跳至主要内容
临床试验/NCT00910494
NCT00910494终止不适用

Intraoperative Radiotherapy (IORT) for Rectal Cancer Using the Photon Radiosurgery System (PRS): A Phase I Clinical Trial

University of Dundee2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2010年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
9
试验地点
2
主要终点
surgical complication rate

研究概览

简要总结

The investigators would like to test the safety and efficacy of intraoperative radiotherapy (IORT) in rectal cancer using the Photon Radiosurgery System (PRS).

详细描述

Rectal cancer is usually managed by a combination of surgery and x-ray treatments (radiotherapy). The standard way of delivering radiotherapy is with external 'beams' directed at the tumour site. However, although in rectal cancer these treatments are effective, patients are often troubled by late side effects. An alternative option is to deliver the x-rays at the same time as surgery. This is known as intraoperative radiotherapy, or IORT, and a number of techniques have already been tried. There is a new IORT technology known as the Photon Radiosurgery System (PRS) which we are using to treat breast and brain cancers. Our experience to date has informed us that IORT with this x-ray source is safe and effective. We would like to use the technology to treat rectal cancer and believe that it may improve disease outcomes without the side effects associated with standard radiotherapy. We would also like to study the biological processes that follow radiation. It is not understood why some people are more sensitive to x-ray treatments than others. If we knew the reasons for this then we might be able to individualise treatments.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Operable rectal cancer

排除标准

  • Locally advanced disease requiring long course pre-operative chemoradiation, metastatic disease

研究组 & 干预措施

12 Gray IORT

Experimental

干预措施: Photon Radiosurgery System IORT (Radiation)

15 Gray IORT

Experimental

干预措施: Photon Radiosurgery System IORT (Radiation)

结局指标

主要结局

surgical complication rate

时间窗: 30 days post treatment

次要结局

  • survival(5 year)
  • local control(5 year)

研究者

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

Ian Sanders

Specialist Registrar

University of Dundee

研究点 (2)

Loading locations...

相似试验

Intraoperative Radiotherapy for Rectal Cancer Using... | 临床试验