The PROGRAM-study: Awake Mapping Versus Asleep Mapping Versus No Mapping for Glioblastoma Resections
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 453
- 试验地点
- 8
- 主要终点
- Extent of resection
研究概览
简要总结
The study is designed as an international, multicenter prospective cohort study. Patients with presumed glioblastoma (GBM) in- or near eloquent areas on diagnostic MRI will be selected by neurosurgeons. Patients will be treated following one of three study arms: 1) a craniotomy where the resection boundaries for motor or language functions will be identified by the "awake" mapping technique (awake craniotomy, AC); 2) a craniotomy where the resection boundaries for motor functions will be identified by "asleep" mapping techniques (MEPs, SSEPs, continuous dynamic mapping); 3) a craniotomy where the resection boundaries will not be identified by any mapping technique ("no mapping group"). All patients will receive follow-up according to standard practice.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years and ≤ 90 years
- •Tumor diagnosed as GBM on MRI as assessed by the neurosurgeon
- •Tumors situated in or near eloquent areas; motor cortex, sensory cortex, subcortical pyramidal tract, speech areas or visual areas as indicated on MRI (Sawaya Grading II and II)
- •The tumor is suitable for resection (according to neurosurgeon)
- •Written informed consent
排除标准
- •Tumors of the cerebellum, brain stem or midline
- •Multifocal contrast enhancing lesions
- •Medical reasons precluding MRI (e.g. pacemaker)
- •Inability to give written informed consent (e.g. because of severe language barrier)
- •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
Extent of resection
时间窗: Assessed within 72 hours on postoperative MRI scan
Resection percentage as assessed by an independent neuroradiologist on MRI contrast images with volumetric analysis
Neurological morbidity
时间窗: Between baseline and 6 weeks/3 months/6 months postoperatively
NIHSS deterioration of 1 point or more as compared to baseline value.
次要结局
- Overall survival(Between surgery and 12 months postoperatively)
- Onco-functional outcome(Between baseline and 6 weeks/3 months/6 months postoperatively)
- Frequency and severity of Serious Adverse Events (SAEs)(Between surgery and 6 weeks postoperatively)
- Progression-free survival(Between surgery and 12 months postoperatively)
- MRC deterioration (for motor gliomas)(Between baseline and 6 weeks/3 months/6 months postoperatively)
- Residual tumor volume(Assessed within 72 hours on postoperative MRI scan)
研究者
Jasper Gerritsen
Principal Investigator
Erasmus Medical Center