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

Обзор

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.

Первичные конечные точки

• Overall survival (OS) [Срок оценки: 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 [Срок оценки: 6 weeks and 3 months after surgery]

Вторичные конечные точки (8)

• Progression-free survival (PFS), defined as the time from diagnosis to disease progression [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: 3 months postoperative]
• Comparison of the (S)AEs in both groups. [Срок оценки: 6 weeks postoperative]
• Cost-effectiveness between the two treatments. [Срок оценки: 12 months postoperative]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Нидерланды · 6 центров

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

Идентификаторы

NCT: NCT05641220 · MEC-2022-0678

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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