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: 7942715
• 负责人: NICHOLAS M BARBARO
• 金额: $ 333.6万
• 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 2012-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7942715
• 关键词: Aftercare; Anterior Temporal Lobectomy; Binding; Biological Preservation; Clinical Trials; Confidence Intervals; Cost Measures; Epilepsy; Equipoise; Excision; Free Will; Freedom; Gamma Knife Radiosurgery; Inferior; Instruction; Language; Living Costs; Living Wills; Lobectomy; Measures; Memory; Methods; Morbidity - disease rate; Operative Surgical Procedures; Outcome; Patients; Phase III Clinical Trials; Population; Quality of life; Radiosurgery; Refractory; Resistance; Seizures; Side; Speech; Temporal Lobe; Temporal Lobe Epilepsy; Toxic effect; Treatment Cost; Upper arm; base; compare effectiveness; cost; cost effectiveness; improved; neuropsychological; treatment effect

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.

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 有医学上难治性癫痫发作。单侧颞叶癫痫发作的患者有极好的 颞叶切除术后无癫痫发作的机会。基于成功完成 初步临床试验显示，癫痫缓解率超过80%，毒性可接受， 对于经过精心挑选的患者进行放射外科手术或颞叶切除术是均衡的。目的 本研究旨在比较放射外科与颞叶切除术治疗鼻咽癌的疗效。 耐药的颞叶癫痫患者包括癫痫发作自由，癫痫发作减少， 神经心理结果、生活质量和成本效益。目的1：比较无癫痫发作的 伽玛刀治疗耐药颞叶患者的疗效和并发症 脑叶癫痫与开腹颞叶切除术的病例。我们的主要假设是放射外科和 肺叶切除术在治疗后25-36个月(癫痫发作一年)有同等的无癫痫发生率 治疗后两年开始的自由)。如果单边95%，两个手臂将被认为是相等的 可信区间排除了癫痫缓解率下降15%的可能性。我们的第二个假设是 与基线相比，放射外科将显著减少癫痫发作，并将减少2年。 在治疗后，这两种治疗方法的癫痫发作减少百分比相同。目标2：至 比较接受放射外科和颞叶手术的患者的神经心理结果， 尤其是关于语言占优势的大脑半球治疗患者的言语记忆功能。我们的 假说是，接受颞叶切除术治疗的以言语为主的颞叶癫痫的患者将 显示言语记忆显著下降，接受放射外科治疗的患者不会有 显著减少言语记忆的测量。目标3：确定质量发生了什么变化 颞叶癫痫患者放射外科治疗后与开放治疗后生活质量的比较 做手术。我们的主要假设是会有改善(比较治疗3年后的基线) 在两组的生活质量测量中。我们的第二个假设是，无论是开放手术 放射外科受试者因治疗而导致的生活质量指标一过性下降。 在治疗后的第一年内有效果，但对于成为 无癫痫发作，独立于治疗组。目标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比临时手术更具成本效益。 在病人的一生中进行肺叶切除术。