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EF-32 (Trident)

Title A Pivotal Randomized, Open-Label Study of Optube (TTFields, 100KHZ) Concomitant with Radiation Therapy and Temozolomide for the Treatment of Newly Diagnosed Glioblastoma
Therapeutic Area Glioblastoma
Principal Investigator Suriya Jeyapalan, MD
Min Age 22 Years
Gender Both
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This trial is to test the effectiveness and safety of Optune® given with radiation therapy (RT) and temozolomide (TMZ) in newly diagnosed GBM patients, compared to radiation therapy and temozolomide alone. In both arms, Optune® and maintenance temozolomide are continued following radiation therapy.

Study Details

Inclusion Criteria

1.)Confirmed diagnosis of GBM according to WHO classification criteria

2.)Recovered from maximal debulking surgery, if applicable

3.)Karnofsky performance status of greater than or equal to 70

Exclusion Criteria

1.) Progressive disease, infratentorial or leptomeningeal disease
2.) Participation in another clinical treatment study during the pre-treatment or treatment phase of the study
3.) Standard TTFields exclusion, e.g. active implanted medical devices, bullet fragments or skull defects

Study Requirements

Clinical and research visits are to occur every 4 weeks until study participation ends at 24 months. Questionnaires will be given every 12 weeks.