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

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Minor 2 versions Re-verified since Jun 4, 2026, no change to tracked fieldsv14-v15
  2. Notable Primary completion date: Dec 2025 to Oct 2026
    • Study completion date: Jun 2026 to Oct 2026
    v13
  3. Notable Primary completion date: Jun 1, 2025 to Dec 2025
    • Study completion date: Dec 1, 2025 to Jun 2026
    v12
  4. Notable Primary completion date: Dec 1, 2024 to Jun 1, 2025
    • Study completion date: Jun 1, 2025 to Dec 1, 2025
    v11
  5. Notable Primary completion date: Jun 1, 2024 to Dec 1, 2024
    • Study completion date: Jan 1, 2025 to Jun 1, 2025
    v10
Show 8 earlier versionsHide 8 earlier versions
  1. Minor Primary completion date: Jan 1, 2024 to Jun 1, 2024v9
  2. Notable Primary completion date: Jun 1, 2023 to Jan 1, 2024
    • Study completion date: Jun 1, 2024 to Jan 1, 2025
    v8
  3. Minor Primary completion date: Jan 1, 2023 to Jun 1, 2023
    • Study completion date: Jan 1, 2024 to Jun 1, 2024
    v7
  4. Minor Re-verified, no change to tracked fieldsv6
  5. Minor Study site revisedv5
  6. Minor Site contact updatedv4
  7. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 28, 2020 to Feb 7, 2020
    • Site details revised
    v3
  8. Notable Start date: Jan 1, 2020 to Feb 28, 2020v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04218617
Lead Sponsor Case Comprehensive Cancer Center
Conditions
(from sponsor)
Spine Metastases, Spine Stereotactic Radiosurgery (sSRS)
Enrollment 130 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov