Clinical trial · Interventional
Surgery for Recurrent Glioblastoma
RESURGE - Randomized Controlled Comparative Phase II Trial on Surgery for Glioblastoma Recurrence
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Second-line therapy alone | Procedure | — | UNRESOLVED |
| Surgery followed by adjuvant second-line therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Surgery followed by adjuvant second-line therapy
- description
- Surgery followed by adjuvant second-line therapy
- interventionNames
- Procedure: Surgery followed by adjuvant second-line therapy
- type
- ACTIVE_COMPARATOR
- label
- Second-line therapy alone
- description
- Second-line therapy alone
- interventionNames
- Procedure: Second-line therapy alone
Primary outcomes (1)
- measure
- Overall survival from the date of inclusion
- timeFrame
- From the date of inclusion until death/end of study, assessed up to 5.7 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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) Exclusion Criteria
References
Publications (0)
Data not yet available