Surgery for Recurrent Glioblastoma

NCT02394626 | Recruiting Phase 2 DMC

• 1 other identifier: 368/14
• Study Type: interventional
• Target: 120
• Locations: 9 countries
• Sites: 25

Brief 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.

Conditions

Glioblastoma

Keywords

Recurrent glioblastoma; Surgery; Complete resection of enhancing tumor; Survival; Quality of life

Outcome Measures

Primary Outcomes (1)

• Overall survival from the date of inclusion

  From the date of inclusion until death/end of study, assessed up to 5.7 years

Secondary Outcomes (5)

• Recruitment rate for all screened patients

  Screening and inclusion

• Progression-free survival

  From the date of inclusion until the date of objective progression or the date of patient's death, whichever occurs first, assessed up to 5.7 years

• Morbidity of surgery

  Every 3 months up to 2 years or until death, assessed up to 5.7 years

• Total number of days spent at home after recurrence

  From the date of inclusion until death/end of study, assessed up to 5.7 years

• Total number of days spent outside home after recurrence

  From the date of inclusion until death/end of study, assessed up to 5.7 years

Study Arms (2)

Surgery followed by adjuvant second-line therapy

EXPERIMENTAL

Surgery followed by adjuvant second-line therapy

Procedure: Surgery followed by adjuvant second-line therapy

Second-line therapy alone

ACTIVE COMPARATOR

Second-line therapy alone

Procedure: Second-line therapy alone

Interventions

Surgery followed by adjuvant second-line therapy PROCEDURE

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.

Surgery followed by adjuvant second-line therapy

Second-line therapy alone PROCEDURE

Patients randomized to the non-surgical cohort receive second-line therapy according to local guidelines. Modalities thereof are not stipulated by study protocol.

Second-line therapy alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (25)

Universitätsklinikum Innsbruck

Innsbruck, Austria

RECRUITING

Johannes Kepler University Linz University, Clinic for Neurosurgery

Linz, Austria

RECRUITING

Medical University of Vienna, Department of Neurosurgery

Vienna, Austria

RECRUITING

Centre Hospitalier Universitaire Dijon Bourgogne, Department of Neurosurgery

Dijon, France

RECRUITING

Hospices Civils de Lyon - CHU de Lyon, Department of Neuro-Oncology

Lyon, France

RECRUITING

Assistance Publique - Hôpitaux de Marseille, Department of Neuro-Oncology

Marseille, France

RECRUITING

Centre Hospitalier Universitaire de Nice, Department of Neurosurgery

Nice, France

RECRUITING

Assistance Publique - Hôpitaux de Paris (AP-HP), Department of Neurosurgery

Paris, France

RECRUITING

Centre Hospitalier Universitaire de Saint-Étienne, Department of Neurosurgery

Saint-Etienne, France

RECRUITING

Institut de Cancérologie Strasbourg Europe (ICANS), Department of Oncology

Strasbourg, France

RECRUITING

Centre Hospitalier Régional et Universitaire de Tours (CHRU Tours), Department of Neurosurgery

Tours, France

RECRUITING

Helios Klinikum Erfurt

Erfurt, 99089, Germany

RECRUITING

Universitätsklinikum Münster

Münster, 48149, Germany

RECRUITING

Department of Neurosurgery, Hospital of Larissa & General Hospital of Larissa

Larissa, 412 21, Greece

RECRUITING

Department of Neurosurgery, Amsterdam University Medical Center

Amsterdam, Netherlands

RECRUITING

Department of Neurosurgery, Radboud University Medical Center, Nijmegen

Nijmegen, Netherlands

RECRUITING

Department of Neurosurgery, Haaglanden Medical Center, The Hague

The Hague, Netherlands

RECRUITING

Department of Neurosurgery, Centro Hospitalar Universitário Lisboa Norte - Hospital de Santa Maria

Lisbon, 1649-035, Portugal

RECRUITING

Department of Neurosurgery, L'Hospitalet de Llobregat, Barcelona

Barcelona, Spain

RECRUITING

University of Gothenburg, Department of Clinical Neuroscience

Gothenburg, Sweden

NOT YET RECRUITING

University Hospital of Umeå, Department of Diagnostics and Intervention

Umeå, Sweden

NOT YET RECRUITING

Universitätsspital Basel

Basel, 4031, Switzerland

RECRUITING

Dep. of Neurosurgery, Bern University Hospital

Bern, 3010, Switzerland

RECRUITING

Dep. of Neurosurgery, Centre hospitalier universitaire vaudois

Lausanne, 1011, Switzerland

RECRUITING

Ospedale Regionale di Lugano

Lugano, 6900, Switzerland

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Philippe Schucht, Prof. Dr. med.

  Dep. of Neurosurgery, Inselspital Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Schucht, MD

CONTACT

+41 31 66 4 28 65; resurge@insel.ch

David Hasler

CONTACT

+41 31 632 76 80; david.hasler@insel.ch

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2015
• First Posted: March 20, 2015
• Study Start: May 1, 2015
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

GR (1); CH (4); FR (8); NL (3); SE (2); ES (1); PT (1); DE (2); AU (3)