Optimisation of Radiotherapy in Rectal Cancer (ORREC) (ORREC)
2019年9月12日 更新者:DR PETER MBANU、University of Manchester
Optimisation of Radiotherapy to Achieve Increased Organ Preservation in Rectal Cancer (ORREC)
This is a retrospective study using images acquired routinely for diagnosis of rectal cancer to see if these could be used to predict responses to radiotherapy treatment and if it can, whether the treatment can be optimised to produce better outcome for patients.
Using a clinical database, patients who have had neo-adjuvant chemo-radiotherapy will be recruited, their diagnostic images and radiotherapy planning scan will be obtained.
By use of imaging registration and clinical information, the question of why some patients respond well to radiotherapy and some don't could be answered.
研究概览
详细说明
The treatment of locally advanced rectal cancer is primarily radiotherapy (+/- chemotherapy) followed by surgery.
The reason for radiotherapy is to reduce the risk of recurrence after surgery or to shrink the tumour first so that when surgery is done all the cancer will be successfully removed otherwise some will be left behind to grow.
More than 80% of patients require a stoma after their surgery, some get reversed by two years after surgery but a third has it lifelong.
About 15% of patients after radiotherapy have no disease left (clinical complete response) and can be monitored closely after radiotherapy and will not need to have surgery or stoma.
Surgery carries a risk of death and complications, having a stoma have a lot of complications and have an effect on patient's quality of life, most end up not going out much and withdraws from friends and family due to the risk of accidents in public places.
This study is aimed at looking at ways to increase the number of patients that do not require surgery after radiotherapy by looking at the differences between those that responded well to radiotherapy and the ones that did not by comparing their diagnostic and treatment scans.
The main question to answer is why some patients have complete response to radiotherapy and others don't.
Is there a way to increase the number of these patients through changes in radiotherapy?
The study will be looking at the diagnostic images and radiotherapy planning scans to compare these two groups.
Is there a way of predicting who will respond to radiotherapy treatment?
If there is, modifications could be made to the type of treatment given.
This study will be looking to radiomics techniques to develop this.
This retrospective study will only make use of scans that patients have already had for their diagnosis and treatment so no patient intervention is required.
Patients will be recruited using the clinical and research database of the Christie hospital which is the largest cancer centre in the UK.
The study is funded by the charitable fund of the Christie Hospital NHS Foundation Trust.
研究类型
观察性的
注册 (预期的)
1500
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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England
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Manchester、England、英国、M20 4BX
- Christie Hospital NHS Foundation Trust
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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
不适用
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Patients who are treated with neo-adjuvant chemo-radiotherapy recruited from the clinical data of the Christie Hospital NHS databases
描述
Inclusion Criteria:
- Histologically confirmed rectal adenocarcinoma.
- Received pelvic radiotherapy (+/- chemotherapy) as neo-adjuvant treatment
- Age 18 and above
Exclusion Criteria:
- Other rectal pathologies.
- Patients less than 18yrs at diagnosis.
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
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 |
|---|---|---|
|
Radiotherapy volumes (cm^3)
大体时间:24 months
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The volume that receives radiotherapy treatment.
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24 months
|
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Radiotherapy dose distribution (Gy/cm^3)
大体时间:24 months
|
Radiotherapy dose delivered to a given volume
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24 months
|
|
MR radiomics extracted features.
大体时间:24 months
|
Distinctive qualitative pixel features that can be extracted from area of disease in radiological images.
|
24 months
|
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。
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 (预期的)
2019年9月23日
初级完成 (预期的)
2020年4月1日
研究完成 (预期的)
2021年3月31日
研究注册日期
首次提交
2019年9月11日
首先提交符合 QC 标准的
2019年9月12日
首次发布 (实际的)
2019年9月16日
研究记录更新
最后更新发布 (实际的)
2019年9月16日
上次提交的符合 QC 标准的更新
2019年9月12日
最后验证
2019年9月1日
更多信息
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