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NCT01459497 · ClinicalTrials.gov registry record · Phase 3
Hypofractionated Image-Guided Radiation Therapy (IGRT) in Patients With Stage II-III Non-Small Cell Lung Cancer
A Phase 3 study of Non-Small Cell Lung Cancer, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 103
- Enrollment target
- 7
- Study locations
NCT01459497: Completed Phase 3 study of Non-Small Cell Lung Cancer, sponsored by University of Texas Southwestern Medical Center.
NCT01459497 is a Phase 3 study of Non-Small Cell Lung Cancer that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 103 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (84% lower). The trial reports 7 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01459497, a Phase 3 study of Non-Small Cell Lung Cancer, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 103 participants
- Enrollment target
- 7
- Study locations
Study Summary
The study is designed to determine whether an accelerated course of hypofractionated radiation therapy with daily image guidance and motion assessment/control will allow more effective treatment of poor performance status patients with stage II-III NSCLC, who would benefit from local therapy compared to standard radiation therapy (60 Gy in 2 Gy per fraction).
Primary Outcome
Percentage of participants with overall survival at 1 year. To compare the efficacy by overall survival of standard radiation versus accelerated, hypofractionated, image-guided conformal radiotherapy in treatment of stage II-III or recurrent NSCLC in patients with poor performance status. Overall survival time will be estimated using the Kaplan-Meier approach. The stratified log-rank test will be used to test for a statistically significant difference in survival distributions. The Cox proportio
Conditions Studied
Interventions
- RADIATION Radiation Therapy
- RADIATION Conventional radiation
Study Locations (7)
Texas
- Georgetown Cancer Center (Austin Cancer Center) - Austin
- University of Texas Southwestern Medical Center - Dallas
- Md Anderson Cancer Center - Houston
- Baylor Research Institute Dallas, Baylor Irving - Irving
- Texas Oncology - Sherman - Sherman
- Scott & White Memorial Temple - Temple
- Texas Oncology - Tyler - Tyler
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2012-10 |
| Est. Completion | 2023-10-19 |
| Phase | Phase 3 |
What the finished NCT01459497 record still lists
NCT01459497 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Radiation Therapy is the first listed.
NCT01459497 lists 7 locations in 1 state (Texas).
Frequently Asked Questions
What is clinical trial NCT01459497 about?
NCT01459497 is a clinical study titled "Hypofractionated Image-Guided Radiation Therapy (IGRT) in Patients With Stage II-III Non-Small Cell Lung Cancer". The study is designed to determine whether an accelerated course of hypofractionated radiation therapy with daily image guidance and motion assessment/control will allow more effective treatment of poor performance status patients with stage II-III NSCLC, who would benefit from local therapy compare...
What is the current status of trial NCT01459497?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 103 participants. The study started on 2012-10. Estimated completion is 2023-10-19.
What conditions does trial NCT01459497 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT01459497?
The interventions under investigation include: Radiation Therapy (RADIATION), Conventional radiation (RADIATION).
Who is sponsoring clinical trial NCT01459497?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01459497 being conducted?
This trial has 7 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01459497's enrollment target sits among peer trials
103 229th of 454 higher than 225 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer 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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