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NCT00489008 · ClinicalTrials.gov registry record · Phase 2
SRS Study in Patients With Non-Small Cell Lung Cancer
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 141
- Enrollment target
NCT00489008: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00489008 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 141 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00489008, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 141 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if stereotactic body radiotherapy (SBRT) can help to control NSCLC. The safety of SBRT will also be studied. Objectives: To assess therapeutic efficacy and toxicities of stereotactic body radiotherapy (SBRT) for patients with medically inoperable stage I (T1-2, N0,M0), selective stage II (chest wall T3, N0M0) or isolated peripheral lung recurrent non-small cell lung cancer (NSCLC). Primary goal: Improve 2 years progression free survival at the treated primary tumor site. Secondary goals: 1. Improve disease free survival, disease specific survival and overall survival at 2 years. 2. Decrease grade 3 and above acute and/or chronic toxicities. 3. Collect blood for future biomarkers study
Primary Outcome
Progression free survival at the primary site evaluated by series CT of chest with contrast for every follow up (except 6 weeks after radiotherapy) for two years. PET information considered for calculation of PFS particularly for distant metastasis and/or additional lesions. Population proportion for two-year PFS estimated using Clopper-Pearson 95% confidence intervals.
Interventions
- PROCEDURE Stereotactic Body Radiation Therapy (SBRT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 141 participants |
| Start Date | 2005-11-21 |
| Est. Completion | 2017-06-02 |
| Phase | Phase 2 |
What the finished NCT00489008 record still lists
NCT00489008 is an interventional study that assigns participants to a tested intervention. The registered 141 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Stereotactic Body Radiation Therapy (SBRT) is the first listed.
NCT00489008 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00489008 about?
NCT00489008 is a clinical study titled "SRS Study in Patients With Non-Small Cell Lung Cancer". The goal of this clinical research study is to learn if stereotactic body radiotherapy (SBRT) can help to control NSCLC. The safety of SBRT will also be studied. Objectives: To assess therapeutic efficacy and toxicities of stereotactic body radiotherapy (SBRT) for patients with medically inoperabl...
What is the current status of trial NCT00489008?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 141 participants. The study started on 2005-11-21. Estimated completion is 2017-06-02.
What interventions are being tested in trial NCT00489008?
The interventions under investigation include: Stereotactic Body Radiation Therapy (SBRT) (PROCEDURE).
Who is sponsoring clinical trial NCT00489008?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00489008's enrollment target sits among peer trials
141 510th of 2000 higher than 1,489 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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