Biopsy Versus Resection in Elderly Glioblastoma Patients. A Prospective Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 325
- 试验地点
- 6
- 主要终点
- Overall survival (OS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 70 Years 至 95 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Overall survival (OS)
时间窗: 12 months
Defined as the time from diagnosis to the death of the patient from any cause
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
时间窗: 6 weeks and 3 months after surgery
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.
次要结局
- 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)
- Descriptive reporting of differences between the groups in cognitive and neuro-linguistic screening at 3 months compared to baseline.(3 months postoperative)
- Comparison of the (S)AEs in both groups.(6 weeks postoperative)
- Cost-effectiveness between the two treatments.(12 months postoperative)
研究者
A.J.P.E. VIncent
Prof. Dr.
Erasmus Medical Center