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Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Sep 2026 → Jan 2027
See other at-risk trials from Case Comprehensive Cancer Center

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Sep 2026 to Jan 2027 Show 4 more changesShow less
    • Study completion pushed from Sep 2026 to Sep 2027
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 2 of 3 entries
    • Study description expanded, about 2 words
  2. 2 versions Re-verified since Jun 25, 2026, no change to tracked fieldsv30-v31
  3. Primary and study completion dates: Dec 2025 to Sep 2026v29
  4. Primary and study completion dates: Jun 1, 2025 to Dec 2025v28
  5. Primary and study completion dates: Dec 1, 2024 to Jun 1, 2025v27
Show 25 earlier versionsHide 25 earlier versions
  1. Phase: Not applicable to Phase 1/2
    • Primary and study completion dates: Dec 2023 to Dec 1, 2024
    v26
  2. Re-verified, no change to tracked fieldsv25
  3. Primary completion date: Apr 2023 to Dec 2023v24
  4. Primary completion date: Dec 2022 to Apr 2023v23
  5. Primary completion date: Jul 2022 to Dec 2022
    • Study completion date: Jul 2022 to Dec 2023
    v22
  6. Re-verified, no change to tracked fieldsv21
  7. Primary and study completion dates: Jul 2021 to Jul 2022v20
  8. Primary endpoints revised (2)v19 Show 5 more changesShow less
    • Primary and study completion dates: May 2021 to Jul 2021
    • Secondary endpoints: 5 to 3
    • Study description expanded, about 13 words
    • Study sites revised (2)
    • Collaborators shortened, about 4 words
  9. Primary completion date: Dec 2020 to May 2021
    • Study completion date: Feb 2021 to May 2021
    v18
  10. Primary completion date: Aug 2020 to Dec 2020
    • Study completion date: Dec 2020 to Feb 2021
    v17
  11. Study sites revised (2)v16
  12. Primary completion date: Dec 2019 to Aug 2020
    • Study completion date: Dec 2019 to Dec 2020
    v15
  13. Primary and study completion dates: May 2019 to Dec 2019v14
  14. Primary and study completion dates: Dec 2018 to May 2019v13
  15. Primary and study completion dates: Sep 2018 to Dec 2018v12
  16. Primary and study completion dates: Sep 30, 2017 to Sep 2018
    • Start date: Jul 2013 to Jul 3, 2013
    • Study description shortened, about 31 words
    v11
  17. Phase: Phase 1/2 to Not applicable
    • Primary completion date: Jan 2017 to Sep 30, 2017
    • Study completion date: Sep 30, 2017
    v10
  18. Study sites revised (2)v9
  19. Eligibility criteria revisedv8
  20. 2 versions Re-verified since Jul 23, 2015, no change to tracked fieldsv6-v7
  21. Enrollment target: 60 to 36v5
  22. Site details revised at 1 of 2 sitesv4
  23. Re-verified, no change to tracked fieldsv3
  24. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Aug 2013 to Jul 2013
    • Site details revised at 2 of 2 sites
    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.
This Phase I/II trial studies the ability to stop brain metastases from coming back after treatment with radiosurgery followed by surgical resection. It will also evaluate the side effects of these combined treatments and help determine the best radiosurgery dose. Radiosurgery focuses the x-rays directly to the tumor and cause less damage to the normal tissue in the brain.
Trial Details
NCT Number NCT01891318
Lead Sponsor Case Comprehensive Cancer Center
Conditions
(from sponsor)		 Tumors Metastatic to Brain
Related terms Brain Neoplasms
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov