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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: Active NA study of Glioblastoma Multiforme, sponsored by NovoCure.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Survival will be measured from the time of randomization until date patient is alive.
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 |
What the registry record for NCT04471844 still lists
NCT04471844 is an interventional study that assigns participants to a tested intervention. The registered 981 participants enrollment target is mid-sized for trials with a published cap, above the 86-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (1041% higher).
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 names 20 study sites across 5 states, led by 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.
Learn More About Clinical Trials
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Where NCT04471844's enrollment target sits among peer trials
981 2nd of 88 the highest of 88 other Glioblastoma Multiforme trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma Multiforme trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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