Displacement and Deformation Analysis of Adaptive Radiotherapy Based on MR-Linac for Large Brain Metastases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Intra-cranial progression-free survival (IPFS)
研究概览
简要总结
This study is an ambispective cohort study to evaluate the displacement and deformation of large brain metastases (BM) treated with magnetic resonance imaging-guided adaptive radiotherapy (MRIgART)
详细描述
All patients had a pathologically confirmed malignant cancer and were diagnosed with brain metastases (BM) by enhanced magnetic resonance imaging (MRI) with BM volume of 2cm and above. All patients received Unity MR-linac adaptive radiotherapy. Gross tumor volume (GTV) and organs at risk (OARs) were re-delineated for every image set and analyzed for displacement and deformation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Age ≥ 18 years; KPS score ≥
- •pathologically confirmed lung cancer.
- •diagnosed with brain metastases by enhanced MRI.
- •BM volume ≥ 2cm.
- •Anticipated time to survival>3 months.
- •Treated with Unity MR-linac.
- •Good compliance; Able to stay still in supine position for 45 minutes and above.
排除标准
- •Fail to complete radiotherapy as planned; Anticipated time to survival less than 3 months.
- •Suffer from severe back pain in supine position, unable to receive Unity MR-linac.
- •Suffer from severe claustrophobia.
- •Incomplete pre-Unity image data.
结局指标
主要结局
Intra-cranial progression-free survival (IPFS)
时间窗: From the date of radiation until the date of first documented intracalcarine recurrence or progression, or date of death from any cause, whichever came first, assessed up to 12 months.
Defined as the time from date of radiation until the date of first documented intracalcarine recurrence or progression, or date of death from any cause, whichever came first.
次要结局
- Disease control rate (DCR)(Tumor assessment using RECIST will be performed at baseline then every 3 months from first treatment until objective progression or death from any cause, assessed up to 12 months.)
- Local control rate (LCR)(Tumor assessment using RECIST will be performed at baseline then every 3 months from first treatment until objective progression or death from any cause, assessed up to 12 months.)
- Overall survival (OS)(From the date of radiation until the date of any documented death due to any cause,, assessed up to 12 months.)
- Objective Response Rate (ORR)(Tumor assessment using RECIST will be performed at baseline then every 3 months from first treatment until objective progression or death from any cause, assessed up to 12 months.)
- Adverse Event(AEs and SAEs must be collected from the start of treatment to 28 days after discontinuation of radiation, up to 12 months.)