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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04471844
Registration number
NCT04471844
Ethics application status
Date submitted
9/07/2020
Date registered
15/07/2020
Date last updated
1/11/2023
Titles & IDs
Public title
Pivotal, Randomized, Open-label Study of Optune® (Tumor Treating Fields) Concomitant With RT & TMZ for the Treatment of Newly Diagnosed GBM
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Scientific 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
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Secondary ID [1]
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TRIDENT EF-32
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Universal Trial Number (UTN)
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Trial acronym
EF-32
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Glioblastoma Multiforme
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Condition category
Condition code
Cancer
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Brain
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Optune®
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 or 24 months.
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 or 24 months.
Treatment: Devices: 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.
The study treatment plan will continue for 24 months, if no tumor progression.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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Survival will be measured from the time of randomization until date patient is alive.
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Timepoint [1]
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5 years
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Secondary outcome [1]
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Progression Free Survival (PFS)
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Assessment method [1]
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PFS will be measured from the date of randomization to the date of progression.
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Timepoint [1]
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5 years
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Secondary outcome [2]
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1- and 2-year survival rates
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Assessment method [2]
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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.
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Timepoint [2]
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5 years
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Secondary outcome [3]
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Overall Radiological response (ORR)
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Assessment method [3]
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The analyses will be performed based on the RANO criteria, and comparison between the rates of response.
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Timepoint [3]
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5 years
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Secondary outcome [4]
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Next progression-free survival (PFS2)
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Assessment method [4]
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PFS2 will be measured from the time of randomization to second tumor progression.
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Timepoint [4]
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5 years
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Secondary outcome [5]
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Progression-free survival at 6 (PFS6) and 12 months (PFS12)
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Assessment method [5]
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The analyses will be estimated proportions of patients who are progression-free at 6 and 12 months in both arms of the study.
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Timepoint [5]
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5 years
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Secondary outcome [6]
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Severity and frequency of adverse events
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Assessment method [6]
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The analyses will be performed based on the incidence, severity, frequency of adverse events, and their association with study treatments.
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Timepoint [6]
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5 years
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Secondary outcome [7]
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Pathological changes in resected GBM tumors following study treatments
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Assessment method [7]
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Pathological changes in the tumors and also underwent another surgical resection while on the study.
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Timepoint [7]
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5 years
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Secondary outcome [8]
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Quality of Life EORTC Questionnaire
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Assessment method [8]
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The analyses will be assessed using the EORTC QLQ C-30 questionnaire with BN-20 (brain symptom) supplement.
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Timepoint [8]
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5 years
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Secondary outcome [9]
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Dependence of overall survival on TTFields dose at the tumor
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Assessment method [9]
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Examining the dependence of overall survival on TTFields dose delivered to the tumor bed will be performed in both the treatment and control arms.
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Timepoint [9]
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5 years
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Secondary outcome [10]
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The NANO scale
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Assessment method [10]
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The Neurological assessment in Neuro-Oncology will be assessed using the NANO scale questionnaire and per RANO criteria.
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Timepoint [10]
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5 years
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Eligibility
Key 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 ß-HCG pregnancy test documented
within 14 days prior to registration
12. Is able to have MRI with contrast of the brain
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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. Any other cytotoxic or biologic anti-tumor therapy received prior to enrollment will
be considered exclusion.
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 risk the patient according to
the investigator
15. Standard TTFields exclusion criteria include
1. Active implanted medical devices
2. Bullet fragments
3. Skull defects
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/12/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/08/2026
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Actual
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Sample size
Target
950
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Accrual to date
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Final
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Recruitment in Australia
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Funding & Sponsors
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Name
NovoCure GmbH
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04471844
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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Contact person for public queries
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Doron Manzur, MD
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+1 603 206 2337
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04471844
Download to PDF