A Multi-center, Prospective Study to Determine the Efficiency of Icotinib Combined With Radiation Therapy Early Intervention or Late Intervention For NSCLC Patients With Brain Metastases and EGFR(Epidermal Growth Factor Receptor) Mutation
试验速览
- 阶段
- 3 期
- 入组人数
- 296
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of icotinib alone or in combination with radiation therapy for NSCLC patients harboring EGFR mutation with brain metastases. The primary endpoint is overall survival .
详细描述
Non-small cell lung cancer (NSCLC) is one of the malignant tumors with the highest incidence of brain metastases, and most patients died due to the progression of brain metastases. Some research show that icotinib combined with radiation therapy can improve the efficiency of NSCLC with brain metastases, but there is still controversial about the timing of radiation therapy intervention . This study is a prospective, multi-center, randomized, controlled trial of icotinib combined with early intervention or late intervention radiation therapy for NSCLC patients harboring EGFR mutation with brain metastases. They will be treated with icotinib and divided into 2 groups. Group 1: the radiation therapy will start within 1 month after icotinib treatment; Group2: the patients will be treated with icotinib first, radiation therapy intervene if disease progress.
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
- •Histological or cytological confirmation of non-small-cell lung cancer (NSCLC)
- •Positive EGFR mutation（Ex19del or 21L858R）
- •Primary diagnosis of brain metastases
- •Have one or more measurable encephalic lesions according to RECIST
- •Extracranial transfer organ≤3
- •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 : gefitinib, erlotinib, icotinib，or any other TKI
- •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. have quit from the trail before.
- •Any other serious underlying medical, psychological and other condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.
研究组 & 干预措施
Early intervention
Icotinib is administered orally three times per day. Radiation therapy (SRS/ WBRT/ HA-WBRT/SMART) start in 1 month since take icotinib orally.
干预措施: Icotinib (Drug)
Early intervention
Icotinib is administered orally three times per day. Radiation therapy (SRS/ WBRT/ HA-WBRT/SMART) start in 1 month since take icotinib orally.
干预措施: SRS/WBRT/HA-WBRT/SMART (Radiation)
Late intervention
Icotinib is administered orally three times per day. Until emerge the progression of the disease, then is given radiation therapy (SRS/WBRT/HA-WBRT/SMART)
干预措施: Icotinib (Drug)
Late intervention
Icotinib is administered orally three times per day. Until emerge the progression of the disease, then is given radiation therapy (SRS/WBRT/HA-WBRT/SMART)
干预措施: SRS/WBRT/HA-WBRT/SMART (Radiation)
结局指标
主要结局
Overall Survival
时间窗: from date of randomization until the date of death, assessed up to 36 months.
次要结局
- Quality of life measured by FACT-L/LCS 4.0(from date of randomization until the date of death from any cause, assessed up to 36 months)
- Progression-free survival of intracranial lesions(from date of randomization until the date of progression, assessed up to 10 months)
- disease control rate of intracranial lesions(from date of randomization until the date of progression, assessed up to 18 months)
- Neurocognitive function changes measured by MMSE(from date of randomization until the date of death from any cause, assessed up to 36 months)
- Observing acute and late toxicity assessed by CTCAE v4.0(from date of randomization until the date of death from any cause, assessed up to 36 months)