Phase II Study to Evaluate Feasibility and Safety of Stereotactic Body Radiation Radiotherapy (SBRT) for Lung Metastases From Soft Tissue Sarcoma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Local control of treated lesions
研究概览
简要总结
In this study the investigators treat PM oligometastatic patients with SBRT. Our objective is to evaluate rate of local control of treated lesions in patients treated with Intensity Modulated Radiation Therapy (IMRT) using Volumetric Modulated Arc Therapy (VMAT) for lung metastases from STS.
详细描述
The investigators started to treat PM oligometastatic patients with Stereotactic Body Radiotherapy.
The investigators objective is to evaluate rate of local control of treated lesions in patients treated with Intensity Modulated Radiation Therapy (IMRT) using Volumetric Modulated Arc Therapy (VMAT) for lung metastases from soft-tissue sarcomas. Overall and disease free survival will be evaluated as secondary endpoints.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 anni -85 years
- •PS according to ECOG 0-2
- •Histopathologically confirmation of soft tissue sarcoma
- •Metastatic lung lesion less than 4
- •Controlled primary tumor and other metastatic lesions
- •Metastatic lesion less than 5 such as the definition of oligometastatic patients
- •Written informed consent
- •Contraindication to surgical resection
- •Estimated survival ≥ 3 months
- •Absence of progressive disease longer than 6 months
- •No chemotherapy was given for at least 3 months after SBRT
- •Maximum diameter ≤ 5 cm
排除标准
- •Prior thorax radiation therapy
- •Age > 85 years
- •PS according to ECOG >2
- •Pregnant women
- •Maximum diameter ≥ 5.1 cm
- •Total volume of lung lesion greater than 1/3 of the whole pulmonary parenchima
结局指标
主要结局
Local control of treated lesions
时间窗: 12 months
Evaluation of proportion of patients free from progression from starting radiotherapy
次要结局
- Overall survival of treated patients(4 years)
- Disease free survival of treated patients(4 years)
研究者
Michele Tedeschi
MD
Istituto Clinico Humanitas