Biopsy Versus Resection in Elderly Glioblastoma Patients. A Prospective Cohort Study.

Overview

This trial is set up as a prospective observational cohort study to identify if either biopsy or resection should be the surgical modality of choice in elderly glioblastoma patients with a newly diagnosed tumor. Patients who are considered eligible for GBM resection or biopsy will be included. Through shared-decision making patients and their treating physicians will decide upon resection or biopsy. Written informed consent will be obtained. Participants will be followed for 1 year postoperative to assess potential differences in health-related quality of life and overall survival. Follow-up will consist of health-related quality of life questionaires and neurological assessment at 6 weeks, 3 months, 6 months and 12 months postoperative. Additionally Cognitive and neuro-linguistic tests will be done at 3 months postoperative. These will be compared to results pre-operative. After surgery, patients will receive standard adjuvant treatment with concomitant Temozolomide and radiation therapy, and standard follow-up. Patients in whom the diagnosis GBM is not confirmed in histological analyses will be excluded from the study. Total study duration will be 4 years, of which 3 years will comprise patient inclusion, with a follow-up duration of 1 year.

Primary outcome measures

• Overall survival (OS) [Time frame: 12 months]
• The difference in mean change score of physical functioning, as measured with the EORTC QLQ-C30 physical functioning scale, between the two groups at 6 weeks and 3 months after surgery compared to mean score on baseline [Time frame: 6 weeks and 3 months after surgery]

Secondary outcome measures (8)

• Progression-free survival (PFS), defined as the time from diagnosis to disease progression [Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months after surgery]
• The difference in mean change score of physical functioning, as measured with the EORTC QLQ-C30 physical functioning scale, between the two groups at 6 months and 12 months after surgery compared to mean score on baseline. [Time frame: at 6 months and 12 months after surgery]
• The proportion of patients with deterioration, improvement or stable physical functioning, as measured with the EORTC QLQ-C30 physical functioning scale at 6 weeks and 3 months compared to baseline. [Time frame: 6 weeks and 3 months after surgery]
• Descriptive reporting of changes in the mean scores on the other health-related quality of life (HRQoL) scales at 6 weeks and 3 months after surgery. [Time frame: at 6 weeks and 3 months postoperative]
• Proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration, improvement or stability at 6 weeks and 3 months after surgery [Time frame: at 6 weeks and 3 months postoperative]
• Descriptive reporting of differences between the groups in cognitive and neuro-linguistic screening at 3 months compared to baseline. [Time frame: 3 months postoperative]
• Comparison of the (S)AEs in both groups. [Time frame: 6 weeks postoperative]
• Cost-effectiveness between the two treatments. [Time frame: 12 months postoperative]

Eligibility criteria

Inclusion criteria

• Age ≥70 years
• 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.
• Karnofsky Performance Score (KPS) ≥70
• Written Informed consent

Exclusion criteria

• Tumors of the cerebellum, brain stem or midline
• Multifocal contrast enhancing lesions
• Substantial non-contrast enhancing tumor areas suggesting low grade gliomas with malignant transformation
• Medical reasons precluding MRI (e.g. pacemaker)
• Inability to give consent as assessed by neurosurgeon (e.g. language barrier)
• Severe aphasia prohibiting neurolinguistic testing and comprehension of informed consent
• Previous brain tumor surgery
• Previous low-grade glioma
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Netherlands · 6 centers

• Northwest Clinics — Alkmaar
• Medical Spectrum Twente — Enschede
• Maastricht UMC — Maastricht
• Erasmus MC — Rotterdam
• Haaglanden MC — The Hague
• Elisabeth-TweeSteden Hospital — Tilburg

Identifiers

NCT: NCT05641220 · MEC-2022-0678

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗