NCT02726568Unknown2 期
A Phase II Study to Determine the Efficacy and Safety of High Dose Icotinib Combined With Stereotatic Radiosurgery for NSCLC Patients Harboring EGFR Mutation With Brain Metastases
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- intracranial progression-free survival
研究概览
简要总结
This trail is designed to assess the efficacy and safety of high dose Iconitib combined with SRS for NSCLC patients harboring EGFR mutation with brain metastases.
详细描述
The long-term control of brain metastases becomes a clinical challenge. Whole brain radiotherapy, the standard treatment for patients with multiple brain metastases, can only bring a modest survival improvement around 3-6 months. EGFR-TKIs like icotinib with its proven activity in non-small cell lung cancer may provide clinical benefits to brain metastases patients.
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
- •Histological or cytological confirmation of non-small cell lung cancer (NSCLC);
- •Diagnosis of brain metastases on a Gadolinium-enhanced MRI.
- •Less than 10 sites of intracranial metastases, or the longest diameter of the intracranial lesion is less than 4cm.
- •Positive EGFR mutation（Ex19del or 21L858R）.
- •Life expectancy ≥3months.
- •Have one or more measurable encephalic lesions according to RECIST.
- •The patient has not received radiotherapy for the head or extracranial target lesions before.
- •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.
- •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
Icotinib 375mg Tid
Experimental
The human subject gets icotinib 375mg, Tid until intracranial PD or intolerable toxicity reaction.
干预措施: Icotinib (Drug)
Icotinib 375mg Tid
Experimental
The human subject gets icotinib 375mg, Tid until intracranial PD or intolerable toxicity reaction.
干预措施: SRS (Radiation)
结局指标
主要结局
intracranial progression-free survival
时间窗: from date of randomization until the date of first documented intracranial progression, assessed up to 12 months.
次要结局
- overall survival(from date of randomization until the date of death, assessed up to 36 months.)
- progress-free survival(from date of randomization until the date of extracranial progression, assessed up to 18 months.)
- objective response rate(from date of randomization until the date of progression, assessed up to 12 months.)
- disease control rate(from date of randomization until the date of progression, assessed up to 18 months.)
- Quality of life measured by FACT-L/LCS 4.0 and FACT-Br(from date of randomization until the date of death from any cause, assessed up to 36 months.)
研究者
研究点 (1)
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