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Surgery for Recurrent Glioblastoma
Sponsor: Insel Gruppe AG, University Hospital Bern
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.
Official title: RESURGE - Randomized Controlled Comparative Phase II Trial on Surgery for Glioblastoma Recurrence
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2015-05-01
Completion Date
2028-12
Last Updated
2026-02-02
Healthy Volunteers
No
Conditions
Interventions
Surgery followed by adjuvant second-line therapy
Surgery: Surgery must take place between day 1 and 14 after study inclusion and within 21 days from the MRI on which recurrence was diagnosed. The modalities of surgery and the choice of pre- and intra-operative technical adjuncts is at the treating neurosurgery discretion. Surgery must take place between day 1 and 14 after study inclusion and within 21 days from the MRI on which recurrence was diagnosed. The modalities of surgery and the choice of pre- and intra-operative technical adjuncts is at the treating neurosurgery discretion. However, some form of intra-operative resection control (iMRI or intra-operative fluorescence) and function control (electrophysiology) should be available to the surgeon and used when warranted. Adjuvant second-line therapy: Patients will be seen after surgery by the treating neurooncologist. Modalities of adjuvant second-line therapy are individually defined according to local guidelines and are not stipulated by study protocol.
Second-line therapy alone
Patients randomized to the non-surgical cohort receive second-line therapy according to local guidelines. Modalities thereof are not stipulated by study protocol.
Locations (25)
Universitätsklinikum Innsbruck
Innsbruck, Austria
Johannes Kepler University Linz University, Clinic for Neurosurgery
Linz, Austria
Medical University of Vienna, Department of Neurosurgery
Vienna, Austria
Centre Hospitalier Universitaire Dijon Bourgogne, Department of Neurosurgery
Dijon, France
Hospices Civils de Lyon - CHU de Lyon, Department of Neuro-Oncology
Lyon, France
Assistance Publique - Hôpitaux de Marseille, Department of Neuro-Oncology
Marseille, France
Centre Hospitalier Universitaire de Nice, Department of Neurosurgery
Nice, France
Assistance Publique - Hôpitaux de Paris (AP-HP), Department of Neurosurgery
Paris, France
Centre Hospitalier Universitaire de Saint-Étienne, Department of Neurosurgery
Saint-Etienne, France
Institut de Cancérologie Strasbourg Europe (ICANS), Department of Oncology
Strasbourg, France
Centre Hospitalier Régional et Universitaire de Tours (CHRU Tours), Department of Neurosurgery
Tours, France
Helios Klinikum Erfurt
Erfurt, Germany
Universitätsklinikum Münster
Münster, Germany
Department of Neurosurgery, Hospital of Larissa & General Hospital of Larissa
Larissa, Greece
Department of Neurosurgery, Amsterdam University Medical Center
Amsterdam, Netherlands
Department of Neurosurgery, Radboud University Medical Center, Nijmegen
Nijmegen, Netherlands
Department of Neurosurgery, Haaglanden Medical Center, The Hague
The Hague, Netherlands
Department of Neurosurgery, Centro Hospitalar Universitário Lisboa Norte - Hospital de Santa Maria
Lisbon, Portugal
Department of Neurosurgery, L'Hospitalet de Llobregat, Barcelona
Barcelona, Spain
University of Gothenburg, Department of Clinical Neuroscience
Gothenburg, Sweden
University Hospital of Umeå, Department of Diagnostics and Intervention
Umeå, Sweden
Universitätsspital Basel
Basel, Switzerland
Dep. of Neurosurgery, Bern University Hospital
Bern, Switzerland
Dep. of Neurosurgery, Centre hospitalier universitaire vaudois
Lausanne, Switzerland
Ospedale Regionale di Lugano
Lugano, Switzerland