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NCT04040400 · ClinicalTrials.gov registry record · NA
Study of Intraoperative Radiotherapy for Patients With Large Brain Metastases Treated With Neurosurgical Resection
A NA study, sponsored by University of Louisville.
- Terminated
- Registry status
- NA
- Development phase
- 5
- Enrollment target
NCT04040400: Clinical Trial NA study, sponsored by University of Louisville.
NCT04040400 is a NA study that was terminated before completion, run by University of Louisville. The registered enrollment target is 5 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04040400, a NA study, was terminated before completion, sponsored by University of Louisville.
- TERMINATED
- Registry status
- NA
- Development phase
- 5 participants
- Enrollment target
Study Summary
The primary purpose of this study is to establish a maximum tolerated dose (MTD) through a dose-escalation trial using intraoperative radiotherapy (IORT) following neurosurgical resection for large brain metastases, and to determine the progression-free survival rate as in the recurrence rate of treated brain metastasis.
Primary Outcome
Maximum tolerated dose will be determined by classical 3+3 dose-escalation design. Toxicity will be measured using the National Cancer Institute Common terminology criteria for adverse events (version 5.0). The first dose of 18Gy will be administered to the first 3 subjects, after 90 days from treatment a safety assessment for dose limiting toxicities will be done to determine if the next 3 subject will escalation to dose of 21Gy or receive 18Gy. If escalation to 21Gy is permitted, then after
Interventions
- RADIATION intraoperative radiotherapy (IORT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2019-10-23 |
| Est. Completion | 2021-11-19 |
| Phase | NA |
Why NCT04040400 stopped before completion
NCT04040400 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which intraoperative radiotherapy (IORT) is the first listed.
NCT04040400 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04040400 about?
NCT04040400 is a clinical study titled "Study of Intraoperative Radiotherapy for Patients With Large Brain Metastases Treated With Neurosurgical Resection". The primary purpose of this study is to establish a maximum tolerated dose (MTD) through a dose-escalation trial using intraoperative radiotherapy (IORT) following neurosurgical resection for large brain metastases, and to determine the progression-free survival rate as in the recurrence rate of tre...
What is the current status of trial NCT04040400?
This trial is currently terminated. It is a NA study. The enrollment target is 5 participants. The study started on 2019-10-23. Estimated completion is 2021-11-19.
What interventions are being tested in trial NCT04040400?
The interventions under investigation include: intraoperative radiotherapy (IORT) (RADIATION).
Who is sponsoring clinical trial NCT04040400?
This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04040400's enrollment target sits among peer trials
5 1988th of 2000 higher than 5 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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