A Prospective, Phase II Study of Bevacizumab Combined With Fractionated Stereotactic Radiotherapy in Patients With 1 to 10 Brain Metastases From Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Intracranial progression-free survival
研究概览
简要总结
This Phase II randomized study is to determine the efficacy and safety of Bevacizumab combined with fractionated stereotactic radiation therapy(FSRT) in patients with 1 to 10 brain metastases in non-small cell lung cancer by assessing the treatment response, perilesional edema, neurological symptoms and quality of life.
详细描述
This Phase II randomized study is to determine the efficacy and safety of Bevacizumab combined with fractionated stereotactic radiation therapy(FSRT) in patients with 1 to 10 brain metastases in non-small cell lung cancer by assessing the treatment response, neurological symptoms and quality of life.
Patients will receive Bevacizumab(7.5mg/kg, q3w, i.v.) before and after FSRT(40Gy in 10 fractions or 30Gy in 5 fractions) to the brain metastases. The primary endpoint was intra-cranial progression-free survival (IPFS). Secondary endpoints included overall survival (OS), progression-free survival (PFS), quality of life (QOL) scores, and toxicities.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged ≥18 years old;
- •histologically confirmed NSCLC;
- •1-10 BMs on contrast-enhanced MRI;
- •stable extracranial disease status at the time of enrollment;
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
- •Normal function of organs and bone marrow within 14 days: Total bilirubin 1.5 times or less the upper limits of normal (ULN); AST and ALT 1.5 times or less the ULN; absolute neutrophil count≥ 500 cells/mm3; creatinine clearance rate(CCR) ≥45 mL/min; Platelet count≥50,000 cells/mm3; international normalized ratio(INR) ≤1.5，Prothrombin Time (PT)≤ 1.5 × ULN
- •Informed-consent
排除标准
- •Intracranial metastases needed surgical decompression
- •Patients with contraindications for MRI
- •Previous radiotherapy or excision for intracranial metastases
- •The tumor has completely approached, encircled, or invaded the intravascular space of the great vessels (e.g., the pulmonary artery or the superior vena cava)
- •A cavity over 2cm in diameter of primary tumor or metastasis
- •Bleeding tendency or coagulation disorder
- •Hemoptysis (1/2 teaspoon blood/day) happened within 1 month
- •The use of full-dose anticoagulation within the past 1 month
- •Severe vascular disease occurred within 6 months
- •Gastrointestinal fistula, perforation or abdominal abscess occurred within 6 months
- •Hypertensive crisis, hypertensive encephalopathy, symptomatic heart failure (New York class II or above), active cerebrovascular disease or cardiovascular disease occurred within 6 months
- •Uncontrolled hypertension (systolic > 150mmHg and/or diastolic > 100mmHg)
- •Major surgery within 28 days or minor surgery or needle biopsy within 48 hours
- •Urine protein 3-4+, or 24h urine protein quantitative >1g
- •Severe uncontrolled disease
- •Uncontrollable seizure or psychotic patients without self-control ability
- •Women in pregnancy, lactation period
- •Other not suitable conditions determined by the investigators
结局指标
主要结局
Intracranial progression-free survival
时间窗: 1 year
IPFS was calculated from the completion of radiotherapy until the first occurrence of either intracranial progression or death.
次要结局
- overall survival (OS)(1 year)
- progression-free survival (PFS)(1 year)
- Rate of patients with treatment-related adverse events evaluated by CTCAE v5.0(1 year)
- Rate of participants with perilesional edema of brain metastases evaluated by T2-weighted MRI(1 year)
- Quality of life evaluated by EORTC quality of life questionnaire(6 months)
研究者
Hui Liu
Professor
Sun Yat-sen University