Glioma Adaptive Radiotherapy with Development of an Artificial Intelligence Workflow- (GLADIATOR)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Proportion of patients undergoing volumetric and biological adaptation.
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
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Histological diagnosis of diffuse glioma.
- •Patients with IDH-negative GBM (stratum A) and IDH-mutant glioma (astrocytoma or oligodendroglioma) needing radiotherapy (stratum B).
- •Age: 18-70 years.
- •3.Karnofsky Performance Scale (KPS) ≥60.
排除标准
- •Multifocal or multicentric disease • Not eligible for radical intent radiation.
- •• IDH status unknown or uninterpretable (IHC or gene sequencing).
- •• Use of prior radiotherapy to the head-neck region or brain or chemotherapy.
- •• Contraindication/unable to undergo MRI or PET scan during radiation.
结局指标
主要结局
Proportion of patients undergoing volumetric and biological adaptation.
时间窗: Cumulative rate of symptomatic radionecrosis (RN) at 2 years.
• Cumulative rate of symptomatic radionecrosis (RN) at 2 years.
时间窗: Cumulative rate of symptomatic radionecrosis (RN) at 2 years.
次要结局
- Progression free survival,Overall survival(4 years)
研究者
Dr Archya Dasgupta
Tata Memorial Centre,Mumbai
