GlioblastomaNCT04243005
Supramarginal Resection in Glioblastoma
A study testing Supramarginal resection and Conventional surgery in people with Glioblastoma, run by St. Olavs Hospital at 17 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Supramarginal resection and Conventional surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 17 sitesin 6 countries
- Study dates
- 1 Jul 2020to 1 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- History of major psychiatric disorder such as psychosis, schizophrenia and/or mood disorder (e.g. depression and bipolar disorder) in need of hospitalization
- Unfit for participation for any other reason judged by the including physician
Trial locations and contacts
17 sites in 6 countries.
17 sites in 6 countries
Finland5 sites
Helsinki University Hospital
Helsinki
Kuopio University Hospital
Kuopio
Oulu University Hospital
Oulu
Tampere University Hospital
Tampere
Turku University Hospital
Turku
Norway4 sites
Haukeland University Hospital
Bergen
Oslo University Hospital, Rikshospitalet
Oslo
Ullevål University Hospital
Oslo
St Olavs Hospital
Trondheim
Sweden4 sites
Sahlgrenska University Hospital,
Gothenburg
Karolinska University Hospital
Stockholm
University Hospital of Umeå
Umeå
Uppsala University Hospital
Uppsala
About this study
Official title: Supramarginal Resection in Patients With Glioblastoma: A Randomised Controlled Trial
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.
Read more
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
- Being tested
- Supramarginal resection, Conventional surgery
- Keywords
- Neurosurgical procedures
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supramarginal resectionProcedure or 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
Conventional surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional surgery | Active comparator | 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. Receives: Procedure: Conventional surgery |
| Supramarginal surgery | Experimental | 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 Receives: Procedure: Supramarginal resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival according to intention-to-treat
Measured: 36 months after the last included patient.
Secondary outcomes (11)
Proportion alive
Proportion alive
Measured: 24 months after randomization.
Proportion alive
Proportion alive
Measured: 36 months after randomization.
Neurological function
Neurological assessment in Neuro-Oncology (NANO) Scale is a tool used by healthcare providers to objectively quantify the impairment caused by a tumor within the central nervous system. The NANO is composed of 9 items. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NANO scale score. The maximum possible score is 23, with the minimum score being a 0.
Measured: Early postoperative (i.e. prior to radiotherapy) to 36 months
Health-related quality of life assessed by EQ-5D 3L
The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Measured: Early postoperative (i.e. prior to radiotherapy) to 36 months
Health-related quality of life assessed by EORTC QLQ C30
The QLQ-C30 is a cancer health-related quality-of-life questionnaire that has been widely used in clinical trials and investigations using PROs for individual patient management. It includes five function domains (physical, emotional, social, role, cognitive), eight symptoms (fatigue, pain, nausea/vomiting, constipation, diarrhea, insomnia, dyspnea, and appetite loss), as well as global health/quality-of-life and financial impact. Subjects respond on a four-point scale from "not at all" to "very much" for most items. Most items use a "past week" recall period. Raw scores are linearly converted to a 0-100 scale with higher scores reflecting higher levels of function and higher levels of symptom burden.
Measured: Early postoperative (i.e. prior to radiotherapy) to 36 months
Health-related quality of life assessed by BN20
The European Organization for Research and Treatment of Cancer (EORTC) QLQ-BN20 is a quality of life assessment specific to brain neoplasms. Consists of 20 items that assess future uncertainty, visual disorder, motor dysfunction, and communication deficit. Items are presented as questions on a scale ranging from 1 = "not at all" to 4 = "very much." Higher score means worse outcome.
Measured: Early postoperative (i.e. prior to radiotherapy) to 36 months
Neurocognition
The Mini-Mental State Examination (MMSE) or Folstein test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. It examines functions including registration (repeating named prompts), attention and calculation, recall, language, ability to follow simple commands and orientation. Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment.
Measured: Early postoperative (i.e. prior to radiotherapy) to 36 months
Surgical complication
surgical complication grade 3, 4 and 5, assessed using the Dindo-Clavien classification
Measured: 30 days
Proportion with contrast remnant
Resection proportion with contrast remnant
Measured: Within 72 hours postoperative
Extent of resection, T2/FLAIR remnant
Proportion with remnant in terms of hyper intensity changes in T2/FLAIR
Measured: Within 72 hours postoperative
Margin of resection
Cavity volume/contrast enhancement volume
Measured: Within 72 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 Jul 2020
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Sahlgrenska University Hospital, Turku University Hospital, Karolinska University Hospital, Norwegian University of Science and Technology, Uppsala University Hospital, University Hospital, Umeå, Haukeland University Hospital, Ullevaal University Hospital, Rikshospitalet University Hospital, Tampere University Hospital, Helsinki University Central Hospital, Kuopio University Hospital, Oulu University Hospital, Medical University of Vienna, Paracelsus Medical University, Medical Center Haaglanden, The Hague, The Netherlands, Erasmus Medical Center
- Responsible party
- Sponsor
- Investigators
- Asgeir S Jakola, MD, PhD, Principal investigator, St.Olavs University Hospital and Sahlgrenska University HospitalGeir Bråthen, MD, PhD, Study director, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04243005
- Sponsor's protocol ID
- 2019/1046
- Status last verified
- Feb 2026
- First submitted
- 8 Jan 2020
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supramarginal Resection in Patients With Glioblastoma: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04243005
- Acronym / sponsor ID
- 2019/1046
- Conditions
- Glioblastoma
- Keywords
- Neurosurgical procedures
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Odense University Hospital, Sahlgrenska University Hospital, Turku University Hospital, Karolinska University Hospital, Norwegian University of Science and Technology, Uppsala University Hospital, University Hospital, Umeå, Haukeland University Hospital, Ullevaal University Hospital, Rikshospitalet University Hospital, Tampere University Hospital, Helsinki University Central Hospital, Kuopio University Hospital, Oulu University Hospital, Medical University of Vienna, Paracelsus Medical University, Medical Center Haaglanden, The Hague, The Netherlands, Erasmus Medical Center
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional surgery | Active comparator | Procedure: Conventional surgeryAim 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 | Experimental | Procedure: Supramarginal resectionAim 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supramarginal resectionAim 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 or surgery | Supramarginal surgery |
| Conventional surgeryAim 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. | Procedure or surgery | Conventional surgery |
Primary outcome
Overall survival
Time frame: 36 months after the last included patient.
Overall survival according to intention-to-treat
11 secondary outcomes
Proportion alive
Time frame: 24 months after randomization.
Proportion alive
Time frame: 36 months after randomization.
Neurological function
Time frame: Early postoperative (i.e. prior to radiotherapy) to 36 months
Health-related quality of life assessed by EQ-5D 3L
Time frame: Early postoperative (i.e. prior to radiotherapy) to 36 months
Health-related quality of life assessed by EORTC QLQ C30
Time frame: Early postoperative (i.e. prior to radiotherapy) to 36 months
Health-related quality of life assessed by BN20
Time frame: Early postoperative (i.e. prior to radiotherapy) to 36 months
Neurocognition
Time frame: Early postoperative (i.e. prior to radiotherapy) to 36 months
Surgical complication
Time frame: 30 days
Proportion with contrast remnant
Time frame: Within 72 hours postoperative
Extent of resection, T2/FLAIR remnant
Time frame: Within 72 hours postoperative
Margin of resection
Time frame: Within 72 hours postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asgeir S Jakola, MD, PhD principal investigator
St.Olavs University Hospital and Sahlgrenska University Hospital
Geir Bråthen, MD, PhD study director
St. Olavs Hospital
17 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supramarginal resection and Conventional surgery in people with Glioblastoma, run by St. Olavs Hospital at 17 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Finland, Norway, Sweden, Netherlands, Austria and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 36 months after the last included patient.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.