RESURGE - Randomized Controlled Comparative Phase II Trial on Surgery for Glioblastoma Recurrence

Trial ID: NCT02394626

Interventional - Phase 2 - Recruiting

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.

Conditions

• Glioblastoma

Interventions

• Surgery followed by adjuvant second-line therapy
• Second-line therapy alone

Eligibility

Inclusion criteria

• Written informed consent
• ≥18 years of age
• Prior resection of glioblastoma confirmed by histology
• Glioblastoma pretreated with standard radiotherapy without or with temozolomide
• First progression according to RANO criteria
• First progression not within 3 months after completion of radiation therapy
• Complete removal of contrast-enhancing lesion considered feasible without significant risk of permanent speech or motor function according to MRI as confirmed by study eligibility committee after screening and prior to recruitment
• No encroachment of the M1 or A1 segments of the medial and anterior cerebral artery on MRI
• No contrast enhancement in presumed speech and primary motor areas on MRI
• No midline shift on MRI
• No contrast enhancing ventricular spread, multifocal recurrence, meningeosis carcinomatosa or infiltration of the contra-lateral hemisphere on MRI
• No contra-indication for surgery
• Good functional status (KPS ≥ 70)

Sponsor

Insel Gruppe AG, University Hospital Bern, European Organisation for Research and Treatment of Cancer - EORTC

Source: ClinicalTrials.gov

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