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Pivotal, Randomized, Open-label Study of Optune® (Tumor Treating Fields) Concomitant With RT & TMZ for the Treatment of Newly Diagnosed GBM
NCT04471844 · View on ClinicalTrials.gov ↗
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
| Field | Value |
|---|---|
| Enrollment Target | 981 participants |
| Start Date | 2020-12-08 |
| Est. Completion | 2026-01-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04471844
The ClinicalTrials.gov registry entry for NCT04471844 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 981 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NovoCure, which has 32 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04471844 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Arizona, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04471844?
The interventions under investigation include: Optune® (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04471844?
This trial is sponsored by NovoCure, which has 32 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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