NCT04474353

Study of Tumor Treating Fields With Hypofractionated Chemoradiotherapy in Newly Diagnosed Glioblastoma

A Phase 1 Study of Tumor Treating Fields With 5 Day Hypofractionated Stereotactic Radiosurgery and Concurrent and Maintenance Temozolomide in Newly Diagnosed Glioblastoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and efficacy of the combination therapy of TTFields + SRS+ Temozolomide (TMZ) for newly diagnosed glioblastoma (GBM).

Detailed description

Primary Objective: Determine the safety of Tumor Treating Fields (TTFields) started concurrently with 5 fraction stereotactic radiosurgery (SRS) and temozolomide for newly diagnosed glioblastoma. secondary objective: Efficacy for the combination of TTFields started concurrently with 5

Conditions

• Glioblastoma
• Newly Diagnosed Glioblastoma

Interventions

Type	Name	Description
DEVICE	Optune	Noninvasive, portable device which generates tumor treating fields (TTFields) manufactured by Novocure
DRUG	Gadolinium	Gadolinium contrast medium
DRUG	Temozolomide	Chemotherapy agent
RADIATION	Stereotactic radiosurgery (SRS)	Standard of Care: SRS (35 Gy in 5 fractions of 7 Gy), 5-day treatment from Day 2

Timeline

• Start date: 2021-05-21
• Primary completion: 2024-11-14
• Completion: 2025-09-02
• First posted: 2020-07-16
• Last updated: 2025-12-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study