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Single- vs. Two-Fraction Spine Stereotactic Radiosurgery for the Treatment of Vertebral Metastases

Spine Metastases Clinical Trial

Official title:
Single- vs. Two-Fraction Spine Stereotactic Radiosurgery for the Treatment of Vertebral Metastases

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04218617
Study type Interventional
Source Case Comprehensive Cancer Center
Contact Samuel T Chao, MD
Phone 1-866-223-8100
Email TaussigResearch@ccf.org
Status Recruiting
Phase Phase 2
Start date February 7, 2020
Completion date January 1, 2025
View Details
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