Comparing Whole Brain Radiation With Hypofractionated Stereotactic RadioSurgery (HFSRS) in Patients With NSCL Brain Metastases
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 325
- 试验地点
- 1
- 主要终点
- iPFS
研究概览
简要总结
A multi-center phase III randomized controlled study to evaluate the efficacy of Hypofractionated SRS (HFSRS) along with EGFR-TKI in patients with brain metastasis from non-small cell lung cancer (NSCLC). Assuming that HFSRS 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), evaluation of cognitive function, quality of life (QoL) and adverse events.
详细描述
WBRT remains to be standard of care for NSCL patients. Long term survival from WBRT may have noticeable cognitive dysfunction. The EGFR TKI has reasonable control for intracranial disease, but the duration of EGFR TKI control disease is variable due to tendency of drug resistance. To maintain intracranial disease control and improve cognitive function, the investigators propose using hypofractionated SRS in multiple brain metastases or large brain lesions alone with TKI.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Histological or cytological confirmation of non-small cell lung cancer (NSCLC);
- •Diagnosis of brain metastases on a Gadolinium-enhanced MRI.
- •More than 3 sites of intracranial metastases, or the longest diameter of the intracranial lesion is more than 4 cm.
- •Positive EGFR mutation.
- •Life expectancy ≥3months.
- •Have one or more measurable encephalic lesions according to RECIST.
- •Adequate hematological function: Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥100 x 109/L.
- •Adequate renal function: Serum creatinine ≤1.5 x ULN, or ≥ 50 ml/min.
- •Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) and Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases.
- •Female subjects should not be pregnant.
- •All human subjects should able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
- •Written informed consent provided.
排除标准
- •Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
- •CSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal.
- •Allergic to Icotinib.
- •Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.
- •Pregnancy or breast-feeding women.
- •Participate in the other anti-tumor clinical trials in 4 weeks.
研究组 & 干预措施
WBRT along with TKI
Drug: EGFR-TKI
Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid
Other Name: Gefitinib/Tarceva/Icotinib
Radiation: whole brain radiotherapy
3750Gy/15F
Other Name: WBRT
干预措施: WBRT (Radiation)
HFSRS with EGFR TKI
Drug: EGFR-TKI
Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid
Other Name: Gefitinib/Tarceva/Icotinib
Radiation: whole brain radiotherapy
25 to 40 Gy/5F
Other Name: HFSRS
干预措施: HFSRS (Radiation)
结局指标
主要结局
iPFS
时间窗: 18 months
intracranial progression-free survival
次要结局
- cognitive function(18 month)
- Overall survival (OS)(18 months)
研究者
ming zeng, MD
Director of Cancer Center
Sichuan Provincial People's Hospital