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GBM: Tumor Treating Fields: Post-Debulking: TRIDENT

EF-32 (TRIDENT): Pivotal, Randomized, Open-Label Study of Optune® (Tumor Treating Fields, 200kHz) Concomitant With Radiation Therapy and Temozolomide for the Treatment of Newly Diagnosed Glioblastoma

Title
Novocure TRIDENT EF-32 (GBM, Optune)
Study Title

EF-32 (TRIDENT): Pivotal, Randomized, Open-Label Study of Optune® (Tumor Treating Fields, 200kHz) Concomitant With Radiation Therapy and Temozolomide for the Treatment of Newly Diagnosed Glioblastoma

Site Link
Malignancy
Glioblastoma multiforme, brain cancer
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
Following debulking surgery
Investigational Agent
Optune Tumor Treating Fields
Drug Class
Electric field generation
PI
Manjari Pandey, MD
Sponsor
NovoCure GmbH
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Histologic confirmed diagnosis of GBM per WHO classification criteria
  • Age >or= 22
  • Recovered from maximal debulking surgery, if applicable (gross total resection, partial resection, and biopsy-only patients are all acceptable)
  • Planned treatment with RT-TMZ followed by TTFields and maintenance TMZ
  • KPS >or= 70%
  • Must have stable or decreasing steroid use
  • Concomitant RT with TMZ planned to start no later than 8 weeks post surgery
  • Able to undergo MRI with contrast of brain
  • No infratentorial or leptomeningeal disease
  • No plts <100, ANC <1.5, AST/ALT > 3xULN, Tbili >1.5x ULN, creatinine >1.7
  • No institutionalized patients
  • No active implanted medical devices, bullet fragments, or other skull defects
Objective
  • Primary:
    • OS
  • Secondary:
    • PFS
    • Landmark survival
    • ORR
    • PFS2
    • Landmark PFS
    • AEs
    • Path changes following treatment
    • QOL
Assessment Frequency
_
Assessment Frequency 2
_



Assessment Frequency Link
Path
GBM
Dosing Frequency
Control Agents
Study Protocol
Randomized
Yes
X