Magnetic Resonance Tumour Regression Grade (mrTRG) as a Novel Biomarker - Phase III Non CTIMP Trial

Last updated: October 16, 2024
Sponsor: Imperial College London
Overall Status: Active - Recruiting

Phase

N/A

Condition

Rectal Cancer

Colon Cancer

Digestive System Neoplasms

Treatment

High resolution MRI scan

mrTRG assessment

Clinical Study ID

NCT02704520
DOCUMAS: 23HH8209
  • Ages > 16
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. MRI defined locally advanced rectal carcinoma i.e. one or more: greater than orequal to mrT3c; mrEMVI positive; mr N1c; mr CRM positive

  2. Biopsy confirmed adenocarcinoma of radiologically defined rectum

  3. Be deemed to require preoperative chemoradiotherapy (CRT) or total neoadjuvanttherapy (TNT)

Exclusion

Exclusion Criteria:

  1. Metastatic disease

  2. MRI, radiotherapy and/or chemotherapy contraindications

  3. A post-treatment MRI performed more than 10 weeks after the completion ofradiotherapy if given

  4. Previous malignancy within preceding 5 years if risk of recurrence >5%

Study Design

Total Participants: 441
Treatment Group(s): 2
Primary Treatment: High resolution MRI scan
Phase:
Study Start date:
March 01, 2016
Estimated Completion Date:
December 31, 2036

Study Description

The only phase III clinical trial in the UK offering watch and wait, the TRIGGER trial aims to validate mrTRG as an imaging biomarker for the stratified management of patients with locally advanced rectal cancer. The 'good responders' (mrTRG1&2) often have no evidence of tumour and it may be possible to avoid surgery in this group and so maintaining QoL while not impacting survival rates. The 'poor responders' (mrTRG3-5) are at high risk of poor oncological outcomes and this knowledge is useful in planning ongoing treatment and surveillance.

TRIGGER is now a non-cTIMP trial as the protocol does not specify chemotherapy or IMP treatments. Decisions about the use of chemotherapy will be based upon local MDT discussions as is normal practice and national policy and the trial CRFs will capture these decisions and whether more treatment is given to patients or not. TRIGGER does not mandate or recommend the use of any treatments: specifically it does not suggest the use of investigational medicinal products. If any centre wishes to use IMPs this would be in the context of separate trial protocols and would not preclude entry into TRIGGER.

Connect with a study center

  • Aberdeen Royal Infirmary - NHS Grampion

    Aberdeen, Aberdeenshire AB252ZN
    United Kingdom

    Active - Recruiting

  • Hampshire Hospitals NHS Foundation Trust

    Basingstoke, Hampshire RG24 9NA
    United Kingdom

    Active - Recruiting

  • University Hospital of North Midlands NHS Trust - Royal Stoke

    Stoke-on-Trent, Staffordshire ST4 6QS
    United Kingdom

    Active - Recruiting

  • Salisbury NHS Foundation Trust

    Salisbury, Wiltshire SP2 8BJ
    United Kingdom

    Active - Recruiting

  • Bristol Royal Infirmary

    Bristol, BS2 8ED
    United Kingdom

    Active - Recruiting

  • Colchester General Hospital

    Colchester, CO4 5JL
    United Kingdom

    Active - Recruiting

  • NHS Lanarkshire - Hairmyres Hospital

    East Kilbride, G75 8RG
    United Kingdom

    Active - Recruiting

  • Diana Princess of Wales Hospital

    Grimsby, DN33 2BA
    United Kingdom

    Active - Recruiting

  • Royal Marsden NHS Foundation Trust

    London & Sutton,
    United Kingdom

    Site Not Available

  • University Hospital of North Tees

    Stockton-on-Tees, TS19 8PE
    United Kingdom

    Active - Recruiting

  • Royal Marsden NHS Foundation Trust

    Sutton, SM2 5PT
    United Kingdom

    Active - Recruiting

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