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Spine Radiosurgery for Symptomatic Metastatic Neoplasms

Study acronym: SPORTSMEN
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Start date: Sep 3, 2025 to Sep 9, 2025v15
  2. Start date changed from estimate of Aug 31, 2025 to Sep 3, 2025v14
  3. Trial status: Active, Not Recruiting to Recruitingv13 Show 8 more changesShow less
    • Enrollment target: 16 to 240
    • Primary completion date: Jun 30, 2026 to Sep 30, 2028
    • Start date: Jan 25, 2023 to Aug 31, 2025
    • Primary endpoint revised
    • Study sites: 1 to 2
    • Study completion date: Dec 31, 2026 to Sep 30, 2029
    • Secondary endpoints revised (7)
    • Study description expanded, about 59 words
  4. Lead sponsor: Case Comprehensive Cancer Center to University of Oklahomav12
  5. Trial status: Suspended to Active, Not Recruiting
    • Enrollment target: estimated 240 to confirmed 16
    v11
Show 9 earlier versionsHide 9 earlier versions
  1. Trial status: Recruiting to Suspended Sponsor's reason: PI left the institution
    • Site details revised
    v10
  2. Site contact updatedv9
  3. Re-verified, no change to tracked fieldsv8
  4. Eligibility criteria shortened, about 20 wordsv7
  5. Eligibility criteria expanded, about 22 words
    • Secondary endpoints: details revised at 2 of 7 entries
    v6
  6. Eligibility criteria revisedv5
  7. Start date changed from estimate of Jan 2023 to Jan 25, 2023v4
  8. Eligibility criteria expanded, about 7 wordsv3
  9. Trial status: Not Yet Recruiting to Recruiting
    • Primary endpoint revised
    • Secondary endpoints revised (7)
    • Site details revised
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to compare three types of radiation therapy for cancer that has spread to the spine. The two types of radiation therapy used in this trial are External Beam Radiation Therapy (EBRT) and Stereotactic Body Radiation Therapy (SBRT). EBRT delivers tightly targeted radiation beams from outside the body. SBRT is a specialized type of radiation therapy that allows high doses of radiation to small targets. This study will include standard dose SBRT and higher dose SBRT. Each participant will be randomly assigned to either EBRT, standard dose SBRT, or higher dose SBRT.
Trial Details
NCT Number NCT05617716
Lead Sponsor University of Oklahoma
Conditions
(from sponsor)		 Metastatic Neoplasm to the Spine, Metastatic Neoplasm
Related terms Neoplasm Metastasis
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov