Tyrosine Kinase Inhibitor Followed by Thoracic Radiotherapy for Stage IV EGFR Mutant Non-small Cell Lung Cancer: A Phase II Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
In this phase II trial with single arm, we aim to investigate the clinical efficacy and toxicity profile of local radiotherapy on all disease sites for EGFR-mutant oligo-metastatic NSCLC (no more than 3 metastatic lesions) who did not experience disease progression after at least 3 months of TKI therapy.
详细描述
Tyrosine kinase inhibitor (TKI) has been widely accepted as the first-line therapy for stage IV NSCLC with active mutation of EGFR. Olio-metastasis is a disease status between localized and extended status of disease, namely with the limited number of lesions, which is generally defined as ≤ 5. A couple of phase II studies have shown that consolidation local management was able to prolong the local-regional tumor control and might further improve overall survival (OS) for oligo-metastatic NSCLC who have gained disease control from systemic therapy. However, there is lack of data regarding whether local radiotherapy (RT) could improve progression free survival (PFS) and OS for NSCLC with active EGFR mutation who have benefited from TKI. In this phase II trial with single arm, we aim to investigate the clinical efficacy and toxicity profile of local radiotherapy on all disease sites for EGFR-mutant oligo-metastatic NSCLC (no more than 3 metastatic lesions) who did not experience disease progression after at least 3 months of TKI therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age ≥18 and ≤75;
- •ECOG performance status 0-1;
- •Patients must provide study specific informed consent prior to study entry;
- •Pathologically or cytologically diagnosed as NSCLC;
- •EGFR activating mutation to TKI approved by histology, cytology or circulation tumor DNA;
- •Stage IV NSCLC with ≤ 3 metastatic lesions (AJCC, 8th ed.) confirmed by meticulous radiographic examination. Brain MRI and 18F PET/CT is strongly recommended unless there is a contraindication;
- •Patients have received≥3 months of TKI therapy and do not received disease progression;
- •HB ≥ 10.0 g/dL;
- •Absolute number of neutrophil granulocyte ≥ 1.5 × 109/L;
- •Absolute number of PLT ≥ 100 × 109/L;
- •Total bilirubin ≤ 1.5 folds of the maximum extent;
- •ALT and AST ≤ 2.0 folds of the maximum extent;
- •Cr ≤ 1.25 folds of the maximum extent and Ccr ≥ 60mLl/min.
排除标准
- •Patients have received thoracic radiotherapy before;
- •Malignant pleural effusion, pericardial effusion or peritoneal effusion;
- •Patients have severe pulmonary comorbidity, such as ILD, COPD or other active pulmonary disease;
- •Any unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, CHF (NYHA ≥ II), MI within 6 months of enrollment, severe arrhythmia requiring medication，hepatic, nephric or metabolic disease;
- •HIV infection；
- •Pregnancy or lactation women;
- •ECOG status ≥2；
- •Mixed SCLC component;
- •Other factors that is considered ineligible.
研究组 & 干预措施
Local therapy
Consolidation local radiotherapy
干预措施: Local radiation therapy (Radiation)
结局指标
主要结局
Progression free survival
时间窗: 1 year
Duration between the first date of TKI administration and disease progression or last follow-up
次要结局
- Time to appearance of new metastatic lesions(1 year)
- Treatment related toxicity(1 year)
- EORTC Quality of life(1 year)
- Overall survival(2 year)
- Overall response(1 month after RT)
- Time to progression of initial lesions(1 year)
研究者
Jingbo Wang
Principal Investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences