What stage is this trial?
The NovoTTF-100A trial is a Pivotal (Phase III) trial that builds on experience from a clinical pilot study. The Pivotal Trial, if successful, is often the last clinical step before securing FDA approval for commercial use of the device.
How can I take part in the trial?
Please contact an investigator at the trial center closest to you (CENTERS). You may also contact NovoCure, the trial sponsor, if you need assistance reaching a trial center (CONTACT).
Do patients pay to participate in the trial?
No. The trial sponsor will provide the NovoTTF-100A device and all supporting accessories free of charge.
What are the expected side effects of the therapy?
Unlike chemotherapy or radiation, the NovoTTF-100A does not appear to have significant side effects. Some patients have experienced skin irritation beneath the electrodes (CLINICAL EXPERIENCE).
What does it feel like to wear the system?
The device causes mild warming of the scalp.
If I enroll in study, will I receive the new therapy?
The trial is randomized with 50% of patients receiving the therapy and 50% receiving the best standard of care.
If I am randomized to "best standard of care" arm, what treatment will I receive?
Half of the trial participants will be randomly selected to receive the most advanced glioblastoma treatments currently practiced as the best standard of care at the nation’s leading brain cancer institutes. These patients will receive neurological and other exams more frequently than typical glioblastoma patients not in the trial. This increased exam frequency will allow physicians to adjust, if necessary, the treatments to each patient’s individual condition.
How long do I wear the device?
Patients wear the device throughout the day and night. Patient may remove the device for short breaks to accommodate personal needs.
Can I leave the trial once it begins?
Yes. Patients may leave the trial at any time.