Status:
UNKNOWN
NovoTTF-200A Together With Radiation Therapy and Temozolomide in Patients With Newly Diagnosed GBM
Lead Sponsor:
Tel-Aviv Sourasky Medical Center
Conditions:
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Study Objectives: To compare the efficacy and safety outcome of newly diagnosed GBM patients treated with NovoTTF-200A concomitant to RT and TMZ to those treated with RT and TMZ alone Study Design: Pr...
Detailed Description
Glioblastoma (GBM), a malignant form of astrocytoma, is the most common primary intracranial neoplasm in adults2. The incidence of GBM increases steadily above 45 years of age with a prevalence of app...
Eligibility Criteria
Inclusion
- Histologically confirmed diagnosis of GBM according to WHO classification criteria.
- age ≥ 18 years
- Recovered from debulking surgery or biopsy-only.
- Planned treatment with RT/TMZ following 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 effective contraception.
- All patients must sign written informed consent.
- Stable or decreasing dose of corticosteroids for the last 7 days prior to randomization, if applicable.
Exclusion
- Early progressive disease before initiation of TMZ/RT.
- Participation in another clinical treatment trial
- Pregnancy
- 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)
- 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.
Key Trial Info
Start Date :
October 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03869242
Start Date
October 1 2018
End Date
December 1 2021
Last Update
March 11 2019
Active Locations (1)
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1
Tel Aviv saurasky medical center
Tel Aviv, Israel