Stereotactic Radiotherapy for Non-small Cell Lung Cancer With Oligo-residual Intracranial Disease After First-line Third-generation EGFR Inhibitors: a Multicenter, Randomized Clinical Trial.
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
Despite the impressive response rate to third-generation EGFR-TKIs, resistance inevitably develops in most patients. Stereotactic radiotherapy plays a growing role in the management of patients with brain metastasis. This study aims to evaluate the efficacy and safety of stereotactic radiotherapy for oligo-residual intracranial disease after first-line third-generation EGFR Inhibitors.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed non-small cell lung cancer;
- •Clinical stage IV (AJCC, 8th edition, 2017);
- •EGFR mutations: EGFR L858R, EGFR exon 19 deletion;
- •Age ≥18 years;
- •KPS score ≥70;
- •Brain metastasis at the time of diagnosis;
- •Complete baseline imaging assessment of metastatic lesions, including enhanced MRI for brain;
- •Receiving first-line treatment with third-generation EGFR inhibitors;
- •After 3-6 months of third-generation EGFR inhibitor treatment, imaging review indicates no progression of extracranial lesions, and brain lesions are evaluated by thin-layer (1mm layer) enhanced MRI, meeting the following criteria:
- •No more than 10 remaining brain lesions;
- •The maximum diameter of the remaining brain lesions does not exceed 3cm;
- •At least one remaining brain lesion has a diameter greater than 5mm;
- •After evaluation by the researcher, all remaining brain lesions are suitable for stereotactic radiotherapy.
- •Patient informed consent.
排除标准
- •Poor compliance with the study protocol in the investigator's opinion;
- •Patients withdrew their informed consent and requested to withdraw from the study;
- •Patients were unable to receive regular doses of third-generation EGFR inhibitors due to other underlying conditions, viral side effects, economic factors, etc. (e.g., continuous discontinuation for more than 1 week, cumulative discontinuation for more than 2 weeks).
- •Patients did not follow the protocol for follow-up visits as required by this study.
研究组 & 干预措施
3rd generation EGFR-TKI+SRS
The experimental arm will undergo stereotactic radiotherapy targeting all residual lesions in the brain (completed in a single or multiple treatment courses within one month), while continuing EGFR-TKI therapy until disease progression or intolerable toxicity occurs.
干预措施: EGFR-TK Inhibitor (Drug)
3rd generation EGFR-TKI+SRS
The experimental arm will undergo stereotactic radiotherapy targeting all residual lesions in the brain (completed in a single or multiple treatment courses within one month), while continuing EGFR-TKI therapy until disease progression or intolerable toxicity occurs.
干预措施: Stereotactic radiotherapy (Radiation)
3rd generation EGFR-TKI
The control group will receive 3rd generation EGFR-TKI until disease progression or intolerable toxicity occurs.
干预措施: EGFR-TK Inhibitor (Drug)
结局指标
主要结局
Progression-free survival
时间窗: Two years
PFS was measured from the date of randomization to the date of disease progression as defined by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 or death
次要结局
- Overall Survival(Three years)
- Intracranial progression-free survival(Two years)
- Health-related quality of life per QLQ-C30(Two years)
- Health-related quality of life per QLQ-LC13(Two years)
- Percentage of Participants With Adverse Events(Two years)