Non-interventional Observational Study of Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- One year local control
研究概览
简要总结
The investigators recently published 2 phase II trials on the use of helical tomotherapy for oligometastatic colorectal cancer [1,2]. Despite a dose increase from 40 to 50 Gy, delivered in 2 weeks time, the one-year local control was 54% only [1,2]. The high local failure rate is probably the result of geographical misses due to tumor motion and a biologically effective dose (BED) of < 100 Gy. The current study will investigate whether the one-year local control rate can be improved to 70%, using respiration correlated CT to individualize the margin needed to account for tumor motion, to avoid geographical miss, together with a Monte Carlo or collapsed cone dose calculation algorithm delivering 50 Gy to the 80% isodose, allowing higher doses in the tumor core. As the concept of an internal target volume (ITV) may result in large margins for patients displaying metastases in high mobile organs, such as liver and lung, which may lead to exposure of a relatively high dose to a large volume of normal tissue, dynamic tumor tracking by the VERO SBRT system will be applied in those patients.
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 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with metastatic cancer from any primary origin and no more than 5 metastases on CT--scan
- •Primary tumor treated with curative intention (surgery, radiotherapy, chemoradiotherapy)
- •Functional liver volume > 1000cc in case of liver metastases and a lung diffusion capacity for carbon monoxide (DLCO) of > 30% if lung mets
- •No Child B or C liver cirrhosis
- •No systemic treatment within 1 month before initiation of radiotherapy
- •No contra-indications for radiation of all metastatic disease (= no violation of constraints of organs at risk (OAR))
- •No metastases from another carcinoma
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- •Age > 18 years
排除标准
- 未提供
结局指标
主要结局
One year local control
时间窗: one year post radiotherapy
次要结局
- Acute toxicity(Up to 3 months post radiotherapy)
- Survival(3 to 36 months post Radiotherapy)
- Progression Free Survival(3 to 36 months post Radiotherapy)
- Late toxicity(3 to 36 months post Radiotherapy)
研究者
Benedikt Engels, MD, PhD
Radiation Oncologist
Universitair Ziekenhuis Brussel
