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Treatment Intensification With Temozolomide in Adults With a Glioblastoma

Study acronym: StrateGlio
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status changed: Recruiting → Active, Not Recruiting
    • Primary completion pushed from Feb 2027 to Jun 2027
    • Study completion moved earlier from May 1, 2028 to Jun 2027
    • Study sites: 19 to 17
    v8
  2. Re-verified, no change to tracked fieldsv7
  3. Primary completion date: May 31, 2025 to Feb 2027
    • Study completion date: Nov 1, 2027 to May 1, 2028
    v6
  4. Primary completion date: Aug 1, 2024 to May 31, 2025
    • Study completion date: Nov 1, 2026 to Nov 1, 2027
    v5
  5. Primary completion date: May 1, 2022 to Aug 1, 2024
    • Enrollment target: 535 to 486
    • Study completion date: May 1, 2023 to Nov 1, 2026
    • Site details revised at 7 of 19 sites
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Study sites: 1 to 19v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 1, 2018 to Mar 13, 2019
    • Study sites: 0 to 1
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Centre Oscar Lambret
100 trials monitored
See 2 trials at risk
Glioma
1,251 trials monitored
See 88 trials at risk
Glioblastoma
710 trials monitored
See 52 trials at risk
Due to conflicting data on the optimal moment to start TMZ chemotherapy and the impact of prolongation of the adjuvant phase with TMZ, the ANOCEF (Association des Neuro-Oncologues d'Expression Francophone) group proposes this randomized trial comparing an intensified arm (early TMZ and extended adjuvant TMZ until toxicity, progression or patient refusal) versus the classical EORTC regimen as control (RT and concomitant TMZ started 4-6 weeks after surgery followed by a number of adjuvant TMZ cycles strictly limited to 6) for primary GBM adult patients.
Trial Details
NCT Number NCT03663725
Lead Sponsor Centre Oscar Lambret
Collaborators: Association de Neuro-Oncologues d'Expression Francaise, Erasme University Hospital
Conditions
(from sponsor)		 Glioblastoma
Related terms Glioblastoma
Enrollment 486 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov