TRIGGER Trial Version 1.0
Research type
Research Study
Full title
Magnetic Resonance Tumour Regression Grade (mrTRG) as a Novel Biomarker to Stratify Management of Good And Poor Responders To Chemoradiotherapy: A Rectal Cancer Multicentre Randomised Control Trial
IRAS ID
156408
Contact name
Gina Brown
Contact email
Sponsor organisation
Royal Marsden NHS Foundation Trust
Eudract number
2015-003009-40
Duration of Study in the UK
5 years, 9 months, 31 days
Research summary
Approximately half of patients diagnosed with rectal cancer are offered chemotherapy and radiotherapy treatment (CRT) before surgery. There is great variability in how each tumour responds to CRT. Approximately 30% of tumours completely respond to and no cancer cells can be found in the cancer specimen. Other tumours do not respond at all or occasionally continue to grow during treatment.
In many hospitals patients receive an MRI scan before and after CRT treatment. Emerging evidence suggests that by viewing the MRI scans in a smarter way by assessing ‘mrTRG’ (MRI Tumour Regression Grade) it is possible to assess how the tumour has responded to treatment. The TRIGGER Trial aims to evaluate mrTRG as a tool for stratifying patients according to their response to treatment.
Patients will be randomised (1:2 ratio) to a control and intervention arm. Patients in the control arm will receive best current practice of surgery at 6-8 weeks after CRT and then a standard course of chemotherapy. Patients in the intervention arm will receive a treatment plan according to their response to CRT, assessed using the MRI tumour regression grade (mrTRG). Patients who have a good response to CRT will defer surgery until the cancer stops reducing in size or avoid surgery altogether if the cancer cannot be detected with repeat scans and assessments. Patients who have a poor response to CRT will have additional pre-operative chemotherapy. We will be able to see if this reduces the size of the tumour further, before a decision is made about proceeding to surgery, and if this lowers the risk of the tumour spreading.
The feasibility trial will involve the recruitment of approximately 90 patients with locally advanced rectal cancer at approximately at both UK and international sites.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
15/LO/1836
Date of REC Opinion
18 Dec 2015
REC opinion
Further Information Favourable Opinion