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

NCT02179086 | Active Not Recruiting Phase 2

• 4 other identifiers: NRG-BN001NCI-2014-01072P50CA127001U10CA180868
• Study Type: interventional
• Target: 606
• Locations: 2 countries
• Sites: 237

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.

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Will be compared between dose-escalated and -intensified photon intensity-modulated radiation therapy or proton beam therapy with concomitant and adjuvant temozolomide and the standard-dose photon irradiation with concomitant and adjuvant temozolomide. The proportion of patients alive will be estimated using the Kaplan-Meier method.

  Date of randomization to the date of death due to any cause, assessed up to 5 years

Secondary Outcomes (5)

• Overall survival

  Date of randomization to the date of death, assessed up to 5 years

• Progression-free survival

  Date of randomization to the date of progression or death, assessed up to 5 years

• Incidence of treatment-related toxicity, as measured by the Common Terminology Criteria for Adverse Events version 4

  Up to 5 years

• Change in perceived cognitive function, as measured by M.D. Anderson Symptom Inventory Brain Tumor

  Baseline to up to 60 weeks

• 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

  Baseline to up to 60 weeks

Other Outcomes (3)

• CD4 lymphopenia count

  Baseline to up to 5 years

• Use of magnetic resonance diffusion and perfusion imaging to differentiate between tumor progression and pseudo-progression

  Baseline - cycle 4

• Use of magnetic resonance diffusion and perfusion imaging as early predictors of overall survival

  Baseline up to 12 months

Study Arms (4)

Arm A1 (control)

ACTIVE COMPARATOR

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 cycles in the absence of disease progression or unacceptable toxicity.

Radiation: 3-Dimensional Conformal Radiation Therapy; Radiation: Intensity-Modulated Radiation Therapy; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Temozolomide

Arm A2 (control)

ACTIVE COMPARATOR

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 cycles in the absence of disease progression or unacceptable toxicity.

Radiation: 3-Dimensional Conformal Radiation Therapy; Radiation: Intensity-Modulated Radiation Therapy; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Temozolomide

Arm B (photon IMRT)

EXPERIMENTAL

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 cycles in the absence of disease progression or unacceptable toxicity.

Radiation: Intensity-Modulated Radiation Therapy; Other: Laboratory Biomarker Analysis; Radiation: Photon Beam Radiation Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Temozolomide

Arm C (proton beam radiation therapy)

EXPERIMENTAL

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 cycles in the absence of disease progression or unacceptable toxicity.

Other: Laboratory Biomarker Analysis; Radiation: Proton Beam Radiation Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Temozolomide

Interventions

Intensity-Modulated Radiation Therapy RADIATION

Undergo standard-dose IMRT

Also known as: IMRT, Intensity modulated radiation therapy (procedure), Intensity Modulated RT, Intensity-Modulated Radiotherapy, Radiation, Intensity-Modulated Radiotherapy

Arm A1 (control); Arm A2 (control)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm A1 (control); Arm A2 (control); Arm B (photon IMRT); Arm C (proton beam radiation therapy)

Photon Beam Radiation Therapy RADIATION

Undergo dose-escalated and -intensified photon IMRT

Also known as: External beam radiation therapy using photons (procedure), Photon, Photon EBRT, Photon External Beam Radiotherapy, PHOTON Therapy, Radiation, Photon Beam

Arm B (photon IMRT)

Proton Beam Radiation Therapy RADIATION

Undergo dose-escalated and -intensified proton beam radiation therapy

Also known as: External beam radiation therapy protons (procedure), External Beam Radiotherapy (protons), PBRT, Proton, Proton EBRT, Proton External Beam Radiotherapy, Proton Radiation Therapy, PROTON Therapy, Radiation, Proton Beam

Arm C (proton beam radiation therapy)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm A1 (control); Arm A2 (control); Arm B (photon IMRT); Arm C (proton beam radiation therapy)

Questionnaire Administration OTHER

Ancillary studies

Arm A1 (control); Arm A2 (control); Arm B (photon IMRT); Arm C (proton beam radiation therapy)

Temozolomide DRUG

Given PO

Also known as: CCRG-81045, Gliotem, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831, M and B 39831, Methazolastone, RP-46161, SCH 52365, Temcad, Temizole, Temodal, Temodar, Temomedac, TMZ

Arm A1 (control); Arm A2 (control); Arm B (photon IMRT); Arm C (proton beam radiation therapy)

3-Dimensional Conformal Radiation Therapy RADIATION

Undergo standard-dose 3D-CRT

Also known as: 3-dimensional radiation therapy, 3D Conformal, 3D CONFORMAL RADIATION THERAPY, 3D CRT, 3D radiotherapy, 3D-CRT, Conformal Therapy, Radiation Conformal Therapy, Radiation, 3D Conformal, Three dimensional external beam radiation therapy (procedure)

Arm A1 (control); Arm A2 (control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PRIOR TO STEP 1 REGISTRATION
• A diagnostic contrast-enhanced MRI (no other scan type allowed) of the brain must be performed postoperatively; the residual enhancing tumor and/or resection cavity must have a maximal diameter of 5 cm or less; 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
• The postoperative brain MRI should be obtained within 72 hours of resection; if it is not obtained within 72 hours post-resection, then an MRI obtained 2 weeks or longer after surgery is required and can be utilized to ensure maximal diameter of residual tumor and/or resection cavity is 5 cm or less
• For cases where a gross total resection of enhancing tumor is performed, but postoperative surgical cavity is NOT identifiable, the patient will be excluded from the trial
• Tumor tissue must be available for submission for central pathology review
• Timing requirements:
• If MGMT has been assessed locally by LabCorps or MD Anderson Cancer Center Molecular Diagnostics Lab (MDACC-MDL):
• Tissue for central pathology review and central MGMT assessment and the official LabCorps or MDACC-MDL MGMT result must be received by the NRG Oncology Biospecimen Bank on or before postoperative calendar day 40
• The site's local MGMT report from LabCorp or MDACC-MDL will then be used to stratify the patient; a post-stratification MGMT central review will be performed, but step 2 registration and protocol treatment can proceed without central review of MGMT
• Patients whose tissue for central pathology review and official LabCorps or MDACC-MDL MGMT result cannot be received by NRG Oncology Biospecimen Bank on or before 40 calendar days after surgery may NOT enroll on this trial, as central pathology review and stratification will not be complete in time for the patient to start treatment within 49 calendar days following surgery
• If MGMT has not been assessed locally by LabCorps or MDACC-MDL:
• Tissue for central pathology review and central MGMT assessment must be received by the NRG Oncology Biospecimen Bank on or before postoperative calendar day 30
• Central MGMT analysis will be performed at MDACC-MDL and used for patient stratification; results will be conveyed to NRG Oncology within 10 business days of receipt of the tissue
• Patients who have not had local MGMT assessment by LabCorps or MDACC-MDL and whose tissue for central pathology review cannot be received by NRG Oncology Biospecimen Bank on or before 30 calendar days after surgery may NOT enroll on this trial, as central pathology review and stratification will not be complete in time for the patient to start treatment within 49 calendar days following surgery
• Tissue Requirements:

You may not qualify if:

• 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 (Note: EKG to be performed only if clinical suspicion of cardiac issue)
• 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

Sponsors & Collaborators

• NRG Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (237)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States

Location

Saint Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, 85054, United States

Location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Arizona Oncology Associates-West Orange Grove

Tucson, Arizona, 85704, United States

Location

Banner University Medical Center - Tucson

Tucson, Arizona, 85719, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Sutter Cancer Centers Radiation Oncology Services-Auburn

Auburn, California, 95603, United States

Location

AIS Cancer Center at San Joaquin Community Hospital

Bakersfield, California, 93301, United States

Location

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, 94704, United States

Location

Sutter Cancer Centers Radiation Oncology Services-Cameron Park

Cameron Park, California, 95682, United States

Location

Eden Hospital Medical Center

Castro Valley, California, 94546, United States

Location

Fresno Cancer Center

Fresno, California, 93720, United States

Location

Marin General Hospital

Greenbrae, California, 94904, United States

Location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Los Angeles General Medical Center

Los Angeles, California, 90033, United States

Location

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Fremont - Rideout Cancer Center

Marysville, California, 95901, United States

Location

Memorial Medical Center

Modesto, California, 95355, United States

Location

Kaiser Permanente Oakland-Broadway

Oakland, California, 94611, United States

Location

Saint Joseph Hospital - Orange

Orange, California, 92868, United States

Location

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

Palo Alto Medical Foundation Health Care

Palo Alto, California, 94301, United States

Location

Pomona Valley Hospital Medical Center

Pomona, California, 91767, United States

Location

Kaiser Permanente-Rancho Cordova Cancer Center

Rancho Cordova, California, 95670, United States

Location

Rohnert Park Cancer Center

Rohnert Park, California, 94928, United States

Location

Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, 95661, United States

Location

The Permanente Medical Group-Roseville Radiation Oncology

Roseville, California, 95678, United States

Location

Sutter Medical Center Sacramento

Sacramento, California, 95816, United States

Location

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

South Sacramento Cancer Center

Sacramento, California, 95823, United States

Location

California Pacific Medical Center-Pacific Campus

San Francisco, California, 94115, United States

Location

Palo Alto Medical Foundation-Santa Cruz

Santa Cruz, California, 95065, United States

Location

Kaiser Permanente Cancer Treatment Center

South San Francisco, California, 94080, United States

Location

Palo Alto Medical Foundation-Sunnyvale

Sunnyvale, California, 94086, United States

Location

John Muir Medical Center-Walnut Creek

Walnut Creek, California, 94598, United States

Location

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, 80909, United States

Location

Poudre Valley Hospital

Fort Collins, Colorado, 80524, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Boca Raton Regional Hospital

Boca Raton, Florida, 33486, United States

Location

UF Health Cancer Institute - Gainesville

Gainesville, Florida, 32610, United States

Location

Baptist MD Anderson Cancer Center

Jacksonville, Florida, 32207, United States

Location

University of Florida Health Science Center - Jacksonville

Jacksonville, Florida, 32209, United States

Location

Baptist Medical Center South

Jacksonville, Florida, 32258, United States

Location

Miami Cancer Institute

Miami, Florida, 33176, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Emory Proton Therapy Center

Atlanta, Georgia, 30308, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, 31405, United States

Location

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, 83706, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Rush MD Anderson Cancer Center

Chicago, Illinois, 60612, United States

Location

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

Location

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, 60115, United States

Location

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, 60134, United States

Location

UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, 60451, United States

Location

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States

Location

OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Springfield Memorial Hospital

Springfield, Illinois, 62781, United States

Location

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, 60555, United States

Location

Radiation Oncology Associates PC

Fort Wayne, Indiana, 46804, United States

Location

Parkview Hospital Randallia

Fort Wayne, Indiana, 46805, United States

Location

Parkview Regional Medical Center

Fort Wayne, Indiana, 46845, United States

Location

IU Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Community Cancer Center East

Indianapolis, Indiana, 46219, United States

Location

Community Cancer Center South

Indianapolis, Indiana, 46227, United States

Location

Community Cancer Center North

Indianapolis, Indiana, 46256, United States

Location

IU Health Ball Memorial Hospital

Muncie, Indiana, 47303, United States

Location

Mercy Hospital

Cedar Rapids, Iowa, 52403, United States

Location

Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

Location

University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States

Location

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, 66210, United States

Location

Norton Hospital Pavilion and Medical Campus

Louisville, Kentucky, 40202, United States

Location

Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121, United States

Location

Willis-Knighton Medical and Cancer Center

Shreveport, Louisiana, 71103, United States

Location

Maryland Proton Treatment Center

Baltimore, Maryland, 21201, United States

Location

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

Location

UM Upper Chesapeake Medical Center

Bel Air, Maryland, 21014, United States

Location

Central Maryland Radiation Oncology in Howard County

Columbia, Maryland, 21044, United States

Location

UM Baltimore Washington Medical Center/Tate Cancer Center

Glen Burnie, Maryland, 21061, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Mass General/North Shore Cancer Center

Danvers, Massachusetts, 01923, United States

Location

Lowell General Hospital

Lowell, Massachusetts, 01854, United States

Location

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106, United States

Location

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

McLaren Cancer Institute-Bay City

Bay City, Michigan, 48706, United States

Location

Corewell Health Dearborn Hospital

Dearborn, Michigan, 48124, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

McLaren Cancer Institute-Flint

Flint, Michigan, 48532, United States

Location

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, 49503, United States

Location

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, 49503, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States

Location

McLaren Cancer Institute-Lapeer Region

Lapeer, Michigan, 48446, United States

Location

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154, United States

Location

McLaren Cancer Institute-Macomb

Mount Clemens, Michigan, 48043, United States

Location

McLaren Cancer Institute-Central Michigan

Mount Pleasant, Michigan, 48858, United States

Location

McLaren Cancer Institute-Owosso

Owosso, Michigan, 48867, United States

Location

McLaren Cancer Institute-Northern Michigan

Petoskey, Michigan, 49770, United States

Location

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, 48341, United States

Location

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, 48073, United States

Location

Corewell Health Lakeland Hospitals - Saint Joseph Hospital

Saint Joseph, Michigan, 49085, United States

Location

Corewell Health Beaumont Troy Hospital

Troy, Michigan, 48085, United States

Location

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, 56601, United States

Location

Saint Luke's Hospital of Duluth

Duluth, Minnesota, 55805, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Coborn Cancer Center at Saint Cloud Hospital

Saint Cloud, Minnesota, 56303, United States

Location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

North Kansas City Hospital

Kansas City, Missouri, 64116, United States

Location

University of Kansas Cancer Center - North

Kansas City, Missouri, 64154, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Billings Clinic Cancer Center

Billings, Montana, 59101, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89148, United States

Location

Renown Regional Medical Center

Reno, Nevada, 89502, United States

Location

Saint Mary's Regional Medical Center

Reno, Nevada, 89503, United States

Location

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, 03756, United States

Location

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08903, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Capital Health Medical Center-Hopewell

Pennington, New Jersey, 08534, United States

Location

ProCure Proton Therapy Center-Somerset

Somerset, New Jersey, 08873, United States

Location

Virtua Voorhees

Voorhees Township, New Jersey, 08043, United States

Location

New York-Presbyterian/Brooklyn Methodist Hospital

Brooklyn, New York, 11215, United States

Location

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Northwell Health/Center for Advanced Medicine

Lake Success, New York, 11042, United States

Location

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016, United States

Location

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467, United States

Location

Mission Hospital

Asheville, North Carolina, 28801, United States

Location

Novant Health Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Sanford Bismarck Medical Center

Bismarck, North Dakota, 58501, United States

Location

Sanford Roger Maris Cancer Center

Fargo, North Dakota, 58122, United States

Location

Cleveland Clinic Akron General

Akron, Ohio, 44307, United States

Location

UHHS-Chagrin Highlands Medical Center

Beachwood, Ohio, 44122, United States

Location

Geauga Hospital

Chardon, Ohio, 44024, United States

Location

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, 45219, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Cancer Center/Fairview Hospital

Cleveland, Ohio, 44111, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Mercy Cancer Center-Elyria

Elyria, Ohio, 44035, United States

Location

Cleveland Clinic Cancer Center Independence

Independence, Ohio, 44131, United States

Location

Hillcrest Hospital Cancer Center

Mayfield Heights, Ohio, 44124, United States

Location

UH Seidman Cancer Center at Lake Health Mentor Campus

Mentor, Ohio, 44060, United States

Location

UH Seidman Cancer Center at Southwest General Hospital

Middleburg Heights, Ohio, 44130, United States

Location

University Hospitals Parma Medical Center

Parma, Ohio, 44129, United States

Location

North Coast Cancer Care

Sandusky, Ohio, 44870, United States

Location

UH Seidman Cancer Center at Firelands Regional Medical Center

Sandusky, Ohio, 44870, United States

Location

Cleveland Clinic Cancer Center Strongsville

Strongsville, Ohio, 44136, United States

Location

University of Toledo

Toledo, Ohio, 43614, United States

Location

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, 45069, United States

Location

UHHS-Westlake Medical Center

Westlake, Ohio, 44145, United States

Location

Cleveland Clinic Wooster Family Health and Surgery Center

Wooster, Ohio, 44691, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Willamette Valley Cancer Center

Eugene, Oregon, 97401, United States

Location

Legacy Mount Hood Medical Center

Gresham, Oregon, 97030, United States

Location

Legacy Good Samaritan Hospital and Medical Center

Portland, Oregon, 97210, United States

Location

Saint Luke's University Hospital-Bethlehem Campus

Bethlehem, Pennsylvania, 18015, United States

Location

Northeast Radiation Oncology Center

Dunmore, Pennsylvania, 18512, United States

Location

Ephrata Cancer Center

Ephrata, Pennsylvania, 17522, United States

Location

Adams Cancer Center

Gettysburg, Pennsylvania, 17325, United States

Location

UPMC Pinnacle Cancer Center/Community Osteopathic Campus

Harrisburg, Pennsylvania, 17109, United States

Location

Sechler Family Cancer Center

Lebanon, Pennsylvania, 17042, United States

Location

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Jefferson Torresdale Hospital

Philadelphia, Pennsylvania, 19114, United States

Location

Reading Hospital

West Reading, Pennsylvania, 19611, United States

Location

WellSpan Health-York Cancer Center

York, Pennsylvania, 17403, United States

Location

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, 29316, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, 29605, United States

Location

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, 29615, United States

Location

Self Regional Healthcare

Greenwood, South Carolina, 29646, United States

Location

Prisma Health Cancer Institute - Greer

Greer, South Carolina, 29650, United States

Location

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, 29672, United States

Location

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134, United States

Location

Tennessee Cancer Specialists-Dowell Springs

Knoxville, Tennessee, 37909, United States

Location

Dell Seton Medical Center at The University of Texas

Austin, Texas, 78701, United States

Location

Austin Cancer Centers-Central Austin

Austin, Texas, 78702, United States

Location

Texas Oncology-Austin Midtown

Austin, Texas, 78705, United States

Location

Texas Oncology - Central Austin Cancer Center

Austin, Texas, 78731, United States

Location

Texas Oncology - South Austin Cancer Center

Austin, Texas, 78745, United States

Location

Austin Cancer Centers-North

Austin, Texas, 78758, United States

Location

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390, United States

Location

Texas Oncology - Denison Cancer Center

Denison, Texas, 75020, United States

Location

Texas Oncology-Flower Mound

Flower Mound, Texas, 75028, United States

Location

Texas Oncology - Fort Worth Cancer Center

Fort Worth, Texas, 76104, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0565, United States

Location

Memorial Hermann Memorial City Medical Center

Houston, Texas, 77024, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

UTMB Cancer Center at Victory Lakes

League City, Texas, 77573, United States

Location

Covenant Medical Center-Lakeside

Lubbock, Texas, 79410, United States

Location

Texas Oncology-Seton Williamson

Round Rock, Texas, 78665, United States

Location

Texas Oncology - Round Rock Cancer Center

Round Rock, Texas, 78681, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Texas Oncology Cancer Center Sugar Land

Sugar Land, Texas, 77479, United States

Location

Texas Oncology - Tyler

Tyler, Texas, 75702, United States

Location

Logan Regional Hospital

Logan, Utah, 84321, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

McKay-Dee Hospital Center

Ogden, Utah, 84403, United States

Location

Utah Valley Regional Medical Center

Provo, Utah, 84604, United States

Location

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

Location

Saint George Regional Medical Center

St. George, Utah, 84770, United States

Location

Central Vermont Medical Center/National Life Cancer Treatment

Berlin Corners, Vermont, 05602, United States

Location

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

Dartmouth Cancer Center - North

Saint Johnsbury, Vermont, 05819, United States

Location

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, 23298, United States

Location

FHCC at Northwest Hospital

Seattle, Washington, 98133, United States

Location

FHCC Proton Therapy Center

Seattle, Washington, 98133, United States

Location

University of Washington Medical Center - Montlake

Seattle, Washington, 98195, United States

Location

Compass Oncology Vancouver

Vancouver, Washington, 98684, United States

Location

Legacy Salmon Creek Hospital

Vancouver, Washington, 98686, United States

Location

Wheeling Hospital/Schiffler Cancer Center

Wheeling, West Virginia, 26003, United States

Location

Langlade Hospital and Cancer Center

Antigo, Wisconsin, 54409, United States

Location

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

Location

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792, United States

Location

Froedtert Menomonee Falls Hospital

Menomonee Falls, Wisconsin, 53051, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, 53188, United States

Location

Aspirus Regional Cancer Center

Wausau, Wisconsin, 54401, United States

Location

BCCA-Vancouver Island Cancer Centre

Victoria, British Columbia, V8R 6V5, Canada

Location

Ottawa Hospital and Cancer Center-General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Windsor Regional Cancer Centre

Windsor, Ontario, N8W 2X3, Canada

Location

CHUM - Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2X 3E4, Canada

Location

The Research Institute of the McGill University Health Centre (MUHC)

Montreal, Quebec, H3H 2R9, Canada

Location

CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)

Québec, Quebec, G1R 2J6, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Radiotherapy, Conformal; Radiotherapy, Intensity-Modulated; Photons; Radiation; Proton Therapy; Protons; Temozolomide

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Elementary Particles; Physical Phenomena; Light; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Optical Phenomena; Radiation, Nonionizing; Heavy Ion Radiotherapy; Cations, Monovalent; Cations; Ions; Electrolytes; Inorganic Chemicals; Hydrogen; Elements; Gases; Nucleons; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Minesh P Mehta

  NRG Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2014
• First Posted: July 1, 2014
• Study Start: December 4, 2014
• Primary Completion: July 7, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

CA (7); US (230)