Surgery for patients with recurrent glioblastoma

RESURGE - Randomized Controlled Comparative Phase II Trial on Surgery for Glioblastoma Recurrence

This study is testing if surgery to remove tumors can help people with recurrent glioblastoma live longer when combined with other treatments, compared to just getting those treatments alone.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Insel Gruppe AG, University Hospital Bern (Academic / other)
• Drugs / interventions: radiation, chemotherapy
• Locations: 25 sites (Innsbruck and 24 other locations)
• Trial ID: NCT02394626 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of craniotomy and tumor resection followed by adjuvant second-line therapy compared to receiving second-line therapy alone in patients with recurrent glioblastoma. The study is designed as a randomized controlled trial to address the uncertainty surrounding the survival benefits of surgical intervention at recurrence. Participants will be carefully selected based on specific MRI criteria to ensure that surgery can be performed safely without significant risk to neurological function. The trial seeks to provide clearer evidence on whether surgical resection can improve survival outcomes for these patients.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of recurrent glioblastoma who have previously undergone surgery and meet specific MRI criteria for safe resection.

Not a fit: Patients with multifocal recurrence, significant neurological risks, or those who do not meet the MRI criteria for safe surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide evidence that surgery at recurrence improves survival and quality of life for patients with glioblastoma.

How similar studies have performed: While retrospective studies suggest a survival benefit from surgery for recurrent glioblastoma, this trial is novel in its randomized controlled design aimed at providing definitive evidence.

Eligibility criteria

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

Where this trial is running

Innsbruck and 24 other locations

• 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, Germany (Recruiting)
• Universitätsklinikum Münster — Münster, Germany (Recruiting)
• Department of Neurosurgery, Hospital of Larissa & General Hospital of Larissa — Larissa, 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, 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, Switzerland (Recruiting)
• Dep. of Neurosurgery, Bern University Hospital — Bern, Switzerland (Recruiting)
• Dep. of Neurosurgery, Centre hospitalier universitaire vaudois — Lausanne, Switzerland (Recruiting)
• Ospedale Regionale di Lugano — Lugano, Switzerland (Recruiting)

Study contacts

• Principal investigator: Philippe Schucht, Prof. Dr. med. — Dep. of Neurosurgery, Inselspital Bern
• Study coordinator: Philippe Schucht, MD

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