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

Glioblastoma Clinical Trial

— BIOPSY  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05641220
• Other study ID #: MEC-2022-0678
• Status: Not yet recruiting
• Start date: January 1, 2023
• Est. completion date: January 1, 2027

Study information

• Verified date: November 2022
• Source: Erasmus Medical Center
• Contact: Yvette de Haan, drs
• Phone: +31612594000
• Email: y.dehaan[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 325
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glioblastoma

Locations

Country	Name	City	State
Netherlands	Northwest Clinics	Alkmaar
Netherlands	Haaglanden MC	Den Haag
Netherlands	Medical Spectrum Twente	Enschede
Netherlands	Maastricht UMC	Maastricht
Netherlands	Erasmus MC	Rotterdam
Netherlands	Elisabeth-TweeSteden Hospital	Tilburg

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)	Defined as the time from diagnosis to the death of the patient from any cause	12 months
Primary	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	Progression-free survival (PFS), defined as the time from diagnosis to disease progression	Increase in residual tumor volume of more than 25%, or occurrence of a new tumor lesion with a volume greater than 0.175cm3), or death. As according to the RANO criteria.	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
Secondary	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.	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.	at 6 months and 12 months after surgery
Secondary	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.	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.	6 weeks and 3 months after surgery
Secondary	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.	HRQoL will be measured using the Measured with the European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life questionnaire (QLQ-C30), EORTC , EORTC brain cancer module (QLQ-BN20) and EuroQol 5 Dimensions (EQ-5D) questionnaires. A higher scores means a worse outcome.	at 6 weeks and 3 months postoperative
Secondary	Proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration, improvement or stability at 6 weeks and 3 months after surgery	In which deterioration is defined as an increase of at least one point and improvement as a decrease of at least one point on the total NIHSS score compared to this score at baseline.	at 6 weeks and 3 months postoperative
Secondary	Descriptive reporting of differences between the groups in cognitive and neuro-linguistic screening at 3 months compared to baseline.	as measured by the Aphasia Bedside Check (ABC), Shortened Token Test, verbal fluency (category and letter), Montreal Cognitive Assessment (MOCA) and optionally CAT-NL Picture Description and Object Naming.	3 months postoperative
Secondary	Comparison of the (S)AEs in both groups.		6 weeks postoperative
Secondary	Cost-effectiveness between the two treatments.	Measured as total intramural medical costs, for a 1 year time horizon	12 months postoperative