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Study Evaluating the Efficacy of Radiotherapy With SIB-IMRT, Associated With Temozolomide in Glioblastomas

Study acronym: Glio-SIB-Up
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv8
  2. Primary completion date: Dec 7, 2021 to Sep 2, 2023 Trial status: Recruiting to Active, Not Recruiting · Completion date: Dec 2, 2023 to Sep 2, 2025 · Site details revised at 7 of 7 sitesv7 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Completion date: Dec 2, 2023 to Sep 2, 2025
    • Site details revised at 7 of 7 sites
  3. Re-verified, no change to tracked fieldsv6
  4. Primary completion date: Jun 15, 2017 to Dec 7, 2021 Study sites: 6 to 7 · Completion date: Sep 15, 2020 to Dec 2, 2023v5 Show 2 more changesShow less
    • Study sites: 6 to 7
    • Completion date: Sep 15, 2020 to Dec 2, 2023
  5. Primary completion date: May 4, 2017 to Jun 15, 2017 Completion date: Aug 4, 2020 to Sep 15, 2020 · Start date: May 4, 2017 to Apr 7, 2017v4 Show 2 more changesShow less
    • Completion date: Aug 4, 2020 to Sep 15, 2020
    • Start date: May 4, 2017 to Apr 7, 2017
Show 2 earlier versionsHide 2 earlier versions
  1. Primary completion date changed from estimate of Apr 7, 2019 to May 4, 2017 Completion date: Dec 7, 2021 to Aug 4, 2020 · Start date: Apr 7, 2017 to May 4, 2017v3 Show 2 more changesShow less
    • Completion date: Dec 7, 2021 to Aug 4, 2020
    • Start date: Apr 7, 2017 to May 4, 2017
  2. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Glioblastoma (GBM) is the most aggressive and most frequent brain tumour. Approximately four people per 100,000 inhabitants are diagnosed with this disease every year. The standard treatment comprises surgical resection (whenever possible), normofractionated radiotherapy at a dose of 60Gray (Gy) and temozolomide (TMZ). Median overall survival in these patients is 14.6 months \[13.2-16.8\]. In a previous phase I clinical trial, dose escalation tolerance using simultaneous-integrated boost intensity-modulated radiation therapy (SIB-IMRT) technic has been evaluated. The investigator demonstrated that SIB-IMRT until a dose of 80Gy in 32 daily fractions, associated with TMZ is feasible and well tolerated by patients with glioblastoma. The aim of this present phase II clinical trial is to evaluate the overall survival at 18 months for patients with glioblastoma receiving TMZ, according to standard protocol, associated to radiotherapy delivered at 80Gy using SIB-IMRT technic. The first planning target volume (PTV), including oedema and tumour highlighted on T2 flair magnetic resonance imaging (MRI) sequences, will receive 60.8Gy in 32 daily fractions. The second PTV, including tumour highlighted on T1 MRI sequences, will receive 80.0Gy in 32 daily fractions. Secondary objectives are tolerance, survival free progression and quality of live evaluations. Sixty seven patients will be enrolled in this present trial.
Trial Details
NCT Number NCT03181477
Lead Sponsor Centre Georges Francois Leclerc
Conditions Glioblastoma, Adult
Enrollment 67 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov