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NCT00591838 · ClinicalTrials.gov registry record · Phase 1
A Phase I/II Trial of Stereotactic Body Radiation Therapy
A Phase 1 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 74
- Enrollment target
NCT00591838: Completed Phase 1 study, sponsored by Washington University School of Medicine.
NCT00591838 is a Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 74 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00591838, a Phase 1 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 74 participants
- Enrollment target
Study Summary
The purpose of this study is to use SBRT in patients with early stage lung cancer and find out what effects (good and bad) SBRT has on their cancer. This research is being done because SBRT has not been used very often in patients with early stage lung cancer or in patients with other serious health problems. In addition, this study also will gather information about patient's health and hospitalization history. This information will be used to find out if there are any factors that can help predict recovery or outcome of patients with lung cancer.
Primary Outcome
The phase 1 portion had a "5+3" strategy with four escalating dose levels, only one of which was open for accrual at any time. Five patients were accrued to each dose level, and once closed, the next dose level could not be opened until the preceding dose was deemed acceptable. With a minimum of 90 days from the start of RT, if there were no acute grade 3 or 4 non-hematologic toxicities in the five patients, the current dose was deemed acceptable. If one such toxicity was observed, an additional
Interventions
- RADIATION Stereotactic Body Radiation Therapy (SBRT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2006-09-21 |
| Est. Completion | 2018-06-12 |
| Phase | Phase 1 |
What the finished NCT00591838 record still lists
NCT00591838 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% higher).
The record links to 0 conditions, and to 1 intervention - of which Stereotactic Body Radiation Therapy (SBRT) is the first listed.
NCT00591838 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00591838 about?
NCT00591838 is a clinical study titled "A Phase I/II Trial of Stereotactic Body Radiation Therapy". The purpose of this study is to use SBRT in patients with early stage lung cancer and find out what effects (good and bad) SBRT has on their cancer. This research is being done because SBRT has not been used very often in patients with early stage lung cancer or in patients with other serious health...
What is the current status of trial NCT00591838?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 74 participants. The study started on 2006-09-21. Estimated completion is 2018-06-12.
What interventions are being tested in trial NCT00591838?
The interventions under investigation include: Stereotactic Body Radiation Therapy (SBRT) (RADIATION).
Who is sponsoring clinical trial NCT00591838?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00591838's enrollment target sits among peer trials
74 725th of 2000 higher than 1,269 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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