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Post-Surgical Stereotactic Radiotherapy (SRT) Versus GammaTile-ROADS (Radiation One and Done Study)

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv45
  2. Primary completion date: Dec 30, 2025 to Aug 30, 2029 Trial status: Recruiting to Active, Not Recruiting · Enrollment target: 180 to 230 · Study sites: 38 to 37 · 1 morev44 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: 180 to 230
    • Study sites: 38 to 37
    • Completion date: Dec 30, 2027 to Aug 30, 2029
  3. Study sites: 37 to 38v43
  4. Study sites: 36 to 37v42
  5. Study sites: 35 to 36v41
Show 39 earlier versionsHide 39 earlier versions
  1. Study sites: 34 to 35v40
  2. Study sites revised (34)v39 See this version in full on ClinicalTrials.gov ↗
  3. Study sites revised (34)v38 See this version in full on ClinicalTrials.gov ↗
  4. Study sites: 32 to 34v37
  5. Study sites: 33 to 32v36
  6. Study sites: 34 to 33v35
  7. Study sites: 33 to 34v34
  8. Study sites: 28 to 33 Eligibility criteria expanded, about 103 words · Study description expanded, about 16 wordsv33 Show 2 more changesShow less
    • Eligibility criteria expanded, about 103 words
    • Study description expanded, about 16 words

    See this version in full on ClinicalTrials.gov ↗

  9. Study sites: 27 to 28v32
  10. Study sites: 26 to 27v31
  11. Study sites: 25 to 26v30
  12. Study sites revised (25)v29 See this version in full on ClinicalTrials.gov ↗
  13. Study sites: 23 to 25v28
  14. Site contacts updated at 1 of 23 sitesv27
  15. Study sites: 22 to 23v26
  16. Re-verified, no change to tracked fieldsv25
  17. Study description expanded, about 8 words Eligibility criteria expanded, about 2 wordsv24 Show 1 more changeShow less
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  18. Study sites: 21 to 22v23
  19. Site contacts updated at 1 of 21 sitesv22
  20. Study sites: 20 to 21v21
  21. Study sites: 18 to 20v20
  22. Study sites: 17 to 18v19
  23. Eligibility criteria expanded, about 1 wordv18 See this version in full on ClinicalTrials.gov ↗
  24. Site contacts updated at 1 of 17 sitesv17
  25. Study sites: 16 to 17v16
  26. Site contacts updated at 1 of 16 sitesv15
  27. Study sites revised (16)v14 See this version in full on ClinicalTrials.gov ↗
  28. Study sites: 15 to 16v13
  29. Study sites: 14 to 15v12
  30. Study sites: 12 to 14v11
  31. Study sites revised (12)v10 See this version in full on ClinicalTrials.gov ↗
  32. Study title expanded, about 5 wordsv9 See this version in full on ClinicalTrials.gov ↗
  33. Study sites: 9 to 12v8
  34. Re-verified, no change to tracked fieldsv7
  35. Study sites: 2 to 9v6
  36. Study description expanded, about 4 wordsv5 See this version in full on ClinicalTrials.gov ↗
  37. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date changed from estimate of Feb 15, 2021 to Apr 6, 2021 · Eligibility criteria expanded, about 157 wordsv4 Show 3 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of Feb 15, 2021 to Apr 6, 2021
    • Eligibility criteria expanded, about 157 words

    See this version in full on ClinicalTrials.gov ↗

  38. Start date: Sep 30, 2020 to Feb 15, 2021 Primary completion date: Sep 30, 2025 to Dec 30, 2025 · Completion date: Sep 30, 2027 to Dec 30, 2027 · Study title shortened, about 2 wordsv3 Show 3 more changesShow less
    • Primary completion date: Sep 30, 2025 to Dec 30, 2025
    • Completion date: Sep 30, 2027 to Dec 30, 2027
    • Study title shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  39. Secondary endpoints revised (7) Collaborators shortened, about 4 wordsv2 Show 1 more changeShow less
    • Collaborators shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  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 trial will be a randomized controlled study comparing the efficacy and safety of intraoperative radiation therapy using GammaTilesTM (GT) versus SRT 3-4 weeks following metastatic tumor resection which is the current standard of care.
Trial Details
NCT Number NCT04365374
Lead Sponsor GT Medical Technologies, Inc.
Conditions Brain Metastases
Enrollment 230 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov