EF-32 A Pivotal Randomized, Open-Label Study of OptuneĀ® (TTFields, 200khz) Concomitant with Radiation Therapy and Temozolomide for the Treatment of Newly Diagnosed Glioblastoma

About this Study

The purpose of the study is to test if early addition of the Optune treatment concomitant with RT and temozolomide as treatment for newly diagnosed GBM, significantly improves the clinical outcome of patients, compared to the standard of care, which is addition of Optune treatment concomitant with maintenance temozolomide after the completion of RT treatment.

Sponsor Protocol ID:EF-32
IRB Number:UMMC-IRB -2022-78
Actively Enrolling
Observational/Not Applicable
October 10, 2022
Eligibility Criteria
22 years old
Both Male and Female

Inclusion Criteria
  • Histologically confirmed diagnosis of GBM
  • 22 years of year and older
  • Recovered from maximal debulking surgery, if applicable
  • Planned treatment with RT/TMZ followed by TTFields and maintenance TMZ
  • Stable or decreasing dose of corticosteroids for the last 7 days prior to randomization, if applicable
  • Concomitant RT with TMZ treatment planned to start no later than 8 weeks from surgery
  • Able to have MRI with contrast of the brain

Exclusion Criteria
  • Progressive disease
  • Infratentorial or leptomeningeal disease
  • Participation in another clinical treatment study during the pre-treatment and/or the treatment phase of the study
  • Pregnancy or breast-feeding
  • Significant co-morbidities at baseline which would preclude maintenance RT or TMZ treatment
  • Implanted pacemaker, defibrillator, deep brain stimulator, other implanted electronic devices in the brain or documented clinically significant arrhythmias
  • Evidence of increased intracranial pressure
  • History of hypersensitivity reaction to TMZ or a history of hypersensitivity to DTIC
  • Prior radiation treatment to brain for the treatment of GBM

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Participating Locations
Cancer Center and Research Institute - UMMC
Contact Information
Contact Name: Lynnette Harper
Phone Number: 601-984-1965
Email: lharper@umc.edu
Principal Investigator:Anderson, Mark D, M.D.
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