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ACTIVE NOT RECRUITING
NCT04243005
NA

Supramarginal Resection in Glioblastoma

Sponsor: St. Olavs Hospital

View on ClinicalTrials.gov

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.

Official title: Supramarginal Resection in Patients With Glioblastoma: A Randomised Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2020-07-01

Completion Date

2030-12-01

Last Updated

2026-03-03

Healthy Volunteers

No

Conditions

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.

Locations (17)

Medical University of Vienna

Vienna, Austria

Odense University Hospital

Odense, Denmark

Helsinki University Hospital

Helsinki, Finland

Kuopio University Hospital

Kuopio, Finland

Oulu University Hospital

Oulu, Finland

Tampere University Hospital

Tampere, Finland

Turku University Hospital

Turku, Finland

Erasmus MC

Rotterdam, Netherlands

Haaglanden MC

The Hague, Netherlands

Haukeland University Hospital

Bergen, Norway

Oslo University Hospital, Rikshospitalet

Oslo, Norway

Ullevål University Hospital

Oslo, Norway

St Olavs Hospital

Trondheim, Norway

Sahlgrenska University Hospital,

Gothenburg, Sweden

Karolinska University Hospital

Stockholm, Sweden

University Hospital of Umeå

Umeå, Sweden

Uppsala University Hospital

Uppsala, Sweden