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NCT04471844 · ClinicalTrials.gov registry record · NA

Pivotal, Randomized, Open-label Study of Optune® (Tumor Treating Fields) Concomitant With RT & TMZ for the Treatment of Newly Diagnosed GBM

A NA study of Glioblastoma Multiforme, sponsored by NovoCure.

Active
Registry status
NA
Development phase
981
Enrollment target
20
Study locations

NCT04471844 is a NA study of Glioblastoma Multiforme that is active but no longer recruiting, run by NovoCure. The registered enrollment target is 981 participants, above the 86-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (1041% higher). The trial reports 20 study locations across 5 states.

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The verdict

NCT04471844, a NA study of Glioblastoma Multiforme, is active but no longer recruiting, sponsored by NovoCure.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
981 participants
Enrollment target
20
Study locations

Study Summary

To test the effectiveness and safety of Optune® given concomitantly with radiation therapy (RT) and temozolomide (TMZ) in newly diagnosed GBM patients, compared to radiation therapy and temozolomide alone. In both arms, Optune® and maintenance temozolomide are continued following radiation therapy.

Conditions Studied

Interventions

  • DEVICE Optune®

Study Locations (20)

California

  • Providence St. Joseph Medical Center and The Roy and Patricia Disney Family Cancer Center - Burbank
  • City of Hope National Medical Center - Duarte
  • TRIO - St. Jude Heritage Healthcare/St. Jude Medical Center - Fullerton
  • University of California at San Diego - Moores Cancer Center - La Jolla
  • Norris Comprehensive Cancer Center at USC - Los Angeles
  • Cedars - Sinai Medical Center - Los Angeles
  • Hoag Memorial Hospital - Hoag Cancer Center - Newport Beach
  • St. Joseph Hospital of Orange - Orange
  • University of California - Irvine/UCI Medical Center - Orange
  • Stanford University Cancer Institute - Palo Alto
  • Sharp Memorial Hospital - X-Ray Medical Group Radiation Oncology - San Diego
  • University of California San Francisco Medical Center - San Francisco
  • John Wayne Cancer Institute at St. John's Health Center - Santa Monica

Arizona

  • Banner MD Anderson Cancer Center - Gilbert
  • Mayo Clinic- Arizona - Phoenix
  • University of Arizona Cancer Center - Tucson

Colorado

  • University of Colorado Cancer Center Anschutz - Aurora
  • HCA Research Institute - Blue Sky Neurology - Denver - Englewood

Alabama

  • Grandview Cancer Center - Birmingham

Arkansas

  • Highlands Oncology Group - Fayetteville

Trial Details

FieldValue
Enrollment Target 981 participants
Start Date 2020-12-08
Est. Completion 2026-01-30
Phase NA

Sponsor

NovoCure

11 total trials

What the Registry Record Tells You About NCT04471844

The ClinicalTrials.gov registry entry for NCT04471844 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 981 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 86-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (1041% higher). The listed sponsor is NovoCure, which has 11 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Glioblastoma Multiforme appearing as the primary indexed condition, and to 1 intervention - of which Optune® is the first listed.

NCT04471844 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Arizona, Colorado.

Frequently Asked Questions

What is clinical trial NCT04471844 about?

NCT04471844 is a clinical study titled "Pivotal, Randomized, Open-label Study of Optune® (Tumor Treating Fields) Concomitant With RT & TMZ for the Treatment of Newly Diagnosed GBM". To test the effectiveness and safety of Optune® given concomitantly with radiation therapy (RT) and temozolomide (TMZ) in newly diagnosed GBM patients, compared to radiation therapy and temozolomide alone. In both arms, Optune® and maintenance temozolomide are continued following radiation therapy.

What is the current status of trial NCT04471844?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 981 participants. The study started on 2020-12-08. Estimated completion is 2026-01-30.

What conditions does trial NCT04471844 study?

This clinical trial studies the following conditions: Glioblastoma Multiforme.

What interventions are being tested in trial NCT04471844?

The interventions under investigation include: Optune® (DEVICE).

Who is sponsoring clinical trial NCT04471844?

This trial is sponsored by NovoCure, which has 11 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04471844 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.