Whole Brain Radiotherapy Concurrent With EGFR-TKI Versus EGFR-TKI Alone in the Treatment of Non-small Cell Lung Cancer Patients With Brain Metastasis
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 601
- 试验地点
- 1
- 主要终点
- intracranial PFS (iPFS)
研究概览
简要总结
This is a multi-center phase III randomized controlled study, designing to access whether the efficacy of EGFR-TKI alone on patients with brain metastasis from non-small cell lung cancer (NSCLC) harboring EGFR mutant type is not inferior to EGFR-TKI concurrent with whole brain radiotherapy (WBRT), the primary end point is intracranial PFS (iPFS), while secondary outcomes included overall survival (OS), objective response rate (ORR), evaluation of cognitive function, quality of life (QoL) and adverse events.
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
- •Patients who was confirmed non-small cell lung cancer (NSCLC) by histology or cytology, harboring EGFR mutant type (19 and/or 21 exon mutation).
- •Patients who was confirmed with asymptomatic, treatment naive brain metastasis (didn't receive any treatment after diagnosed with brain metastasis) by MRI, couldn't receive operation or stereotactic radiosurgery（SRS）.
- •Appraisable disease, that is there must be at least one lesion with the longest diameter>10mm in brain (by brain MRI).
- •Adult patients (18 to 75 years old). Eastern Cooperative Oncology Group（ECOG） performance status 0 to
- •Life expectancy of at least 12 weeks. Haemoglobin > 10g/dl, absolute neutrophil count (ANC) > 1.5 x 10^9/L, platelets > 100 x 10^9/L; total bilirubin < 1.5x upper limit of normal (ULN). Alanine aminotransferase（ALT） and aspartate aminotransferase（AST）< 1.5x ULN in the absence of liver metastases, or < 5x ULN in case of liver metastases. Creatinine clearance > 60ml/min (calculated according to Cockcroft-gault formula).
- •Patients should be contraceptive during the period of the trial.
排除标准
- •Patients who had received brain radiotherapy or EGFR-TKI before.
- •Patients who can't receive WBRT.
- •Uncontrolled intracranial hypertension after steroid or dehydration therapy.
- •Patients who take phenytoin, Carbamazepine, Rifampicin, Barbital, or St John's Wort which will interfere with the metabolism of TKI.
- •Patients with interstitial lung disease, significant ocular disease, or serious uncontrolled systematic disease.
- •Patients who can't take oral tablets, with active peptic ulcer diseases.
- •Pregnancy or breast-feeding women.
研究组 & 干预措施
Arm 1
Patients take EGFR-TKI alone till tumor progression
干预措施: EGFR-TKI (Drug)
Arm 2
Patients take EGFR-TKI concurrent with whole brain radiotherapy (WBRT) till tumor progression, WBRT started within the first week of taking TKI
干预措施: EGFR-TKI (Drug)
Arm 2
Patients take EGFR-TKI concurrent with whole brain radiotherapy (WBRT) till tumor progression, WBRT started within the first week of taking TKI
干预措施: whole brain radiotherapy (Radiation)
结局指标
主要结局
intracranial PFS (iPFS)
时间窗: up to 41 months
Compare intracranial PFS (iPFS) of two arms
次要结局
- objective response rate (ORR)(up to 41 months)
- overall survival (OS)(up to 77 months)
研究者
Li-kun Chen
Associate Professor/Associate chief physician
Sun Yat-sen University