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Effect of NovoTTF-100A Together With Temozolomide in Newly Diagnosed Glioblastoma Multiforme (GBM)


A Prospective, Multi-center Trial of NovoTTF-100A Together With Temozolomide Compared to Temozolomide Alone in Patients With Newly Diagnosed GBM.




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

Kathy Smolenski, RN BSN OCN 216-445-1067

Condition Intervention Phase
Glioblastoma Multiforme Device: NovoTTF-100A device
Drug: Temozolomide
Phase 3

Verified by NovoCure Ltd. December, 2013

Sponsored by: NovoCure Ltd.
Information provided by: NovoCure Ltd. 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

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