Stereotactic Radiosurgery (SRS) Dose-Escalation Study for Brain Metastasis

Study acronym: SRS
StatusActive, Not Recruiting
PhaseNot applicable
Started

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Record History

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  1. Results posted: Oct 7, 2026 Show 4 more changesShow less
    • Final enrollment: 105 participants (planned 135)
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints revised (4)
    • Primary endpoint revised
  2. Re-verified, no change to tracked fieldsv18
  3. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Dec 2026 to Mar 23, 2025
    • Study completion date: Dec 2026 to Dec 23, 2026
    • Site details revised
    v17
  4. Re-verified, no change to tracked fieldsv16
  5. Eligibility criteria shortened, about 37 wordsv15
Show 13 earlier versionsHide 13 earlier versions
  1. Study title expanded, about 2 wordsv14
  2. Primary and study completion dates: Dec 2022 to Dec 2026v13
  3. Secondary endpoints: 7 to 4v12
  4. Eligibility criteria expanded, about 39 wordsv11
  5. Secondary endpoints: 6 to 7v10
  6. Primary and study completion dates: Dec 2020 to Dec 2022
    • Enrollment target: 180 to 135
    • Eligibility criteria expanded, about 135 words
    • Secondary endpoints: details revised at 1 of 6 entries
    v9
  7. Re-verified, no change to tracked fieldsv8
  8. Eligibility criteria expanded, about 10 wordsv7
  9. Trial status: Suspended to Recruiting
    • Site details revised
    v6
  10. Trial status: Recruiting to Suspended Sponsor's reason: Failed Audit; it was due to safety concerns after annual DSMC review, specifically safety assessments not being performed per protocol
    • Site details revised
    v5
  11. 2 versions Re-verified since Jan 29, 2019, no change to tracked fieldsv3-v4
  12. Phase: Phase 1 to Not applicable
    • Start date: Dec 2015 to Dec 18, 2015
    • Secondary endpoints: 13 to 6
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
SRS dose escalation for brain metastases in radiation-naïve patients will establish true tolerable doses, which may exceed the current standard doses. This may lead to an improvement in local control, patient survival, and/or quality-of life.
Trial Details
NCT Number NCT02645487
Lead Sponsor University of Texas Southwestern Medical Center
Conditions
(from sponsor)		 Brain Neoplasms, Adult, Malignant
Related terms Brain Neoplasms
Enrollment 105 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov