Clinical Trial TitleA Phase III Randomized, open-label study of Optune® (TTFields, 200KHZ) concomitant with radiation therapy and temozolomide for the treatment of newly diagnosed glioblastoma
National Clinical Trial Number:NCT04471844
Clinical Trial Protocol Description:
Optune® is a medical device that has been approved for the treatment of recurrent and newly diagnosed glioblastoma (GBM) by the Food and Drug Administration (FDA) in the United States. This study will test if the earlier introduction of Optune®, at the time of radiation therapy (which is given together with temozolomide), improves clinical outcomes compared to the standard of care.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have histologically confirmed diagnosis of GBM according to WHO classification criteria.
- Have recovered from maximal debulking surgery, if applicable (gross total resection, partial resection, and biopsy-only patients are all acceptable).
- Participants of childbearing age must use highly effective contraception. An effective method of birth control is defined as one that results in a failure rate of less than 1% per year when used consistently and correctly. The Investigator must approve the selected method, and may consult with a gynecologist as needed.
- Are able to have MRI with contrast of the brain.
You will be excluded from the study if any of the following criteria apply to you:
- Have progressive disease (per investigator's assessment).
- Have infratentorial or leptomeningeal disease.
- Are participating in another clinical treatment study during the pre-treatment and/or the treatment phase of the study.
- Have an implanted pacemaker, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias.
- Have had prior radiation treatment to the brain for the treatment of GBM.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.