Surgical approach for glioblastoma treatment

Supramarginal Resection in Patients with Glioblastoma: a Randomised Controlled Trial

This study tests if a more aggressive type of brain surgery can help some patients with glioblastoma do better, while others might need a gentler approach.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: St. Olavs Hospital (Academic / other)
• Locations: 17 sites (Vienna and 16 other locations)
• Trial ID: NCT04243005 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of supramarginal resection in patients diagnosed with glioblastoma, a highly aggressive brain tumor. The study aims to personalize surgical decision-making by determining whether some patients can benefit from more radical surgical approaches while others may require conservative treatment. The approach involves a thorough evaluation by two neurosurgery specialists to assess the feasibility of supramarginal resection based on preoperative imaging. The trial seeks to improve patient outcomes by tailoring surgical interventions to individual disease characteristics.

Who should consider this trial

Good fit: Ideal candidates for this study are patients with a suspected diagnosis of supratentorial glioblastoma who are eligible for surgical treatment.

Not a fit: Patients with other primary tumors or those whose condition does not allow for supramarginal resection may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved survival rates and quality of life for glioblastoma patients.

How similar studies have performed: While the concept of individualized surgical approaches is established in other oncology fields, this specific method for glioblastoma is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. A suspected diagnosis of supratentorial glioblastoma by MRI.(A)
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:

1. Not willing to be randomized.
2. Informed consent not possible (e.g. language barriers, aphasia, cognitive severely impaired).
3. Contrast enhancement volume bilateral OR involving corpus callosum.
4. Contrast enhancement along the ependymal lining of ventricles (contact is however not an exclusion criteria).
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

Where this trial is running

Vienna and 16 other locations

• Medical University of Vienna — Vienna, Austria (Recruiting)
• Odense University Hospital — Odense, Denmark (Recruiting)
• Helsinki University Hospital — Helsinki, Finland (Recruiting)
• Kuopio University Hospital — Kuopio, Finland (Recruiting)
• Oulu University Hospital — Oulu, Finland (Recruiting)
• Tampere University Hospital — Tampere, Finland (Recruiting)
• Turku University Hospital — Turku, Finland (Recruiting)
• Erasmus MC — Rotterdam, Netherlands (Recruiting)
• Haaglanden MC — The Hague, Netherlands (Recruiting)
• Haukeland University Hospital — Bergen, Norway (Recruiting)
• Oslo University Hospital, Rikshospitalet — Oslo, Norway (Recruiting)
• Ullevål University Hospital — Oslo, Norway (Recruiting)
• St Olavs Hospital — Trondheim, Norway (Recruiting)
• Sahlgrenska University Hospital, — Göteborg, Sweden (Recruiting)
• Karolinska University Hospital — Stockholm, Sweden (Recruiting)
• University Hospital of Umeå — Umeå, Sweden (Recruiting)
• Uppsala University Hospital — Uppsala, Sweden (Recruiting)

Study contacts

• Principal investigator: Asgeir S Jakola, MD, PhD — St.Olavs University Hospital and Sahlgrenska University Hospital
• Study coordinator: Asgeir S Jakola, MD, PhD

Conditions Glioblastoma; Neurosurgical procedures