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ACTIVE NOT RECRUITING
NCT02179086
PHASE2

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

Sponsor: NRG Oncology

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

606

Start Date

2014-12-04

Completion Date

2026-12-31

Last Updated

2026-01-14

Healthy Volunteers

No

Conditions

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

Locations (237)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Saint Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, United States

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Arizona Oncology Associates-West Orange Grove

Tucson, Arizona, United States

Banner University Medical Center - Tucson

Tucson, Arizona, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Sutter Cancer Centers Radiation Oncology Services-Auburn

Auburn, California, United States

AIS Cancer Center at San Joaquin Community Hospital

Bakersfield, California, United States

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, United States

Sutter Cancer Centers Radiation Oncology Services-Cameron Park

Cameron Park, California, United States

Eden Hospital Medical Center

Castro Valley, California, United States

Fresno Cancer Center

Fresno, California, United States

Marin General Hospital

Greenbrae, California, United States

Loma Linda University Medical Center

Loma Linda, California, United States

Los Angeles General Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

Fremont - Rideout Cancer Center

Marysville, California, United States

Memorial Medical Center

Modesto, California, United States

Kaiser Permanente Oakland-Broadway

Oakland, California, United States

Saint Joseph Hospital - Orange

Orange, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

Palo Alto Medical Foundation Health Care

Palo Alto, California, United States

Pomona Valley Hospital Medical Center

Pomona, California, United States

Kaiser Permanente-Rancho Cordova Cancer Center

Rancho Cordova, California, United States

Rohnert Park Cancer Center

Rohnert Park, California, United States

Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, United States

The Permanente Medical Group-Roseville Radiation Oncology

Roseville, California, United States

Sutter Medical Center Sacramento

Sacramento, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

South Sacramento Cancer Center

Sacramento, California, United States

California Pacific Medical Center-Pacific Campus

San Francisco, California, United States

Palo Alto Medical Foundation-Santa Cruz

Santa Cruz, California, United States

Kaiser Permanente Cancer Treatment Center

South San Francisco, California, United States

Palo Alto Medical Foundation-Sunnyvale

Sunnyvale, California, United States

John Muir Medical Center-Walnut Creek

Walnut Creek, California, United States

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, United States

Poudre Valley Hospital

Fort Collins, Colorado, United States

Hartford Hospital

Hartford, Connecticut, United States

Boca Raton Regional Hospital

Boca Raton, Florida, United States

UF Health Cancer Institute - Gainesville

Gainesville, Florida, United States

Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States

University of Florida Health Science Center - Jacksonville

Jacksonville, Florida, United States

Baptist Medical Center South

Jacksonville, Florida, United States

Miami Cancer Institute

Miami, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Emory Proton Therapy Center

Atlanta, Georgia, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

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

Savannah, Georgia, United States

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

Northwestern University

Chicago, Illinois, United States

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, United States

Rush MD Anderson Cancer Center

Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, United States

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, United States

UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, United States

Advocate Lutheran General Hospital

Park Ridge, Illinois, United States

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Springfield Memorial Hospital

Springfield, Illinois, United States

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, United States

Radiation Oncology Associates PC

Fort Wayne, Indiana, United States

Parkview Hospital Randallia

Fort Wayne, Indiana, United States

Parkview Regional Medical Center

Fort Wayne, Indiana, United States

IU Health Methodist Hospital

Indianapolis, Indiana, United States

Community Cancer Center East

Indianapolis, Indiana, United States

Community Cancer Center South

Indianapolis, Indiana, United States

Community Cancer Center North

Indianapolis, Indiana, United States

IU Health Ball Memorial Hospital

Muncie, Indiana, United States

Mercy Hospital

Cedar Rapids, Iowa, United States

Iowa Methodist Medical Center

Des Moines, Iowa, United States

University of Kansas Cancer Center

Kansas City, Kansas, United States

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, United States

Norton Hospital Pavilion and Medical Campus

Louisville, Kentucky, United States

Ochsner Medical Center Jefferson

New Orleans, Louisiana, United States

Willis-Knighton Medical and Cancer Center

Shreveport, Louisiana, United States

Maryland Proton Treatment Center

Baltimore, Maryland, United States

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, United States

UM Upper Chesapeake Medical Center

Bel Air, Maryland, United States

Central Maryland Radiation Oncology in Howard County

Columbia, Maryland, United States

UM Baltimore Washington Medical Center/Tate Cancer Center

Glen Burnie, Maryland, United States

Tufts Medical Center

Boston, Massachusetts, United States

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Boston Medical Center

Boston, Massachusetts, United States

Mass General/North Shore Cancer Center

Danvers, Massachusetts, United States

Lowell General Hospital

Lowell, Massachusetts, United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, United States

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

McLaren Cancer Institute-Bay City

Bay City, Michigan, United States

Corewell Health Dearborn Hospital

Dearborn, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

McLaren Cancer Institute-Flint

Flint, Michigan, United States

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, United States

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, United States

West Michigan Cancer Center

Kalamazoo, Michigan, United States

McLaren Cancer Institute-Lapeer Region

Lapeer, Michigan, United States

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, United States

McLaren Cancer Institute-Macomb

Mount Clemens, Michigan, United States

McLaren Cancer Institute-Central Michigan

Mount Pleasant, Michigan, United States

McLaren Cancer Institute-Owosso

Owosso, Michigan, United States

McLaren Cancer Institute-Northern Michigan

Petoskey, Michigan, United States

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, United States

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, United States

Corewell Health Lakeland Hospitals - Saint Joseph Hospital

Saint Joseph, Michigan, United States

Corewell Health Beaumont Troy Hospital

Troy, Michigan, United States

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, United States

Saint Luke's Hospital of Duluth

Duluth, Minnesota, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Coborn Cancer Center at Saint Cloud Hospital

Saint Cloud, Minnesota, United States

Regions Hospital

Saint Paul, Minnesota, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

North Kansas City Hospital

Kansas City, Missouri, United States

University of Kansas Cancer Center - North

Kansas City, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Billings Clinic Cancer Center

Billings, Montana, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Renown Regional Medical Center

Reno, Nevada, United States

Saint Mary's Regional Medical Center

Reno, Nevada, United States

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, United States

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

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

New Brunswick, New Jersey, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Capital Health Medical Center-Hopewell

Pennington, New Jersey, United States

ProCure Proton Therapy Center-Somerset

Somerset, New Jersey, United States

Virtua Voorhees

Voorhees Township, New Jersey, United States

New York-Presbyterian/Brooklyn Methodist Hospital

Brooklyn, New York, United States

Memorial Sloan Kettering Commack

Commack, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Northwell Health/Center for Advanced Medicine

Lake Success, New York, United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, United States

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

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States

Mission Hospital

Asheville, North Carolina, United States

Novant Health Forsyth Medical Center

Winston-Salem, North Carolina, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Sanford Bismarck Medical Center

Bismarck, North Dakota, United States

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States

Cleveland Clinic Akron General

Akron, Ohio, United States

UHHS-Chagrin Highlands Medical Center

Beachwood, Ohio, United States

Geauga Hospital

Chardon, Ohio, United States

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, United States

Case Western Reserve University

Cleveland, Ohio, United States

Cleveland Clinic Cancer Center/Fairview Hospital

Cleveland, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Riverside Methodist Hospital

Columbus, Ohio, United States

Mercy Cancer Center-Elyria

Elyria, Ohio, United States

Cleveland Clinic Cancer Center Independence

Independence, Ohio, United States

Hillcrest Hospital Cancer Center

Mayfield Heights, Ohio, United States

UH Seidman Cancer Center at Lake Health Mentor Campus

Mentor, Ohio, United States

UH Seidman Cancer Center at Southwest General Hospital

Middleburg Heights, Ohio, United States

University Hospitals Parma Medical Center

Parma, Ohio, United States

North Coast Cancer Care

Sandusky, Ohio, United States

UH Seidman Cancer Center at Firelands Regional Medical Center

Sandusky, Ohio, United States

Cleveland Clinic Cancer Center Strongsville

Strongsville, Ohio, United States

University of Toledo

Toledo, Ohio, United States

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, United States

UHHS-Westlake Medical Center

Westlake, Ohio, United States

Cleveland Clinic Wooster Family Health and Surgery Center

Wooster, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Willamette Valley Cancer Center

Eugene, Oregon, United States

Legacy Mount Hood Medical Center

Gresham, Oregon, United States

Legacy Good Samaritan Hospital and Medical Center

Portland, Oregon, United States

Saint Luke's University Hospital-Bethlehem Campus

Bethlehem, Pennsylvania, United States

Northeast Radiation Oncology Center

Dunmore, Pennsylvania, United States

Ephrata Cancer Center

Ephrata, Pennsylvania, United States

Adams Cancer Center

Gettysburg, Pennsylvania, United States

UPMC Pinnacle Cancer Center/Community Osteopathic Campus

Harrisburg, Pennsylvania, United States

Sechler Family Cancer Center

Lebanon, Pennsylvania, United States

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Jefferson Torresdale Hospital

Philadelphia, Pennsylvania, United States

Reading Hospital

West Reading, Pennsylvania, United States

WellSpan Health-York Cancer Center

York, Pennsylvania, United States

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, United States

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, United States

Self Regional Healthcare

Greenwood, South Carolina, United States

Prisma Health Cancer Institute - Greer

Greer, South Carolina, United States

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, United States

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States

Tennessee Cancer Specialists-Dowell Springs

Knoxville, Tennessee, United States

Dell Seton Medical Center at The University of Texas

Austin, Texas, United States

Austin Cancer Centers-Central Austin

Austin, Texas, United States

Texas Oncology-Austin Midtown

Austin, Texas, United States

Texas Oncology - Central Austin Cancer Center

Austin, Texas, United States

Texas Oncology - South Austin Cancer Center

Austin, Texas, United States

Austin Cancer Centers-North

Austin, Texas, United States

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States

Texas Oncology - Denison Cancer Center

Denison, Texas, United States

Texas Oncology-Flower Mound

Flower Mound, Texas, United States

Texas Oncology - Fort Worth Cancer Center

Fort Worth, Texas, United States

University of Texas Medical Branch

Galveston, Texas, United States

Memorial Hermann Memorial City Medical Center

Houston, Texas, United States

M D Anderson Cancer Center

Houston, Texas, United States

UTMB Cancer Center at Victory Lakes

League City, Texas, United States

Covenant Medical Center-Lakeside

Lubbock, Texas, United States

Texas Oncology-Seton Williamson

Round Rock, Texas, United States

Texas Oncology - Round Rock Cancer Center

Round Rock, Texas, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Texas Oncology Cancer Center Sugar Land

Sugar Land, Texas, United States

Texas Oncology - Tyler

Tyler, Texas, United States

Logan Regional Hospital

Logan, Utah, United States

Intermountain Medical Center

Murray, Utah, United States

McKay-Dee Hospital Center

Ogden, Utah, United States

Utah Valley Regional Medical Center

Provo, Utah, United States

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

Saint George Regional Medical Center

St. George, Utah, United States

Central Vermont Medical Center/National Life Cancer Treatment

Berlin Corners, Vermont, United States

University of Vermont Medical Center

Burlington, Vermont, United States

Dartmouth Cancer Center - North

Saint Johnsbury, Vermont, United States

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, United States

FHCC at Northwest Hospital

Seattle, Washington, United States

FHCC Proton Therapy Center

Seattle, Washington, United States

University of Washington Medical Center - Montlake

Seattle, Washington, United States

Compass Oncology Vancouver

Vancouver, Washington, United States

Legacy Salmon Creek Hospital

Vancouver, Washington, United States

Wheeling Hospital/Schiffler Cancer Center

Wheeling, West Virginia, United States

Langlade Hospital and Cancer Center

Antigo, Wisconsin, United States

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, United States

Froedtert Menomonee Falls Hospital

Menomonee Falls, Wisconsin, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, United States

Aspirus Regional Cancer Center

Wausau, Wisconsin, United States

BCCA-Vancouver Island Cancer Centre

Victoria, British Columbia, Canada

Ottawa Hospital and Cancer Center-General Campus

Ottawa, Ontario, Canada

Windsor Regional Cancer Centre

Windsor, Ontario, Canada

CHUM - Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada

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

Montreal, Quebec, Canada

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

Québec, Quebec, Canada

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada