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Testing the Addition of the Chemotherapy Drug Lomustine (Gleostine) to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Methylated Glioblastoma

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

Record History

  1. Completion pushed from Aug 8, 2026 to Feb 12, 2031v23
  2. Study sites revised (420)v22 See this version in full on ClinicalTrials.gov ↗
  3. Primary completion moved earlier from Aug 8, 2026 to Feb 12, 2026 Site details revised at 1 of 420 sitesv21 Show 1 more changeShow less
    • Site details revised at 1 of 420 sites
  4. Site details revised at 1 of 420 sitesv20
  5. Study sites: 421 to 420v19
Show 17 earlier versionsHide 17 earlier versions
  1. Trial status: Suspended to Active, Not Recruiting Enrollment target: estimated 306 to confirmed 265v18 Show 1 more changeShow less
    • Enrollment target: estimated 306 to confirmed 265
  2. Trial status: Recruiting to Suspended Sponsor's reason: Other - Other Study sites: 403 to 421 · Eligibility criteria shortened, about 1 wordv17 Show 2 more changesShow less
    • Study sites: 403 to 421
    • Eligibility criteria shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 399 to 403v16
  4. Study sites: 386 to 399v15
  5. Study sites: 373 to 386v14
  6. Start date: Nov 29, 2021 to Mar 28, 2022 Study sites: 360 to 373 · Completion date: Aug 8, 2031 to Aug 8, 2026 · Interventions: Lomustine (Drug), Photon Beam Radiation Therapy (Radiation), Quality-of-Life Assessment (Other), Questionnaire Administration (Other)… to Lomustine (Drug), Magnetic Resonance Imaging (Procedure), Photon Beam Radiation Therapy (Radiation), Questionnaire Administration (Other)… · 5 morev13 Show 8 more changesShow less
    • Study sites: 360 to 373
    • Completion date: Aug 8, 2031 to Aug 8, 2026
    • Interventions: Lomustine (Drug), Photon Beam Radiation Therapy (Radiation), Quality-of-Life Assessment (Other), Questionnaire Administration (Other)… to Lomustine (Drug), Magnetic Resonance Imaging (Procedure), Photon Beam Radiation Therapy (Radiation), Questionnaire Administration (Other)…
    • Eligibility criteria expanded, about 82 words
    • Secondary endpoints revised (3)
    • Primary endpoint revised
    • Study description expanded, about 23 words
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  7. Study sites: 352 to 360v12
  8. Study sites: 264 to 352v11
  9. Study sites: 244 to 264v10
  10. Study sites: 235 to 244v9
  11. Study sites: 231 to 235 Eligibility criteria shortened, about 2 wordsv8 Show 1 more changeShow less
    • Eligibility criteria shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  12. Study sites: 225 to 231v7
  13. Study sites: 211 to 225v6
  14. Study sites: 120 to 211v5
  15. Study sites: 38 to 120v4
  16. Study sites: 18 to 38v3
  17. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 18 · Start date changed from estimate of May 6, 2022 to Nov 29, 2021v2 Show 2 more changesShow less
    • Study sites: 0 to 18
    • Start date changed from estimate of May 6, 2022 to Nov 29, 2021
  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
Glioblastoma
670 trials monitored
See 44 trials at risk
This phase III trial compares the effect of adding lomustine to standard chemotherapy with temozolomide and radiation therapy versus temozolomide and radiation therapy alone in shrinking or stabilizing newly diagnosed MGMT methylated glioblastoma. MGMT methylated tumors are more likely to respond to temozolomide chemotherapy. Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill tumor cells and slow down or stop tumor growth. Lomustine is a chemotherapy drug and in a class of medications called alkylating agents. It damages the cell's DNA and may kill tumor cells. Radiation therapy uses high energy x-ray photons to kill tumor cells and shrink tumors. Adding lomustine to standard chemotherapy with temozolomide and radiation therapy may shrink or stabilize glioblastoma.
Trial Details
NCT Number NCT05095376
Lead Sponsor NRG Oncology
Collaborators: National Cancer Institute (NCI)
Conditions Glioblastoma, Gliosarcoma
Enrollment 265 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov