Thank you for visiting NovocureTrial.com to learn about our newly diagnosed glioblastoma clinical trial. This glioblastoma trial, also known as a GBM clinical trial or simply a GBM trial, is an FDA approved Pivotal/Phase III clinical trial evaluating the safety and efficacy of the NovoTTF-100A device, a non-invasive device, for the treatment of patients with newly diagnosed GBM. Novocure Ltd., the trial sponsor, maintains this website to help recruit patients for the trial.
The Device and Treatment
The NovoTTF-100A is a portable, investigational device for the treatment of newly diagnosed GBM. The device is used to apply TTFields – Tumor Treating Fields (SCIENCE) to the brain. The device is intended for continuous home use by patients (TREATMENT) with a newly diagnosed GBM tumor (ELIGIBILITY). Results from a pilot study of the device suggest that the investigational treatment may increase the length of time before disease progression and may also increase median overall survival of newly diagnosed GBM patients (CLINICAL EXPERIENCE). However, these results were from a small study and have not yet been validated in a larger study. The Pivotal/Phase III clinical trial evaluating the NovoTTF-100A for newly diagnosed GBM is the large scale study designed to assess the safety and efficacy of the device.
The Clinical Trial
The study is a Pivotal (analogous to drug Phase III), randomized, controlled trial, designed to test the efficacy and safety of a medical device, the NovoTTF-100A (TRIAL) for newly diagnosed GBM patients when used in combination with an oral chemotherapy called temozolomide as compared to temozolomide alone. The trial is expected to enroll a total of 700 patients. The trial is now enrolling patients in multiple centers in the US and Europe (CENTERS).
CAUTION: Investigational Device for Newly Diagnosed GBM. Limited by U.S. law to INVESTIGATION USE ONLY.