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The PROGRAM-study: Awake Mapping Versus Asleep Mapping Versus No Mapping for Glioblastoma Resections

Study acronym: PROGRAM
StatusUnknown
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 6, 2022 (before its estimated October 1, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since May 2022); last known: Recruiting
  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Feb 1, 2021 to Jan 1, 2022 · Study sites: 3 to 8v2 Show 2 more changesShow less
    • Start date changed from estimate of Feb 1, 2021 to Jan 1, 2022
    • Study sites: 3 to 8
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The study is designed as an international, multicenter prospective cohort study. Patients with presumed glioblastoma (GBM) in- or near eloquent areas on diagnostic MRI will be selected by neurosurgeons. Patients will be treated following one of three study arms: 1) a craniotomy where the resection boundaries for motor or language functions will be identified by the "awake" mapping technique (awake craniotomy, AC); 2) a craniotomy where the resection boundaries for motor functions will be identified by "asleep" mapping techniques (MEPs, SSEPs, continuous dynamic mapping); 3) a craniotomy where the resection boundaries will not be identified by any mapping technique ("no mapping group"). All patients will receive follow-up according to standard practice.
Trial Details
NCT Number NCT04708171
Lead Sponsor Erasmus Medical Center
Collaborators: Medical Center Haaglanden, Universitaire Ziekenhuizen KU Leuven, University of California, San Francisco
Conditions Glioblastoma
Enrollment 453 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov