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COMPLETED
NCT04471844
NA

Pivotal, Randomized, Open-label Study of Optune® (Tumor Treating Fields) Concomitant With RT & TMZ for the Treatment of Newly Diagnosed GBM

Sponsor: NovoCure Ltd.

View on ClinicalTrials.gov

Summary

To test the effectiveness and safety of Optune® given concomitantly with radiation therapy (RT) and temozolomide (TMZ) in newly diagnosed GBM patients, compared to radiation therapy and temozolomide alone. In both arms, Optune® and maintenance temozolomide are continued following radiation therapy.

Official title: EF-32: Pivotal, Randomized, Open-Label Study of Optune® (Tumor Treating Fields, 200kHz) Concomitant With Radiation Therapy and Temozolomide for the Treatment of Newly Diagnosed Glioblastoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

981

Start Date

2020-12-08

Completion Date

2026-02-19

Last Updated

2026-10-05

Healthy Volunteers

No

Interventions

DEVICE

Optune®

Optune® is a commercial, portable, battery-operated device intended for continuous home use, which delivers TTFields at a frequency of 200kHz to the brain by means of insulated transducer arrays. The Optune® device produces electric forces intended to disrupt cancer cell division. In treatment arm I, the patient starts Optune® concurrently with RT/TMZ for 6 weeks, followed by Optune® + TMZ until second disease progression. In treatment arm II, the patient starts RT/TMZ for 6 weeks, followed by Optune® + TMZ until second disease progression.

Locations (130)

Grandview Cancer Center

Birmingham, Alabama, United States

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Mayo Clinic- Arizona

Phoenix, Arizona, United States

University of Arizona Cancer Center

Tucson, Arizona, United States

Highlands Oncology Group

Fayetteville, Arkansas, United States

Providence St. Joseph Medical Center and The Roy and Patricia Disney Family Cancer Center

Burbank, California, United States

City of Hope National Medical Center

Duarte, California, United States

TRIO - St. Jude Heritage Healthcare/St. Jude Medical Center

Fullerton, California, United States

University of California at San Diego - Moores Cancer Center

La Jolla, California, United States

Norris Comprehensive Cancer Center at USC

Los Angeles, California, United States

Cedars - Sinai Medical Center

Los Angeles, California, United States

Hoag Memorial Hospital - Hoag Cancer Center

Newport Beach, California, United States

St. Joseph Hospital of Orange

Orange, California, United States

University of California - Irvine/UCI Medical Center

Orange, California, United States

Stanford University Cancer Institute

Palo Alto, California, United States

Sharp Memorial Hospital - X-Ray Medical Group Radiation Oncology

San Diego, California, United States

University of California San Francisco Medical Center

San Francisco, California, United States

John Wayne Cancer Institute at St. John's Health Center

Santa Monica, California, United States

University of Colorado Cancer Center Anschutz

Aurora, Colorado, United States

HCA Research Institute - Blue Sky Neurology - Denver

Englewood, Colorado, United States

Hartford Healthcare Medical Group - Hartford Hospital The Gray Cancer Center

Hartford, Connecticut, United States

Lynn Cancer Institute, Marcus Neuroscience Institute

Boca Raton, Florida, United States

Baptist Health - Jacksonville

Jacksonville, Florida, United States

Mayo Clinic

Jacksonville, Florida, United States

AdventHealth

Orlando, Florida, United States

Orlando Health UF Health Cancer Center

Orlando, Florida, United States

H. Lee Moffitt Cancer Center and Research Institute, Inc

Tampa, Florida, United States

Piedmont Healthcare Brain Tumor Center

Atlanta, Georgia, United States

The Emory Clinic - Emory Healthcare - Winship Cancer Institute

Atlanta, Georgia, United States

Northside Hospital, Inc.

Atlanta, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

Parkview Cancer Institute - Fort Wayne Radiation Oncology Associates

Fort Wayne, Indiana, United States

The University of Kansas Cancer Center

Topeka, Kansas, United States

University of Louisville - James Graham Brown Cancer Center

Louisville, Kentucky, United States

Norton Cancer Institute

Louisville, Kentucky, United States

Mary Bird Cancer Center Neuromedical Center

Baton Rouge, Louisiana, United States

LSU Health Sciences Center, New Orleans

New Orleans, Louisiana, United States

Ochsner Health System

New Orleans, Louisiana, United States

Maine Medical Partners Neurology - Neurosurgery & Spine Associates

South Portland, Maine, United States

John Hopkins School of Medicine

Baltimore, Maryland, United States

Tufts Medical Center

Boston, Massachusetts, United States

University of Massachusetts Chan Medical School

Worcester, Massachusetts, United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Abbott Northwestern Hospital - Givens Brain Tumor Center

Minneapolis, Minnesota, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

University of Missouri - Ellis Fischel Cancer Center

Columbia, Missouri, United States

Health Midwest Ventures Group, Inc - Sarah Cannon HCA Midwest Brain and Spine

Kansas City, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

JFK Neuroscience Institute, HMH JFK University Medical Center

Edison, New Jersey, United States

Hackensack University Medical Center - John Theurer Cancer Center

Hackensack, New Jersey, United States

Jersey Shore University Medical Center

Neptune City, New Jersey, United States

Northwell Health System Brain Tumor Center

Lake Success, New York, United States

NYU Langone - Laura & Issac Perimutter Cancer Center

New York, New York, United States

Mount Sinai - Icahn School of Medicine

New York, New York, United States

New York Presbyterian - Columbia University

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

SUNY Upstate Medical University

Syracuse, New York, United States

University of North Carolina Brain Tumor Program - UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Novant Health Cancer Institute Radiation Oncology

Charlotte, North Carolina, United States

Vidant Medical Center

Greenville, North Carolina, United States

Forsyth Medical Center-Novant Health

Winston-Salem, North Carolina, United States

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

University of Cincinnati Cancer Institute

Cincinnati, Ohio, United States

The James Cancer Hospital and Solove Research Institute - Arthur G James Cancer Hospital

Columbus, Ohio, United States

Oregon Health & Science University (OHSU)

Portland, Oregon, United States

Neuroscience Center, Philadelphia - University of Pennsylvania

Philadelphia, Pennsylvania, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Allegheny Health Network Cancer Institute

Pittsburgh, Pennsylvania, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

MUSC Radiation Oncology Brain & Spine Tumor Program

Charleston, South Carolina, United States

SCRI - Tennessee Oncology

Chattanooga, Tennessee, United States

West Cancer Center - Germantown

Germantown, Tennessee, United States

SCRI - Tennessee Oncology

Nashville, Tennessee, United States

Texas Oncology Midtown - Austin Brain Tumor Center

Austin, Texas, United States

Baylor Charles A. Sammons Cancer Center - Baylor University Medical Center

Dallas, Texas, United States

John Peter Smith Health Network - JPS Cancer Center

Fort Worth, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

UT Health Mischer Neuroscience - Memorial Herman - UT Neurosciences

Houston, Texas, United States

Baylor Scott & White Medical Center

Temple, Texas, United States

The University of Vermont Medical Center - University of Vermont Cancer Center

Burlington, Vermont, United States

UW Medical Center - Alvord Brain Tumor Center

Seattle, Washington, United States

Swedish Health Services

Seattle, Washington, United States

West Virginia University Cancer Institute

Morgantown, West Virginia, United States

Innsbruck University Hospital

Innsbruck, Innsbruck, Austria

Kepler University Hospital

Linz, Linz, Austria

University Hospital Salzburg

Salzburg, State of Salzburg, Austria

University Hospital Liege - Sart Tilman

Liège, Belgium

BC Cancer - Vancouver

Vancouver, British Columbia, Canada

Nova Scotia Health Authority

Sydney, Nova Scotia, Canada

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Sunnybrook Research Institute - Odette Cancer Centre

Toronto, Ontario, Canada

CHUM Centre de Recherche

Montreal, Quebec, Canada

Universite de Sherbrooke - Sherbrooke Centre Hospitalier Universita

Sherbrooke, Quebec, Canada

Masaryk Memorial Cancer Institute

Brno, Brno, Czechia

University Hospital Plzeň

Pilsen, Pilsen, Czechia

Na Homolce Hospital

Prague, Prague, Czechia

Institut de cancérologie de l'Ouest

Angers, France

Pierre Wertheimer Hospital

Bron, France

Hôpital la Timone

Marseille, France

University Hospital Nice

Nice, France

Pitié-Salpêtrière University Hospital

Paris, France

Institut de cancérologie de l'Ouest

Saint-Herblain, France

University Institute Cancer Toulouse Oncopole

Toulouse, France

Gustave Roussy Institute

Villejuif, France

University Hospital Essen

Essen, Germany

University Medical Center Freiburg

Freiburg im Breisgau, Germany

University Hospital Leipzig

Leipzig, Germany

Rechts der Isar Hospital

Munich, Germany

University Hospital Tübingen

Tübingen, Germany

Rambam Medical Center

Haifa, Haifa District, Israel

Rabin Medical Center

Petah Tikva, Petah Tikva, Israel

Sheba Medical Center

Ramat Gan, Ramat Gan, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Tel Aviv, Israel

Hadassah Medical Center - Ein Kerem

Jerusalem, Israel

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, Japan

Saitama Medical University International Medical Center

Hidaka-shi, Saitama, Japan

Kyorin University Hospital

Mitaka-shi, Tokyo-To, Japan

Tokyo Women's Medical University Hospital

Shinjuku-ku, Tokyo-To, Japan

Lausanne University Hospital

Lausanne, Switzerland

University Hospital Zurich

Zurich, Switzerland

Clatterbridge Cancer Centre

Liverpool, United Kingdom

Guy's Hospital

London, United Kingdom

Charing Cross Hospital

London, United Kingdom

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

Royal Preston Hospital

Preston, United Kingdom