SeizURe Frequency During a Radiotherapy COurse for High-Grade Gliomas
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Number of Participants With Increased Seizure Activity
研究概览
简要总结
The primary objective of this trial is to evaluate the seizure frequency during a course of radiotherapy for high-grade (grade III or IV) gliomas. The patients keep a seizure diary during and up to 6 weeks following radiotherapy. Every day, the patients document the number (and type) of seizures and intake of anti-epileptic medication. At the end of radiotherapy, the patients are asked to complete a questionnaire regarding their satisfaction with the seizure diary.
Progression of seizure activity compared to baseline is defined as increase of frequency of seizures by more than 50%, increase of severity of seizures, or as Initiation or increase anti-epileptic medication by at least 25%. To obtain an objective assessment of seizure activity in addition to patient reported outcomes, an electroencephalography (EEG) is performed during the first and the sixth week of radiotherapy, and during the sixth week following radiotherapy.
The main goal of the study is to generate objective data regarding the occurrence, frequency and severity of seizures as well as regarding the use of anti-epileptic medication during the course of radiotherapy for high-grade gliomas. These data are used to evaluate the potential effect of radiotherapy on occurrence of seizures in these patients and generate hypotheses. Therefore, statistical analyses of primary and secondary endpoints focus on descriptive methods. If statistical tests are applied, they are to be interpreted from an exploratory perspective.
Thirty-two patients with documented start of radiotherapy and any documented diary data at baseline and after start of radiotherapy should be subjected to statistical analysis. Assuming that 10% of patients do not fulfil these requirements, a total of 35 patients should be enrolled to this trial. Recruitment should be completed within 12 months.
With this sample size a one-sample binomial test with a one-sided significance level of 2.5% has a power of 80% to yield statistical significance if the rate of patients with progression of seizure events during the course of radiotherapy compared to baseline is 30% (rate under the alternative hypothesis) assuming a 'natural' background progression-rate of 10% without radiotherapy (null hypothesis). If the natural course of the disease would lead to a progression-rate of 5% without radiotherapy only, the power increases to 98%.
详细描述
Gliomas represent the most common type of primary brain tumors and are frequently associated with clinical symptoms including seizures. The majority of patients with high-grade gliomas (grade III or IV according to the classification of the World Health Organization) receive radiotherapy with or without chemotherapy, either after neurosurgical resection or as definitive treatment after biopsy. For patients with grade III or IV gliomas, pre-treatment seizure rates of 29-67% and 9-45%, respectively, were reported. In a study from our group, the prevalence of seizures prior to radiotherapy was 48.8% in patients with grade III gliomas and 21.5% in patients with grade IV gliomas, respectively.
Radiotherapy can improve long-term seizure outcomes in glioma patients. However, due to an acute inflammatory reaction, radiotherapy may lead to acute onset or progression of clinical symptoms including seizures. To our knowledge, no studies are available that focused on the subacute effect of radiotherapy on seizure frequency during radiation treatment in glioma patients. These data would be important to improve the monitoring and, if required, the anti-epileptic treatment of these patients.
The primary objective of this trial is to evaluate the seizure frequency during a course of radiotherapy for high-grade (grade III or IV) gliomas.
The patients keep a seizure diary during the period of radiotherapy and up to 6 weeks following radiotherapy. Every day, the patients document the number (and type) of seizures and intake of anti-epileptic medication. At the end of radiotherapy, the patients are asked to complete a questionnaire regarding their satisfaction with the seizure diary. One a week during the radiotherapy course, the seizure diary will be reviewed by a medical staff member. During the 6 weeks following radiotherapy, the patients are contacted by phone (to minimise the number of visits to the hospital) once a week to obtain the information from the seizure diary regarding number and type of seizures. During and following radiotherapy, the weekly findings of the seizure diary are discussed with a neurologist to initiate or adjust anti-epileptic medication, if necessary. Patient satisfaction with the seizure diary will be assessed at the end of radiotherapy using a questionnaire and subjected to descriptive analysis. In case of a dissatisfaction rate >40%, the seizure diary will be considered not suitable for patients with high-grade gliomas.
To assess the rate of patients with progression of seizure activity during the course of radiotherapy compared to baseline, defined as
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven grade III or IV glioma
- •Indication for normo-fractionated radiotherapy
- •Age ≥18 years
- •Written informed consent
- •Capacity of the patient to contract
排除标准
- •Pregnancy, Lactation
- •Expected Non-Compliance (patient unable to use the seizure diary)
结局指标
主要结局
Number of Participants With Increased Seizure Activity
时间窗: 6 - 6.5 weeks (during the radiotherapy course)
Seizure activity will be assessed using the patient's seizure diary.
次要结局
未报告次要终点
研究者
Prof Dirk Rades
Professor and Chair
University Hospital Schleswig-Holstein