Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2020-07-01
2030-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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.
Supramarginal surgery
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
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
Interventions
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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
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.
Eligibility Criteria
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Inclusion Criteria
2. Indication for surgical treatment and where supramarginal resection is considered possible according to the preoperative imaging. This consideration needs to be verified by two specialists in neurosurgery.
3. Negative work-up for other primary tumor(B)
4. Karnofsky performance status of 70 - 100.
A) If randomized to supramarginal surgery, intraoperative frozen section must conclude with "high-grade glioma" to be able to proceed. Surgery in two sessions is also possible in supramarginal group if there is no intraoperative frozen section available or frozen section indicate another diagnosis, but final histopathology reveals a glioblastoma. In case of surgery in two session, there must be no more than 30 days between procedures. See flow-chart in attachment 1.
B) No suspected primary tumor seen on CT chest, abdomen and pelvis. If relevant symptoms/clinical suspicion also supplement with mammography, dermatologist exam, relevant endoscopies etc.
Exclusion Criteria
2. Informed consent not possible (e.g. language barriers, aphasia, cognitive severely impaired).
3. Contrast enhancement volume bilateral OR involving corpus callosum.
5. Contrast enhancement involving several lobes.
6. History of major psychiatric disorder such as psychosis, schizophrenia and/or mood disorder (e.g. depression and bipolar disorder) in need of hospitalization
7. Unfit for participation for any other reason judged by the including physician
18 Years
ALL
No
Sponsors
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Odense University Hospital
OTHER
Sahlgrenska University Hospital
OTHER
Turku University Hospital
OTHER_GOV
Karolinska University Hospital
OTHER
Norwegian University of Science and Technology
OTHER
Uppsala University Hospital
OTHER
University Hospital, Umeå
OTHER
Haukeland University Hospital
OTHER
Ullevaal University Hospital
OTHER
Rikshospitalet University Hospital
OTHER
Tampere University Hospital
OTHER
Helsinki University Central Hospital
OTHER
Kuopio University Hospital
OTHER
Oulu University Hospital
OTHER
Medical University of Vienna
OTHER
Paracelsus Medical University
OTHER
Medical Center Haaglanden, The Hague, The Netherlands
UNKNOWN
Erasmus Medical Center
OTHER
St. Olavs Hospital
OTHER
Responsible Party
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Principal Investigators
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Asgeir S Jakola, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
St.Olavs University Hospital and Sahlgrenska University Hospital
Geir Bråthen, MD, PhD
Role: STUDY_DIRECTOR
St. Olavs Hospital
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Sami Tetri
Role: primary
Role: backup
Other Identifiers
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2019/1046
Identifier Type: -
Identifier Source: org_study_id
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