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Phase I/IIa Study of Concomitant Radiotherapy With Olaparib and Temozolomide in Unresectable High Grade Gliomas Patients

Study acronym: OLA-TMZ-RTE-01
StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 4, 2025 (before its estimated September 13, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Publications: 2 to 3v23
  2. Primary completion date: Sep 13, 2025 to Sep 13, 2026
    • Study completion date: Dec 31, 2025 to Dec 31, 2026
    v22
  3. Primary completion date: Sep 13, 2024 to Sep 13, 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Mar 4, 2025 to Dec 31, 2025
    • Site details revised at 15 of 15 sites
    v21
  4. Primary completion date: Apr 4, 2024 to Sep 13, 2024
    • Study completion date: Oct 4, 2024 to Mar 4, 2025
    v20
  5. Re-verified, no change to tracked fieldsv19
Show 17 earlier versionsHide 17 earlier versions
  1. Site details revised at 6 of 15 sitesv18
  2. Study sites: 14 to 15v17
  3. Re-verified, no change to tracked fieldsv16
  4. Primary completion date: Mar 4, 2023 to Apr 4, 2024
    • Study completion date: Sep 4, 2023 to Oct 4, 2024
    v15
  5. Study sites: 6 to 14v14
  6. Enrollment target: 79 to 91v13
  7. Primary completion date: Jan 31, 2022 to Mar 4, 2023
    • Study completion date: Jun 30, 2022 to Sep 4, 2023
    v12
  8. 2 versions Re-verified since Feb 6, 2020, no change to tracked fieldsv10-v11
  9. Site contacts updated at 3 of 6 sitesv9
  10. Site details revised at 2 of 6 sitesv8
  11. Study sites: 5 to 6v7
  12. Study sites: 6 to 5v6
  13. Re-verified, no change to tracked fieldsv5
  14. Eligibility criteria expanded, about 132 wordsv4
  15. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 1, 2017 to Sep 4, 2017
    • Site details revised at 6 of 6 sites
    v3
  16. Interventions: Olaparib (Drug) to IMRT (Intensity Modulated Radiation Therapy) (Radiation), Olaparib (Drug), Temozolomide (TMZ) (Drug)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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 Francois Baclesse
45 trials monitored
See 1 trial at risk
Glioma
1,251 trials monitored
See 88 trials at risk
The Stupp protocol is the standard treatment of glioblastoma multiform (GBM) which prognosis remains poor. The non-dividing nature of normal brain cells provides an opportunity to enhance the therapeutic ratio by combining radiation with inhibitors of replication-specific DNA repair pathways such poly(ADP-ribose) polymerase (PARP) inhibitors, thus inducing more cytotoxic effects of DNA-damage related to treatment modalities, including alkylating reagents like temozolomide (TMZ). Olaparib, a potent PARP inhibitor, overcomes apoptotic resistance and sensitizes GBM cells for death receptor-mediated apoptosis induced by TRAIL (Tumor necrosis factor-Related Apoptosis Inducing Ligand). Moreover, inhibition of PARP activity increases cellular sensitivity to ionizing radiation: it was even suggested to be more pronounced in tumors than in normal tissue. Lastly, progress in technical imaging and intensity-modulated-radiotherapy (IMRT) techniques provide new possibilities for sparing healthy tissues.
Trial Details
NCT Number NCT03212742
Lead Sponsor Centre Francois Baclesse
Collaborators: National Cancer Institute, France
Conditions
(from sponsor)		 Malignant Gliomas, Radiotherapy, PARP Inhibitor
Related terms Glioma
Enrollment 91 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov