Supramarginal Resection in Glioblastoma

Summary

Gliomas are the most common malignant brain tumor. Glioblastoma, WHO grade IV astrocytoma, is the most common subtype and unfortunately also the most aggressive subtype with median survival in population based cohorts being only 10 months. Extensive surgical resections followed by postoperative fractioned radiotherapy and concomitant and adjuvant temozolomide prolong survival and is the standard treatment.

The investigators think there is significant potential in individualized surgical decision-making in glioblastoma management. The idea that some patients are amendable to radical surgery, while others should be treated more conservatively, is not controversial in other fields of oncology. The current concept in all patients with glioblastoma is "maximum safe resection of the contrast enhancing tumor", but this may in selected cases be extended to simply "maximum safe resection" tailored to the patient and extent of disease at hand.

Densely proliferating tumor cells have been found from at an average of 10 mm beyond the margins of contrast enhancement in high-grade gliomas. There are now several case series, using various definitions of supramarginal resection, but they have in common that they report a benefit of resection with a margin. This potential benefit also comes together with an associated neurological risk, making this approach unethical and simply not feasible in the patients with glioblastoma as a whole.

Objective of this study is: To investigate if resection with a margin, that is significantly beyond the radiological contrast enhancement, improves survival in selected patients with glioblastoma.

Conditions

• Glioblastoma

Interventions

PROCEDURE

Supramarginal resection

Aim of supramarginal resection, where a margin of at least 10 mm is considered feasible prior to surgery. The resection is guided by the T2 volume (i.e. zone of edema) where removal of as much as possible of this zone (or beyond) is attempted as long as considered safe

PROCEDURE

Conventional surgery

Aim of gross total resection (i.e. removal of contrast enhancing tumor) according to institutional practice. No limit in use of technical adjuncts in this arm.

Sponsors & Collaborators

• Odense University Hospital

  collaborator OTHER

• Sahlgrenska University Hospital

  collaborator OTHER

• Turku University Hospital

  collaborator OTHER_GOV

• Karolinska University Hospital

  collaborator OTHER

• Norwegian University of Science and Technology

  collaborator OTHER

• Uppsala University Hospital

  collaborator OTHER

• University Hospital, Umeå

  collaborator OTHER

• Haukeland University Hospital

  collaborator OTHER

• Ullevaal University Hospital

  collaborator OTHER

• Rikshospitalet University Hospital

  collaborator OTHER

• Tampere University Hospital

  collaborator OTHER

• Helsinki University Central Hospital

  collaborator OTHER

• Kuopio University Hospital

  collaborator OTHER

• Oulu University Hospital

  collaborator OTHER

• Medical University of Vienna

  collaborator OTHER

• Paracelsus Medical University

  collaborator OTHER

• Medical Center Haaglanden, The Hague, The Netherlands

  collaborator UNKNOWN

• Erasmus Medical Center

  collaborator OTHER

• St. Olavs Hospital

  lead OTHER

Principal Investigators

• Asgeir S Jakola, MD, PhD · St.Olavs University Hospital and Sahlgrenska University Hospital

• Geir Bråthen, MD, PhD · St. Olavs Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-07-01

Primary Completion

2027-12-01

Completion

2030-12-01

Countries

• Austria
• Denmark
• Finland
• Netherlands
• Norway
• Sweden

Study Locations