STEREOMIC: Studio Retrospettivo Multicentrico Su Pazienti Trattati Con Radiochirurgia/Radioterapia STEREotassica Per Lesioni Encefaliche Singole. Valutazione Di Efficacy E Safety Del Trattamento Anche Mediante Metodiche Di Analisi RadiOMICa
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 372
- 试验地点
- 4
- 主要终点
- Toxicity profile
研究概览
简要总结
The study design concerns all patients diagnosed witha singular brain metastasis who underwent stereotactic radiosurgery/radiotherapy between January 2010 and December 2022
详细描述
The study will include patients of both sexes diagnosed with single brain metastases who underwent radiosurgical/stereotactic treatment. Attention will be paid to data related to local control, potential recurrence, and/or radionecrosis. Once a sufficient number of treated patients is reached, the feasibility of a radiomic feature analysis will be assessed in order to identify potential correlations and/or predictive values for treatment response or radionecrosis. If the sample size is adequate, participating centers will be asked to share pre- and post-RT MRI (brain MRI with contrast using thin slices) and treatment volumes for radiomic evaluation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Treatment with SRS/SRT techniques for a single secondary brain lesion
- •Availability of pre-RT brain MRI with contrast (1mm slice thickness)
- •Availability of CT simulation imaging for treatment
- •Availability of relevant clinical data in the medical record for the study's objectives
- •Follow-up of at least 6 months after the completion of SRS or SRT
- •Follow-up evaluation through brain MRI
排除标准
- •Age under 18 years
- •Lack of clinical/radiological data for the patient
- •Unavailability of the required imaging
- •Previous whole-brain radiotherapy treatment
结局指标
主要结局
Toxicity profile
时间窗: due to the retrospective nature of the study, we did not have specific time points.We will evaluate the possible onset of toxicity events from the last day of treatment up to 18 months from the treatment
"The toxicity profile of the treatment will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute."
Local control
时间窗: We will evaluate Lc at one, two, and five years from the treatment
It will be Calculated 'per lesion,' and it is defined as the time interval between irradiation and the onset of disease recurrence at the site of the treated area
次要结局
未报告次要终点