A Pivotal Randomized Open-Label Study of Optune (TTFields 200khz) Concomitant with Radiation Therapy and Temozolomide for the Treatment of Newly Diagnosed Glioblastoma

Brief description of study

The purpose of the study is to test the effectiveness and safety of TTFields given to newly diagnosed glioblastoma patients, concomitantly with radiation therapy and temozolomide compared to treatment with radiation therapy and temozolomide. We want to know which treatment is better than the other. Optune has been FDA approved for the treatment of recurrent glioblastoma. In this study, Optune will deliver TTFields at a frequency of 200kHz to the brain by means of insulated transducer arrays. The Optune device produces electric forces intended to disrupt cancer cell division.


Clinical Study Identifier: s20-00369
ClinicalTrials.gov Identifier: NCT04471844
Principal Investigator: Erik P. Sulman.
Other Investigators: Beverly E Smith, Minerva A Utate, Maria Del Pilar Guillermo Prieto Eibl, Thomas B. Daniels, Sylvia Amor Tenefrancia Crispino, Todd J Carpenter, Lynda J Boulio, Benjamin Cooper, Joshua S. Silverman, David L Barbee.


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