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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

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ClinicalTrials.gov Identifier: NCT02179086
Recruitment Status : Recruiting
First Posted : July 1, 2014
Last Update Posted : November 5, 2018
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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 606 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 2019
Estimated Study Completion Date : May 2024

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.



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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.


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


  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Cancer Center Active, not recruiting
Birmingham, Alabama, United States, 35233
United States, Arizona
Saint Joseph's Hospital and Medical Center Suspended
Phoenix, Arizona, United States, 85013
Mayo Clinic Hospital Recruiting
Phoenix, Arizona, United States, 85054
Contact: Site Public Contact    855-776-0015      
Principal Investigator: Sujay A. Vora         
Mayo Clinic in Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Site Public Contact    855-776-0015      
Principal Investigator: Sujay A. Vora         
Arizona Oncology Associates-West Orange Grove Active, not recruiting
Tucson, Arizona, United States, 85704
The University of Arizona Medical Center-University Campus Suspended
Tucson, Arizona, United States, 85724
United States, Arkansas
University of Arkansas for Medical Sciences Suspended
Little Rock, Arkansas, United States, 72205
United States, California
Sutter Cancer Centers Radiation Oncology Services-Auburn Suspended
Auburn, California, United States, 95603
AIS Cancer Center at San Joaquin Community Hospital Suspended
Bakersfield, California, United States, 93301
Alta Bates Summit Medical Center-Herrick Campus Suspended
Berkeley, California, United States, 94704
Sutter Cancer Centers Radiation Oncology Services-Cameron Park Suspended
Cameron Park, California, United States, 95682
Eden Hospital Medical Center Suspended
Castro Valley, California, United States, 94546
Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92354
Contact: Site Public Contact    909-558-3375      
Principal Investigator: Joseph I. Kang         
Los Angeles County-USC Medical Center Suspended
Los Angeles, California, United States, 90033
USC / Norris Comprehensive Cancer Center Suspended
Los Angeles, California, United States, 90033
Cedars Sinai Medical Center Suspended
Los Angeles, California, United States, 90048
Fremont - Rideout Cancer Center Suspended
Marysville, California, United States, 95901
Memorial Medical Center Suspended
Modesto, California, United States, 95355
Kaiser Permanente Oakland-Broadway Suspended
Oakland, California, United States, 94611
Saint Joseph Hospital - Orange Active, not recruiting
Orange, California, United States, 92868
UC Irvine Health/Chao Family Comprehensive Cancer Center Suspended
Orange, California, United States, 92868
Palo Alto Medical Foundation Health Care Suspended
Palo Alto, California, United States, 94301
Pomona Valley Hospital Medical Center Suspended
Pomona, California, United States, 91767
Kaiser Permanente-Rancho Cordova Cancer Center Suspended
Rancho Cordova, California, United States, 95670
Rohnert Park Cancer Center Suspended
Rohnert Park, California, United States, 94928
Sutter Cancer Centers Radiation Oncology Services-Roseville Suspended
Roseville, California, United States, 95661
The Permanente Medical Group-Roseville Radiation Oncology Suspended
Roseville, California, United States, 95678
Sutter Medical Center Sacramento Suspended
Sacramento, California, United States, 95816
University of California Davis Comprehensive Cancer Center Suspended
Sacramento, California, United States, 95817
South Sacramento Cancer Center Suspended
Sacramento, California, United States, 95823
California Pacific Medical Center-Pacific Campus Suspended
San Francisco, California, United States, 94115
Palo Alto Medical Foundation-Santa Cruz Suspended
Santa Cruz, California, United States, 95065
Kaiser Permanente Cancer Treatment Center Suspended
South San Francisco, California, United States, 94080
Palo Alto Medical Foundation-Sunnyvale Suspended
Sunnyvale, California, United States, 94086
Sutter Cancer Centers Radiation Oncology Services-Vacaville Suspended
Vacaville, California, United States, 95687
John Muir Medical Center-Walnut Creek Active, not recruiting
Walnut Creek, California, United States, 94598
United States, Colorado
UCHealth Memorial Hospital Central Suspended
Colorado Springs, Colorado, United States, 80909
Poudre Valley Hospital Suspended
Fort Collins, Colorado, United States, 80524
United States, Connecticut
Hartford Hospital Suspended
Hartford, Connecticut, United States, 06102
United States, Florida
Boca Raton Regional Hospital Active, not recruiting
Boca Raton, Florida, United States, 33486
University of Florida Health Science Center - Gainesville Suspended
Gainesville, Florida, United States, 32610
Baptist MD Anderson Cancer Center Active, not recruiting
Jacksonville, Florida, United States, 32207
University of Florida Health Science Center - Jacksonville Recruiting
Jacksonville, Florida, United States, 32209
Contact: Site Public Contact    412-339-5294    Roster@nrgoncology.org   
Principal Investigator: Ronny L. Rotondo         
Baptist Medical Center South Active, not recruiting
Jacksonville, Florida, United States, 32258
Moffitt Cancer Center Suspended
Tampa, Florida, United States, 33612
United States, Georgia
Emory University Hospital/Winship Cancer Institute Suspended
Atlanta, Georgia, United States, 30322
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Suspended
Savannah, Georgia, United States, 31405
United States, Idaho
Saint Alphonsus Cancer Care Center-Boise Suspended
Boise, Idaho, United States, 83706
United States, Illinois
Northwestern University Suspended
Chicago, Illinois, United States, 60611
John H Stroger Jr Hospital of Cook County Suspended
Chicago, Illinois, United States, 60612
Rush University Medical Center Suspended
Chicago, Illinois, United States, 60612
University of Chicago Comprehensive Cancer Center Suspended
Chicago, Illinois, United States, 60637
Decatur Memorial Hospital Suspended
Decatur, Illinois, United States, 62526
Northwestern Medicine Cancer Center Kishwaukee Recruiting
DeKalb, Illinois, United States, 60115
Contact: Site Public Contact    630-315-1918    claudine.gamster@nm.org   
Principal Investigator: Vinai Gondi         
Northwestern Medicine Cancer Center Delnor Recruiting
Geneva, Illinois, United States, 60134
Contact: Site Public Contact    630-315-1918    Claudine.Gamster@CadenceHealth.org   
Principal Investigator: Vinai Gondi         
UC Comprehensive Cancer Center at Silver Cross Suspended
New Lenox, Illinois, United States, 60451
Advocate Lutheran General Hospital Active, not recruiting
Park Ridge, Illinois, United States, 60068
OSF Saint Francis Medical Center Suspended
Peoria, Illinois, United States, 61637
Memorial Medical Center Recruiting
Springfield, Illinois, United States, 62781
Contact: Site Public Contact    217-788-3528      
Principal Investigator: Bryan A. Faller         
Northwestern Medicine Cancer Center Warrenville Recruiting
Warrenville, Illinois, United States, 60555
Contact: Site Public Contact    630-315-1918    Claudine.Gamster@CadenceHealth.org   
Principal Investigator: Vinai Gondi         
United States, Indiana
Radiation Oncology Associates PC Suspended
Fort Wayne, Indiana, United States, 46804
Parkview Hospital Randallia Suspended
Fort Wayne, Indiana, United States, 46805
IU Health Methodist Hospital Active, not recruiting
Indianapolis, Indiana, United States, 46202
Community Cancer Center East Active, not recruiting
Indianapolis, Indiana, United States, 46219
Community Cancer Center South Active, not recruiting
Indianapolis, Indiana, United States, 46227
Community Cancer Center North Active, not recruiting
Indianapolis, Indiana, United States, 46256
IU Health Ball Memorial Hospital Active, not recruiting
Muncie, Indiana, United States, 47303
United States, Iowa
Mercy Hospital Suspended
Cedar Rapids, Iowa, United States, 52403
Iowa Methodist Medical Center Active, not recruiting
Des Moines, Iowa, United States, 50309
United States, Kansas
University of Kansas Cancer Center Suspended
Kansas City, Kansas, United States, 66160
University of Kansas Cancer Center-Overland Park Suspended
Overland Park, Kansas, United States, 66210
United States, Kentucky
Norton Hospital Pavilion and Medical Campus Active, not recruiting
Louisville, Kentucky, United States, 40202
United States, Louisiana
Ochsner Medical Center Jefferson Active, not recruiting
New Orleans, Louisiana, United States, 70121
Willis-Knighton Medical and Cancer Center Recruiting
Shreveport, Louisiana, United States, 71103
Contact: Site Public Contact    318-212-8671    bbarrow@wkhs.com   
Principal Investigator: Augusto C. Ochoa         
United States, Maryland
Maryland Proton Treatment Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Site Public Contact    410-369-5226    info@mdproton.com   
Principal Investigator: Mark V. Mishra         
University of Maryland/Greenebaum Cancer Center Suspended
Baltimore, Maryland, United States, 21201
Upper Chesapeake Medical Center Recruiting
Bel Air, Maryland, United States, 21014
Contact: Site Public Contact    443-643-3010      
Principal Investigator: Jack J. Hong         
Central Maryland Radiation Oncology in Howard County Suspended
Columbia, Maryland, United States, 21044
Tate Cancer Center Suspended
Glen Burnie, Maryland, United States, 21061
United States, Massachusetts
Tufts Medical Center Suspended
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital Cancer Center Recruiting
Boston, Massachusetts, United States, 02114
Contact: Site Public Contact    877-726-5130      
Principal Investigator: Helen A. Shih         
Boston Medical Center Active, not recruiting
Boston, Massachusetts, United States, 02118
Mass General/North Shore Cancer Center Suspended
Danvers, Massachusetts, United States, 01923
Lowell General Hospital Active, not recruiting
Lowell, Massachusetts, United States, 01854
United States, Michigan
Saint Joseph Mercy Hospital Suspended
Ann Arbor, Michigan, United States, 48106
University of Michigan Comprehensive Cancer Center Active, not recruiting
Ann Arbor, Michigan, United States, 48109
Henry Ford Hospital Active, not recruiting
Detroit, Michigan, United States, 48202
McLaren Cancer Institute-Flint Active, not recruiting
Flint, Michigan, United States, 48532
Mercy Health Saint Mary's Active, not recruiting
Grand Rapids, Michigan, United States, 49503
Spectrum Health at Butterworth Campus Active, not recruiting
Grand Rapids, Michigan, United States, 49503
West Michigan Cancer Center Active, not recruiting
Kalamazoo, Michigan, United States, 49007
McLaren Cancer Institute-Lapeer Region Active, not recruiting
Lapeer, Michigan, United States, 48446
Saint Mary Mercy Hospital Suspended
Livonia, Michigan, United States, 48154
McLaren Cancer Institute-Macomb Active, not recruiting
Mount Clemens, Michigan, United States, 48043
McLaren Cancer Institute-Central Michigan Active, not recruiting
Mount Pleasant, Michigan, United States, 48858
McLaren Cancer Institute-Owosso Active, not recruiting
Owosso, Michigan, United States, 48867
McLaren Cancer Institute-Northern Michigan Active, not recruiting
Petoskey, Michigan, United States, 49770
Saint Joseph Mercy Oakland Suspended
Pontiac, Michigan, United States, 48341
Lakeland Medical Center Saint Joseph Active, not recruiting
Saint Joseph, Michigan, United States, 49085
United States, Minnesota
Sanford Clinic North-Bemidgi Suspended
Bemidji, Minnesota, United States, 56601
Saint Luke's Hospital of Duluth Suspended
Duluth, Minnesota, United States, 55805
Coborn Cancer Center at Saint Cloud Hospital Active, not recruiting
Saint Cloud, Minnesota, United States, 56303
Regions Hospital Active, not recruiting
Saint Paul, Minnesota, United States, 55101
United States, Mississippi
University of Mississippi Medical Center Active, not recruiting
Jackson, Mississippi, United States, 39216
United States, Missouri
North Kansas City Hospital Suspended
Kansas City, Missouri, United States, 64116
The University of Kansas Cancer Center-North Suspended
Kansas City, Missouri, United States, 64154
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Site Public Contact    800-600-3606    info@siteman.wustl.edu   
Principal Investigator: Jiayi Huang         
United States, Montana
Billings Clinic Cancer Center Suspended
Billings, Montana, United States, 59101
United States, Nevada
Comprehensive Cancer Centers of Nevada Active, not recruiting
Las Vegas, Nevada, United States, 89148
Renown Regional Medical Center Active, not recruiting
Reno, Nevada, United States, 89502
Saint Mary's Regional Medical Center Active, not recruiting
Reno, Nevada, United States, 89503
United States, New Hampshire
Dartmouth Hitchcock Medical Center Active, not recruiting
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Memorial Sloan Kettering Basking Ridge Suspended
Basking Ridge, New Jersey, United States, 07920
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Site Public Contact    732-235-8675      
Principal Investigator: Rahul R. Parikh         
Rutgers Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Site Public Contact    732-235-8675      
Principal Investigator: Rahul R. Parikh         
Capital Health Medical Center-Hopewell Suspended
Pennington, New Jersey, United States, 08534
ProCure Proton Therapy Center-Somerset Suspended
Somerset, New Jersey, United States, 08873
Virtua Voorhees Active, not recruiting
Voorhees, New Jersey, United States, 08043
United States, New York
Montefiore Medical Center - Moses Campus Active, not recruiting
Bronx, New York, United States, 10467
New York-Presbyterian/Brooklyn Methodist Hospital Suspended
Brooklyn, New York, United States, 11215
Memorial Sloan Kettering Commack Suspended
Commack, New York, United States, 11725
Memorial Sloan Kettering Westchester Suspended
Harrison, New York, United States, 10604
Northwell Health/Center for Advanced Medicine Active, not recruiting
Lake Success, New York, United States, 11042
Columbia University/Herbert Irving Cancer Center Active, not recruiting
New York, New York, United States, 10032
Memorial Sloan Kettering Cancer Center Suspended
New York, New York, United States, 10065
United States, North Carolina
Mission Hospital Inc-Memorial Campus Suspended
Asheville, North Carolina, United States, 28801
Novant Health Forsyth Medical Center Active, not recruiting
Winston-Salem, North Carolina, United States, 27103
Wake Forest University Health Sciences Suspended
Winston-Salem, North Carolina, United States, 27157
United States, North Dakota
Sanford Bismarck Medical Center Suspended
Bismarck, North Dakota, United States, 58501
Roger Maris Cancer Center Suspended
Fargo, North Dakota, United States, 58122
United States, Ohio
Cleveland Clinic Akron General Suspended
Akron, Ohio, United States, 44307
UHHS-Chagrin Highlands Medical Center Suspended
Beachwood, Ohio, United States, 44122
Geauga Hospital Suspended
Chardon, Ohio, United States, 44024
University of Cincinnati/Barrett Cancer Center Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Site Public Contact    513-558-4553    uchealthnews@uc.edu   
Principal Investigator: Jordan Kharofa         
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44106
Contact: Site Public Contact    800-641-2422    CTUReferral@UHhospitals.org   
Principal Investigator: Mitchell Machtay         
Cleveland Clinic Cancer Center/Fairview Hospital Suspended
Cleveland, Ohio, United States, 44111
Cleveland Clinic Foundation Suspended
Cleveland, Ohio, United States, 44195
Ohio State University Comprehensive Cancer Center Suspended
Columbus, Ohio, United States, 43210
Riverside Methodist Hospital Active, not recruiting
Columbus, Ohio, United States, 43214
Mercy Cancer Center-Elyria Suspended
Elyria, Ohio, United States, 44035
Cleveland Clinic Cancer Center Independence Suspended
Independence, Ohio, United States, 44131
Hillcrest Hospital Cancer Center Suspended
Mayfield Heights, Ohio, United States, 44124
Lake University Ireland Cancer Center Suspended
Mentor, Ohio, United States, 44060
Southwest General Health Center Ireland Cancer Center Suspended
Middleburg Heights, Ohio, United States, 44130
University Hospitals Parma Medical Center Suspended
Parma, Ohio, United States, 44129
Ireland Cancer Center at Firelands Regional Medical Center Suspended
Sandusky, Ohio, United States, 44870
North Coast Cancer Care Suspended
Sandusky, Ohio, United States, 44870
Cleveland Clinic Cancer Center Strongsville Suspended
Strongsville, Ohio, United States, 44136
University of Toledo Active, not recruiting
Toledo, Ohio, United States, 43614
University Pointe Recruiting
West Chester, Ohio, United States, 45069
Contact: Site Public Contact       clinicaltrials@ucphysicians.com   
Principal Investigator: Jordan Kharofa         
UHHS-Westlake Medical Center Suspended
Westlake, Ohio, United States, 44145
Cleveland Clinic Wooster Family Health and Surgery Center Suspended
Wooster, Ohio, United States, 44691
United States, Oklahoma
University of Oklahoma Health Sciences Center Suspended
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Willamette Valley Cancer Center Suspended
Eugene, Oregon, United States, 97401
Legacy Mount Hood Medical Center Suspended
Gresham, Oregon, United States, 97030
Legacy Good Samaritan Hospital and Medical Center Suspended
Portland, Oregon, United States, 97210
United States, Pennsylvania
Saint Luke's University Hospital-Bethlehem Campus Suspended
Bethlehem, Pennsylvania, United States, 18015
Northeast Radiation Oncology Center Suspended
Dunmore, Pennsylvania, United States, 18512
Ephrata Cancer Center Suspended
Ephrata, Pennsylvania, United States, 17522
Adams Cancer Center Suspended
Gettysburg, Pennsylvania, United States, 17325
UPMC Pinnacle Cancer Center/Community Osteopathic Campus Suspended
Harrisburg, Pennsylvania, United States, 17109
Sechler Family Cancer Center Recruiting
Lebanon, Pennsylvania, United States, 17042
Contact: Site Public Contact    717-741-8303    doxenberg@wellspan.org   
Principal Investigator: Amit B. Shah         
University of Pennsylvania/Abramson Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Site Public Contact    800-474-9892      
Principal Investigator: Robert A. Lustig         
Thomas Jefferson University Hospital Suspended
Philadelphia, Pennsylvania, United States, 19107
Aria Health-Torresdale Campus Suspended
Philadelphia, Pennsylvania, United States, 19114
Reading Hospital Suspended
West Reading, Pennsylvania, United States, 19611
WellSpan Health-York Cancer Center Recruiting
York, Pennsylvania, United States, 17403
Contact: Site Public Contact    877-441-7957      
Principal Investigator: Amit B. Shah         
United States, South Carolina
Medical University of South Carolina Active, not recruiting
Charleston, South Carolina, United States, 29425
Greenville Health System Cancer Institute-Faris Suspended
Greenville, South Carolina, United States, 29605
Greenville Health System Cancer Institute-Eastside Suspended
Greenville, South Carolina, United States, 29615
Self Regional Healthcare Active, not recruiting
Greenwood, South Carolina, United States, 29646
Greenville Health System Cancer Institute-Greer Suspended
Greer, South Carolina, United States, 29650
Greenville Health System Cancer Institute-Seneca Suspended
Seneca, South Carolina, United States, 29672
Greenville Health System Cancer Institute-Spartanburg Suspended
Spartanburg, South Carolina, United States, 29307
United States, South Dakota
Sanford USD Medical Center - Sioux Falls Suspended
Sioux Falls, South Dakota, United States, 57117-5134
United States, Tennessee
Tennessee Cancer Specialists-Dowell Springs Suspended
Knoxville, Tennessee, United States, 37909
United States, Texas
Dell Seton Medical Center at The University of Texas Recruiting
Austin, Texas, United States, 78701
Contact: Site Public Contact    512-324-7991      
Principal Investigator: Brian D. Vaillant         
Austin Cancer Centers-Central Austin Recruiting
Austin, Texas, United States, 78702
Contact: Site Public Contact    412-339-5294    Roster@nrgoncology.org   
Principal Investigator: Brian D. Vaillant         
Texas Oncology-Austin Midtown Suspended
Austin, Texas, United States, 78705
Texas Oncology - Central Austin Cancer Center Suspended
Austin, Texas, United States, 78731
Texas Oncology - South Austin Cancer Center Suspended
Austin, Texas, United States, 78745
Austin Cancer Centers-North Suspended
Austin, Texas, United States, 78758
UT Southwestern/Simmons Cancer Center-Dallas Suspended
Dallas, Texas, United States, 75390
Texas Oncology-Flower Mound Recruiting
Flower Mound, Texas, United States, 75028
Contact: Site Public Contact    972-537-4100      
Principal Investigator: Vivek S. Kavadi         
The Klabzuba Cancer Center Suspended
Fort Worth, Texas, United States, 76104
University of Texas Medical Branch Active, not recruiting
Galveston, Texas, United States, 77555-0565
Memorial Hermann Memorial City Medical Center Active, not recruiting
Houston, Texas, United States, 77024
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Site Public Contact    877-312-3961      
Principal Investigator: Andrew J. Bishop         
UTMB Cancer Center at Victory Lakes Active, not recruiting
League City, Texas, United States, 77573
Covenant Medical Center-Lakeside Suspended
Lubbock, Texas, United States, 79410
Texas Oncology-Seton Williamson Suspended
Round Rock, Texas, United States, 78665
Texas Oncology - Round Rock Cancer Center Suspended
Round Rock, Texas, United States, 78681
University of Texas Health Science Center at San Antonio Suspended
San Antonio, Texas, United States, 78229
Texas Cancer Center-Sherman Suspended
Sherman, Texas, United States, 75090
Texas Oncology Cancer Center Sugar Land Suspended
Sugar Land, Texas, United States, 77479
Tyler Cancer Center Suspended
Tyler, Texas, United States, 75702
United States, Utah
Logan Regional Hospital Suspended
Logan, Utah, United States, 84321
Intermountain Medical Center Suspended
Murray, Utah, United States, 84107
McKay-Dee Hospital Center Suspended
Ogden, Utah, United States, 84403
Utah Valley Regional Medical Center Suspended
Provo, Utah, United States, 84604
Dixie Medical Center Regional Cancer Center Suspended
Saint George, Utah, United States, 84770
Huntsman Cancer Institute/University of Utah Suspended
Salt Lake City, Utah, United States, 84112
United States, Vermont
Central Vermont Medical Center/National Life Cancer Treatment Suspended
Berlin, Vermont, United States, 05602
University of Vermont Medical Center Suspended
Burlington, Vermont, United States, 05401
Norris Cotton Cancer Center-North Active, not recruiting
Saint Johnsbury, Vermont, United States, 05819
United States, Virginia
Virginia Commonwealth University/Massey Cancer Center Suspended
Richmond, Virginia, United States, 23298
United States, Washington
ProCure Proton Therapy Center-Seattle Suspended
Seattle, Washington, United States, 98133
Seattle Cancer Care Alliance at Northwest Hospital Recruiting
Seattle, Washington, United States, 98133
Contact: Site Public Contact    206-606-5800      
Principal Investigator: Lia M. Halasz         
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Site Public Contact    800-804-8824      
Principal Investigator: Lia M. Halasz         
Compass Oncology Vancouver Suspended
Vancouver, Washington, United States, 98684
Legacy Salmon Creek Hospital Suspended
Vancouver, Washington, United States, 98686
United States, West Virginia
Wheeling Hospital/Schiffler Cancer Center Suspended
Wheeling, West Virginia, United States, 26003
United States, Wisconsin
Langlade Hospital and Cancer Center Active, not recruiting
Antigo, Wisconsin, United States, 54409
Gundersen Lutheran Medical Center Active, not recruiting
La Crosse, Wisconsin, United States, 54601
University of Wisconsin Hospital and Clinics Active, not recruiting
Madison, Wisconsin, United States, 53792
Community Memorial Hospital Suspended
Menomonee Falls, Wisconsin, United States, 53051
Froedtert and the Medical College of Wisconsin Suspended
Milwaukee, Wisconsin, United States, 53226
UW Cancer Center at ProHealth Care Active, not recruiting
Waukesha, Wisconsin, United States, 53188
Aspirus Regional Cancer Center Active, not recruiting
Wausau, Wisconsin, United States, 54401
Canada, British Columbia
BCCA-Vancouver Island Cancer Centre Suspended
Victoria, British Columbia, Canada, V8R 6V5
Canada, Ontario
Ottawa Hospital and Cancer Center-General Campus Active, not recruiting
Ottawa, Ontario, Canada, K1H 8L6
Windsor Regional Cancer Centre Suspended
Windsor, Ontario, Canada, N8W 2X3
Canada, Quebec
CHUM - Hopital Notre-Dame Recruiting
Montreal, Quebec, Canada, H2L 4M1
Contact: Jean-Paul Bahary    514-890-8000 ext 14788    marie-josee.samson.chum@ssss.gouv.qc.ca   
Principal Investigator: Jean-Paul Bahary         
McGill University Department of Oncology Suspended
Montreal, Quebec, Canada, H2W 1S6
CHUM - Centre Hospitalier de l'Universite de Montreal Suspended
Montreal, Quebec, Canada, H2X 3E4
The Research Institute of the McGill University Health Centre (MUHC) Suspended
Montreal, Quebec, Canada, H3H 2R9
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ) Suspended
Quebec City, Quebec, Canada, G1R 2J6
Canada, Saskatchewan
Saskatoon Cancer Centre Active, not recruiting
Saskatoon, Saskatchewan, Canada, S7N 4H4
Sponsors and Collaborators
NRG Oncology
National Cancer Institute (NCI)
Radiation Therapy Oncology Group
Investigators
Principal Investigator: Minesh Mehta NRG Oncology

Responsible Party: NRG Oncology
ClinicalTrials.gov Identifier: NCT02179086     History of Changes
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: November 5, 2018
Last Verified: November 2018

Additional relevant MeSH terms:
Glioblastoma
Gliosarcoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents