Precision Radiation Treatment for Epilepsy (PRECISION)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Radiotherapy adapted Engel classification (RAEC) is I, II or III
研究概览
简要总结
The PRECISION-study offers a non-invasive, curative intervention for drug-resistant localised epilepsy patients who are not eligible for surgery. The intervention will consist of a single LINAC based SRT treatment and is given by the radiation-oncologist after detailed localisation of the epileptogenic zone with the neurologist, radiologist and neurosurgeon.
This intervention will make curative-intent treatment possible where this could otherwise not be given and is a non-invasive and non-competitive alternative to epilepsy surgery. It is expected that the health costs for this curative treatment will not exceed standard treatment, such as lifelong medication and neuromodulation.
详细描述
In this PRECISION-study including adult patients with drug-resistant, localised epilepsy, not eligible for surgery, we offer non-invasive linear accelerator (LINAC) based Stereotactic Radiotherapy (SRT) with curative intent.
SRT and stereotactic radio-surgery (SRS) have been used to treat several types of neoplasms in the brain for several decades. Several publications (level 2 evidence) have shown the potential value of SRT in patients with drug-resistant epilepsy, however no level-1 evidence was given enabling guideline development. A recent systematic review from our institution has shown that SRT resulted in a significant seizure cure or reduction in 58% of the 170 included patients, within 2 years after treatment. Interestingly, the ROSE trial, randomising between open surgery and SRT, has demonstrated a seizure remission of 52% in the radiotherapy group after 2 years with the proportion of seizure-free patients still increasing with a longer follow-up up to 74% after 3 years. Therefore, SRT may be considered a curative treatment for drug resistant localised epilepsy. Currently, randomized controlled SRT epilepsy trials are lacking and there is a need for high quality evidence, so SRT can be clinically implemented for localised drug-resistant epilepsy patients in the Netherlands as well.
The PRECISION-study is a randomised waitlist-controlled trial in which SRT is the intervention and AED continuation and neuromodulation are the standard treatment with a 1:1 randomization. After 2-year follow up the waitlist-control group, patients are offered the intervention (optional).
We hypothesize that SRT alters the epileptogenic cerebral tissue to yield a reduction in seizures and possibly cure after 2 years, with a significant increase in the patients' quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations
- •Willingness to use contraception by a method that is deemed effective by the Investigator during the SRT treatment and for at least 30 days following the SRT therapy
- •The patient or caretaker is able to keep an epilepsy diary
- •The patient has a diagnosis of epilepsy established by a dedicated neurologist
- •The patient had at least 3 focal-onset seizures over a 3-month period despite two or more antiepileptic medication trials (according ILAE Task Force on therapeutic strategies)
- •Video electroencephalography and work-up in the epilepsy surgery working group to determine a well-circumscribed seizure focus is available
- •Evidence (e.g. 3T-MRI or a clear SEEG delineation) of the anatomic region to be targeted with SRT, correlating with the EZ hypothesis;
- •A functional MRI to lateralize language or localize visual, motor and/or sensory eloquent cortex has been performed in selected patients (if the lesion is expected to be located, based on anatomy, in the language areas).
- •The patient has completed a standard battery of neuropsychological testing
- •The patient been deemed an appropriate candidate for stereotactic radiosurgery by a dedicated Radiation Oncologist and Neurosurgeon/Epileptologist and referred for the study by one of the Dutch regional multidisciplinary epilepsy surgery working groups
- •Patients that were rejected for surgery in an earlier stage can participate in the trial if the last change of the NVS/DBS settings were more than 1 year ago or NVS/DBS was not (yet) tried.
排除标准
- •If a radiation treatment plan without exceeding the constraints for the organs at risk is not feasible.
- •Prior cranial radiotherapy
- •If radiotherapy treatment is not possible for diverse reasons.
- •If the subject has clinically significant and uncontrolled major other medical condition(s) including but not limited to:
- •ii. psychiatric illness/social situation that would limit compliance with study requirements iii. any medical condition, with the opinion of the study investigator, places the subject at an unacceptably high risk for toxicities iv. Progressive co-morbidity which limits overall survival.
结局指标
主要结局
Radiotherapy adapted Engel classification (RAEC) is I, II or III
时间窗: Baseline (before treatment), 1 year, 2 year, 3 year, 4 year and 5 year after treatment
Radiotherapy adapted Engel classification (RAEC). For analysis of outcomes in the incidence of seizures, we use in this study the Engel classification, adapted for radiotherapy. This includes four classes: class I - seizure free, class II - rarely seizures, class III improved, more than 75% IV- no significant improvement.
次要结局
- Seizure-free days(Baseline (before treatment), 1 year, 2 year, 3 year, 4 year and 5 year after treatment)
- EQ-5D 5 Level (EQ-5D-5L)(Baseline (before treatment), 1 year, 2 year, 3 year, 4 year and 5 year after treatment)
- 'Cost-effectiveness Resource use' is measured with iMTA Productivity Cost Questionnaire (iPCQ)(Baseline (before treatment), 1 year, 2 year, 3 year, 4 year and 5 year after treatment)
- Seizure frequency(Baseline (before treatment), 1 year, 2 year, 3 year, 4 year and 5 year after treatment)
- Type of epilepsy(Baseline (before treatment), 1 year, 2 year, 3 year, 4 year and 5 year after treatment)
- 'Patients' experiences' are measured with the instrument 'Patient Reported Experience Measures Medical Specialtic Care' (PREM MSZ) Medical Specialistic Care (PREM MSZ)(Baseline (before treatment), 1 year, 2 year, 3 year, 4 year and 5 year after treatment)
- The Assessment of Quality of Life-8 Dimensions Score (AQoL-8D Score)(Baseline (before treatment), 1 year, 2 year, 3 year, 4 year and 5 year after treatment)
- 'Cost-effectiveness Resource use' is measured with iMTA Medical Consumption Questionnaire (iMCQ)(Baseline (before treatment), 1 year, 2 year, 3 year, 4 year and 5 year after treatment)
- Quality of life in Epilepsy-31 Inventory (QOLIE-31)(Baseline (before treatment), 1 year, 2 year, 3 year, 4 year and 5 year after treatment)
- 'Informal care' is meausured with iMTA Valuation of Informal Care Questionnaire (iVICQ)(Baseline (before treatment), 1 year, 2 year, 3 year, 4 year and 5 year after treatment)