Actively Recruiting
Magnetic Resonance Tumour Regression Grade (mrTRG) as a Novel Biomarker - Phase III Non CTIMP Trial
Led by Imperial College London · Updated on 2024-10-17
441
Participants Needed
10
Research Sites
1082 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Open to patients undergoing any pre-operative treatment for locally advanced rectal cancer, TRIGGER is the only phase III clinical trial in the UK offering watch and wait. All patients will have post treatment MRI scans routinely performed, no change from the MERCURY trials high resolution MRI protocol is required. Patients will be randomised to either the control arm for management according to national guidelines - conventional MDT, clinical assessment post-treatment planning using the baseline MRI. Patients in the interventional arm will have their post treatment MRI scans read by a radiologist trained and supported to reliably report the mrTRG grade and have their management directed accordingly - 'Good response' (mrTRG 1\&2) - watch and wait (avoidance of surgery) offered. 'Poor response' (mrTRG 3-5) - local colorectal MDT is informed and uses information to discuss and agree next steps in treatment and surveillance. Patients are followed up for five years with QoL questionnaires completed at registration, 3 and 5 years.
CONDITIONS
Official Title
Magnetic Resonance Tumour Regression Grade (mrTRG) as a Novel Biomarker - Phase III Non CTIMP Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- MRI defined locally advanced rectal carcinoma with at least one of the following: mrT3c or higher, positive mrEMVI, positive mr N1c, or positive mr CRM
- Biopsy confirmed adenocarcinoma located in the radiologically defined rectum
- Patients considered to need preoperative chemoradiotherapy (CRT) or total neoadjuvant therapy (TNT)
You will not qualify if you...
- Presence of metastatic disease
- Contraindications to MRI, radiotherapy, or chemotherapy
- Post-treatment MRI performed more than 10 weeks after completing radiotherapy if given
- Previous malignancy within the last 5 years with a recurrence risk greater than 5%
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Aberdeen Royal Infirmary - NHS Grampion
Aberdeen, Aberdeenshire, United Kingdom, AB252ZN
Actively Recruiting
2
Hampshire Hospitals NHS Foundation Trust
Basingstoke, Hampshire, United Kingdom, RG24 9NA
Actively Recruiting
3
University Hospital of North Midlands NHS Trust - Royal Stoke
Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QS
Actively Recruiting
4
Salisbury NHS Foundation Trust
Salisbury, Wiltshire, United Kingdom, SP2 8BJ
Actively Recruiting
5
Bristol Royal Infirmary
Bristol, United Kingdom, BS2 8ED
Actively Recruiting
6
Colchester General Hospital
Colchester, United Kingdom, CO4 5JL
Actively Recruiting
7
NHS Lanarkshire - Hairmyres Hospital
East Kilbride, United Kingdom, G75 8RG
Actively Recruiting
8
Diana Princess of Wales Hospital
Grimsby, United Kingdom, DN33 2BA
Actively Recruiting
9
University Hospital of North Tees
Stockton-on-Tees, United Kingdom, TS19 8PE
Actively Recruiting
10
Royal Marsden NHS Foundation Trust
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
C
Caroline Martin
CONTACT
S
Syvella Ellis
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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