Prospective Non-randomized Phase II Study on Stereotactic Body Radiation Therapy for Medically Inoperable Lung and Liver Oligometastases From Breast Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Local control of disease after SBRT according to EORTC questionnaire
研究概览
简要总结
Investigators designed a phase II study to evaluate safety and efficacy of lung and liver stereotactic radiation therapy (SRT) in oligometastatic breast cancer patients unsuitable for surgery, using VMAT RapidArc approach.
详细描述
Investigators designed a prospective phase II study to evaluate safety and efficacy of lung and liver stereotactic radiation therapy (SRT) scheduled for oligometastatic breast cancer patients unsuitable for surgery with age major than 18 years old and with adequate performance status (ECOG), 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
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients aged >18 years with ECOG 0-2
- •Diagnosis of Breast Cancer
- •DFI (Disease-free interval) > 1 year
- •No extrapulmonary and/or extrahepatic disease or other metastatic sites stable or responding after chemotherapy
- •No life threatening conditions
- •Lung and liver lesions < 5 (with maximum diameter < 5 cm)
- •Chemotherapy completed at least 3 weeks before treatment
- •Chemotherapy started at least 2 weeks after treatment allowed
- •Systemic therapies other than chemotherapy allowed (i.e hormonal therapies and/or immunotherapy)
- •Written informed consent
排除标准
- •ECOG > 2
- •Pregnant women
- •Patients with inability to consent
结局指标
主要结局
Local control of disease after SBRT according to EORTC questionnaire
时间窗: 2 years
Toxicity in oligometastatic breast cancer patients monitoring using CTCAE v.4
时间窗: 3 years
次要结局
- Overall survival using Kaplan-Meyer statistical curves(2 months)
- Progression free survival using Kaplan-Meyer statistical curves(2 months)
- Quality of life at the end of the treatment with questionnaire EORTC QLQ C30(2 months)
研究者
Michele Tedeschi
MD
Istituto Clinico Humanitas