Pivotal, Randomized, Open-label Study of Optune® (Tumor Treating Fields) Concomitant With RT & TMZ for the Treatment of Newly Diagnosed GBM
NCT ID: NCT04471844
Last Updated: 2025-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
981 participants
INTERVENTIONAL
2020-12-08
2026-01-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Tumor Treating Fields for Newly Diagnosed Glioblastoma: Two Emulated Trials With Chinese Multi-Hospital Based Real-World Data
NCT06346821
Study of Tumor Treating Fields With Hypofractionated Chemoradiotherapy in Newly Diagnosed Glioblastoma
NCT04474353
Tumor Treating Fields With Chemoradiation in Newly Diagnosed GBM
NCT03705351
Temozolomide, Radiation Therapy, and Tumor Treating Fields Therapy in Treating Participants With Glioblastoma
NCT03477110
Optune(NOVOTTF-100A)+ Bevacizumab+ Hypofractionated Stereotactic Irradiation Bevacizumab-Naive Recurrent Glioblastoma (GCC 1344)
NCT01925573
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
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®.
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Optune® + RT + TMZ for 6 weeks
Optune® + RT + TMZ for 6 weeks, followed by Optune® + TMZ until the tumor progresses. Optune treatment is maintained until second disease progression.
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.
RT +TMZ for 6 weeks
RT +TMZ for 6 weeks followed by Optune® + TMZ until the tumor progresses. Optune treatment is maintained until second disease progression.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Age ≥ 22 years in US and Age ≥ 18 years in Ex-US
3. Recovered from maximal debulking surgery, if applicable (gross total resection, partial resection, and biopsy-only patients are all acceptable)
4. Planned treatment with RT/TMZ followed by TTFields and maintenance TMZ (150-200 mg/m2 daily x 5 d, q28 days)
5. Karnofsky performance status ≥ 70
6. Life expectancy ≥ least 3 months
7. 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.
8. All patients must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.
9. Stable or decreasing dose of corticosteroids for the last 7 days prior to randomization, if applicable.
10. Concomitant RT with TMZ treatment planned to start no later than 8 weeks from surgery
11. Women of childbearing potential must have a negative β-HCG pregnancy test documented within 14 days prior to randomization
12. Is able to have MRI with contrast of the brain
Exclusion Criteria
2. Infratentorial or leptomeningeal disease
3. Participation in another clinical treatment study during the pre-treatment and/or the treatment phase of the study
4. Pregnancy or breast-feeding.
5. Significant co-morbidities at baseline which would preclude maintenance RT or TMZ treatment, as determined by the investigator:
1. Thrombocytopenia (platelet count \< 100 x 103/μL)
2. Neutropenia (absolute neutrophil count \< 1.5 x 103/μL)
3. CTC grade 4 non-hematological Toxicity (except for alopecia, nausea, vomiting)
4. Significant liver function impairment - AST or ALT \> 3 times the upper limit of normal
5. Total bilirubin \> 1.5 x upper limit of normal
6. Significant renal impairment (serum creatinine \> 1.7 mg/dL, or \> 150 µmol/l)
7. 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
6. Implanted pacemaker, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias.
7. Evidence of increased intracranial pressure (midline shift \> 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
8. History of hypersensitivity reaction to TMZ or a history of hypersensitivity to DTIC.
9. Additional malignancies that are progressing or required active treatment in the last two years.
10. Admitted to an institution by administrative or court order.
11. Known allergies to medical adhesives or hydrogel
12. A skull defect (such as, missing bone with no replacement)
13. Prior radiation treatment to the brain for the treatment of GBM
14. Any serious surgical/post-operative condition that may put the participant at risk according to the investigator.
1. Active implanted medical devices
2. Bullet fragments
3. Skull defects
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
NovoCure Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Massey Cancer Center - VCU Medical Center
Richmond, Virginia, 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, , Austria
Kepler University Hospital
Linz, , Austria
University Hospital Salzburg
Salzburg, , Austria
Hospital Erasme
Brussels, , Belgium
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, , Czechia
University Hospital Plzeň
Pilsen, , Czechia
Na Homolce Hospital
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
Charité Campus Virchow Clinic
Berlin, , Germany
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, , Israel
Hadassah Medical Center - Ein Kerem
Jerusalem, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , 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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TRIDENT EF-32
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.