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Stereotactic Radiosurgery Compared With Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) Plus Memantine for 5 or More Brain Metastases

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 58 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Minor Site details revised at 1 of 86 sitesv58
  2. Minor Site contacts updated at 1 of 86 sitesv57
  3. Minor Site details revised at 3 of 86 sitesv56
  4. Minor Study sites revised (86)v55
  5. Minor Site details revised at 4 of 86 sitesv54
Show 45 earlier versionsHide 45 earlier versions
  1. Minor Site details revised at 7 of 86 sitesv53
  2. Minor Study sites: 85 to 86v52
  3. Minor Study sites revised (85)v51
  4. Minor Re-verified, no change to tracked fieldsv50
  5. Minor Site details revised at 5 of 85 sitesv49
  6. Minor Site details revised at 2 of 85 sitesv48
  7. Minor Study sites: 84 to 85v47
  8. Minor Site details revised at 3 of 84 sitesv46
  9. Minor Study sites revised (84)v45
  10. Minor Site details revised at 3 of 84 sitesv44
  11. Minor Site details revised at 2 of 84 sitesv43
  12. Minor Re-verified, no change to tracked fieldsv42
  13. Minor Study sites: 73 to 84v41
  14. Notable Primary completion date: Dec 31, 2023 to Jun 30, 2027
    • Study completion date: Jun 30, 2024 to Dec 31, 2027
    v40
  15. Notable Start date: May 25, 2018 to Nov 22, 2018v39
  16. Notable Primary completion date: Dec 31, 2022 to Dec 31, 2023
    • Study completion date: Jun 30, 2023 to Jun 30, 2024
    v38
  17. Minor Study title expanded, about 2 wordsv37
  18. Minor Site details revised at 1 of 73 sitesv36
  19. Minor Study sites: 71 to 73v35
  20. Minor Re-verified, no change to tracked fieldsv34
  21. Minor Site details revised at 1 of 71 sitesv33
  22. Minor Site details revised at 3 of 71 sitesv32
  23. Minor Site details revised at 1 of 71 sitesv31
  24. Minor Study sites: 70 to 71v30
  25. Minor Site details revised at 18 of 70 sitesv29
  26. Minor Site details revised at 4 of 70 sitesv28
  27. Minor Study sites: 68 to 70v27
  28. Minor Study sites: 67 to 68v26
  29. Minor Re-verified, no change to tracked fieldsv25
  30. Notable Primary completion date: Dec 31, 2021 to Dec 31, 2022
    • Study completion date: Jun 30, 2022 to Jun 30, 2023
    • Secondary endpoints: details revised at 15 of 15 entries
    v24
  31. Minor Study sites: 66 to 67v23
  32. Minor Study sites: 65 to 66v22
  33. Minor Study sites: 64 to 65v21
  34. Minor Study sites: 63 to 64v20
  35. Minor Study sites: 59 to 63v19
  36. Minor Study sites: 56 to 59v18
  37. Minor Site details revised at 2 of 56 sitesv17
  38. Notable Start date: Feb 15, 2018 to May 25, 2018v16
  39. Minor Study sites: 54 to 56v15
  40. Minor Study sites: 51 to 54v14
  41. Minor Study sites: 48 to 51v13
  42. Minor Site details revised at 3 of 48 sitesv12
  43. Minor Study sites: 44 to 48v11
  44. Minor Study sites: 39 to 44v10
  45. Minor Study sites: 7 to 39v9 Show 6 more changesShow less
    • Interventions: Memantine (Drug), Stereotactic Radiosurgery (SRS) (Procedure), Whole Brain Radiotherapy (WBRT) (Radiation) to Hippocampal-avoidant (HA-WBRT) Radiotherapy (Radiation), Memantine (Drug), Stereotactic Radiosurgery (SRS) (Procedure)
    • Eligibility criteria expanded, about 46 words
    • Secondary endpoints revised (15)
    • Study description revised
    • Collaborators: 1 to 2
    • Study title expanded, about 3 words
  • 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.
Stereotactic radiosurgery (SRS) is a commonly used treatment for brain tumors. It is a one-day (or in some cases two day), out-patient procedure during which a high dose of radiation is delivered to small spots in the brain while excluding the surrounding normal brain. Whole brain radiation therapy with hippocampal avoidance (HA-WBRT) is when radiation therapy is given to the whole brain, while trying to decrease the amount of radiation that is delivered to the area of the hippocampus. The hippocampus is a brain structure that is important for memory. Memantine is a drug that is given to help relieve symptoms that can be caused by WBRT, including problems with memory and other mental symptoms. Health Canada, the regulatory body that oversees the use of drugs in Canada, has not approved the sale or use of memantine in combination with WBRT to treat this kind of cancer, although they have allowed its use in this study.
Trial Details
NCT Number NCT03550391
Lead Sponsor Canadian Cancer Trials Group
Collaborators: Alliance for Clinical Trials in Oncology, NRG Oncology
Conditions
(from sponsor)
Brain Metastases
Related terms Brain Neoplasms
Enrollment 206 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov