Observation or Upfront Cranial RT in Oncogene Driver Mutated NSCLC With Asymptomatic Brain Metastases: A Phase III Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Intracranial progression free survival at 24 months
研究概览
简要总结
Tyrosine Kinase Inhibitors (TKIs) especially higher generation TKI have higher CNS penetration rates and have shown favorable response rates in brain metastases. Brain radiotherapy/surgery is the standard treatment in brain metastases especially symptomatic metastases, however, the role of local treatment especially in driver mutation-positive non-small cell lung cancer with asymptomatic brain metastases is being questioned given their potential side effects. No randomized trial has shown the superiority of early vs delayed cranial RT in asymptomatic BM of driver mutated NSCLC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Patients with ECOG performance status of 0-2
- •Patients with pathologically proven diagnosis of NSCLC
- •Patients with positive oncogene mutation status (EGFR/ALK)
- •Patients with radiologically confirmed parenchymal brain metastases
- •Patients with asymptomatic Synchronous or Metachronous brain metastases
- •Patients willing for written informed consent and must be willing to comply with the specified follow-up schedule
排除标准
- •Patients with CSF dissemination only without any parenchymal brain metastases
- •Patients with brain metastases in the brain stem
- •Patients with prior history of radiation therapy to the brain
- •Patient not suitable for TKI therapy as per the medical oncologist
- •Pregnant or lactating females
研究组 & 干预措施
Upfront Cranial Radiotherapy
Stereotactic radiosurgery or Whole brain radiotherapy upfront in asymptomatic brain metastases
干预措施: Stereotactic radiosurgery/whole brain radiotherapy (Radiation)
Upfront Cranial Radiotherapy
Stereotactic radiosurgery or Whole brain radiotherapy upfront in asymptomatic brain metastases
干预措施: Tyrosine kinase inhibitor (Drug)
Observation (Delayed Cranial Radiotherapy)
Observation (Delayed Cranial radiotherapy) of Asymptomatic brain metastases
干预措施: Tyrosine kinase inhibitor (Drug)
结局指标
主要结局
Intracranial progression free survival at 24 months
时间窗: 2 year
Intracranial progression free survival will be defined as the time from the date of randomization until the date of intracranial progression is documented. Death without intracranial progression will be considered as a competing event. Intracranial response will be graded as per the Response Assessment in Neuro-Oncology (RANO) guidelines for brain metastases
次要结局
- Progression free survival(upto 2 year)
- Toxicity using CTC v5.1(Upto 2 years)
- Overall Survival(Upto 5-year)
- Neurocognition toxicity(Upto 12 months)
- Local Control(Upto 2 years)
研究者
Anil Tibdewal
Dr. Anil Tibdewal, Associate Professor, Radiation Oncology
Tata Memorial Hospital