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

NCT04474353 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-12-26

No results posted yet for this study

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).

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Scott G Soltys · Stanford Universiy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-21
Primary Completion
2024-11-14
Completion
2025-09-02
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04474353 on ClinicalTrials.gov