Elimination of PTV Margins Based on MRI-guided Adaptive Stereotactic Radiotherapy for Non-small Cell Lung Cancer With Brain Metastasis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Radiation-related brain necrosis incidence rate
研究概览
简要总结
This study aims to explore the safety and efficacy of eliminating the planning target volume (PTV) margins based on MRI-guided adaptive stereotactic radiotherapy for non-small cell lung cancer (NSCLC) patients with brain metastasis.
详细描述
This study aims to explore the safety and efficacy of eliminating the planning target volume (PTV) margins based on MRI-guided adaptive stereotactic radiotherapy for NSCLC patients with brain metastasis. In this study, patients will be randomly assigned in a 1:1 ratio to the study group or the control group. Patients in the study group will receive MRI-guided adaptive stereotactic radiotherapy (SRT) (without PTV expansion margin), while patients in the control group will receive CT-guided conventional standard SRT (with PTV expansion margin). After the completion of treatment, patients will be followed up regularly to assess safety and efficacy.
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
- •Aged 18-75 years
- •Histologically or cytologically confirmed non-small cell lung cancer
- •1-10 metastases on contrast-enhanced MRI
- •Radiotherapy for extracranial lesions is permitted
- •Tyrosine kinase inhibitors (TKI) are permitted in patients with progression of
- •intracranial metastases during previous TKI therapy
- •Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •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
- •Small cell carcinoma of lung
- •Intracranial metastases needed surgical decompression
- •Patients with contraindications for MRI
- •Previous radiotherapy or excision for intracranial metastases
- •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
Radiation-related brain necrosis incidence rate
时间窗: 1 year
"Radiation-related brain necrosis" refers to brain tissue damage that occurs as a result of radiation therapy. It can be detected by brain MRI imaging.
次要结局
- Overall survival(1 year)
- intracranial progression-free survival rate(1 year)
- Objective response rate(1-year)
- Radiation-related Neurotoxicity(1 year)
研究者
Hui Liu
Professor
Sun Yat-sen University