Optimisation of Radiotherapy in Rectal Cancer (ORREC)

NCT04090450 | Unknown

• 1 other identifier: IRAS 265989
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Adenocarcinoma

Outcome Measures

Primary Outcomes (3)

• Radiotherapy volumes (cm^3)

  The volume that receives radiotherapy treatment.

  24 months

• Radiotherapy dose distribution (Gy/cm^3)

  Radiotherapy dose delivered to a given volume

  24 months

• MR radiomics extracted features.

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

  24 months

Interventions

chemo-radiotherapy RADIATION

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Manchester: lead
• The Christie NHS Foundation Trust: collaborator

Study Sites (1)

Christie Hospital NHS Foundation Trust

Manchester, England, M20 4BX, United Kingdom

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Peter Mbanu

CONTACT

01619183422; peter.mbanu@postgrad.manchester.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Fellow

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: September 16, 2019
• Study Start: September 23, 2019
• Primary Completion: April 1, 2020
• Study Completion: March 31, 2021
• Last Updated: September 16, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)