Safety and Efficacy of SBRT in the Treatment of Thoracic Malignant Tumors at Different Sites
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Local progression free survival
研究概览
简要总结
SBRT (stereotactic radiotherapy) can provide a higher dose to the target area without increasing the risk of surrounding normal tissue / organ injury in selective cases. At present, SBRT has been widely used in radiotherapy of lung cancer and it can also play a better local control for lung metastasis.
However, there are parallel organs and series organs in the chest, and different organs have different tolerance to radiotherapy, so the toxicities of SBRT in different sites are different, and the prescription dose is also different.
This study intends to make a detailed division of the chest region and explore the safety and efficacy of SBRT in different areas. It is divided into four types: chest wall type: the lesion is directly adjacent or overlapped with the chest wall; peripheral type: the lesion is more than 1cm away from the chest wall and more than 2cm away from the bronchial tree; central type: the lesion is less than 2cm away from the bronchial tree; ultral-central type: the lesion is directly adjacent or overlapped with the mediastinal structure.
48-60Gy / 4-10f (EQD2 = 62.5Gy ~ 99.7Gy) was given according to the location of the tumor. Main outcome measures are local progression free survival and radiation toxicities; secondary outcome measure is overall survival.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathological diagnosis was malignant tumor.
- •The location of the target lesion belongs to one of five types and the lesion diameter is ≤ 5cm.
- •There is no extensive systemic metastasis or although there is metastasis, the metastasis have been controlled by previous treatment.
- •KPS>70, no serious or uncontrolled underlying diseases, such as severe or uncontrolled hypertension, diabetes, cardiovascular and cerebrovascular diseases and organ dysfunction, and patients are expected to be tolerated by radiotherapy.
排除标准
- •Poor basic pulmonary function or symptom correlation caused by various reasons, unable to lie flat or cooperate with treatment.
- •The general condition is poor, and the expected survival time is less than 3 months.
- •Psychiatric patients or poor compliance, unable to cooperate to complete treatment.
- •For other reasons, the researcher believes that it is not suitable to participate in this trial.
结局指标
主要结局
Local progression free survival
时间窗: From the beginning of the treatment to 2 years after the treatment.
The time from the date of SBRT to the date of local recurrence or death or the date of last observation.
Toxicities
时间窗: From the beginning of the treatment to 2 years after the treatment.
Adverse events of radiation of normal tissues (Including lung, trachea, bronchus, esophagus, blood vessels, ribs, spinal cord, brachial plexus).
次要结局
- Overall survival(From the beginning of the treatment to 2 years after the treatment.)