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Glioblastoma MultiformeEF-32NCT04471844

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

A study testing Optune® in people with Glioblastoma Multiforme, run by NovoCure Ltd. at 130 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma Multiforme
What is being tested?
Optune®
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
981 participants
Where
130 sitesin 11 countries
Study dates
8 Dec 2020to 19 Feb 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
Show all 25Show fewer
  • 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.
  • Additional malignancies that are progressing or required active treatment in the last two years.
  • Admitted to an institution by administrative or court order.
  • Known allergies to medical adhesives or hydrogel
  • A skull defect (such as, missing bone with no replacement)
  • Prior radiation treatment to the brain for the treatment of GBM
  • Any serious surgical/post-operative condition that may put the participant at risk according to the investigator.
  • Standard TTFields exclusion criteria include
  • Active implanted medical devices
  • Bullet fragments
  • Skull defects

Trial locations and contacts

130 sites in 11 countries.

130 sites in 11 countries

United States86 sites

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Piedmont Healthcare Brain Tumor Center

    Atlanta, Georgia, 30309

  • The Emory Clinic - Emory Healthcare - Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Northside Hospital, Inc.

    Atlanta, Georgia, 30342

  • University of Colorado Cancer Center Anschutz

    Aurora, Colorado, 80045

  • Texas Oncology Midtown - Austin Brain Tumor Center

    Austin, Texas, 78705

  • John Hopkins School of Medicine

    Baltimore, Maryland, 21287

  • Mary Bird Cancer Center Neuromedical Center

    Baton Rouge, Louisiana, 70810

  • Grandview Cancer Center

    Birmingham, Alabama, 35243

  • Lynn Cancer Institute, Marcus Neuroscience Institute

    Boca Raton, Florida, 33486

  • Tufts Medical Center

    Boston, Massachusetts, 02111

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

    Burbank, California, 91505

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

    Burlington, Vermont, 05401

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

    Chapel Hill, North Carolina, 27599

  • MUSC Radiation Oncology Brain & Spine Tumor Program

    Charleston, South Carolina, 29425

  • Novant Health Cancer Institute Radiation Oncology

    Charlotte, North Carolina, 28204

  • SCRI - Tennessee Oncology

    Chattanooga, Tennessee, 37404

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Chicago

    Chicago, Illinois, 60617

  • University of Cincinnati Cancer Institute

    Cincinnati, Ohio, 45219

  • University of Missouri - Ellis Fischel Cancer Center

    Columbia, Missouri, 65212

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

    Columbus, Ohio, 43210

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

    Dallas, Texas, 75246

  • City of Hope National Medical Center

    Duarte, California, 91010

  • JFK Neuroscience Institute, HMH JFK University Medical Center

    Edison, New Jersey, 08820

  • HCA Research Institute - Blue Sky Neurology - Denver

    Englewood, Colorado, 80113

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72762

  • Parkview Cancer Institute - Fort Wayne Radiation Oncology Associates

    Fort Wayne, Indiana, 46845

  • John Peter Smith Health Network - JPS Cancer Center

    Fort Worth, Texas, 76104

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

    Fullerton, California, 92835

  • West Cancer Center - Germantown

    Germantown, Tennessee, 38138

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • Vidant Medical Center

    Greenville, North Carolina, 27834

  • Hackensack University Medical Center - John Theurer Cancer Center

    Hackensack, New Jersey, 07601

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

    Hartford, Connecticut, 06106

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • UT Health Mischer Neuroscience - Memorial Herman - UT Neurosciences

    Houston, Texas, 77030

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Baptist Health - Jacksonville

    Jacksonville, Florida, 32207

  • Mayo Clinic

    Jacksonville, Florida, 32224

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

    Kansas City, Missouri, 64132

  • University of California at San Diego - Moores Cancer Center

    La Jolla, California, 92093

  • Northwell Health System Brain Tumor Center

    Lake Success, New York, 11042

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Norris Comprehensive Cancer Center at USC

    Los Angeles, California, 90033

  • Cedars - Sinai Medical Center

    Los Angeles, California, 90048

  • University of Louisville - James Graham Brown Cancer Center

    Louisville, Kentucky, 40202

  • Norton Cancer Institute

    Louisville, Kentucky, 40241

  • Abbott Northwestern Hospital - Givens Brain Tumor Center

    Minneapolis, Minnesota, 55407

  • West Virginia University Cancer Institute

    Morgantown, West Virginia, 26506

  • SCRI - Tennessee Oncology

    Nashville, Tennessee, 37203

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

  • LSU Health Sciences Center, New Orleans

    New Orleans, Louisiana, 70072

  • Ochsner Health System

    New Orleans, Louisiana, 70121-2429

  • NYU Langone - Laura & Issac Perimutter Cancer Center

    New York, New York, 10016

  • Mount Sinai - Icahn School of Medicine

    New York, New York, 10029

  • New York Presbyterian - Columbia University

    New York, New York, 10032

  • Hoag Memorial Hospital - Hoag Cancer Center

    Newport Beach, California, 92663

  • St. Joseph Hospital of Orange

    Orange, California, 92868

  • University of California - Irvine/UCI Medical Center

    Orange, California, 92868

  • AdventHealth

    Orlando, Florida, 32804

  • Orlando Health UF Health Cancer Center

    Orlando, Florida, 32806

  • Stanford University Cancer Institute

    Palo Alto, California, 94303

  • Neuroscience Center, Philadelphia - University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Mayo Clinic- Arizona

    Phoenix, Arizona, 85054

  • Allegheny Health Network Cancer Institute

    Pittsburgh, Pennsylvania, 15212

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Oregon Health & Science University (OHSU)

    Portland, Oregon, 97239

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Sharp Memorial Hospital - X-Ray Medical Group Radiation Oncology

    San Diego, California, 92123

  • University of California San Francisco Medical Center

    San Francisco, California, 94143

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

    Santa Monica, California, 90404

  • UW Medical Center - Alvord Brain Tumor Center

    Seattle, Washington, 98109

  • Swedish Health Services

    Seattle, Washington, 98122

  • Maine Medical Partners Neurology - Neurosurgery & Spine Associates

    South Portland, Maine, 04106

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

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

    Tampa, Florida, 33612

  • Baylor Scott & White Medical Center

    Temple, Texas, 76508

  • The University of Kansas Cancer Center

    Topeka, Kansas, 66606

  • University of Arizona Cancer Center

    Tucson, Arizona, 85719

  • Forsyth Medical Center-Novant Health

    Winston-Salem, North Carolina, 27103

  • Wake Forest Baptist Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157

  • University of Massachusetts Chan Medical School

    Worcester, Massachusetts, 01655

Other trials in United States

France8 sites

  • Institut de cancérologie de l'Ouest

    Angers, 49055

  • Pierre Wertheimer Hospital

    Bron, 69677

  • Hôpital la Timone

    Marseille, 13305

  • University Hospital Nice

    Nice, 06000

  • Pitié-Salpêtrière University Hospital

    Paris, 75013

  • Institut de cancérologie de l'Ouest

    Saint-Herblain, 44800

  • University Institute Cancer Toulouse Oncopole

    Toulouse, 31059

  • Gustave Roussy Institute

    Villejuif, 94805

Other trials in France

Canada7 sites

  • CHUM Centre de Recherche

    Montreal, Quebec, H2X1R9

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario

  • Universite de Sherbrooke - Sherbrooke Centre Hospitalier Universita

    Sherbrooke, Quebec

  • Nova Scotia Health Authority

    Sydney, Nova Scotia, B1P 1P3

  • Princess Margaret Cancer Centre

    Toronto, Ontario

  • Sunnybrook Research Institute - Odette Cancer Centre

    Toronto, Ontario

  • BC Cancer - Vancouver

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Germany5 sites

  • University Hospital Essen

    Essen, 45147

  • University Medical Center Freiburg

    Freiburg im Breisgau, 79106

  • University Hospital Leipzig

    Leipzig, 04103

  • Rechts der Isar Hospital

    Munich, 81675

  • University Hospital Tübingen

    Tübingen, 72076

Other trials in Germany

Israel5 sites

  • Rambam Medical Center

    Haifa, Haifa District, 3109601

  • Hadassah Medical Center - Ein Kerem

    Jerusalem, 9112001

  • Rabin Medical Center

    Petah Tikva, Petah Tikva, 49100

  • Sheba Medical Center

    Ramat Gan, Ramat Gan, 52621

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, Tel Aviv, 64239

Other trials in Israel

Japan5 sites

  • Saitama Medical University International Medical Center

    Hidaka-shi, Saitama, 350-1298

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641

  • Kyorin University Hospital

    Mitaka-shi, Tokyo-To, 181-8611

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

  • Tokyo Women's Medical University Hospital

    Shinjuku-ku, Tokyo-To, 162-8666

Other trials in Japan

United Kingdom5 sites

  • Clatterbridge Cancer Centre

    Liverpool, L7 8YA

  • Guy's Hospital

    London, SE1 9RT

  • Charing Cross Hospital

    London, W6 8RF

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG5 1PB

  • Royal Preston Hospital

    Preston, PR29HT

Other trials in United Kingdom

Austria3 sites

  • Innsbruck University Hospital

    Innsbruck, Innsbruck, 6020

  • Kepler University Hospital

    Linz, Linz, 4020

  • University Hospital Salzburg

    Salzburg, State of Salzburg, 5020

Other trials in Austria

Czechia3 sites

  • Masaryk Memorial Cancer Institute

    Brno, Brno, 656 53

  • University Hospital Plzeň

    Pilsen, Pilsen, 305 99

  • Na Homolce Hospital

    Prague, Prague, 150 30

Other trials in Czechia

Switzerland2 sites

  • Lausanne University Hospital

    Lausanne, CH-1011

  • University Hospital Zurich

    Zurich, 8091

Other trials in Switzerland

Belgium1 site

  • University Hospital Liege - Sart Tilman

    Liège, B35, 4000

Other trials in Belgium

About this study

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

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.

Read the detailed description

Optune® is a medical device that has been approved for the treatment of recurrent and newly diagnosed glioblastoma (GBM) by the Food and Drug Administration (FDA) in the United States. Optune® has obtained a CE mark in Europe for recurrent and newly diagnosed GBM.

The current standard of care for GBM includes the addition of Optune® to maintenance temozolomide (TMZ), following the completion of radiation therapy (RT).

The purpose of the current study is to test if the earlier introduction of Optune®, at the time of radiation therapy (which is given together with temozolomide), improves clinical outcomes compared to the standard of care.

The study will randomize 950 subjects equally to one of two treatment arms:

  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®.

All patients are to receive standard RT and TMZ treatment followed by maintenance TMZ chemotherapy and Optune® according to the current standard of care regimen.

Optune® will continue until second disease progression per 2010 RANO Criteria unless any of the treatment discontinuation conditions described under criteria for patient withdrawal or termination are met.

After surgery or biopsy, subjects that would like to participate will be required to submit samples of their tumor to a lab for testing. The results of this test will be used for randomization into the trial.

If the subject is assigned to the treatment group that will start Optune® therapy during radiation therapy, Optune® therapy will begin within 10 days of enrolling in the study and no later than the first day of RT and TMZ treatment.

After the initial visit, subjects will continue treatment at home, while pursuing normal daily routines. Subjects are required to use the device for at least 18 hours a day. Short breaks in treatment for personal hygiene and other personal needs is allowed. Total usage time will be recorded and provided to the site and sponsor.

Subjects will be required to return to the clinic per the study protocol.

After the second disease progression, subjects will return to the clinic for one final visit approximately 30 days after the last treatment with Optune® or after second disease progression, the latter of the two per protocol.

After completing active participation in the study, subjects will be contacted once per month to answer basic questions about their health status.

Being tested
Optune®
Keywords
GBM
Medical subject headings
Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT04471844
Study groupRoleWhat they receive
Optune® + RT + TMZ for 6 weeksExperimentalOptune® + RT + TMZ for 6 weeks, followed by Optune® + TMZ until the tumor progresses. Optune treatment is maintained until second disease progression.
Receives: Device: Optune®
RT +TMZ for 6 weeksActive comparatorRT +TMZ for 6 weeks followed by Optune® + TMZ until the tumor progresses. Optune treatment is maintained until second disease progression.
Receives: Device: Optune®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

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

    Measured: 5 years

Secondary outcomes (8)

  1. Progression Free Survival (PFS)

    PFS will be measured from the date of randomization to the date of progression based on the 2010 RANO Criteria.

    Measured: 5 years

  2. 1- and 2-year survival rates

    The analyses will be performed based on estimated proportions of patients who are on study at 12 and 24 months in both arms of the study.

    Measured: 5 years

  3. Overall Radiological response (ORR)

    The analyses will be performed based on the 2010 RANO criteria, and comparison between the rates of response.

    Measured: 5 years

  4. Next progression-free survival (PFS2)

    PFS2 will be measured from the time of randomization to second tumor progression.

    Measured: 5 years

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

    The analyses will be estimated proportions of patients who are progression-free at 6 and 12 months in both arms of the study.

    Measured: 5 years

  6. Severity and frequency of adverse events

    The analyses will be performed based on the incidence, severity, frequency of adverse events, and their association with study treatments.

    Measured: 5 years

  7. Quality of Life EORTC Questionnaire

    The analyses will be assessed using the EORTC QLQ C-30 questionnaire with BN-20 (brain symptom) supplement.

    Measured: 5 years

  8. The NANO scale

    The Neurological assessment in Neuro-Oncology will be assessed using the NANO scale questionnaire and per the 2010 RANO criteria.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2020
  2. Study start8 Dec 2020
  3. Primary completion19 Feb 2026
  4. Study completion19 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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®.
Masking
None (open label)
Enrolment
981 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04471844
Sponsor's protocol ID
TRIDENT EF-32
Acronym
EF-32
Status last verified
Mar 2026
First submitted
9 Jul 2020
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • 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.

    PubMed 36336899

  • 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.

    PubMed 35574391

Questions about this trial

What is this clinical trial studying?

A study testing Optune® in people with Glioblastoma Multiforme, run by NovoCure Ltd. at 130 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 130 sites in United States, France, Canada, Germany, Israel and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04471844, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.

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