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Pivotal, Randomized, Open-label Study of Optune® (Tumor Treating Fields) Concomitant With RT & TMZ for the Treatment of Newly Diagnosed GBM
Sponsor: NovoCure Ltd.
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
Conditions
Interventions
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