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NCT00855803 · ClinicalTrials.gov registry record · Phase 2
Stereotactic Body Radiation Therapy and Vertebroplasty in Treating Patients With Localized Spinal Metastasis
A Phase 2 study of Pain and Metastatic Cancer, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT00855803: Completed Phase 2 study of Pain and Metastatic Cancer, sponsored by University of Texas Southwestern Medical Center.
NCT00855803 is a Phase 2 study of Pain and Metastatic Cancer that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 35 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00855803, a Phase 2 study of Pain and Metastatic Cancer, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study Summary
RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Vertebroplasty may help prevent fractures and spinal cord compression caused by spinal metastasis. Giving stereotactic body radiation therapy together with vertebroplasty may help lessen pain and improve quality of life of patients with spinal metastasis. PURPOSE: This phase II trial is studying how well giving stereotactic body radiation therapy together with vertebroplasty works in treating patients with localized spinal metastasis.
Primary Outcome
Pain reduction as measured by Visual Analogue Scoring System (VAS) at 3 months Patient pain was recorded on a 10-point scale (0: no pain, 10: most severe pain). At baseline patients were required to have a pain score of 4 or higher associated with spine metastases. Pain response was recorded again during follow-up visits to determine the pain response: A pain score of 0 represents a complete response A decrease in the pain score by at least 2 points represents a partial response VAS scores wer
Conditions Studied
Interventions
- RADIATION radiation
Study Locations (1)
Texas
- University of Texas Southwestern Medical Center - Dallas - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2009-02 |
| Est. Completion | 2021-01-20 |
| Phase | Phase 2 |
What the finished NCT00855803 record still lists
NCT00855803 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 304-participant average among 374 other Pain trials with a reported enrollment target (88% lower).
The record links to 3 conditions, with Pain appearing as the primary indexed condition, and to 1 intervention - of which radiation is the first listed.
NCT00855803 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT00855803 about?
NCT00855803 is a clinical study titled "Stereotactic Body Radiation Therapy and Vertebroplasty in Treating Patients With Localized Spinal Metastasis". RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Vertebroplasty may help prevent fractures and spinal cord compression caused by spinal metastasis. Giving stereotactic body radiation therapy together with vertebro...
What is the current status of trial NCT00855803?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2009-02. Estimated completion is 2021-01-20.
What conditions does trial NCT00855803 study?
This clinical trial studies the following conditions: Pain, Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific.
What interventions are being tested in trial NCT00855803?
The interventions under investigation include: radiation (RADIATION).
Who is sponsoring clinical trial NCT00855803?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00855803 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00855803's enrollment target sits among peer trials
35 299th of 374 higher than 74 of 374 other Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain 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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