Status:
ACTIVE_NOT_RECRUITING
Pivotal, Randomized, Open-label Study of Optune® (Tumor Treating Fields) Concomitant With RT & TMZ for the Treatment of Newly Diagnosed GBM
Lead Sponsor:
NovoCure Ltd.
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
Phase:
NA
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 a...
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 obt...
Eligibility Criteria
Inclusion
- \*Age Limits - 18 years or older outside of the US, 22 years or older within the US.
- 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
Exclusion
- 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.
- 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
Key Trial Info
Start Date :
December 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2026
Estimated Enrollment :
981 Patients enrolled
Trial Details
Trial ID
NCT04471844
Start Date
December 8 2020
End Date
January 30 2026
Last Update
August 7 2025
Active Locations (133)
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1
Grandview Cancer Center
Birmingham, Alabama, United States, 35243
2
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
3
Mayo Clinic- Arizona
Phoenix, Arizona, United States, 85054
4
University of Arizona Cancer Center
Tucson, Arizona, United States, 85719