Safety and Efficacy of SBRT in the Reirradiation for Ultra-central Thoracic Malignant Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Local control time
研究概览
简要总结
The reirradiation of thoracic tumor is difficult. The possibility of surgery or re course radiotherapy is very small. In the NCCN guideline, only systemic treatment is recommended. However, the effective rate of systemic treatment is low. SBRT has the characteristics of high dose in tumor target area and low dose in surrounding normal tissues. In theory, SBRT is more conducive to the protection of normal tissues and can potentially be used in the salvage treatment of recurrent lesions after radiotherapy. Even so, SBRT is still controversial in the rescue treatment of recurrent lung cancer after radiotherapy, especially for "ultral-central" lesions close to mediastinal structures (such as bronchus, esophagus and large blood vessels), which have a high probability of fatal side effects. However, a few studies on the application of SBRT in the reirradiation for ultral-central lung cancer have shown acceptable safety and efficacy. Generally speaking, there are few studies on SBRT in the treatment of recurrent ultral-central tumor with limited data. The purpose of this study is to further evaluate the efficacy and toxicities of SBRT in the treatment of recurrent ultral-central tumors after radiotherapy.
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 is malignant tumor.
- •The location of the target lesion belongs to the ultra-central type of chest.
- •The target lesion had a history of radiotherapy, 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 control time
时间窗: From the beginning of the treatment to 3 years after the treatment.
The time from the date of SBRT to the date of recurrence of the target tumor or the date of last observation.
Toxcicties
时间窗: From the beginning of the treatment to 3 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 time(From the beginning of the treatment to 3 years after the treatment.)
- Disease progression time(From the beginning of the treatment to 3 years after the treatment.)