跳至主要内容
临床试验/NCT02403050
NCT02403050Unknown不适用

Feasibility Study to Assess the Benefit of Using Fiducial Markers for Patients Receiving Radiotherapy for Cancer of the Oesophagus

NHS Greater Glasgow and Clyde1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Intra- and inter-observer variability of tumor target volume (cubic centimetres) estimation

研究概览

简要总结

Currently, patients of suitable fitness with non-metastatic esophageal cancer are treated with surgery, radiotherapy or chemoradiotherapy. If treated with radio or chemoradiotherapy, a Computerised tomography (CT) scan is performed and is the dataset used for planning radiotherapy. Information from the endoscopic ultrasound (EUS), performed during routine staging, is used to help localize the tumor, as tumors of the esophagus are poorly visualised on CT. This information is subjective and dependant on the clinician performing the procedure. The tumor is described in relation to common anatomical landmarks. Interpretion of this information can lead to over-compensation when attempting to cover the tumor with a radiation field, to avoid a "miss". It is thought that using fiducial markers called Visicoils placed in or adjacent to the tumor's top and bottom extent at the time of EUS, will lead to better definition of the tumor in the planning process and hence, improvement in local tumor control, and reduction in radiotherapy dose to normal tissue.

研究设计

研究类型
Observational
观察模型
Case Control

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

  • esophageal adenocarcinoma or squamous carcinoma, or undifferentiated carcinoma.
  • No previous radiotherapy or chemotherapy.
  • Fit for radical treatment of their cancer with reasonable lung function, Fev1 >40%, and EUS planned.
  • ECOG Performance Status 0-1: 0 - Fully active, able to carry on all predisease performance without restriction 1 - Restricted in physically strenuous activity

排除标准

  • Pregnancy or breast feeding.
  • Allergy to ciprofloxacin antibiotics

结局指标

主要结局

Intra- and inter-observer variability of tumor target volume (cubic centimetres) estimation

时间窗: baseline (pre-radiotherapy)

Comparison of intra- and inter-observer variability in estimation of tumor target volume (mean and standard deviation) in the prospective (fiducial markers) and retrospective (no fiducial markers) cohorts. Data will be reported using planning volumes measured in cubic centimetres.

次要结局

  • Patient survival(2 years post radiotherapy)
  • local recurrence of tumor(2 years post radiotherapy)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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