Overview
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 Novo-TTF device,
a non-invasive device. 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 cancer treatment
using TTFields – Tumor Treating Fields (SCIENCE). 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 increase median overall survival
newly diagnosed GBM patients. These results were from a small study
and have not yet been validated. The device has not yet been proven
to be safe and effective for any indication. (CLINICAL
EXPERIENCE).
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 new medical device,
the NovoTTF-100A (TRIAL) for newly diagnosed GBM patients when used
in combination with temozolomide as compared to temozolomide alone. The
trial’s expected total enrollment is 283 patients. The trial
is now enrolling patients in multiple centers in the US and Europe (CENTERS).
Publication of Early Study Results
Please visit the Proceedings of the National Academy of Sciences to read
the about the basic science behind the NovoTTF and the results from our
pilot study for recurrent GBM patients:. http://www.pnas.org
Please visit BMC Medical Physics to read about the background on combination treatments involving the NovoTTF and the results from our pilot study for newly diagnosed GBM patients: http://www.biomedcentral.com/1756-6649/9/1
CAUTION. Investigational Device. Limited by U.S. law to INVESTIGATION
USE ONLY.
