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NCT04474353 · ClinicalTrials.gov registry record · Phase 1
Study of Tumor Treating Fields With Hypofractionated Chemoradiotherapy in Newly Diagnosed Glioblastoma
A Phase 1 study, sponsored by Stanford University.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT04474353: Completed Phase 1 study, sponsored by Stanford University.
NCT04474353 is a Phase 1 study that has completed, run by Stanford University. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04474353, a Phase 1 study, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
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).
Primary Outcome
Dose limiting toxicities (DLTs) are defined as possibly, probably, or definitely related adverse events that are severe or medically significant, and needing topical \& systemic therapy; needing surgery intervention; needing hospitalization; needing treatment interruption; or life threatening. Late DLTs will be assessed as the number of DLTs that occur in the period from 31 days after the start of treatment through 5 months after the start of treatment. The outcome will be reported as a number w
Interventions
- DRUG Temozolomide
- DRUG Gadolinium
- DEVICE Optune
- RADIATION Stereotactic radiosurgery (SRS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2021-05-21 |
| Est. Completion | 2025-09-02 |
| Phase | Phase 1 |
What the finished NCT04474353 record still lists
NCT04474353 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 4 interventions - of which Temozolomide is the first listed.
NCT04474353 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04474353 about?
NCT04474353 is a clinical study titled "Study of Tumor Treating Fields With Hypofractionated Chemoradiotherapy in Newly Diagnosed Glioblastoma". 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).
What is the current status of trial NCT04474353?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2021-05-21. Estimated completion is 2025-09-02.
What interventions are being tested in trial NCT04474353?
The interventions under investigation include: Temozolomide (DRUG), Gadolinium (DRUG), Optune (DEVICE), Stereotactic radiosurgery (SRS) (RADIATION).
Who is sponsoring clinical trial NCT04474353?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04474353's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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