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NCT02394626Recruiting

Surgery for Recurrent Glioblastoma

Official recordSimplified version

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.

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

Contacts

The trial team's contact details are shown on request.

See the official trial record
Status
Recruiting
Phase
Phase 2
Study type
Interventional
Countries
Switzerland, France, Germany, Austria, Greece, Netherlands, Portugal, Spain, Sweden
Sponsor
Insel Gruppe AG, University Hospital Bern(Other)
Protocol no.
368/14
Conditions
Glioblastoma
Interventions
Procedure

Treatments studied

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

Collaborators

European Organisation for Research and Treatment of Cancer - EORTC

Locations · 23

  • Basel, SwitzerlandUniversitätsspital BaselRecruiting at this site
  • Bern, SwitzerlandDep. of Neurosurgery, Bern University HospitalRecruiting at this site
  • Lausanne, SwitzerlandDep. of Neurosurgery, Centre hospitalier universitaire vaudoisRecruiting at this site
  • Lugano, SwitzerlandOspedale Regionale di LuganoRecruiting at this site
  • Dijon, FranceCentre Hospitalier Universitaire Dijon Bourgogne, Department of NeurosurgeryRecruiting at this site
  • Lyon, FranceHospices Civils de Lyon - CHU de Lyon, Department of Neuro-OncologyRecruiting at this site
  • Marseille, FranceAssistance Publique - Hôpitaux de Marseille, Department of Neuro-OncologyRecruiting at this site
  • Nice, FranceCentre Hospitalier Universitaire de Nice, Department of NeurosurgeryRecruiting at this site
  • Paris, FranceAssistance Publique - Hôpitaux de Paris (AP-HP), Department of NeurosurgeryRecruiting at this site
  • Saint-Etienne, FranceCentre Hospitalier Universitaire de Saint-Étienne, Department of NeurosurgeryRecruiting at this site
  • Strasbourg, FranceInstitut de Cancérologie Strasbourg Europe (ICANS), Department of OncologyRecruiting at this site
  • Tours, FranceCentre Hospitalier Régional et Universitaire de Tours (CHRU Tours), Department of NeurosurgeryRecruiting at this site
  • Erfurt, GermanyHelios Klinikum ErfurtRecruiting at this site
  • Münster, GermanyUniversitätsklinikum MünsterRecruiting at this site
  • Innsbruck, AustriaUniversitätsklinikum InnsbruckRecruiting at this site
  • Linz, AustriaJohannes Kepler University Linz University, Clinic for NeurosurgeryRecruiting at this site
  • Vienna, AustriaMedical University of Vienna, Department of NeurosurgeryRecruiting at this site
  • Larissa, GreeceDepartment of Neurosurgery, Hospital of Larissa & General Hospital of LarissaRecruiting at this site
  • Amsterdam, NetherlandsDepartment of Neurosurgery, Amsterdam University Medical CenterRecruiting at this site
  • Nijmegen, NetherlandsDepartment of Neurosurgery, Radboud University Medical Center, NijmegenRecruiting at this site
  • The Hague, NetherlandsDepartment of Neurosurgery, Haaglanden Medical Center, The HagueRecruiting at this site
  • Lisbon, PortugalDepartment of Neurosurgery, Centro Hospitalar Universitário Lisboa Norte - Hospital de Santa MariaRecruiting at this site
  • Barcelona, SpainDepartment of Neurosurgery, L'Hospitalet de Llobregat, BarcelonaRecruiting at this site

In total, worldwide, 23 of the 25 sites listed in the registry are recruiting; the other 2 are not currently recruiting.

Site status per the ClinicalTrials.gov registry (last update posted: February 2, 2026).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

See also

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.