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临床试验/NCT00910546
NCT00910546已完成不适用

Image Guided and Breathing Adapted Radiotherapy of Early Stage Lung Cancer

Gitte Fredberg Persson2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2009年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
试验地点
2
主要终点
motion of lung tumours

研究概览

简要总结

The purpose of this study is to quantify the variation in tumour middle position during a course of stereotactic body radiotherapy (SBRT), and thereby be able to design radiotherapy margins that takes into account the full motion span throughout an entire course of SBRT.

详细描述

Lung tumours move with respiration. This must be considered when designing margins for radiotherapy. This movement can be quantified by fluoroscopy or 4DCT. It is possible to identify a tumour middle position for planning. This middle position will vary from day to day and the extent of this variation is not fully known. The aim of this study is to quantify the variation in tumour middle position during a course of stereotactic body radiotherapy (SBRT), and thereby be able to design margins for patients that take into account the full motion span throughout an entire course of SBRT Patients: 15 consecutive patients with inoperable low stage lung cancer or solitary metastases to the lung (1-2) referred for SBRT - 45 Gy/3 fractions.

Methods: A gold coil will be implanted into the lung tumour one week before the planning. At planning and all treatment days supplementary 4DCT of thorax and two orthogonal fluoroscopy sessions will be performed. Tumour motion in the superior-inferior, medio-lateral and cranio-caudal direction will be measured and variation in amplitude and baseline for the tumour motion will be reported.

Perspective: By examining the variation in tumour movement it will be possible design margins for SBRT, accounting for the full tumour motion span and minimizing the risk of geographical miss and thereby optimizing the chance for local tumour control.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • tumor > 6 cm
  • no more than 2 tumours
  • histological proven non small celled lung cancer
  • signed Informed Consent

排除标准

  • Serious bleeding disorder
  • Performance status 3-4
  • Tumour close to large vessels (judged by interventional radiologist)

结局指标

主要结局

motion of lung tumours

时间窗: 3 weeks

measured on 4DCT

次要结局

  • toxicity of implanting gold coils into lung tumours(1 year)

研究者

发起方
Gitte Fredberg Persson
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gitte Fredberg Persson

MD PhD

Rigshospitalet, Denmark

研究点 (2)

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