Study:
A Prospective, Multi-center Trial of NovoTTF-100A Together With Temozolomide Compared to Temozolomide Alone in Patients With Newly Diagnosed GBM.
Rationale:
n/a
Purpose:
The study is a prospective, randomly controlled pivotal trial, designed to test the efficacy
and safety of a medical device, the NovoTTF-100A, as an adjuvant to the best standard of
care in the treatment of newly diagnosed GBM patients. The device is an experimental,
portable, battery operated device for chronic administration of alternating electric fields
(termed TTFields or TTF) to the region of the malignant tumor, by means of surface,
insulated electrode arrays.
Study Status: Recruiting
Recruiting:
Kathy Smolenski, RN BSN OCN 216-445-1067 smolenk2@ccf.org
| Condition |
Intervention |
Phase |
|
Glioblastoma Multiforme |
Device: NovoTTF-100A device
Drug: Temozolomide |
Phase 3 |
Verified by
NovoCure Ltd.
May, 2013
Sponsored by: NovoCure Ltd.
Information provided by: NovoCure Ltd.
ClinicalTrials.gov identifier: NCT00916409
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio 44195
United States
Roger Stupp, MD., Study Director
Philip H. Gutin, MD., Study Director
Eric T. Wong, MD., Study Director
Herbert H. Engelhard, MD, PhD., Study Director
Manfred Westphal, Prof. MD., Study Director