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Observation or Radiation Therapy in Treating Patients With Newly Diagnosed Grade II Meningioma That Has Been Completely Removed by Surgery

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

Record History

  1. Enrollment closed, study ongoing Enrollment target: estimated 163 to confirmed 162 · Eligibility criteria expanded, about 25 words · Secondary endpoints: details revised at 10 of 14 entries · 1 more Show 4 more changesShow less
    • Enrollment target: estimated 163 to confirmed 162
    • Eligibility criteria expanded, about 25 words
    • Secondary endpoints: details revised at 10 of 14 entries
    • Site details revised at 215 of 215 sites
  2. Completion pushed from Jun 15, 2027 to Jun 15, 2032v45
  3. Study sites: 214 to 215v44
  4. Site details revised at 1 of 214 sitesv43
  5. Study sites: 212 to 214v42
Show 40 earlier versionsHide 40 earlier versions
  1. Study sites: 210 to 212v41
  2. Study sites: 209 to 210v40
  3. Study sites: 208 to 209v39
  4. Study sites: 206 to 208v38
  5. Start date: Jun 14, 2017 to Sep 12, 2017 Enrollment target: 148 to 163 · Completion date: Aug 31, 2027 to Jun 15, 2027 · Interventions: Clinical Observation (Other), Radiation Therapy (Radiation) to Biospecimen Collection (Procedure), Clinical Observation (Other), Intensity-Modulated Radiation Therapy (Radiation), Laboratory Biomarker… · 5 morev37 Show 8 more changesShow less
    • Enrollment target: 148 to 163
    • Completion date: Aug 31, 2027 to Jun 15, 2027
    • Interventions: Clinical Observation (Other), Radiation Therapy (Radiation) to Biospecimen Collection (Procedure), Clinical Observation (Other), Intensity-Modulated Radiation Therapy (Radiation), Laboratory Biomarker…
    • Eligibility criteria shortened, about 25 words
    • Secondary endpoints: 11 to 14
    • Primary endpoint revised
    • Study description expanded, about 53 words
    • Site details revised at 9 of 206 sites

    See this version in full on ClinicalTrials.gov ↗

  6. Study sites: 205 to 206v36
  7. Study sites: 198 to 205v35
  8. Study sites revised (198)v34 See this version in full on ClinicalTrials.gov ↗
  9. Study sites: 196 to 198v33
  10. Study sites revised (196)v32 See this version in full on ClinicalTrials.gov ↗
  11. Study sites: 195 to 196v31
  12. Study sites: 191 to 195v30
  13. Site details revised at 5 of 191 sitesv29
  14. Site details revised at 10 of 191 sitesv28
  15. Study sites: 190 to 191v27
  16. Study sites: 189 to 190v26
  17. Study sites: 185 to 189v25
  18. Study sites: 183 to 185v24
  19. Study sites: 182 to 183v23
  20. Study sites: 178 to 182v22
  21. Study sites: 175 to 178v21
  22. Study sites: 172 to 175v20
  23. Study sites: 169 to 172v19
  24. Study sites: 164 to 169v18
  25. Study sites: 159 to 164v17
  26. Study sites: 157 to 159v16
  27. Study sites: 155 to 157v15
  28. Study sites: 153 to 155v14
  29. Study sites: 142 to 153v13
  30. Study sites: 136 to 142v12
  31. Study sites: 134 to 136v11
  32. Study sites: 116 to 134v10
  33. Study sites: 103 to 116v9
  34. Phase: Not applicable to Phase 3v8
  35. Study sites: 83 to 103v7
  36. Study sites: 81 to 83v6
  37. Study sites: 69 to 81v5
  38. Study sites: 44 to 69v4
  39. Study sites: 1 to 44v3
  40. Start date changed from estimate of Aug 4, 2017 to Jun 14, 2017v2
  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.
NRG Oncology
67 trials monitored
See 5 trials at risk
This randomized phase III trial studies how well radiation therapy works compared with observation in treating patients with newly diagnosed grade II meningioma that has been completely removed by surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.
Trial Details
NCT Number NCT03180268
Lead Sponsor NRG Oncology
Collaborators: National Cancer Institute (NCI)
Conditions Grade 2 Meningioma, Intracranial Meningioma
Enrollment 162 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov