Prospective Observational Study on a Risk Adaptive Scheme for Stereotactic Body Radiation Therapy (SBRT) for Medically Inoperable Thoracic Nodes Metastases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Local control of disease
研究概览
简要总结
Oligometastatic patients with inoperable thoracic nodes metastases from any primary, except for hematologic malignancies, will undergo a risk adaptive scheme of stereotactic body radiation therapy (SBRT).
详细描述
The observational study is designed to evaluate safety and efficacy of a risk adaptive scheme of stereotactic body radiation therapy (SRT) in oligometastatic patients with thoracic nodes metastases, medically inoperable, using VMAT RapidArc approach. The potential advantage of this technique is the ability to deliver a more selective irradiation to tumour's target while reducing doses to normal tissue, optimizing the therapeutic window.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged >18 years with ECOG 0-2
- •Karnofsky index > 70% (ECOG >2)
- •Any primary, except for hematologic malignancies
- •DFI (Disease-free interval) from diagnosis > 6 months
- •Unresectable lesions or inoperable patients or patients who refused surgery
- •Less than 3 metastatic thoracic nodes
- •No extrathoracic disease or other metastatic sites stable or responding after chemotherapy, with less than 5 metastatic sites
- •No life threatening conditions
- •Chemotherapy completed at least 1 week before treatment
- •Chemotherapy started at least 1 week after treatment allowed
- •Systemic therapies other than chemotherapy allowed (i.e hormonal therapies and/or immunotherapy)
- •Written informed consent
排除标准
- •Previous RT in the same region
- •Pregnant women
- •Patients with inability to consent
结局指标
主要结局
Local control of disease
时间窗: 7 years
Local control of the thoracic nodes stereotactic radiation therapy schedules for medically inoperable oligometastatic patients
次要结局
- Progression-free survival for patients(7 years)
- Overall survival for patients(7 years)
- Quality of life evaluated by EORTC QLQ C30 questionnaires(7 years)
- Hematologic and non-hematologic toxicities(7 years)
研究者
Michele Tedeschi
Medical Doctor
Istituto Clinico Humanitas