States, 98133
University of Washington Medical Center - Montlake
Seattle, Washington, United States, 98195
Compass Oncology Vancouver
Vancouver, Washington, United States, 98684
Legacy Salmon Creek Hospital
Vancouver, Washington, United States, 98686
United States, West Virginia
Wheeling Hospital/Schiffler Cancer Center
Wheeling, West Virginia, United States, 26003
United States, Wisconsin
Langlade Hospital and Cancer Center
Antigo, Wisconsin, United States, 54409
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, United States, 53051
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, United States, 53188
Aspirus Regional Cancer Center
Wausau, Wisconsin, United States, 54401
Canada, British Columbia
BCCA-Vancouver Island Cancer Centre
Victoria, British Columbia, Canada, V8R 6V5
Canada, Ontario
Ottawa Hospital and Cancer Center-General Campus
Ottawa, Ontario, Canada, K1H 8L6
Windsor Regional Cancer Centre
Windsor, Ontario, Canada, N8W 2X3
Canada, Quebec
CHUM - Hopital Notre-Dame
Montreal, Quebec, Canada, H2L 4M1
McGill University Department of Oncology
Montreal, Quebec, Canada, H2W 1S6
CHUM - Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2X 3E4
The Research Institute of the McGill University Health Centre (MUHC)
Montreal, Quebec, Canada, H3H 2R9
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
Quebec City, Quebec, Canada, G1R 2J6
Canada, Saskatchewan
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Sponsors and Collaborators
NRG Oncology
National Cancer Institute (NCI)
Radiation Therapy Oncology Group
Investigators
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Principal Investigator: Minesh Mehta, MD NRG Oncology
Principal Investigator: Vinai Gondi, MD NRG Oncology
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Responsible Party: NRG Oncology
ClinicalTrials.gov Identifier: NCT02179086    
Obsolete Identifiers: NCT02163135
Other Study ID Numbers: NRG-BN001
NCI-2014-01072 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NRG-BN001 ( Other Identifier: NRG Oncology )
NRG-BN001 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
First Posted: July 1, 2014    Key Record Dates
Last Update Posted: May 19, 2022
Last Verified: May 2022
Additional relevant MeSH terms:
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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
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents