Supramarginal Resection in Patients with Glioblastoma: a Randomised Controlled Trial

Status: Recruiting
Location: See all (17) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

⁃ 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.

Locations
Other Locations
Austria
Medical University of Vienna
RECRUITING
Vienna
Denmark
Odense University Hospital
RECRUITING
Odense
Finland
Helsinki University Hospital
RECRUITING
Helsinki
Kuopio University Hospital
RECRUITING
Kuopio
Oulu University Hospital
RECRUITING
Oulu
Tampere University Hospital
RECRUITING
Tampere
Turku University Hospital
RECRUITING
Turku
Netherlands
Erasmus MC
RECRUITING
Rotterdam
Haaglanden MC
RECRUITING
The Hague
Norway
Haukeland University Hospital
RECRUITING
Bergen
Oslo University Hospital, Rikshospitalet
RECRUITING
Oslo
Ullevål University Hospital
RECRUITING
Oslo
St Olavs Hospital
RECRUITING
Trondheim
Sweden
Sahlgrenska University Hospital,
RECRUITING
Gothenburg
Karolinska University Hospital
RECRUITING
Stockholm
University Hospital of Umeå
RECRUITING
Umeå
Uppsala University Hospital
RECRUITING
Uppsala
Contact Information
Primary
Asgeir S Jakola, MD, PhD
legepost@gmail.com
+47 72 57 30 00
Backup
Sasha Gulati, MD, PhD
sasha.gulati@ntnu.no
+47 72 57 30 00
Time Frame
Start Date: 2020-07-01
Estimated Completion Date: 2030-03
Participants
Target number of participants: 90
Treatments
Active_comparator: 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.
Experimental: 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
Sponsors
Collaborators: University Hospital, Umeå, Oulu University Hospital, Tampere University Hospital, Ullevaal University Hospital, Karolinska University Hospital, Odense University Hospital, Medical Center Haaglanden, The Hague, The Netherlands, Paracelsus Medical University, Uppsala University Hospital, Helsinki University Central Hospital, Erasmus Medical Center, Rikshospitalet University Hospital, Medical University of Vienna, Haukeland University Hospital, Turku University Hospital, Sahlgrenska University Hospital, Kuopio University Hospital, Norwegian University of Science and Technology
Leads: St. Olavs Hospital

This content was sourced from clinicaltrials.gov