Beyond Observed Lesion Diameter (BOLD) glioblastoma surgery: a multicenter randomized controlled trial

Phase 2

Conditions: brain tumor
glioblastoma
10029211
10009720

Registration Number: NL-OMON56831

Lead Sponsor: St. Olavs University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

The subjects must fulfill all the following inclusion criteria to be eligible
for participation in the study, unless otherwise specified:
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. Age 18 years or older.
5. Karnofsky performance status of 70 - 100.41

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

Potential study subjects who meet any of the following criteria are not
eligible for participation in the study:
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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint is overall survival according to intention-to-treat<br /><br>principle 36 months after the last included and randomized patient.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Investigate survival 24 and 36 months after randomization.<br /><br>• Investigate the neurological function using the Neurological assessment in<br /><br>Neuro-Oncology (NANO) at early postoperative control and at study closure.<br /><br>• Determine health-related quality of life using EQ-5D 3L, EORTC QLQ C30 and<br /><br>BN20 questionnaires.<br /><br>• Determine Neurocognition according to Mini Mental Status Examination (MMSE).<br /><br>• Investigate perioperative 30 day surgical complications grade 3, 4 and 5,<br /><br>assessed using the Dindo-Clavien classification.<br /><br>• Determine the extent of resection using unintended contrast remnant, T2/FLAIR<br /><br>remnant and Cavity volume/contrast enhancement volume data</p><br>