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Phase III Trial of Anaplastic Glioma Without 1p/19q Loss of Heterozygosity (LOH)

Study acronym: CATNON
StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Notable Results first posted: Sep 11, 2023v42 Show 9 more changesShow less
    • Primary completion date changed from estimate of Dec 2025 to Sep 5, 2018
    • Study completion date: Dec 2025 to Dec 2029
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: 5 to 3
    • Primary endpoint revised
    • Study description expanded, about 12 words
    • Site details revised at 5 of 132 sites
    • Collaborators: 5 to 4
    • Study title expanded, about 3 words
  2. Notable Primary completion date: Jan 2022 to Dec 2025
    • Study completion date: Jan 2024 to Dec 2025
    v41
  3. Minor Re-verified, no change to tracked fieldsv40
  4. Notable Primary completion date: Jan 2020 to Jan 2022
    • Study completion date: Jan 2024
    v39
  5. Notable Primary completion date: Jun 2015 to Jan 2020v38 Show 7 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 1360 to confirmed 751
    • Study sites: 14 to 132
    • Secondary endpoints: details revised at 5 of 5 entries
    • Collaborators: 4 to 5
    • Study arms: 0 to 4
    • Study title shortened, about 3 words
Show 36 earlier versionsHide 36 earlier versions
  1. Notable Enrollment target: 748 to 1360
    • Eligibility criteria expanded, about 48 words
    • Study description expanded, about 6 words
    v37
  2. Minor Study sites: 12 to 14
    • Collaborators: 3 to 4
    v36
  3. Minor Study sites: 10 to 12v35
  4. Minor Study sites: 2 to 10v34
  5. Minor 15 versions Re-verified since Apr 2, 2010, no change to tracked fieldsv19-v33
  6. Minor Study sites: 1 to 2v18
  7. Minor 5 versions Re-verified since Dec 2, 2009, no change to tracked fieldsv13-v17
  8. Minor Secondary endpoints revised (5)v12
  9. Minor 2 versions Re-verified since Oct 2, 2009, no change to tracked fieldsv10-v11
  10. Minor Collaborators revised (3)v9
  11. Minor Interventions: DNA methylation analysis (Procedure), adjuvant therapy (Procedure), laboratory biomarker analysis (Procedure), quality-of-life assessment… to DNA methylation analysis (Genetic), adjuvant therapy (Procedure), laboratory biomarker analysis (Other), quality-of-life assessment…v8
  12. Minor 4 versions Re-verified since Jul 23, 2008, no change to tracked fieldsv4-v7
  13. Minor Interventions: DNA methylation analysis (Procedure), adjuvant therapy (Procedure), chemotherapy (Procedure), laboratory biomarker analysis (Procedure)… to DNA methylation analysis (Procedure), adjuvant therapy (Procedure), laboratory biomarker analysis (Procedure), quality-of-life assessment…v3
  14. Minor Re-verified, no change to tracked fieldsv2
  1. Minor 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.
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known whether giving temozolomide during and/or after radiation therapy is more effective than radiation therapy alone in treating anaplastic glioma. PURPOSE: This randomized phase III trial is studying giving temozolomide during and/or after radiation therapy to see how well it works compared to radiation therapy alone in treating patients with anaplastic glioma.
Trial Details
NCT Number NCT00626990
Lead Sponsor European Organisation for Research and Treatment of Cancer - EORTC
Collaborators: NCIC Clinical Trials Group, Radiation Therapy Oncology Group, Medical Research Council, Merck Sharp & Dohme LLC
Conditions
(from sponsor)
Brain and Central Nervous System Tumors
Related terms Astrocytoma, Central Nervous System Neoplasms, Oligodendroglioma
Enrollment 751 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov