Clinical trial NCT05641220: Biopsy Versus Resection in Elderly Glioblastoma Patients. A Prospective Cohort Study.
Official title: Biopsy Versus Resection in Elderly Glioblastoma Patients. A Prospective Cohort Study.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Glioblastoma
Keywords: Glioblastoma
High grade glioma
Surgical management
Biopsy
Resection
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 325
Sex: ALL
Minimum age (years): 70
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults with presumed Glioblastoma on first diagnostic MRI-scan.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: 12 months
measure: 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
timeFrame: 6 weeks and 3 months after surgery
Secondary outcomes:
measure: Progression-free survival (PFS), defined as the time from diagnosis to disease progression
timeFrame: 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
measure: 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.
timeFrame: at 6 months and 12 months after surgery
measure: 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.
timeFrame: 6 weeks and 3 months after surgery
measure: 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.
timeFrame: at 6 weeks and 3 months postoperative
measure: Proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration, improvement or stability at 6 weeks and 3 months after surgery
timeFrame: at 6 weeks and 3 months postoperative
measure: Descriptive reporting of differences between the groups in cognitive and neuro-linguistic screening at 3 months compared to baseline.
timeFrame: 3 months postoperative
measure: Comparison of the (S)AEs in both groups.
timeFrame: 6 weeks postoperative
measure: Cost-effectiveness between the two treatments.
timeFrame: 12 months postoperative
Other outcomes:
Locations:
city: Alkmaar
country: Netherlands
facility: Northwest Clinics
city: Den Haag
country: Netherlands
facility: Haaglanden MC
city: Enschede
country: Netherlands
facility: Medical Spectrum Twente
city: Maastricht
country: Netherlands
facility: Maastricht UMC
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Tilburg
country: Netherlands
facility: Elisabeth-TweeSteden Hospital
Study officials:
affiliation: Erasmus MC, department of neurosurgery
name: Arnaud J.P.E. Vincent, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: