Radiosurgery vs lobectomy for temporal lobe epilepsy: Phase 3 Clinical Trial

放射外科与肺叶切除术治疗颞叶癫痫：3 期临床试验

• 批准号: 7918003
• 负责人: NICHOLAS M BARBARO
• 金额: $ 261.22万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-01 至 2014-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7918003
• 关键词: Radiosurgery; vs; lobectomy; temporal; lobe

DESCRIPTION (provided by applicant): It is estimated that 0.5%-1.0% of the U.S. population has epilepsy, and that 20% of patients with epilepsy have medically refractory seizures. Patients with unilateral temporal lobe seizure onsets have an excellent chance of becoming seizure-free following temporal lobectomy. Based on the successful completion of a Pilot Clinical Trial showing that seizure-free rates were in excess of 80% and with acceptable toxicity, there is equipoise for treating well-selected patients with either radiosurgery or temporal resection. The purpose of this study is to compare the effectiveness of radiosurgery with temporal lobectomy in the treatment of patients with pharmaco-resistant temporal lobe epilepsy including freedom from seizures, seizure reduction, neuropsychological outcomes, quality of life and cost-effectiveness. Aim 1: To compare the seizure-free outcomes and morbidity of Gamma Knife radiosurgery (GKS) for patients with pharmaco-resistant temporal lobe epilepsy with those of open temporal lobectomy. Our primary hypothesis is that radiosurgery and lobectomy will have equivalent seizure-free rates at 25-36 months following therapy (one-year of seizure freedom beginning 2 years after treatment). The two arms will be considered equivalent if a one-sided 95% confidence interval precludes a decrease in seizure-free rate of 15%. Our secondary hypothesis is that radiosurgery will result in significant reductions in seizures compared to baseline and that by 2 years following treatment the percentage reduction in seizures will be identical for these two treatments. Aim 2: To compare the neuropsychological outcomes in patients undergoing radiosurgery and temporal lobe surgery, in particular with respect to verbal memory function for language-dominant hemisphere treated patients. Our hypothesis is that patients treated for speech-dominant temporal lobe seizures with temporal lobectomy will show significant reductions in verbal memory and those patients treated with radiosurgery will not have significant reduction in measures of verbal memory. Aim 3: To determine what changes occur in the quality of life of patients with temporal lobe epilepsy following radiosurgical treatment as compared with open surgery. Our primary hypothesis is that there will be improvements (comparing baseline with 3 years post- treatment) in quality of life measures in both groups. Our secondary hypothesis is that both open surgery and radiosurgery subjects will undergo transient reductions in quality of life measures caused by treatment effects during the first year following treatment, but that quality of life will improve for subjects who become seizure-free, independent of treatment group. Aim 4: To compare the cost-effectiveness of radiosurgery compared with open surgery. We hypothesize that radiosurgery will be cost-effective compared to temporal lobectomy over the lifetime of the patient. The purpose of this study is to compare two methods of treatment of surgically-amenable epilepsy: standard anterior temporal lobectomy versus noninvasive Gamma Knife radiosurgery. Beyond the main outcome of the number of patients rendered seizure-free, we will compare preservation of language functions, quality of life measures, and the cost of treatment. PUBLIC HEALTH RELEVANCE: Pharmaco-resistant epilepsy is a significant health problem for which new therapies are needed. This study is designed to compare traditional surgery (temporal lobectomy) with the novel technique of Gamma Knife radiosurgery in the treatment of patients with temporal lobe epilepsy. This therapy would offer a non-invasive approach to this problem with potential reduction in morbidity (surgical complications, reduced language function). The study is designed to show that this therapy will improve quality of life for patients with epilepsy with reduced complications and cost-savings.

描述(申请人提供)：据估计，美国有0.5%-1.0%的人口患有癫痫，20%的癫痫患者患有药物难治性癫痫发作。单侧颞叶癫痫发作的患者在颞叶切除术后有很好的机会摆脱癫痫。根据一项试点临床试验的成功完成，表明癫痫缓解率超过80%，且毒性可接受，因此可以通过放射外科或颞叶切除来治疗经过精心挑选的患者。本研究的目的是比较放射外科和颞叶切除术在治疗耐药的颞叶癫痫患者中的疗效，包括癫痫的缓解、癫痫的减少、神经心理结果、生活质量和成本-效果。目的：比较伽玛刀放射外科(GKS)与开腹颞叶切除术治疗难治性颞叶癫痫的疗效和并发症。我们的基本假设是，放射外科手术和肺叶切除术在治疗后25-36个月(治疗后两年开始的一年无癫痫发作)具有相同的无癫痫发生率。如果单边95%的可信区间排除了15%的无癫痫发作发生率，这两个武器将被认为是相等的。我们的第二个假设是，与基线相比，放射外科治疗将导致癫痫发作的显着减少，并且在治疗后2年，这两种治疗方法的癫痫发作减少的百分比将相同。目的：比较放射外科手术和颞叶手术患者的神经心理结果，特别是语言占优势的大脑半球患者的言语记忆功能。我们的假设是，接受颞叶切除术治疗的以言语为主的颞叶癫痫患者的言语记忆将显着下降，而接受放射外科治疗的患者的言语记忆指标不会显着下降。目的：确定与开放手术相比，放射外科治疗后颞叶癫痫患者的生活质量发生了哪些变化。我们的基本假设是，两组患者的生活质量指标都会有所改善(比较基线和治疗后3年)。我们的第二个假设是，开放手术和放射外科受试者在治疗后的第一年内，由于治疗效果，生活质量指标都会出现一过性的下降，但对于没有癫痫发作、独立于治疗组的受试者，生活质量将得到改善。目的：比较放射外科与开放手术的成本-效果。我们假设，在患者的一生中，放射外科手术将比颞叶切除术更具成本效益。本研究的目的是比较两种治疗可手术治疗的癫痫的方法：标准前颞叶切除术和非侵入性伽玛刀放射外科治疗。除了主要结果是无癫痫发作的患者数量外，我们还将比较语言功能的保留、生活质量指标和治疗成本。 公共卫生相关性：耐药癫痫是一个重大的健康问题，需要新的治疗方法。本研究旨在比较传统手术(颞叶切除术)与伽玛刀放射外科新技术治疗颞叶癫痫的疗效。这种疗法将为这一问题提供一种非侵入性的方法，并有可能减少发病率(手术并发症、语言功能下降)。这项研究旨在表明，这种疗法将改善癫痫患者的生活质量，减少并发症并节省成本。