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

NCT04471844 | Completed DMC FDA Device

• 1 other identifier: TRIDENT EF-32
• Study Type: interventional
• Target: 981
• Locations: 11 countries
• Sites: 133

Brief 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.

Conditions

Glioblastoma Multiforme

Keywords

GBM

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Survival will be measured from the time of randomization until date patient is alive.

  5 years

Secondary Outcomes (8)

• Progression Free Survival (PFS)

  5 years

• 1- and 2-year survival rates

  5 years

• Overall Radiological response (ORR)

  5 years

• Next progression-free survival (PFS2)

  5 years

• Progression-free survival at 6 (PFS6) and 12 months (PFS12)

  5 years

Study Arms (2)

Optune® + RT + TMZ for 6 weeks

EXPERIMENTAL

Optune® + RT + TMZ for 6 weeks, followed by Optune® + TMZ until the tumor progresses. Optune treatment is maintained until second disease progression.

Device: Optune®

RT +TMZ for 6 weeks

ACTIVE COMPARATOR

RT +TMZ for 6 weeks followed by Optune® + TMZ until the tumor progresses. Optune treatment is maintained until second disease progression.

Device: Optune®

Interventions

Optune® DEVICE

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.

Optune® + RT + TMZ for 6 weeks; RT +TMZ for 6 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of GBM according to WHO 2016 classification criteria.
• Age ≥ 22 years in US and Age ≥ 18 years in Ex-US
• Recovered from maximal debulking surgery, if applicable (gross total resection, partial resection, and biopsy-only patients are all acceptable)
• Planned treatment with RT/TMZ followed by TTFields and maintenance TMZ (150-200 mg/m2 daily x 5 d, q28 days)
• Karnofsky performance status ≥ 70
• Life expectancy ≥ least 3 months
• Participants of childbearing age must use highly effective contraception. An effective method of birth control is defined as one that results in a failure rate of less than 1% per year when used consistently and correctly. The Investigator must approve the selected method, and may consult with a gynecologist as needed.
• All patients must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.
• Stable or decreasing dose of corticosteroids for the last 7 days prior to randomization, if applicable.
• Concomitant RT with TMZ treatment planned to start no later than 8 weeks from surgery
• Women of childbearing potential must have a negative β-HCG pregnancy test documented within 14 days prior to randomization
• Is able to have MRI with contrast of the brain

You may not qualify if:

• Progressive disease (per investigator's assessment)
• Infratentorial or leptomeningeal disease
• Participation in another clinical treatment study during the pre-treatment and/or the treatment phase of the study
• Pregnancy or breast-feeding.
• Significant co-morbidities at baseline which would preclude maintenance RT or TMZ treatment, as determined by the investigator:
• Thrombocytopenia (platelet count \< 100 x 103/μL)
• Neutropenia (absolute neutrophil count \< 1.5 x 103/μL)
• CTC grade 4 non-hematological Toxicity (except for alopecia, nausea, vomiting)
• Significant liver function impairment - AST or ALT \> 3 times the upper limit of normal
• Total bilirubin \> 1.5 x upper limit of normal
• Significant renal impairment (serum creatinine \> 1.7 mg/dL, or \> 150 µmol/l)
• History of any psychiatric condition that might impair patient's ability to understand or comply with the requirements of the study or to provide consent
• Implanted pacemaker, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias.
• Evidence of increased intracranial pressure (midline shift \> 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
• History of hypersensitivity reaction to TMZ or a history of hypersensitivity to DTIC.

Sponsors & Collaborators

• NovoCure Ltd.: lead

Study Sites (133)

Grandview Cancer Center

Birmingham, Alabama, 35243, United States

Location

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

Location

Mayo Clinic- Arizona

Phoenix, Arizona, 85054, United States

Location

University of Arizona Cancer Center

Tucson, Arizona, 85719, United States

Location

Highlands Oncology Group

Fayetteville, Arkansas, 72762, United States

Location

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

Burbank, California, 91505, United States

Location

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

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

Fullerton, California, 92835, United States

Location

University of California at San Diego - Moores Cancer Center

La Jolla, California, 92093, United States

Location

Norris Comprehensive Cancer Center at USC

Los Angeles, California, 90033, United States

Location

Cedars - Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Hoag Memorial Hospital - Hoag Cancer Center

Newport Beach, California, 92663, United States

Location

St. Joseph Hospital of Orange

Orange, California, 92868, United States

Location

University of California - Irvine/UCI Medical Center

Orange, California, 92868, United States

Location

Stanford University Cancer Institute

Palo Alto, California, 94303, United States

Location

Sharp Memorial Hospital - X-Ray Medical Group Radiation Oncology

San Diego, California, 92123, United States

Location

University of California San Francisco Medical Center

San Francisco, California, 94143, United States

Location

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

Santa Monica, California, 90404, United States

Location

University of Colorado Cancer Center Anschutz

Aurora, Colorado, 80045, United States

Location

HCA Research Institute - Blue Sky Neurology - Denver

Englewood, Colorado, 80113, United States

Location

Hartford Healthcare Medical Group - Hartford Hospital The Gray Cancer Center

Hartford, Connecticut, 06106, United States

Location

Lynn Cancer Institute, Marcus Neuroscience Institute

Boca Raton, Florida, 33486, United States

Location

Baptist Health - Jacksonville

Jacksonville, Florida, 32207, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

AdventHealth

Orlando, Florida, 32804, United States

Location

Orlando Health UF Health Cancer Center

Orlando, Florida, 32806, United States

Location

H. Lee Moffitt Cancer Center and Research Institute, Inc

Tampa, Florida, 33612, United States

Location

Piedmont Healthcare Brain Tumor Center

Atlanta, Georgia, 30309, United States

Location

The Emory Clinic - Emory Healthcare - Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Northside Hospital, Inc.

Atlanta, Georgia, 30342, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Chicago

Chicago, Illinois, 60617, United States

Location

Parkview Cancer Institute - Fort Wayne Radiation Oncology Associates

Fort Wayne, Indiana, 46845, United States

Location

The University of Kansas Cancer Center

Topeka, Kansas, 66606, United States

Location

University of Louisville - James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40241, United States

Location

Mary Bird Cancer Center Neuromedical Center

Baton Rouge, Louisiana, 70810, United States

Location

LSU Health Sciences Center, New Orleans

New Orleans, Louisiana, 70072, United States

Location

Ochsner Health System

New Orleans, Louisiana, 70121-2429, United States

Location

Maine Medical Partners Neurology - Neurosurgery & Spine Associates

South Portland, Maine, 04106, United States

Location

John Hopkins School of Medicine

Baltimore, Maryland, 21287, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01655, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Abbott Northwestern Hospital - Givens Brain Tumor Center

Minneapolis, Minnesota, 55407, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

University of Missouri - Ellis Fischel Cancer Center

Columbia, Missouri, 65212, United States

Location

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

Kansas City, Missouri, 64132, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

JFK Neuroscience Institute, HMH JFK University Medical Center

Edison, New Jersey, 08820, United States

Location

Hackensack University Medical Center - John Theurer Cancer Center

Hackensack, New Jersey, 07601, United States

Location

Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States

Location

Northwell Health System Brain Tumor Center

Lake Success, New York, 11042, United States

Location

NYU Langone - Laura & Issac Perimutter Cancer Center

New York, New York, 10016, United States

Location

Mount Sinai - Icahn School of Medicine

New York, New York, 10029, United States

Location

New York Presbyterian - Columbia University

New York, New York, 10032, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

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

Chapel Hill, North Carolina, 27599, United States

Location

Novant Health Cancer Institute Radiation Oncology

Charlotte, North Carolina, 28204, United States

Location

Vidant Medical Center

Greenville, North Carolina, 27834, United States

Location

Forsyth Medical Center-Novant Health

Winston-Salem, North Carolina, 27103, United States

Location

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location

University of Cincinnati Cancer Institute

Cincinnati, Ohio, 45219, United States

Location

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

Columbus, Ohio, 43210, United States

Location

Oregon Health & Science University (OHSU)

Portland, Oregon, 97239, United States

Location

Neuroscience Center, Philadelphia - University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Allegheny Health Network Cancer Institute

Pittsburgh, Pennsylvania, 15212, United States

Location

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MUSC Radiation Oncology Brain & Spine Tumor Program

Charleston, South Carolina, 29425, United States

Location

SCRI - Tennessee Oncology

Chattanooga, Tennessee, 37404, United States

Location

West Cancer Center - Germantown

Germantown, Tennessee, 38138, United States

Location

SCRI - Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

Texas Oncology Midtown - Austin Brain Tumor Center

Austin, Texas, 78705, United States

Location

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

Dallas, Texas, 75246, United States

Location

John Peter Smith Health Network - JPS Cancer Center

Fort Worth, Texas, 76104, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

UT Health Mischer Neuroscience - Memorial Herman - UT Neurosciences

Houston, Texas, 77030, United States

Location

Baylor Scott & White Medical Center

Temple, Texas, 76508, United States

Location

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

Burlington, Vermont, 05401, United States

Location

Massey Cancer Center - VCU Medical Center

Richmond, Virginia, 23298, United States

Location

UW Medical Center - Alvord Brain Tumor Center

Seattle, Washington, 98109, United States

Location

Swedish Health Services

Seattle, Washington, 98122, United States

Location

West Virginia University Cancer Institute

Morgantown, West Virginia, 26506, United States

Location

Innsbruck University Hospital

Innsbruck, Innsbruck, 6020, Austria

Location

Kepler University Hospital

Linz, Linz, 4020, Austria

Location

University Hospital Salzburg

Salzburg, Salzburg, 5020, Austria

Location

Hospital Erasme

Brussels, 1070, Belgium

Location

University Hospital Liege - Sart Tilman

Liège, B35, 4000, Belgium

Location

BC Cancer - Vancouver

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Nova Scotia Health Authority

Sydney, Nova Scotia, B1P 1P3, Canada

Location

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Location

Sunnybrook Research Institute - Odette Cancer Centre

Toronto, Ontario, Canada

Location

CHUM Centre de Recherche

Montreal, Quebec, H2X1R9, Canada

Location

Universite de Sherbrooke - Sherbrooke Centre Hospitalier Universita

Sherbrooke, Quebec, Canada

Location

Masaryk Memorial Cancer Institute

Brno, Brno, 656 53, Czechia

Location

University Hospital Plzeň

Pilsen, Pilsen, 305 99, Czechia

Location

Na Homolce Hospital

Prague, Prague, 150 30, Czechia

Location

Institut de cancérologie de l'Ouest

Angers, 49055, France

Location

Pierre Wertheimer Hospital

Bron, 69677, France

Location

Hôpital la Timone

Marseille, 13305, France

Location

University Hospital Nice

Nice, 06000, France

Location

Pitié-Salpêtrière University Hospital

Paris, 75013, France

Location

Institut de cancérologie de l'Ouest

Saint-Herblain, 44800, France

Location

University Institute Cancer Toulouse Oncopole

Toulouse, 31059, France

Location

Gustave Roussy Institute

Villejuif, 94805, France

Location

Charité Campus Virchow Clinic

Berlin, 13353, Germany

Location

University Hospital Essen

Essen, 45147, Germany

Location

University Medical Center Freiburg

Freiburg im Breisgau, 79106, Germany

Location

University Hospital Leipzig

Leipzig, 04103, Germany

Location

Rechts der Isar Hospital

Munich, 81675, Germany

Location

University Hospital Tübingen

Tübingen, 72076, Germany

Location

Rambam Medical Center

Haifa, Haifa District, 3109601, Israel

Location

Rabin Medical Center

Petah Tikva, Petah Tikva, 49100, Israel

Location

Sheba Medical Center

Ramat Gan, Ramat Gan, 52621, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, Tel Aviv, 64239, Israel

Location

Hadassah Medical Center - Ein Kerem

Jerusalem, 9112001, Israel

Location

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8648, Japan

Location

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

Saitama Medical University International Medical Center

Hidaka-shi, Saitama, 350-1298, Japan

Location

Kyorin University Hospital

Mitaka-shi, Tokyo-To, 181-8611, Japan

Location

Tokyo Women's Medical University Hospital

Shinjuku-ku, Tokyo-To, 162-8666, Japan

Location

Lausanne University Hospital

Lausanne, CH-1011, Switzerland

Location

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Clatterbridge Cancer Centre

Liverpool, L7 8YA, United Kingdom

Location

Guy's Hospital

London, SE1 9RT, United Kingdom

Location

Charing Cross Hospital

London, W6 8RF, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, NG5 1PB, United Kingdom

Location

Royal Preston Hospital

Preston, PR29HT, United Kingdom

Location

Related Publications (2)

• Miller R, Niazi M, Russial O, Poiset S, Shi W. Tumor treating fields with radiation for glioblastoma: a narrative review. Chin Clin Oncol. 2022 Oct;11(5):40. doi: 10.21037/cco-22-90.

  PMID: 36336899 DERIVED

• Miller R, Song A, Ali A, Niazi M, Bar-Ad V, Martinez N, Glass J, Alnahhas I, Andrews D, Judy K, Evans J, Farrell C, Werner-Wasik M, Chervoneva I, Ly M, Palmer J, Liu H, Shi W. Scalp-Sparing Radiation With Concurrent Temozolomide and Tumor Treating Fields (SPARE) for Patients With Newly Diagnosed Glioblastoma. Front Oncol. 2022 Apr 29;12:896246. doi: 10.3389/fonc.2022.896246. eCollection 2022.

  PMID: 35574391 DERIVED

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomly assigned equally to one of two groups: 1. Treatment arm I: Patients receive TTFields at 200 kHz to the brain using the Optune® System together with RT and TMZ, followed by maintenance TMZ concomitant with the Optune® treatment. 2. Treatment arm II: Patients receive RT and TMZ alone, followed by maintenance TMZ concomitant with TTFields at 200 kHz to the brain using the Optune®.

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 15, 2020
• Study Start: December 8, 2020
• Primary Completion: February 19, 2026
• Study Completion: February 19, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

CA (7); CH (2); IL (5); GB (5); US (87); FR (8); AU (3); CZ (3); JP (5); DE (6); BE (2)