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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

606

Participants

Timeline

Start Date

December 4, 2014

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Glioblastoma
Interventions
RADIATION

3-Dimensional Conformal Radiation Therapy

Undergo standard-dose 3D-CRT

RADIATION

Intensity-Modulated Radiation Therapy

Undergo standard-dose IMRT

RADIATION

Intensity-Modulated Radiation Therapy

Undergo dose-escalated and -intensified photon IMRT

OTHER

Laboratory Biomarker Analysis

Correlative studies

RADIATION

Photon Beam Radiation Therapy

Undergo dose-escalated and -intensified photon IMRT

RADIATION

Proton Beam Radiation Therapy

Undergo dose-escalated and -intensified proton beam radiation therapy

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

DRUG

Temozolomide

Given PO

Trial Locations (237)

10016

Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York

10032

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York

10065

Memorial Sloan Kettering Cancer Center, New York

10467

Montefiore Medical Center - Moses Campus, The Bronx

10604

Memorial Sloan Kettering Westchester, Harrison

11042

Northwell Health/Center for Advanced Medicine, Lake Success

11215

New York-Presbyterian/Brooklyn Methodist Hospital, Brooklyn

11725

Memorial Sloan Kettering Commack, Commack

17042

Sechler Family Cancer Center, Lebanon

17109

UPMC Pinnacle Cancer Center/Community Osteopathic Campus, Harrisburg

17325

Adams Cancer Center, Gettysburg

17403

WellSpan Health-York Cancer Center, York

17522

Ephrata Cancer Center, Ephrata

18015

Saint Luke's University Hospital-Bethlehem Campus, Bethlehem

18512

Northeast Radiation Oncology Center, Dunmore

19104

University of Pennsylvania/Abramson Cancer Center, Philadelphia

19107

Thomas Jefferson University Hospital, Philadelphia

19114

Jefferson Torresdale Hospital, Philadelphia

19611

Reading Hospital, West Reading

21014

UM Upper Chesapeake Medical Center, Bel Air

21044

Central Maryland Radiation Oncology in Howard County, Columbia

21061

UM Baltimore Washington Medical Center/Tate Cancer Center, Glen Burnie

21201

Maryland Proton Treatment Center, Baltimore

University of Maryland/Greenebaum Cancer Center, Baltimore

23298

VCU Massey Comprehensive Cancer Center, Richmond

26003

Wheeling Hospital/Schiffler Cancer Center, Wheeling

27103

Novant Health Forsyth Medical Center, Winston-Salem

27157

Wake Forest University Health Sciences, Winston-Salem

28801

Mission Hospital, Asheville

29316

Prisma Health Cancer Institute - Spartanburg, Boiling Springs

29425

Medical University of South Carolina, Charleston

29605

Prisma Health Cancer Institute - Faris, Greenville

29615

Prisma Health Cancer Institute - Eastside, Greenville

29646

Self Regional Healthcare, Greenwood

29650

Prisma Health Cancer Institute - Greer, Greer

29672

Prisma Health Cancer Institute - Seneca, Seneca

30308

Emory Proton Therapy Center, Atlanta

Emory University Hospital Midtown, Atlanta

30322

Emory University Hospital/Winship Cancer Institute, Atlanta

31405

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

32207

Baptist MD Anderson Cancer Center, Jacksonville

32209

University of Florida Health Science Center - Jacksonville, Jacksonville

32258

Baptist Medical Center South, Jacksonville

32610

University of Florida Health Science Center - Gainesville, Gainesville

33176

Miami Cancer Institute, Miami

33486

Boca Raton Regional Hospital, Boca Raton

33612

Moffitt Cancer Center, Tampa

35233

University of Alabama at Birmingham Cancer Center, Birmingham

37909

Tennessee Cancer Specialists-Dowell Springs, Knoxville

39216

University of Mississippi Medical Center, Jackson

40202

Norton Hospital Pavilion and Medical Campus, Louisville

43210

Ohio State University Comprehensive Cancer Center, Columbus

43214

Riverside Methodist Hospital, Columbus

43614

University of Toledo, Toledo

44024

Geauga Hospital, Chardon

44035

Mercy Cancer Center-Elyria, Elyria

44060

UH Seidman Cancer Center at Lake Health Mentor Campus, Mentor

44106

Case Western Reserve University, Cleveland

44111

Cleveland Clinic Cancer Center/Fairview Hospital, Cleveland

44122

UHHS-Chagrin Highlands Medical Center, Beachwood

44124

Hillcrest Hospital Cancer Center, Mayfield Heights

44129

University Hospitals Parma Medical Center, Parma

44130

UH Seidman Cancer Center at Southwest General Hospital, Middleburg Heights

44131

Cleveland Clinic Cancer Center Independence, Independence

44136

Cleveland Clinic Cancer Center Strongsville, Strongsville

44145

UHHS-Westlake Medical Center, Westlake

44195

Cleveland Clinic Foundation, Cleveland

44307

Cleveland Clinic Akron General, Akron

44691

Cleveland Clinic Wooster Family Health and Surgery Center, Wooster

44870

North Coast Cancer Care, Sandusky

UH Seidman Cancer Center at Firelands Regional Medical Center, Sandusky

45069

University of Cincinnati Cancer Center-West Chester, West Chester

45219

University of Cincinnati Cancer Center-UC Medical Center, Cincinnati

46202

IU Health Methodist Hospital, Indianapolis

46219

Community Cancer Center East, Indianapolis

46227

Community Cancer Center South, Indianapolis

46256

Community Cancer Center North, Indianapolis

46804

Radiation Oncology Associates PC, Fort Wayne

46805

Parkview Hospital Randallia, Fort Wayne

46845

Parkview Regional Medical Center, Fort Wayne

47303

IU Health Ball Memorial Hospital, Muncie

48043

McLaren Cancer Institute-Macomb, Mount Clemens

48073

Corewell Health William Beaumont University Hospital, Royal Oak

48085

Corewell Health Beaumont Troy Hospital, Troy

48106

Trinity Health Saint Joseph Mercy Hospital Ann Arbor, Ann Arbor

48109

University of Michigan Comprehensive Cancer Center, Ann Arbor

48124

Corewell Health Dearborn Hospital, Dearborn

48154

Trinity Health Saint Mary Mercy Livonia Hospital, Livonia

48202

Henry Ford Hospital, Detroit

48341

Trinity Health Saint Joseph Mercy Oakland Hospital, Pontiac

48446

McLaren Cancer Institute-Lapeer Region, Lapeer

48532

McLaren Cancer Institute-Flint, Flint

48706

McLaren Cancer Institute-Bay City, Bay City

48858

McLaren Cancer Institute-Central Michigan, Mount Pleasant

48867

McLaren Cancer Institute-Owosso, Owosso

49007

West Michigan Cancer Center, Kalamazoo

49085

Corewell Health Lakeland Hospitals - Saint Joseph Hospital, Saint Joseph

49503

Corewell Health Grand Rapids Hospitals - Butterworth Hospital, Grand Rapids

Trinity Health Grand Rapids Hospital, Grand Rapids

49770

McLaren Cancer Institute-Northern Michigan, Petoskey

50309

Iowa Methodist Medical Center, Des Moines

52403

Mercy Hospital, Cedar Rapids

53051

Froedtert Menomonee Falls Hospital, Menomonee Falls

53188

UW Cancer Center at ProHealth Care, Waukesha

53226

Medical College of Wisconsin, Milwaukee

53792

University of Wisconsin Carbone Cancer Center - University Hospital, Madison

54401

Aspirus Regional Cancer Center, Wausau

54409

Langlade Hospital and Cancer Center, Antigo

54601

Gundersen Lutheran Medical Center, La Crosse

55101

Regions Hospital, Saint Paul

55805

Saint Luke's Hospital of Duluth, Duluth

55905

Mayo Clinic in Rochester, Rochester

56303

Coborn Cancer Center at Saint Cloud Hospital, Saint Cloud

56601

Sanford Joe Lueken Cancer Center, Bemidji

58122

Sanford Roger Maris Cancer Center, Fargo

58501

Sanford Bismarck Medical Center, Bismarck

59101

Billings Clinic Cancer Center, Billings

60068

Advocate Lutheran General Hospital, Park Ridge

60115

Northwestern Medicine Cancer Center Kishwaukee, DeKalb

60134

Northwestern Medicine Cancer Center Delnor, Geneva

60451

UC Comprehensive Cancer Center at Silver Cross, New Lenox

60555

Northwestern Medicine Cancer Center Warrenville, Warrenville

60611

Northwestern University, Chicago

60612

John H Stroger Jr Hospital of Cook County, Chicago

Rush University Medical Center, Chicago

60637

University of Chicago Comprehensive Cancer Center, Chicago

61637

OSF Saint Francis Medical Center, Peoria

62526

Decatur Memorial Hospital, Decatur

62781

Springfield Memorial Hospital, Springfield

63110

Washington University School of Medicine, St Louis

64116

North Kansas City Hospital, Kansas City

64154

University of Kansas Cancer Center - North, Kansas City

66160

University of Kansas Cancer Center, Kansas City

66210

University of Kansas Cancer Center-Overland Park, Overland Park

70121

Ochsner Medical Center Jefferson, New Orleans

71103

Willis-Knighton Medical and Cancer Center, Shreveport

72205

University of Arkansas for Medical Sciences, Little Rock

73104

University of Oklahoma Health Sciences Center, Oklahoma City

75020

Texas Oncology - Denison Cancer Center, Denison

75028

Texas Oncology-Flower Mound, Flower Mound

75390

UT Southwestern/Simmons Cancer Center-Dallas, Dallas

75702

Texas Oncology - Tyler, Tyler

76104

Texas Oncology - Fort Worth Cancer Center, Fort Worth

77024

Memorial Hermann Memorial City Medical Center, Houston

77030

M D Anderson Cancer Center, Houston

77479

Texas Oncology Cancer Center Sugar Land, Sugar Land

77573

UTMB Cancer Center at Victory Lakes, League City

78229

University of Texas Health Science Center at San Antonio, San Antonio

78665

Texas Oncology-Seton Williamson, Round Rock

78681

Texas Oncology - Round Rock Cancer Center, Round Rock

78701

Dell Seton Medical Center at The University of Texas, Austin

78702

Austin Cancer Centers-Central Austin, Austin

78705

Texas Oncology-Austin Midtown, Austin

78731

Texas Oncology - Central Austin Cancer Center, Austin

78745

Texas Oncology - South Austin Cancer Center, Austin

78758

Austin Cancer Centers-North, Austin

79410

Covenant Medical Center-Lakeside, Lubbock

80524

Poudre Valley Hospital, Fort Collins

80909

UCHealth Memorial Hospital Central, Colorado Springs

83706

Saint Alphonsus Cancer Care Center-Boise, Boise

84107

Intermountain Medical Center, Murray

84112

Huntsman Cancer Institute/University of Utah, Salt Lake City

84321

Logan Regional Hospital, Logan

84403

McKay-Dee Hospital Center, Ogden

84604

Utah Valley Regional Medical Center, Provo

84770

Saint George Regional Medical Center, St. George

85013

Saint Joseph's Hospital and Medical Center, Phoenix

85054

Mayo Clinic Hospital in Arizona, Phoenix

85259

Mayo Clinic in Arizona, Scottsdale

85704

Arizona Oncology Associates-West Orange Grove, Tucson

85719

Banner University Medical Center - Tucson, Tucson

89148

Comprehensive Cancer Centers of Nevada, Las Vegas

89502

Renown Regional Medical Center, Reno

89503

Saint Mary's Regional Medical Center, Reno

90033

Los Angeles General Medical Center, Los Angeles

USC / Norris Comprehensive Cancer Center, Los Angeles

90048

Cedars Sinai Medical Center, Los Angeles

91767

Pomona Valley Hospital Medical Center, Pomona

92354

Loma Linda University Medical Center, Loma Linda

92868

Saint Joseph Hospital - Orange, Orange

UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange

93301

AIS Cancer Center at San Joaquin Community Hospital, Bakersfield

93720

Fresno Cancer Center, Fresno

94080

Kaiser Permanente Cancer Treatment Center, South San Francisco

94086

Palo Alto Medical Foundation-Sunnyvale, Sunnyvale

94115

California Pacific Medical Center-Pacific Campus, San Francisco

94301

Palo Alto Medical Foundation Health Care, Palo Alto

94546

Eden Hospital Medical Center, Castro Valley

94598

John Muir Medical Center-Walnut Creek, Walnut Creek

94611

Kaiser Permanente Oakland-Broadway, Oakland

94704

Alta Bates Summit Medical Center-Herrick Campus, Berkeley

94904

Marin General Hospital, Greenbrae

94928

Rohnert Park Cancer Center, Rohnert Park

95065

Palo Alto Medical Foundation-Santa Cruz, Santa Cruz

95355

Memorial Medical Center, Modesto

95603

Sutter Cancer Centers Radiation Oncology Services-Auburn, Auburn

95661

Sutter Cancer Centers Radiation Oncology Services-Roseville, Roseville

95670

Kaiser Permanente-Rancho Cordova Cancer Center, Rancho Cordova

95678

The Permanente Medical Group-Roseville Radiation Oncology, Roseville

95682

Sutter Cancer Centers Radiation Oncology Services-Cameron Park, Cameron Park

95816

Sutter Medical Center Sacramento, Sacramento

95817

University of California Davis Comprehensive Cancer Center, Sacramento

95823

South Sacramento Cancer Center, Sacramento

95901

Fremont - Rideout Cancer Center, Marysville

97030

Legacy Mount Hood Medical Center, Gresham

97210

Legacy Good Samaritan Hospital and Medical Center, Portland

97401

Willamette Valley Cancer Center, Eugene

98133

FHCC at Northwest Hospital, Seattle

FHCC Proton Therapy Center, Seattle

98195

University of Washington Medical Center - Montlake, Seattle

98684

Compass Oncology Vancouver, Vancouver

98686

Legacy Salmon Creek Hospital, Vancouver

06102

Hartford Hospital, Hartford

02111

Tufts Medical Center, Boston

02114

Massachusetts General Hospital Cancer Center, Boston

02118

Boston Medical Center, Boston

01923

Mass General/North Shore Cancer Center, Danvers

01854

Lowell General Hospital, Lowell

03756

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon

07920

Memorial Sloan Kettering Basking Ridge, Basking Ridge

08903

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

Rutgers Cancer Institute of New Jersey, New Brunswick

08534

Capital Health Medical Center-Hopewell, Pennington

08873

ProCure Proton Therapy Center-Somerset, Somerset

08043

Virtua Voorhees, Voorhees Township

57117-5134

Sanford USD Medical Center - Sioux Falls, Sioux Falls

77555-0565

University of Texas Medical Branch, Galveston

05602

Central Vermont Medical Center/National Life Cancer Treatment, Berlin Corners

05401

University of Vermont Medical Center, Burlington

05819

Dartmouth Cancer Center - North, Saint Johnsbury

V8R 6V5

BCCA-Vancouver Island Cancer Centre, Victoria

K1H 8L6

Ottawa Hospital and Cancer Center-General Campus, Ottawa

N8W 2X3

Windsor Regional Cancer Centre, Windsor

H2X 3E4

CHUM - Centre Hospitalier de l'Universite de Montreal, Montreal

H3H 2R9

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

G1R 2J6

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

S7N 4H4

Saskatoon Cancer Centre, Saskatoon

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

NRG Oncology

OTHER

NCT02179086 - Dose-Escalated Photon IMRT or Proton Beam Radiation Therapy Versus Standard-Dose Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma | Biotech Hunter | Biotech Hunter