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NCT04243005Active, not recruiting

Supramarginal Resection in Glioblastoma

Supramarginal Resection in Patients With Glioblastoma: A Randomised Controlled Trial

Source: ClinicalTrials.gov · Last updated 3 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
90 (estimated)
First submitted
8 Jan 2020
Start date
1 Jul 2020
Primary completion date
1 Dec 2027
Lead sponsor
St. Olavs Hospital
Diseases
Glioblastoma
NCT number
NCT04243005

What you commit to

  • Study type: Interventional
  • Planned participants: 90
  • From 1 Jul 2020 to the primary completion date, 1 Dec 2027
  • 17 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • History of major psychiatric disorder such as psychosis, schizophrenia and/or mood disorder (e.g. depression and bipolar disorder) in need of hospitalization

Other

  • Not willing to be randomized.
  • Informed consent not possible (e.g. language barriers, aphasia, cognitive severely impaired).
  • Contrast enhancement volume bilateral OR involving corpus callosum.
  • Contrast enhancement along the ependymal lining of ventricles (contact is however not an exclusion criteria).
  • Contrast enhancement involving several lobes.
  • Unfit for participation for any other reason judged by the including physician

Who the study is looking for

  • A suspected diagnosis of supratentorial glioblastoma by MRI.(A)
  • 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.
  • Negative work-up for other primary tumor(B)
  • Karnofsky performance status of 70 - 100.
  • 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.
  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (17)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical University of Vienna
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ViennaAustriaUnknown status
Odense University Hospital
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OdenseDenmarkUnknown status
Helsinki University Hospital
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HelsinkiFinlandUnknown status
Kuopio University Hospital
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KuopioFinlandUnknown status
Oulu University Hospital
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OuluFinlandUnknown status
Tampere University Hospital
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TampereFinlandUnknown status
Turku University Hospital
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TurkuFinlandUnknown status
Erasmus MC
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RotterdamNetherlandsUnknown status
Haaglanden MC
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The HagueNetherlandsUnknown status
Haukeland University Hospital
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BergenNorwayUnknown status
Oslo University Hospital, Rikshospitalet
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OsloNorwayUnknown status
Ullevål University Hospital
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OsloNorwayUnknown status
St Olavs Hospital
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TrondheimNorwayUnknown status
Sahlgrenska University Hospital
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GothenburgSwedenUnknown status
Karolinska University Hospital
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StockholmSwedenUnknown status
University Hospital of Umeå
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UmeåSwedenUnknown status
Uppsala University Hospital
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UppsalaSwedenUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.