Surgery for patients with recurrent glioblastoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Philippe Schucht, Prof. Dr. med. — Dep. of Neurosurgery, Inselspital Bern
• Study coordinator: Philippe Schucht, MD
• Email: resurge@insel.ch
• Phone: +41 31 66 4 28 65

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.