Magnetic Resonance Tumour Regression Grade (mrTRG) as a Novel Biomarker - Phase III Non CTIMP Trial
TRIGGER
1 other identifier
interventional
441
1 country
10
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2016
Longer than P75 for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2016
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedFirst Posted
Study publicly available on registry
March 10, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2036
October 17, 2024
October 1, 2024
10.8 years
February 5, 2016
October 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To show that patients can successfully avoid surgery after achieving a good response to treatment as measured on MRI (mrTRG).
Non-inferiority of overall survival at 3 years for the mrTRG (MRI Tumour Regression Grade) good response group (mrTRG 1 and 2) compared with control.
Up to 5 years
Secondary Outcomes (10)
To describe the prognostic features associated with good and poor response to treatment as measured by MRI (mrTRG)
3 years and 5 years
To show mrTRG (Tumour Regression Grade) as a measurement tool can be reproduced by appropriately trained radiologists.
Up to 2 years
Surgical morbidity
30 days post operative
Surgical morbidity
12 months post operative
To investigate the effect of the preoperative treatment regime on mrTRG measurement
Up to 2 years, 3 years and 5 years
- +5 more secondary outcomes
Study Arms (2)
Control arm
OTHERManagement according to national guidelines - conventional MDT, clinical assessment post-treatment planning
Intervention arm
EXPERIMENTALmrTRG directed management 'Good response' (mrTRG 1\&2) - deferral of surgery (watch \& wait) offered. 'Poor response' (mrTRG 3-5) - local colorectal MDT is informed and uses information to discuss and agree next steps in treatment and surveillance.
Interventions
MRI reporting of tumour but not mrTRG in the control arm = standard of care
Watch and wait offered for good responders Consider further treatment for poor responders
Eligibility Criteria
You may qualify if:
- MRI defined locally advanced rectal carcinoma i.e. one or more: greater than or equal to mrT3c; mrEMVI positive; mr N1c; mr CRM positive
- Biopsy confirmed adenocarcinoma of radiologically defined rectum
- Be deemed to require preoperative chemoradiotherapy (CRT) or total neoadjuvant therapy (TNT)
You may not qualify if:
- Metastatic disease
- MRI, radiotherapy and/or chemotherapy contraindications
- A post-treatment MRI performed more than 10 weeks after the completion of radiotherapy if given
- Previous malignancy within preceding 5 years if risk of recurrence \>5%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Aberdeen Royal Infirmary - NHS Grampion
Aberdeen, Aberdeenshire, AB252ZN, United Kingdom
Hampshire Hospitals NHS Foundation Trust
Basingstoke, Hampshire, RG24 9NA, United Kingdom
University Hospital of North Midlands NHS Trust - Royal Stoke
Stoke-on-Trent, Staffordshire, ST4 6QS, United Kingdom
Salisbury NHS Foundation Trust
Salisbury, Wiltshire, SP2 8BJ, United Kingdom
Bristol Royal Infirmary
Bristol, BS2 8ED, United Kingdom
Colchester General Hospital
Colchester, CO4 5JL, United Kingdom
NHS Lanarkshire - Hairmyres Hospital
East Kilbride, G75 8RG, United Kingdom
Diana Princess of Wales Hospital
Grimsby, DN33 2BA, United Kingdom
University Hospital of North Tees
Stockton-on-Tees, TS19 8PE, United Kingdom
Royal Marsden NHS Foundation Trust
Sutton, SM2 5PT, United Kingdom
Related Publications (1)
Battersby NJ, Dattani M, Rao S, Cunningham D, Tait D, Adams R, Moran BJ, Khakoo S, Tekkis P, Rasheed S, Mirnezami A, Quirke P, West NP, Nagtegaal I, Chong I, Sadanandam A, Valeri N, Thomas K, Frost M, Brown G. A rectal cancer feasibility study with an embedded phase III trial design assessing magnetic resonance tumour regression grade (mrTRG) as a novel biomarker to stratify management by good and poor response to chemoradiotherapy (TRIGGER): study protocol for a randomised controlled trial. Trials. 2017 Aug 29;18(1):394. doi: 10.1186/s13063-017-2085-2.
PMID: 28851403DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gina Brown, MD
Imperial College London
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2016
First Posted
March 10, 2016
Study Start
March 1, 2016
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2036
Last Updated
October 17, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share