Short versus Long-term Levetiracetam in Brain Tumors: A Phase 3 Randomized Controlled Trial (LIBRA)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 604
- 试验地点
- 1
- 主要终点
- 2-year seizure-free
研究概览
简要总结
Patients with brain tumors may experience sudden bursts of uncontrolled electrical activities in their brain, which is medically termed a seizure. In routine medical practice, doctors prescribe medications to prevent the consequences of seizures and avoid the occurrence of seizure events. Levetiracetam is the commonly preferred anti-seizure medicine in patients with brain tumors. This drug has reduced the risk of seizure events occurring but is associated with a risk of side effects such as increased headache, drowsiness, loss of muscle coordination, and psychological challenges in patients. In patients undergoing appropriate treatment for brain tumors and controlled of seizures in the initial few months of levetiracetam, the chance of further seizures is relatively low. The optimal duration to give levetiracetam is not well defined for these patients, and currently as standard treatment levetiracetam is continued for 2-3 years. This study aims to answer this question by comparing patients on a short course of levetiracetam (experimental arm) versus a longer course of levetiracetam (standard arm), with the anticipation that a shorter duration of treatment will not lead to increased seizure episodes. The study will be conducted at Tata Memorial Centre with a population of 604 patients for a duration of seven years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •History of seizure Histological diagnosis of primary brain tumor Supratentorial location of primary tumor Controlled on levetiracetam monotherapy for 6 months Index surgery within 1 year Karnofsky Performance Scale (KPS) ≥ 50 Imaging within the previous 6 months demonstrating radiologically stable disease status and clinical stability during screening.
排除标准
- •Include the cumulative incidence of seizures impacting awareness 2-year seizure-free survival in each stratum.
- •Quality of life assessment Cost-benefit analysis Progression-free survival Overall survival Post hoc analysis per histological category for seizure control.
结局指标
主要结局
2-year seizure-free
时间窗: 2 year after accrual of last patient. Considering the expected period of enrolment being 5 years, and another 2 years for follow-up, the primary outcome will be evaluated at 7 years.
survival for both the arms. Date of seizure relapse after randomization will be considered as an event.
时间窗: 2 year after accrual of last patient. Considering the expected period of enrolment being 5 years, and another 2 years for follow-up, the primary outcome will be evaluated at 7 years.
次要结局
- Overall survival(7 year)
- Progression-free survival(7 year)
- Quality of life(7 year)
研究者
Dr Archya Dasgupta
Tata Memorial Centre Mumbai