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

项目总结（见说明）： 据估计，0.5%-1.0%的美国人口患有癫痫，20%的癫痫患者 有医学上难治的癫痫单侧颞叶癫痫发作的患者有极好的 颞叶切除术后无复发的可能性。根据成功完成的一项 初步临床试验表明，无瘤率超过80%，毒性可接受， 是均衡的治疗精心挑选的病人无论是放射外科或颞切除术。的目的 本研究旨在比较放射外科与颞叶切除术治疗颞叶癫痫的疗效。 耐药性颞叶癫痫患者，包括无癫痫发作、癫痫发作减少， 神经心理学结果、生活质量和成本效益。目的1：比较无菌 伽玛刀放射外科（GKS）治疗药物耐药颞叶肿瘤患者的结局和发病率 开放性颞叶切除术的癫痫。我们的主要假设是放射外科和 在治疗后25-36个月（癫痫发作一年），肺叶切除术将具有相同的无癫痫率 治疗后2年开始自由）。如果单侧95% 置信区间排除了15%的无瘤率下降。我们的第二个假设是 与基线相比，放射外科手术将导致癫痫发作显著减少， 治疗后，这两种治疗的癫痫发作减少百分比相同。 比较接受放射外科手术和颞叶手术的患者的神经心理学结果， 特别是关于语言主导半球治疗患者言语记忆功能。我们 一种假设是，接受颞叶切除术治疗的语言主导型颞叶癫痫患者将 显示出言语记忆的显着下降，那些接受放射外科治疗的患者不会有 目的3：确定在非文字记忆的测量中发生了什么变化。 颞叶癫痫患者接受放射外科治疗后的寿命与开放手术相比 手术我们的主要假设是会有改善（比较基线与治疗后3年） 在生活质量的测量上。我们的第二个假设是开放手术 放射外科受试者将经历治疗引起的生活质量测量的短暂降低 在治疗后的第一年内，效果，但生活质量将改善受试者， 目的4：比较放射外科治疗的成本-效果 与开放手术相比。我们假设，放射外科手术将是成本效益相比，颞 在患者的一生中进行肺叶切除术。

PROJECT SUMMARY (See instructions): 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 posttreatment) 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.