Status:
UNKNOWN
TTFields Together With Temozolomide and Radiotherapy in Patients With Newly Diagnosed GBM
Lead Sponsor:
NovoCure Ltd.
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study is a prospective, single arm open label study, designed to test the to evaluate the tolerability and safety outcome of newly diagnosed GBM patients treated with NovoTTF-200A concomitant to R...
Detailed Description
PAST CLINICAL EXPERIENCE: A phase III trial of Optune® (200 kHz) as monotherapy compared to active chemotherapy in recurrent glioblastoma patients showed TTFields to be equivalent to active chemother...
Eligibility Criteria
Inclusion
- Histologically confirmed diagnosis of GBM according to WHO classification criteria.
- Supratentorial tumor location
- Age ≥ 18 years
- Recovered from maximal debulking surgery, if applicable (gross total resection, partial resection and biopsy-only patients are all acceptable)
- Planned standard adjuvant chemoradiotherapy of approx. 60 Gy of Radiotherapy (RT), or biologically equivalent dose, according to local practice, and concomitant Temozolomide (TMZ) chemotherapy (75mg/m\^2 daily). Any other cytotoxic or biologic anti-tumor therapy received prior to enrollment will be considered an exclusion.
- Planned treatment with adjuvant/maintenance TMZ (150-200 mg/m\^2 daily x 5 d, q28 days)
- Karnofsky performance status ≥ 70
- Life expectancy ≥ 3 months
- Participants of childbearing age must use effective contraception.
- All patients must sign written informed consent.
- NovoTTF-200A treatment start date at least 2 weeks out from brain surgery.
- NovoTTF-200A treatment start prior to or at the beginning of RT/TMZ
- Stable or decreasing dose of corticosteroids for the last 7 days prior to enrollment, if applicable.
Exclusion
- Participation in another clinical treatment trial
- Pregnancy or breast feeding
- Significant co-morbidities at baseline which would preclude TMZ treatment
- Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias.
- Infra-tentorial tumor location
- 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.
- Known allergies to medical adhesives or gel
Key Trial Info
Start Date :
April 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03780569
Start Date
April 27 2017
End Date
January 1 2019
Last Update
December 20 2018
Active Locations (1)
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1
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel