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Assessing NovoTTF-100A device for Patients with Newly Diagnosed GBM
||Brain Tumor - Assessing NovoTTF-11A device and Temozolomide vs. Temozolomide alone for Patients with Newly Diagnosed GBM
||Lynne Taylor, MD
||Amy Quinkert, PhD
This study is being done in order to compare the efficacy and safety outcome of the newly diagnosed GBM patients treated with NovoTTF-100A concomitant to Temozolomide to those treated with Temozolomide alone. For more information see a video at: http://youtu.be/aDKkl6KT1cE
- Patients who have received maximal debulking surgery and radiotherapy with Temozolomide
- Able to carry on normal activity and work
- Life expectancy at least 3 months
- Progressive disease
- Implanted pacemakers, defibrillator or deep brain stimulator, or documented clinically significant arrhythmias
- Infra-tentorial tumor
The new experimental device is called the NovoTTF-100A. Participants will randomly be assigned to receive either the device together with maintenance Temozolomide, or maintenance Temozolomide alone.The NovoTTF-100A device is a portable battery operated device which produces TTFields (alternating electric fields) within the human body by means of surface electrodes. These electrodes must be replaced every 3-4 days. The device will consist of 4 electrically insulated electrodes, which participants will wear on their head for the duration of the study (24 months of usage, or less depending on the their clinical condition). The study involves physical exam, neurological exams, blood tests, MRI of the head, and Quality of Life questionnaire.
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