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Tumor Treating Fields With Chemoradiation in Newly Diagnosed GBM

NCT03705351 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2024-03-04

Study results available
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Summary

The study is an open-label pilot study in newly diagnosed glioblastoma patients following surgery. Eligible patients will receive treatment with tumor treating fields therapy using the Optune device starting less than 2 weeks prior to start of chemoradiation. Patients will receive radiation and temozolomide at a routine treatment dose and schedule.

Conditions

Interventions

DEVICE

Tumor Treating Fields

Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM). Treatment will begin approximately 1 week prior to start of radiation and temozolomide treatment and continue concurrently throughout the duration of the study.

DRUG

Temozolomide

Patients will be given temozolomide according to routine treatment dosing and schedule.

RADIATION

Radiation Therapy

Patients will be given radiation therapy according to routine treatment dosing and schedule.

Sponsors & Collaborators

Principal Investigators

  • Ricky Chen, MD · Providence Health and Services

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-02
Primary Completion
2021-02-24
Completion
2022-02-24
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
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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 NCT03705351 on ClinicalTrials.gov