跳至主要内容
临床试验/NCT04090450
NCT04090450Unknown不适用

Optimisation of Radiotherapy to Achieve Increased Organ Preservation in Rectal Cancer (ORREC)

University of Manchester1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2019年9月23日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,500
试验地点
1
主要终点
Radiotherapy volumes (cm^3)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • Histologically confirmed rectal adenocarcinoma.
  • Received pelvic radiotherapy (+/- chemotherapy) as neo-adjuvant treatment
  • Age 18 and above

排除标准

  • Other rectal pathologies.
  • Patients less than 18yrs at diagnosis.

结局指标

主要结局

Radiotherapy volumes (cm^3)

时间窗: 24 months

The volume that receives radiotherapy treatment.

Radiotherapy dose distribution (Gy/cm^3)

时间窗: 24 months

Radiotherapy dose delivered to a given volume

MR radiomics extracted features.

时间窗: 24 months

Distinctive qualitative pixel features that can be extracted from area of disease in radiological images.

次要结局

未报告次要终点

研究者

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

DR PETER MBANU

Clinical Research Fellow

University of Manchester

研究点 (1)

Loading locations...

相似试验

Optimisation of Radiotherapy in Rectal Cancer (ORREC) | 临床试验