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

NCT05641220 | Not Yet Recruiting

• 1 other identifier: MEC-2022-0678
• Study Type: observational
• Target: 325
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Glioblastoma

Keywords

Glioblastoma; High grade glioma; Surgical management; Biopsy; Resection

Outcome Measures

Primary Outcomes (2)

• Overall survival (OS)

  Defined as the time from diagnosis to the death of the patient from any cause

  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

  Measured with the European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire (EORTC QLQ-C30), a higher scores means a worse outcome. We assume a minimally important difference of 7 between the 2 groups.

  6 weeks and 3 months after surgery

Secondary Outcomes (8)

• Progression-free survival (PFS), defined as the time from diagnosis to disease progression

  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.

  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.

  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.

  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

  at 6 weeks and 3 months postoperative

Study Arms (2)

Biopsy

Newly diagnosed elderly (\>70 years of age) glioblastoma patients who undergo biopsy

Resection

Newly diagnosed elderly (\>70 years of age) glioblastoma patients who undergo resection

Eligibility Criteria

• Age: 70 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults with presumed Glioblastoma on first diagnostic MRI-scan.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (6)

Northwest Clinics

Alkmaar, Netherlands

Location

Medical Spectrum Twente

Enschede, Netherlands

Location

Maastricht UMC

Maastricht, Netherlands

Location

Erasmus MC

Rotterdam, Netherlands

Location

Haaglanden MC

The Hague, Netherlands

Location

Elisabeth-TweeSteden Hospital

Tilburg, Netherlands

Location

MeSH Terms

Conditions

Glioblastoma; Glioma

Condition Hierarchy (Ancestors)

Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Arnaud J.P.E. Vincent, Prof. Dr.

  Erasmus MC, department of neurosurgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yvette de Haan, drs

CONTACT

+31612594000; y.dehaan@erasmusmc.nl

Arnaud J.P.E. Vincent, Prof. Dr.

CONTACT

a.vincent@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: December 7, 2022
• Study Start: January 1, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 7, 2022

Record last verified: 2022-11

Locations

NL (6)