Preoperative Radiosurgery for the Treatment of High Grade Glioma, NeoGlioma Trial

StatusRecruiting
PhasePhase 1
Started

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Record History

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  1. Minor Primary completion moved earlier from Sep 15, 2027 to Mar 15, 2027 Show 4 more changesShow less
    • Study completion pushed from Sep 15, 2027 to Mar 15, 2028
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: details revised at 3 of 3 entries
    • Study description revised
  2. Minor 2 versions Re-verified since Apr 20, 2026, no change to tracked fieldsv22-v23
  3. Minor Site details revised at 1 of 2 sitesv21
  4. Notable Primary and study completion dates: Sep 15, 2025 to Sep 15, 2027v20
  5. Minor Enrollment target: 25 to 28
    • Study sites: 1 to 2
    • Eligibility criteria expanded, about 5 words
    v19
Show 17 earlier versionsHide 17 earlier versions
  1. Minor Study description expanded, about 5 wordsv18
  2. Minor Re-verified, no change to tracked fieldsv17
  3. Notable Phase: Phase 1/2 to Phase 1v16 Show 7 more changesShow less
    • Enrollment target: 40 to 25
    • Primary endpoints: 1 to 3
    • Eligibility criteria shortened, about 26 words
    • Secondary endpoints: 4 to 3
    • Study description shortened, about 12 words
    • Study arms: 2 to 1
    • Study title shortened, about 1 word
  4. Minor Site contact updatedv15
  5. Minor Interventions: Radiation Therapy (Radiation), Radiosurgery (Radiation), Stereotactic Biopsy (Procedure), Temozolomide (Drug), Therapeutic Conventional… to Biopsy (Procedure), Biospecimen Collection (Procedure), Magnetic Resonance Imaging (Procedure), Radiation Therapy (Radiation), Radiosurgery…
    • Eligibility criteria expanded, about 23 words
    • Study description expanded, about 13 words
    v14
  6. Minor Site contact updatedv13
  7. Minor Eligibility criteria revisedv12
  8. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 1, 2023 to May 23, 2023
    • Site details revised
    v11
  9. Notable Primary completion date: Sep 15, 2024 to Sep 15, 2025v10
  10. Minor Re-verified, no change to tracked fieldsv9
  11. Minor Collaborators shortened, about 4 wordsv8
  12. Notable Start date: Dec 1, 2022 to Jun 1, 2023v7
  13. Notable Start date: Oct 1, 2022 to Dec 1, 2022v6
  14. Notable Start date: Jul 1, 2022 to Oct 1, 2022v5
  15. Notable Start date: Apr 1, 2022 to Jul 1, 2022v4
  16. Notable Start date: Dec 15, 2021 to Apr 1, 2022v3
  17. Notable Start date: Sep 15, 2021 to Dec 15, 2021v2
  1. Minor Study First Submitted
  • 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.
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This phase I trial finds out the possible benefits and/or side effects of radiosurgery before surgery (preoperative) in treating patients with high grade glioma. Radiosurgery uses special equipment to position the patient and precisely give a single large dose of radiation to the tumor. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving pre-operative radiosurgery may improve the odds of brain tumor control and reduce treatment-related side effects.
Trial Details
NCT Number NCT05030298
Lead Sponsor Mayo Clinic
Conditions
(from sponsor)
Malignant Glioma
Related terms Glioma
Enrollment 28 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov