NovoTTF-200A Together With Radiation Therapy and Temozolomide in Patients With Newly Diagnosed GBM

Inclusion Criteria:

* 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 Criteria:

* 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.