Prediction and Assessment of Response to Therapy in Rectal Cancer
Research type
Research Study
Full title
Prediction and Assessment of Response to Neoadjuvant Therapy in Locally Advanced Rectal Cancer: Identifying Complete Responders.
IRAS ID
179993
Contact name
Tan Arulampalam
Contact email
Sponsor organisation
Colchester Hospital Univerity NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 10 months, 15 days
Research summary
Cancer of the rectum is one of the most common deadly cancers in the western world. Adoption of a multidisciplinary approach, combining radiotherapy, chemotherapy, in addition to surgery has become the standard of care. Management and outcomes of rectal cancer among hospitals is varied, with the spectrum ranging from radical surgery with the removal of the bottom end of the intestines and formation of a permanent stoma; to “watch & wait” policy after radiotherapy.
After patients undergo radiotherapy, a third of patients respond completely, with no cancer cells left; around half respond partially; while a fifth do not respond. There is yet no way to accurately identify those with a favourable outcome. If we are able to accurately identify patients who show complete response, we can preclude surgery from those who do not need it, avoiding the unnecessary surgery, avoiding a stoma bag, and saving the NHS millions of pounds in unnecessary surgery.
This prospective diagnostic accuracy study aims to validate and assess the accuracy of two biomarker imaging techniques -Texture Analysis of Magnetic Resonance Imaging and Positron Emission Tomography- in identifying patients who show favourable responses to therapy.
This study will aim to recruit patients with rectal cancer who are eligible for chemoradiotherapy, who will then have 2 extra PET scans in addition to the standard MRI scans. Enrolling in this study will not alter the patient's’ management. The parameters from the scans will then be compared to the histological outcomes from the resected specimens as golden standard. Accuracy of those scans will be compared to accuracy of standard of care MRI. This study will take place in Colchester General Hospital, with full Multidisciplinary team supervision.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
16/EE/0034
Date of REC Opinion
5 Feb 2016
REC opinion
Unfavourable Opinion