The EF-33 trial is intended for patients who have recently been diagnosed with recurrent Glioblastoma Multiforme (GBM).
Optune® has been approved for the treatment of recurrent and newly diagnosed GBM by the Food and Drug Administration (FDA) in the United States under the Premarket Authorization (PMA) pathway and has obtained a CE mark in Europe for the same indications. In addition TTFields have been recently approved as Optune Lua™ (formerly NovoTTF-100L) for malignant pleural mesothelioma by the FDA, in combination with chemotherapy, under the Humanitarian Device Exemption pathway.
This clinical trial is evaluating the effectiveness and safety of Optune® with a new design of transducer arrays, the High Intensity Transducer Arrays, as monotherapy in recurrent GBM, compared to using the standard transducer arrays.
The device will deliver Tumor Treating Fields (TTFields) to the brain, where the tumor is located.
Novocure, the trial sponsor, maintains this website to help patients get basic information about the clinical trial and facilitate their accessibility to the medical center that offers participation in the trial. If you would like to take part in the EF-33 trial, please contact the participating center as soon as possible. If you have questions concerning your medical condition and recommended treatment, please consult with your treating doctor.