NCT02704520 Magnetic Resonance Tumour Regression Grade (mrTRG) as a Novel Biomarker - Phase III Non CTIMP Trial
| NCT ID | NCT02704520 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Imperial College London |
| Condition | Rectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 441 participants |
| Start Date | 2016-03 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 441 participants in total. It began in 2016-03 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. MRI defined locally advanced rectal carcinoma i.e. one or more: greater than or equal 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 neoadjuvant therapy (TNT) 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 of radiotherapy if given 4. Previous malignancy within preceding 5 years if risk of recurrence \>5%
Contact & Investigator
Gina Brown, MD
PRINCIPAL INVESTIGATOR
Imperial College London
Frequently Asked Questions
Who can join the NCT02704520 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Rectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02704520 currently recruiting?
Yes, NCT02704520 is actively recruiting participants. Contact the research team at cmartin1@imperial.ac.uk for enrollment information.
Where is the NCT02704520 trial being conducted?
This trial is being conducted at Aberdeen, United Kingdom, Basingstoke, United Kingdom, Stoke-on-Trent, United Kingdom, Salisbury, United Kingdom and 6 additional locations.
Who is sponsoring the NCT02704520 clinical trial?
NCT02704520 is sponsored by Imperial College London. The principal investigator is Gina Brown, MD at Imperial College London. The trial plans to enroll 441 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.