Pivotal, Randomized, Open-label Study of Optune® (Tumor Treating Fields) Concomitant with RT & TMZ for the Treatment of Newly Diagnosed GBM
Study Purpose
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.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 18 Years and Over |
| Gender | All |
*Age Limits
- - 18 years or older outside of the US, 22 years or older within the US.
Inclusion Criteria:
1. Histologically confirmed diagnosis of GBM according to WHO classification 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:
1. Progressive disease (per investigator's assessment) 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.
Trial Details
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04471844 |
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Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
N/A |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
NovoCure Ltd. |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
| Principal Investigator Affiliation | N/A |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Active, not recruiting |
| Countries | Austria, Belgium, Canada, Czechia, France, Germany, Israel, Japan, Switzerland, United Kingdom, United States |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Glioblastoma Multiforme |
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 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 by telephone to answer basic questions about their health status.
Arms
Experimental: 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.
Active Comparator: 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.
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.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Address
Grandview Cancer Center
Birmingham, Alabama, 35243
Status
Address
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
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Address
Mayo Clinic- Arizona
Phoenix, Arizona, 85054
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Address
University of Arizona Cancer Center
Tucson, Arizona, 85719
Status
Address
Highlands Oncology Group
Fayetteville, Arkansas, 72762
Status
Address
Providence St. Joseph Medical Center and The Roy and Patricia Disney Family Cancer Center
Burbank, California, 91505
Status
Address
City of Hope National Medical Center
Duarte, California, 91010
Status
Address
TRIO - St. Jude Heritage Healthcare/St. Jude Medical Center
Fullerton, California, 92835
Status
Address
University of California at San Diego - Moores Cancer Center
La Jolla, California, 92093
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Address
Norris Comprehensive Cancer Center at USC
Los Angeles, California, 90033
Status
Address
Cedars - Sinai Medical Center
Los Angeles, California, 90048
Status
Address
Hoag Memorial Hospital - Hoag Cancer Center
Newport Beach, California, 92663
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Address
St. Joseph Hospital of Orange
Orange, California, 92868
Status
Address
University of California - Irvine/UCI Medical Center
Orange, California, 92868
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Address
Stanford University Cancer Institute
Palo Alto, California, 94303
Status
Address
Sharp Memorial Hospital - X-Ray Medical Group Radiation Oncology
San Diego, California, 92123
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Address
University of California San Francisco Medical Center
San Francisco, California, 94143
Status
Address
John Wayne Cancer Institute at St. John's Health Center
Santa Monica, California, 90404
Status
Address
University of Colorado Cancer Center Anschutz
Aurora, Colorado, 80045
Status
Address
HCA Research Institute - Blue Sky Neurology - Denver
Englewood, Colorado, 80113
Status
Address
Hartford Healthcare Medical Group - Hartford Hospital The Gray Cancer Center
Hartford, Connecticut, 06106
Status
Address
Lynn Cancer Institute, Marcus Neuroscience Institute
Boca Raton, Florida, 33486
Status
Address
Baptist Health - Jacksonville
Jacksonville, Florida, 32207
Status
Address
Mayo Clinic
Jacksonville, Florida, 32224
Status
Address
AdventHealth
Orlando, Florida, 32804
Status
Address
Orlando Health UF Health Cancer Center
Orlando, Florida, 32806
Status
Address
H. Lee Moffitt Cancer Center and Research Institute, Inc
Tampa, Florida, 33612
Status
Address
Piedmont Healthcare Brain Tumor Center
Atlanta, Georgia, 30309
Status
Address
The Emory Clinic - Emory Healthcare - Winship Cancer Institute
Atlanta, Georgia, 30322
Status
Address
Northside Hospital, Inc.
Atlanta, Georgia, 30342
Status
Address
Rush University Medical Center
Chicago, Illinois, 60612
Status
Address
University of Chicago
Chicago, Illinois, 60617
Status
Address
Parkview Cancer Institute - Fort Wayne Radiation Oncology Associates
Fort Wayne, Indiana, 46845
Status
Address
The University of Kansas Cancer Center
Topeka, Kansas, 66606
Status
Address
University of Louisville - James Graham Brown Cancer Center
Louisville, Kentucky, 40202
Status
Address
Norton Cancer Institute
Louisville, Kentucky, 40241
Status
Address
Mary Bird Cancer Center Neuromedical Center
Baton Rouge, Louisiana, 70810
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Address
LSU Health Sciences Center, New Orleans
New Orleans, Louisiana, 70072
Status
Address
Ochsner Health System
New Orleans, Louisiana, 70121-2429
Status
Address
Maine Medical Partners Neurology - Neurosurgery & Spine Associates
South Portland, Maine, 04106
Status
Address
John Hopkins School of Medicine
Baltimore, Maryland, 21287
Status
Address
Tufts Medical Center
Boston, Massachusetts, 02111
Status
Address
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655
Status
Address
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Status
Address
Abbott Northwestern Hospital - Givens Brain Tumor Center
Minneapolis, Minnesota, 55407
Status
Address
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Status
Address
University of Missouri - Ellis Fischel Cancer Center
Columbia, Missouri, 65212
Status
Address
Health Midwest Ventures Group, Inc - Sarah Cannon HCA Midwest Brain and Spine
Kansas City, Missouri, 64132
Status
Address
Washington University School of Medicine
Saint Louis, Missouri, 63110
Status
Address
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Status
Address
JFK Neuroscience Institute, HMH JFK University Medical Center
Edison, New Jersey, 08820
Status
Address
Hackensack University Medical Center - John Theurer Cancer Center
Hackensack, New Jersey, 07601
Status
Address
Jersey Shore University Medical Center
Neptune, New Jersey, 07753
Status
Address
Northwell Health System Brain Tumor Center
Lake Success, New York, 11042
Status
Address
NYU Langone - Laura & Issac Perimutter Cancer Center
New York, New York, 10016
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Address
Mount Sinai - Icahn School of Medicine
New York, New York, 10029
Status
Address
New York Presbyterian - Columbia University
New York, New York, 10032
Status
Address
University of Rochester Medical Center
Rochester, New York, 14642
Status
Address
SUNY Upstate Medical University
Syracuse, New York, 13210
Status
Address
University of North Carolina Brain Tumor Program - UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Status
Address
Novant Health Cancer Institute Radiation Oncology
Charlotte, North Carolina, 28204
Status
Address
Vidant Medical Center
Greenville, North Carolina, 27834
Status
Address
Forsyth Medical Center-Novant Health
Winston-Salem, North Carolina, 27103
Status
Address
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
Status
Address
University of Cincinnati Cancer Institute
Cincinnati, Ohio, 45219
Status
Address
The James Cancer Hospital and Solove Research Institute - Arthur G James Cancer Hospital
Columbus, Ohio, 43210
Status
Address
Oregon Health & Science University (OHSU)
Portland, Oregon, 97239
Status
Address
Neuroscience Center, Philadelphia - University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Status
Address
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Status
Address
Allegheny Health Network Cancer Institute
Pittsburgh, Pennsylvania, 15212
Status
Address
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Status
Address
Rhode Island Hospital
Providence, Rhode Island, 02903
Status
Address
MUSC Radiation Oncology Brain & Spine Tumor Program
Charleston, South Carolina, 29425
Status
Address
SCRI - Tennessee Oncology
Chattanooga, Tennessee, 37404
Status
Address
West Cancer Center - Germantown
Germantown, Tennessee, 38138
Status
Address
SCRI - Tennessee Oncology
Nashville, Tennessee, 37203
Status
Address
Texas Oncology Midtown - Austin Brain Tumor Center
Austin, Texas, 78705
Status
Address
Baylor Charles A. Sammons Cancer Center - Baylor University Medical Center
Dallas, Texas, 75246
Status
Address
John Peter Smith Health Network - JPS Cancer Center
Fort Worth, Texas, 76104
Status
Address
Houston Methodist Hospital
Houston, Texas, 77030
Status
Address
UT Health Mischer Neuroscience - Memorial Herman - UT Neurosciences
Houston, Texas, 77030
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Address
Baylor Scott & White Medical Center
Temple, Texas, 76508
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Address
The University of Vermont Medical Center - University of Vermont Cancer Center
Burlington, Vermont, 05401
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Address
Massey Cancer Center - VCU Medical Center
Richmond, Virginia, 23298
Status
Address
UW Medical Center - Alvord Brain Tumor Center
Seattle, Washington, 98109
Status
Address
Swedish Health Services
Seattle, Washington, 98122
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Address
West Virginia University Cancer Institute
Morgantown, West Virginia, 26506
International Sites
Status
Address
Innsbruck University Hospital
Innsbruck, , 6020
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Address
Kepler University Hospital
Linz, , 4020
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Address
University Hospital Salzburg
Salzburg, , 5020
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Address
Hospital Erasme
Brussels, , 1070
Status
Address
University Hospital Liege - Sart Tilman
Liège, , B35, 4000
Status
Address
BC Cancer - Vancouver
Vancouver, British Columbia, V5Z 4E6
Status
Address
Nova Scotia Health Authority
Sydney, Nova Scotia, B1P 1P3
Status
Address
The Ottawa Hospital Cancer Centre
Ottawa, Ontario,
Status
Address
Princess Margaret Cancer Centre
Toronto, Ontario,
Status
Address
Sunnybrook Research Institute - Odette Cancer Centre
Toronto, Ontario,
Status
Address
CHUM Centre de Recherche
Montréal, Quebec, H2X1R9
Status
Address
Universite de Sherbrooke - Sherbrooke Centre Hospitalier Universita
Sherbrooke, Quebec,
Status
Address
Masaryk Memorial Cancer Institute
Brno, , 656 53
Status
Address
University Hospital Plzeň
Pilsen, , 305 99
Status
Address
Na Homolce Hospital
Prague, , 150 30
Status
Address
Institut de cancérologie de l'Ouest
Angers, , 49055
Status
Address
Pierre Wertheimer Hospital
Bron, , 69677
Status
Address
Hôpital la Timone
Marseille, , 13305
Status
Address
University Hospital Nice
Nice, , 06000
Status
Address
Pitié-Salpêtrière University Hospital
Paris, , 75013
Status
Address
Institut de cancérologie de l'Ouest
Saint Herblain, , 44800
Status
Address
University Institute Cancer Toulouse Oncopole
Toulouse, , 31059
Status
Address
Gustave Roussy Institute
Villejuif, , 94805
Status
Address
Charité Campus Virchow Clinic
Berlin, , 13353
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Address
University Hospital Essen
Essen, , 45147
Status
Address
University Medical Center Freiburg
Freiburg, , 79106
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Address
University Hospital Leipzig
Leipzig, , 04103
Status
Address
Rechts der Isar Hospital
Munich, , 81675
Status
Address
University Hospital Tübingen
Tübingen, , 72076
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Address
Rambam Medical Center
Haifa, , 3109601
Status
Address
Hadassah Medical Center - Ein Kerem
Jerusalem, , 9112001
Status
Address
Rabin Medical Center
Petah Tikva, , 49100
Status
Address
Sheba Medical Center
Ramat Gan, , 52621
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Address
Tel Aviv Sourasky Medical Center
Tel Aviv, , 64239
Status
Address
Hokkaido University Hospital
Sapporo-shi, Hokkaido, 060-8648
Status
Address
Kanazawa University Hospital
Kanazawa-shi, Ishikawa-Ken, 920-8641
Status
Address
Saitama Medical University International Medical Center
Hidaka-shi, Saitama-Ken, 350-1298
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Address
Kyorin University Hospital
Mitaka-shi, Tokyo-To, 181-8611
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Address
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo-To, 162-8666
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Address
Lausanne University Hospital
Lausanne, , CH-1011
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Address
University Hospital Zurich
Zürich, , 8091
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Address
Clatterbridge Cancer Centre
Liverpool, , L7 8YA
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Address
Guy's Hospital
London, , SE1 9RT
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Address
Charing Cross Hospital
London, , W6 8RF
Status
Address
Nottingham University Hospitals NHS Trust
Nottingham, , NG5 1PB
Status
Address
Royal Preston Hospital
Preston, , PR29HT
