Background
The study is a Pivotal (Phase III), randomized, controlled trial, designed to test the efficacy and safety of a new medical device, the NovoTTF-100A. The device is an experimental, portable, battery operated device for continuous home treatment of patients with recurrent or progressive glioblastoma multiforme (ELIGIBILITY). The device treats patients with alternating electric fields, termed Tumor Treating Fields or TTFields (SCIENCE).
Trial Design
Eligible GBM patients whose disease has recurred or progressed despite standard treatment (surgery, radiation therapy, Temozolomide treatment) will be randomly assigned to one of two groups: 1) the NovoTTF-100A Group or 2) the Best Standard of Care Group. Each patient has a 50% chance of entering into the NovoTTF-100A Group.
NovoTTF-100A Group
If assigned to the NovoTTF-100A Group, the patients will be treated continuously for as long as their disease is stable or regressing. NovoTTF-100A treatment will consist of wearing four electrodes on the outside of the scalp. Electrode placement will require shaving of the scalp before treatment. After an initial short hospitalization (24 hours), patients will be released to continue treatment at home where they can maintain their regular daily routine (THE TREATMENT).
Benefits of Best Standard of Care Group
The Best Standard of Care Group contributes to future patients by helping to prove the efficacy of a new experimental treatment. If assigned to the Best Standard of Care Group, patients will receive a chemotherapeutic agent chosen based on their prior treatments and the best standard of care practiced at each treating center.
In addition, the Best Standard of Care Group will also receive:
• MRI every second month
• Neurological exam every month
• Patient follow ups tailored to each patient
Study Endpoints
• Primary: Median Overall Survival
• Secondary: Median Time to Disease Progression
• Secondary: Quality of Life Assessment
Enrollment
Expected Total Enrollment: 236
Trial Dates
Enrolling now (CENTERS)
No Trial Costs
The trial sponsor will pay for patient costs associated with the trial, including the NovoTTF-100A device and accessories. The trial sponsor will also reimburse patients for travel to the technical support centers during the trial. Patient insurance will be responsible for medical treatments received in the normal course of patient care.
For More Information
Please go to www.clinicaltrials.gov and search for “NovoCure”.
CAUTION. Investigational Device. Limited by U.S. law to INVESTIGATION USE ONLY.