Actively Recruiting
Surgery for Recurrent Glioblastoma
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2026-02-02
120
Participants Needed
25
Research Sites
709 weeks
Total Duration
On this page
Sponsors
I
Insel Gruppe AG, University Hospital Bern
Lead Sponsor
E
European Organisation for Research and Treatment of Cancer - EORTC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Surgery for Recurrent Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent
- Age 18 years or older
- Prior glioblastoma resection confirmed by histology
- Glioblastoma treated with standard radiotherapy with or without temozolomide
- First progression of glioblastoma according to RANO criteria
- First progression occurs more than 3 months after completing radiation therapy
- Complete removal of contrast-enhancing lesion deemed feasible without major risk to speech or motor function as confirmed by eligibility committee
- No involvement of M1 or A1 segments of cerebral arteries on MRI
- No contrast enhancement in presumed speech and primary motor brain areas on MRI
- No midline shift on MRI
- No contrast enhancing ventricular spread, multifocal recurrence, meningeosis carcinomatosa, or infiltration of opposite hemisphere on MRI
- No contraindication for surgery
- Good functional status with Karnofsky Performance Score at least 70
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 25 locations
1
Universitätsklinikum Innsbruck
Innsbruck, Austria
Actively Recruiting
2
Johannes Kepler University Linz University, Clinic for Neurosurgery
Linz, Austria
Actively Recruiting
3
Medical University of Vienna, Department of Neurosurgery
Vienna, Austria
Actively Recruiting
4
Centre Hospitalier Universitaire Dijon Bourgogne, Department of Neurosurgery
Dijon, France
Actively Recruiting
5
Hospices Civils de Lyon - CHU de Lyon, Department of Neuro-Oncology
Lyon, France
Actively Recruiting
6
Assistance Publique - Hôpitaux de Marseille, Department of Neuro-Oncology
Marseille, France
Actively Recruiting
7
Centre Hospitalier Universitaire de Nice, Department of Neurosurgery
Nice, France
Actively Recruiting
8
Assistance Publique - Hôpitaux de Paris (AP-HP), Department of Neurosurgery
Paris, France
Actively Recruiting
9
Centre Hospitalier Universitaire de Saint-Étienne, Department of Neurosurgery
Saint-Etienne, France
Actively Recruiting
10
Institut de Cancérologie Strasbourg Europe (ICANS), Department of Oncology
Strasbourg, France
Actively Recruiting
11
Centre Hospitalier Régional et Universitaire de Tours (CHRU Tours), Department of Neurosurgery
Tours, France
Actively Recruiting
12
Helios Klinikum Erfurt
Erfurt, Germany, 99089
Actively Recruiting
13
Universitätsklinikum Münster
Münster, Germany, 48149
Actively Recruiting
14
Department of Neurosurgery, Hospital of Larissa & General Hospital of Larissa
Larissa, Greece, 412 21
Actively Recruiting
15
Department of Neurosurgery, Amsterdam University Medical Center
Amsterdam, Netherlands
Actively Recruiting
16
Department of Neurosurgery, Radboud University Medical Center, Nijmegen
Nijmegen, Netherlands
Actively Recruiting
17
Department of Neurosurgery, Haaglanden Medical Center, The Hague
The Hague, Netherlands
Actively Recruiting
18
Department of Neurosurgery, Centro Hospitalar Universitário Lisboa Norte - Hospital de Santa Maria
Lisbon, Portugal, 1649-035
Actively Recruiting
19
Department of Neurosurgery, L'Hospitalet de Llobregat, Barcelona
Barcelona, Spain
Actively Recruiting
20
University of Gothenburg, Department of Clinical Neuroscience
Gothenburg, Sweden
Not Yet Recruiting
21
University Hospital of Umeå, Department of Diagnostics and Intervention
Umeå, Sweden
Not Yet Recruiting
22
Universitätsspital Basel
Basel, Switzerland, 4031
Actively Recruiting
23
Dep. of Neurosurgery, Bern University Hospital
Bern, Switzerland, 3010
Actively Recruiting
24
Dep. of Neurosurgery, Centre hospitalier universitaire vaudois
Lausanne, Switzerland, 1011
Actively Recruiting
25
Ospedale Regionale di Lugano
Lugano, Switzerland, 6900
Actively Recruiting
Research Team
P
Philippe Schucht, MD
CONTACT
D
David Hasler
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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