Clinical Trial - NCT02179086

Dose-Escalated Photon IMRT or Proton Beam Radiation Therapy Versus Standard-Dose Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma

Recruiting

Sponsor: NRG Oncology

Collaborators: National Cancer Institute (NCI), Radiation Therapy Oncology Group

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT02179086

Protocol Info

Short Description: NRG-BN001: Phase II IMRT vs Proton Therapy + Temozolomide in GBM
Long Description: NRG-BN001: 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
MGH Status: Open
Sponsor: Coop/RTOG
Disease Program: Brain/CNS

Next Steps


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Purpose

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 Title Intervention Phase
Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma 3-dimensional conformal radiation therapy intensity-modulated radiation therapy photon beam radiation therapy intensity-modulated radiation therapy proton beam radiation therapy temozolomide laboratory biomarker analysis Phase 2
Study Type Interventional
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

Primary Outcome Measures

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] [Designated as safety issue: ]


Secondary Outcome Measures

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] [Designated as safety issue: ]

Progression-free survival (PFS) [Time Frame: Date of randomization to the date of progression or death, assessed up to 5 years] [Designated as safety issue: ]

Incidence of treatment-related toxicity, as measured by the Common Terminology Criteria for Adverse Events version 4 [Time Frame: Up to 5 years] [Designated as safety issue: ]

Change in perceived cognitive function, as measured by M.D. Anderson Symptom Inventory Brain Tumor [Time Frame: Baseline to up to 60 weeks] [Designated as safety issue: ]

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] [Designated as safety issue: ]

Change in CD4 lymphopenia count [Time Frame: Baseline to up to 5 years] [Designated as safety issue: ]

Use of magnetic resonance diffusion and perfusion imaging to differentiate between tumor progression and pseudo-progression [Time Frame: Up to 5 years] [Designated as safety issue: ]

Estimated Enrollment: 606
Study Start Date: October 2014
Estimated Study Completion Date: May 2026
Estimated Primary Completion Date: May 2021
Arms Assigned Interventions

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.
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:intensity-modulated radiation therapy
Undergo dose-escalated and -intensified photon IMRT

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.

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

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT02179086

Locations

  • 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 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
    • 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 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
    • 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 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
    • The 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
    • 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 Inc-Memorial Campus 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/Barrett Cancer 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 Pointe 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
    • Aria Health-Torresdale Campus 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
    • Medical University of South Carolina Charleston, South Carolina, United States, 29425
    • Greenville Health System Cancer Institute-Faris Greenville, South Carolina, United States, 29605
    • Greenville Health System Cancer Institute-Eastside Greenville, South Carolina, United States, 29615
    • Self Regional Healthcare Greenwood, South Carolina, United States, 29646
    • Greenville Health System Cancer Institute-Greer Greer, South Carolina, United States, 29650
    • Greenville Health System Cancer Institute-Seneca Seneca, South Carolina, United States, 29672
    • Greenville Health System Cancer Institute-Spartanburg Spartanburg, South Carolina, United States, 29307
  • 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-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 Cancer Center-Sherman Sherman, Texas, United States, 75090
    • Texas Oncology Cancer Center Sugar Land Sugar Land, Texas, United States, 77479
    • Tyler Cancer Center Tyler, Texas, United States, 75702
  • United States, Utah
    • 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
    • ProCure Proton Therapy Center-Seattle Seattle, Washington, United States, 98133
    • Seattle Cancer Care Alliance at Northwest Hospital Seattle, Washington, United States, 98133
    • University of Washington Medical Center 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 Hospital and Clinics Madison, Wisconsin, United States, 53792
    • Community Memorial Hospital Menomonee Falls, Wisconsin, United States, 53051
    • Froedtert and the 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

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT02179086
Other Study ID Numbers: NCI-2014-01072
Study First Received:
Last Updated:
Health Authority:

Additional relevant MeSH terms:

Glioblastoma

Gliosarcoma

Temozolomide

Next Steps


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ClinicalTrials.gov processed this data on July 18, 2019