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

NAActive, not recruitingINTERVENTIONAL
Enrollment

981

Participants

Timeline

Start Date

December 8, 2020

Primary Completion Date

January 30, 2026

Study Completion Date

January 30, 2026

Conditions
Glioblastoma Multiforme
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."

Trial Locations (133)

1070

Hospital Erasme, Brussels

4020

Kepler University Hospital, Linz

5020

University Hospital Salzburg, Salzburg

6020

Innsbruck University Hospital, Innsbruck

8091

University Hospital Zurich, Zurich

10016

NYU Langone - Laura & Issac Perimutter Cancer Center, New York

10029

Mount Sinai - Icahn School of Medicine, New York

10032

New York Presbyterian - Columbia University, New York

11042

Northwell Health System Brain Tumor Center, Lake Success

13210

SUNY Upstate Medical University, Syracuse

13305

Hôpital la Timone, Marseille

13353

Charité Campus Virchow Clinic, Berlin

14642

University of Rochester Medical Center, Rochester

15212

Allegheny Health Network Cancer Institute, Pittsburgh

15232

UPMC Hillman Cancer Center, Pittsburgh

19104

Neuroscience Center, Philadelphia - University of Pennsylvania, Philadelphia

19107

Thomas Jefferson University Hospital, Philadelphia

21287

John Hopkins School of Medicine, Baltimore

23298

Massey Cancer Center - VCU Medical Center, Richmond

26506

West Virginia University Cancer Institute, Morgantown

27103

Forsyth Medical Center-Novant Health, Winston-Salem

27157

Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem

27599

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

27834

Vidant Medical Center, Greenville

28204

Novant Health Cancer Institute Radiation Oncology, Charlotte

29425

MUSC Radiation Oncology Brain & Spine Tumor Program, Charleston

30309

Piedmont Healthcare Brain Tumor Center, Atlanta

30322

The Emory Clinic - Emory Healthcare - Winship Cancer Institute, Atlanta

30342

Northside Hospital, Inc., Atlanta

31059

University Institute Cancer Toulouse Oncopole, Toulouse

32207

Baptist Health - Jacksonville, Jacksonville

32224

Mayo Clinic, Jacksonville

32804

AdventHealth, Orlando

32806

Orlando Health UF Health Cancer Center, Orlando

33486

Lynn Cancer Institute, Marcus Neuroscience Institute, Boca Raton

33612

H. Lee Moffitt Cancer Center and Research Institute, Inc, Tampa

35243

Grandview Cancer Center, Birmingham

37203

SCRI - Tennessee Oncology, Nashville

37404

SCRI - Tennessee Oncology, Chattanooga

38138

West Cancer Center - Germantown, Germantown

39216

University of Mississippi Medical Center, Jackson

40202

University of Louisville - James Graham Brown Cancer Center, Louisville

40241

Norton Cancer Institute, Louisville

43210

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

44800

Institut de cancérologie de l'Ouest, Saint-Herblain

45147

University Hospital Essen, Essen

45219

University of Cincinnati Cancer Institute, Cincinnati

46845

Parkview Cancer Institute - Fort Wayne Radiation Oncology Associates, Fort Wayne

48109

University of Michigan Comprehensive Cancer Center, Ann Arbor

49055

Institut de cancérologie de l'Ouest, Angers

49100

Rabin Medical Center, Petah Tikva

52621

Sheba Medical Center, Ramat Gan

55407

Abbott Northwestern Hospital - Givens Brain Tumor Center, Minneapolis

60612

Rush University Medical Center, Chicago

60617

University of Chicago, Chicago

63110

Washington University School of Medicine, St Louis

64132

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

64239

Tel Aviv Sourasky Medical Center, Tel Aviv

65212

University of Missouri - Ellis Fischel Cancer Center, Columbia

66606

The University of Kansas Cancer Center, Topeka

69677

Pierre Wertheimer Hospital, Bron

70072

LSU Health Sciences Center, New Orleans, New Orleans

70810

Mary Bird Cancer Center Neuromedical Center, Baton Rouge

72076

University Hospital Tübingen, Tübingen

72762

Highlands Oncology Group, Fayetteville

75013

Pitié-Salpêtrière University Hospital, Paris

75246

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

76104

John Peter Smith Health Network - JPS Cancer Center, Fort Worth

76508

Baylor Scott & White Medical Center, Temple

77030

Houston Methodist Hospital, Houston

UT Health Mischer Neuroscience - Memorial Herman - UT Neurosciences, Houston

78705

Texas Oncology Midtown - Austin Brain Tumor Center, Austin

79106

University Medical Center Freiburg, Freiburg im Breisgau

80045

University of Colorado Cancer Center Anschutz, Aurora

80113

HCA Research Institute - Blue Sky Neurology - Denver, Englewood

81675

Rechts der Isar Hospital, Munich

85054

Mayo Clinic- Arizona, Phoenix

85234

Banner MD Anderson Cancer Center, Gilbert

85719

University of Arizona Cancer Center, Tucson

90033

Norris Comprehensive Cancer Center at USC, Los Angeles

90048

Cedars - Sinai Medical Center, Los Angeles

90404

John Wayne Cancer Institute at St. John's Health Center, Santa Monica

91010

City of Hope National Medical Center, Duarte

91505

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

92093

University of California at San Diego - Moores Cancer Center, La Jolla

92123

Sharp Memorial Hospital - X-Ray Medical Group Radiation Oncology, San Diego

92663

Hoag Memorial Hospital - Hoag Cancer Center, Newport Beach

92835

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

92868

St. Joseph Hospital of Orange, Orange

University of California - Irvine/UCI Medical Center, Orange

94143

University of California San Francisco Medical Center, San Francisco

94303

Stanford University Cancer Institute, Palo Alto

94805

Gustave Roussy Institute, Villejuif

97239

Oregon Health & Science University (OHSU), Portland

98109

UW Medical Center - Alvord Brain Tumor Center, Seattle

98122

Swedish Health Services, Seattle

3109601

Rambam Medical Center, Haifa

9112001

Hadassah Medical Center - Ein Kerem, Jerusalem

06106

Hartford Healthcare Medical Group - Hartford Hospital The Gray Cancer Center, Hartford

70121-2429

Ochsner Health System, New Orleans

04106

Maine Medical Partners Neurology - Neurosurgery & Spine Associates, South Portland

02111

Tufts Medical Center, Boston

01655

University of Massachusetts Chan Medical School, Worcester

03756

Dartmouth-Hitchcock Medical Center, Lebanon

08820

JFK Neuroscience Institute, HMH JFK University Medical Center, Edison

07601

Hackensack University Medical Center - John Theurer Cancer Center, Hackensack

07753

Jersey Shore University Medical Center, Neptune City

02903

Rhode Island Hospital, Providence

05401

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

B35, 4000

University Hospital Liege - Sart Tilman, Liège

V5Z 4E6

BC Cancer - Vancouver, Vancouver

B1P 1P3

Nova Scotia Health Authority, Sydney

Unknown

The Ottawa Hospital Cancer Centre, Ottawa

Princess Margaret Cancer Centre, Toronto

Sunnybrook Research Institute - Odette Cancer Centre, Toronto

Universite de Sherbrooke - Sherbrooke Centre Hospitalier Universita, Sherbrooke

H2X1R9

CHUM Centre de Recherche, Montreal

656 53

Masaryk Memorial Cancer Institute, Brno

305 99

University Hospital Plzeň, Pilsen

150 30

Na Homolce Hospital, Prague

06000

University Hospital Nice, Nice

04103

University Hospital Leipzig, Leipzig

060-8648

Hokkaido University Hospital, Sapporo

920-8641

Kanazawa University Hospital, Kanazawa

350-1298

Saitama Medical University International Medical Center, Hidaka-shi

181-8611

Kyorin University Hospital, Mitaka-shi

162-8666

Tokyo Women's Medical University Hospital, Shinjuku-ku

CH-1011

Lausanne University Hospital, Lausanne

L7 8YA

Clatterbridge Cancer Centre, Liverpool

SE1 9RT

Guy's Hospital, London

W6 8RF

Charing Cross Hospital, London

NG5 1PB

Nottingham University Hospitals NHS Trust, Nottingham

PR29HT

Royal Preston Hospital, Preston

All Listed Sponsors
lead

NovoCure Ltd.

INDUSTRY