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
when used in combination with temozolomide (standard of care chemotherapeutic
agent) for patients with newly diagnosed GBM. The device is an experimental,
portable, battery operated device for continuous home use (ELIGIBILITY). The
device treats patients with alternating electric fields, termed Tumor Treating
Fields or TTFields (SCIENCE).
Trial Design
Eligible newly diagnosed GBM patients who have completed surgery or biopsy
followed by radiation treatments concurrent with temozolomide will be randomly
assigned to one of two groups: 1) the NovoTTF-100A with temozolomide group
or 2) the temozolomide alone group (Standard of Care control group). Each
patient will have a two thirds chance of entering the NovoTTF-100A group
and a one third chance of entering the temozolomide alone group as determined
by a “randomization process” (similar to a sophisticated coin
flip).
NovoTTF-100A Group
If assigned to the NovoTTF-100A Group, the patients will be treated continuously
for up to two years. 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.
Treatment will be started in an outpatient setting and will include training on the operation of the equipment. Patients will continue treatment at home where they can maintain their regular daily routine (THE TREATMENT). With support from NovoCure, patients will have their head re-shaved and electrodes replaced twice per week.
Benefits of Standard of Care Group
Patients assigned to the temozolomide only Standard of Care control group
will receive standard dosing of FDA approved temozolomide, the treatment
that most newly diagnosed GBM patients receive. Patients will receive
comprehensive monthly follow up exams that include some testing not typically
included in standard of care at no cost to the patient. In addition,
all study participants contribute to future patients by providing additional
information and data used to assess the efficacy of the new experimental
treatment.
Enrollment
Expected Total Enrollment: 283
Trial Dates
Enrolling now (CENTERS)
No Trial Costs
The trial sponsor will pay for patient costs associated with trial procedures
that are outside of the standard of care, including the NovoTTF-100A device
and accessories. The trial sponsor will also reimburse patients for
travel to the technical support centers for electrode replacements during
the trial. Patients and their insurance will be responsible for medical
treatments received in the normal course of patient care.
For More Information
Please go to the trial listing on Clinicaltrials.gov: www.clinicaltrials.gov.
CAUTION. Investigational Device. Limited by U.S. law to INVESTIGATION USE ONLY.