Optimisation of Radiotherapy in Rectal Cancer (ORREC)

Sponsor
University of Manchester (Other)
Overall Status
Unknown status
CT.gov ID
NCT04090450
Collaborator
The Christie NHS Foundation Trust (Other)
1,500
1
18.2
82.3

Study Details

Study Description

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 Phase
  • 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.

Study Design

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

Outcome Measures

Primary Outcome Measures

  1. Radiotherapy volumes (cm^3) [24 months]

    The volume that receives radiotherapy treatment.

  2. Radiotherapy dose distribution (Gy/cm^3) [24 months]

    Radiotherapy dose delivered to a given volume

  3. MR radiomics extracted features. [24 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Christie Hospital NHS Foundation Trust Manchester England United Kingdom M20 4BX

Sponsors and Collaborators

  • University of Manchester
  • The Christie NHS Foundation Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
DR PETER MBANU, Clinical Research Fellow, University of Manchester
ClinicalTrials.gov Identifier:
NCT04090450
Other Study ID Numbers:
  • IRAS 265989
First Posted:
Sep 16, 2019
Last Update Posted:
Sep 16, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 16, 2019