NovoTTF-200A and Temozolomide Chemoradiation for Newly Diagnosed Glioblastoma

"* Begins the day prior to radiotherapy start and continues until the end of temozolomide maintenance cycle #2 or until evidence of disease progression or unacceptable toxicity.~* Arrays are removed immediately prior to radiotherapy and replaced immediately thereafter."

"Concomitant phase:~* 75 mg/m2 per day for 42 days concomitant with radiotherapy.~* Begins 1 day prior to XRT start.~Maintenance phase:~* Begins 4 weeks after concomitant phase completion (+/- 1 week).~* Each cycle is 28 days (5 days of drug treatment followed by 23 days without).~* Cycle 1: 150 mg/m2 once daily for the first 5 days of each treatment cycle.~* Subsequent cycles: daily dose increased to 200 mg/m2, if the CTC non-hematologic toxicity for Cycle 1 is Grade ≤ 2 (except for alopecia, nausea and vomiting), absolute neutrophil count (ANC) is ≥ 1.5 x 109/L, and the platelet count is ≥ 100 x 109/L. The dose remains at 200 mg/m2 per day for the first 5 days of each subsequent cycle except if toxicity occurs."

Radiotherapy will commence 4 weeks after the definitive surgical procedure (+/- 1 week), to a total dose of 54.0 - 60.0 Gy, delivered in 1.8 - 2.0 Gy fractions over 6 - 7 weeks. XRT target volumes will be determined utilizing all available imaging studies that best delineate extent of disease. Fusion image registration for treatment planning will be utilized as possible. Either 3D conformal or intensity modulated radiation therapy (IMRT) will be utilized.