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Optimisation of Radiotherapy in Rectal Cancer (ORREC) (ORREC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04090450
Recruitment Status : Not yet recruiting
First Posted : September 16, 2019
Last Update Posted : September 16, 2019
The Christie NHS Foundation Trust
Information provided by (Responsible Party):
DR PETER MBANU, University of Manchester

Brief Summary:
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.

Condition or disease Intervention/treatment
Rectal Adenocarcinoma Radiation: chemo-radiotherapy

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Optimisation of Radiotherapy to Achieve Increased Organ Preservation in Rectal Cancer (ORREC)
Estimated Study Start Date : September 23, 2019
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : March 31, 2021

Intervention Details:
  • Radiation: chemo-radiotherapy
    The study will not have a direct intervention. It will recruit patients who have had chemo-radiation as part of their standard of care treatment for rectal cancer.

Primary Outcome Measures :
  1. Radiotherapy volumes (cm^3) [ Time Frame: 24 months ]
    The volume that receives radiotherapy treatment.

  2. Radiotherapy dose distribution (Gy/cm^3) [ Time Frame: 24 months ]
    Radiotherapy dose delivered to a given volume

  3. MR radiomics extracted features. [ Time Frame: 24 months ]
    Distinctive qualitative pixel features that can be extracted from area of disease in radiological images.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients who are treated with neo-adjuvant chemo-radiotherapy recruited from the clinical data of the Christie Hospital NHS databases

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04090450

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Contact: Peter Mbanu 01619183422

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United Kingdom
Christie Hospital NHS Foundation Trust
Manchester, England, United Kingdom, M20 4BX
Contact: Peter Mbanu    01619183422   
Sponsors and Collaborators
University of Manchester
The Christie NHS Foundation Trust
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Responsible Party: DR PETER MBANU, Clinical Research Fellow, University of Manchester Identifier: NCT04090450    
Other Study ID Numbers: IRAS 265989
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases