The BIOPSY-trial: Biopsy versus Resection in Elderly Glioblastoma Patients. A prospective cohort study.

Withdrawn

• Conditions: Brain malignancy; brain tumor; 10029211

• Registration Number: NL-OMON52545
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 325

Inclusion Criteria

1. Age >=70 years
2. Tumor diagnosed as glioblastoma on MRI with distinct ring-like pattern of
contrast enhancement with thick irregular walls and a core area reduced signal
suggestive of tumor necrosis as assessed by the surgeon.
3. Karnofsky Performance Score (KPS) >=70
4. Written Informed consent

Exclusion Criteria

1. Tumors of the cerebellum, brain stem or midline
2. Multifocal contrast enhancing lesions
3. Substantial non-contrast enhancing tumor areas suggesting low grade gliomas
with malignant transformation
4. Medical reasons precluding MRI (e.g. pacemaker)
5. Inability to give consent as assessed by neurosurgeon (e.g. language barrier)
6. Severe aphasia prohibiting neurolinguistic testing and comprehension of
informed consent
7. Previous brain tumor surgery
8. Previous low-grade glioma
9. Second primary malignancy within the past 5 years with the exception of
adequately treated in situ carcinoma of any organ or basal cell carcinoma of
the skin.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1) Overall survival (OS) at 12 months, defined as the time from diagnosis to<br /><br>the death of the patient from any cause.<br /><br><br /><br>2) The difference in mean changes scores of physical functioning, as measured<br /><br>with the EORTC QLQ-C30 physical functioning scale, between the two groups at 6<br /><br>weeks and 3 months after surgery compared to mean score on baseline.</p><br>