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

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

Recruiting
18 years and older
All
Phase 2
  • Simplified description (AI rewritten)
  • Technical description (Original)

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.
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Study details
    Spine Metastases
    Spine Stereotactic Radiosurgery (sSRS)

NCT04218617

Case Comprehensive Cancer Center

19 February 2024

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