At a glance
ClinicalIndex Comparison Record- ✓Locally advanced rectal carcinoma with MRI-defined staging criteria (≥T3c, EMVI positive, N1c, or CRM positive)
- ✓Biopsy-confirmed adenocarcinoma of radiologically defined rectum
- ✓Deemed to require preoperative chemoradiotherapy or total neoadjuvant therapy
- ✕Metastatic disease
- ✕MRI, radiotherapy and/or chemotherapy contraindications
- ✕Previous malignancy within 5 years if risk of recurrence >5%
- ✕Post-treatment MRI performed more than 10 weeks after completion of radiotherapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating High resolution MRI scan and mrTRG assessment for Rectal Cancer. Currently recruiting, targeting 441 participants across 10 sites.
Signals
Detailed 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.
Study Details
Timeline
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