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Surgery for Recurrent Glioblastoma

Study acronym: RESURGE
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary and study completion dates: Dec 2025 to Dec 2028
    • Study sites: 26 to 25
    v16
  2. Minor Study sites: 22 to 26v15
  3. Minor 2 versions Re-verified since Oct 16, 2024, no change to tracked fieldsv13-v14
  4. Notable Primary and study completion dates: Oct 2023 to Dec 2025
    • Start date: May 2015 to May 1, 2015
    v12
  5. Minor Re-verified, no change to tracked fieldsv11
Show 9 earlier versionsHide 9 earlier versions
  1. Notable Primary and study completion dates: Oct 2021 to Oct 2023v10
  2. Notable Primary and study completion dates: Oct 2020 to Oct 2021v9
  3. Minor Study sites: 14 to 22v8
  4. Minor Study sites: 5 to 14v7
  5. Minor Study sites: 4 to 5v6
  6. Minor Secondary endpoints: details revised at 1 of 5 entriesv5
  7. Minor Site details revised at 1 of 4 sitesv4
  8. Minor Re-verified, no change to tracked fieldsv3
  9. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Apr 2015 to May 2015
    • Site details revised at 4 of 4 sites
    v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Patients with glioblastoma face a grim prognosis. Despite recent advancement in neurosurgical technology and neuro-oncology glioblastomas almost invariably progress or recur after a median of 4-8 months. The strategy to repeat tumor resection at recurrence in order to minimize tumor load and thus to facilitate subsequent second-line therapy has been shown to be feasible and safe. However, evidence for a survival benefit of surgery for recurrent glioblastoma is scarce and relies entirely on retrospective analyses. While most retrospective analyses report an apparent survival benefit, an EORTC meta-analysis on second-line therapies found no survival difference in patients with or without surgery at recurrence. With regard to the risks and costs inherent to surgery for glioblastoma, a randomized controlled trial is required. The purpose of the study is to compare the effect of craniotomy and tumor resection followed by adjuvant second-line therapy to no surgery followed by second-line therapy on overall survival, neurological status, and quality of life. Analysis of overall survival will be used to improve sample size estimation of a subsequent phase III trial for craniotomy and tumor resection of glioblastoma recurrence in cooperation with the EORTC.
Trial Details
NCT Number NCT02394626
Lead Sponsor Insel Gruppe AG, University Hospital Bern
Collaborators: European Organisation for Research and Treatment of Cancer - EORTC
Conditions
(from sponsor)
Glioblastoma
Related terms Glioblastoma
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov