Magnetic Resonance Tumour Regression Grade (mrTRG) as a Novel Biomarker to Stratify Management of Good and Poor Responders to Radiotherapy: A Rectal Cancer Multicentre Randomised Control Trial to Avoid Surgery With 'Watch and Wait' or Intensify Treatment According to mrTRG

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
United Kingdom
Aberdeen Royal Infirmary - NHS Grampion
RECRUITING
Aberdeen
Hampshire Hospitals NHS Foundation Trust
RECRUITING
Basingstoke
Bristol Royal Infirmary
RECRUITING
Bristol
Colchester General Hospital
RECRUITING
Colchester
NHS Lanarkshire - Hairmyres Hospital
RECRUITING
East Kilbride
Diana Princess of Wales Hospital
RECRUITING
Grimsby
Salisbury NHS Foundation Trust
RECRUITING
Salisbury
University Hospital of North Tees
RECRUITING
Stockton-on-tees
University Hospital of North Midlands NHS Trust - Royal Stoke
RECRUITING
Stoke-on-trent
Royal Marsden NHS Foundation Trust
RECRUITING
Sutton
Contact Information
Primary
Caroline Martin
cmartin1@imperial.ac.uk
+44 (0) 7749 655 817
Backup
Syvella Ellis
giclinicaltrials@imperial.ac.uk
+44 (0) 7732 315 234
Time Frame
Start Date: 2016-03
Estimated Completion Date: 2036-12
Participants
Target number of participants: 441
Treatments
Other: Control arm
Management according to national guidelines - conventional MDT, clinical assessment post-treatment planning
Experimental: Intervention arm
mrTRG 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.
Related Therapeutic Areas
Sponsors
Leads: Imperial College London

This content was sourced from clinicaltrials.gov