跳至主要内容
临床试验/NCT02228356
NCT02228356Unknown不适用

Non-interventional Observational Study of Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Cancer

Universitair Ziekenhuis Brussel1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012年6月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Benedikt Engels, MD, PhD

Radiation Oncologist

Universitair Ziekenhuis Brussel

研究点 (1)

Loading locations...

相似试验

Non-interventional Observational Study of... | 临床试验