Feasibility Study of Fiducial Markers in Oesophageal Cancer
2015年3月25日 更新者:NHS Greater Glasgow and Clyde
Feasibility Study to Assess the Benefit of Using Fiducial Markers for Patients Receiving Radiotherapy for Cancer of the Oesophagus
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.
研究概览
研究类型
观察性的
注册 (预期的)
40
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Glasgow、英国、G12 0YN
- 招聘中
- Beatson Oncology Centre
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接触:
- Vivienne MacLaren, MBChB, MRCP
- 电话号码:441413017093
- 邮箱:v.maclaren@nhs.net
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
A retrospective group of patients images without markers, will be compared to a prospective group of patients who will be imaged and treated following implantation of fiducial tumor markers.
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- Pregnancy or breast feeding.
- Allergy to ciprofloxacin antibiotics
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Fiducial Markers Prospective cohort
2 fiducial markers (Visicoils) to be placed in the tumor area at the routine endoscopic ultrasound (EUS) appointment.
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2 fiducial markers (Visicoils) to be placed in the tumor area
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Retrospective cohort
Images and clinical data from a retrospective group of patients without fiducial markers
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Intra- and inter-observer variability of tumor target volume (cubic centimetres) estimation
大体时间:baseline (pre-radiotherapy)
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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.
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baseline (pre-radiotherapy)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Patient survival
大体时间:6 months post radiotherapy
|
6 months post radiotherapy
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|
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local recurrence of tumor
大体时间:6 months post radiotherapy
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radiological or clinical evidence of disease recurrence
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6 months post radiotherapy
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Patient survival
大体时间:12 months post radiotherapy
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12 months post radiotherapy
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local recurrence of tumor
大体时间:12 months post radiotherapy
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radiological or clinical evidence of disease recurrence
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12 months post radiotherapy
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Patient survival
大体时间:18 months post radiotherapy
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18 months post radiotherapy
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local recurrence of tumor
大体时间:18 months post radiotherapy
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radiological or clinical evidence of disease recurrence
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18 months post radiotherapy
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Patient survival
大体时间:2 years post radiotherapy
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2 years post radiotherapy
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|
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local recurrence of tumor
大体时间:2 years post radiotherapy
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radiological or clinical evidence of disease recurrence
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2 years post radiotherapy
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Vivienne MacLaren, MBChB, FRCP、NHS Greater Glasgow & Clyde
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年3月1日
初级完成 (预期的)
2019年3月1日
研究完成 (预期的)
2019年3月1日
研究注册日期
首次提交
2015年3月16日
首先提交符合 QC 标准的
2015年3月25日
首次发布 (估计)
2015年3月31日
研究记录更新
最后更新发布 (估计)
2015年3月31日
上次提交的符合 QC 标准的更新
2015年3月25日
最后验证
2015年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.