Clinical Trial

Surgery for Recurrent Glioblastoma

Study acronym: RESURGE
Recruiting Phase 2
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Summary
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.
Protocol Amendment History 15 amendments
This ClinicalTrials.gov record has been amended 15 times since 2015-03-19; most recent amendment 2026-01-30.
Status change: Not Yet Recruiting → Recruiting 2015-05-21
Trial Details
NCT Number NCT02394626
Lead Sponsor Insel Gruppe AG, University Hospital Bern
Collaborators: European Organisation for Research and Treatment of Cancer - EORTC
Conditions Glioblastoma
Enrollment 120 participants
Start Date 2015-05-01
Primary Completion 2028-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-02-02