Single- vs. Two-Fraction Spine Stereotactic Radiosurgery for the Treatment of Vertebral Metastases
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- STATUS
- Recruiting
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- participants needed
- 130
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- sponsor
- Case Comprehensive Cancer Center
Summary
Spine radiosurgery (SRS) utilizes advanced treatment planning with focused x-rays to deliver one to four high dose treatments to the spine to help relieve pain and/or neurologic symptoms. Spine SRS uses special equipment to position the participant and guide the focused beams toward the area to be treated and away from normal tissue.
One of the side effects of spine SRS is the development of vertebral compression fractures, many of which are not painful. The goal of this study is to compare the effects, good and/or bad, of spine SRS given in 1 or 2 treatments. Our main goal is to find out which approach will reduce the chances of developing vertebral compression fractures.
Description
The primary objective of this study is to establish the non-inferiority in vertebral compression fracture (VCF) incidence at 6 months between single-fraction and two-fraction sSRS.
Other objectives are to to evaluate the 12-month impact of single- and two-fraction sSRS on local control (LC), pain control (PC), quality of life (QOL), and toxicity (specifically, pain flare, radiation esophagitis/laryngitis/pharyngitis, and radiation myelitis)
This study is planned as a two-arm randomized phase II trial to establish non-inferiority of single fraction sSRS compared to two-fraction sSRS. Approximately 130 participants will be enrolled in this trial; 65 participants in each arm:
- Group 1: If you are assigned to this group, you will undergo spine radiosurgery in a single (1) session.
- Group 2: If you are assigned to this group, you will undergo spine radiosurgery in two (2) sessions.
Details
| Condition | Spine Metastases, Spine Stereotactic Radiosurgery (sSRS) |
|---|---|
| Age | 18-100 years |
| Treatment | Diagnostic MRI, Planning MRI, Simulation CT, QOL assessment, Brief pain inventory (BPI), sSRS in 1 fraction, sSRS in 2 fraction |
| Clinical Study Identifier | NCT04218617 |
| Sponsor | Case Comprehensive Cancer Center |
| Last Modified on | 19 February 2024 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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