Home › Trials › NCT02704520

Using MRI to assess tumor response in rectal cancer

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

Not applicable Interventional Imperial College London · NCT02704520

This study is testing if using MRI scans to see how well rectal cancer is responding to treatment can help some patients avoid surgery and make better treatment choices.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment441 (estimated)
Ages16 Years and up
SexAll
SponsorImperial College London Academic / other
Drugs / interventionschemotherapy
Locations10 sites (Aberdeen, Aberdeenshire and 9 other locations)
Trial IDNCT02704520 on ClinicalTrials.gov

What this trial studies

The TRIGGER trial is designed for patients with locally advanced rectal cancer undergoing pre-operative treatment. It aims to validate magnetic resonance tumor regression grade (mrTRG) as a biomarker to guide treatment decisions, allowing some patients with good responses to avoid surgery. Participants will be randomized into two groups: one receiving standard management based on national guidelines, and the other having their MRI scans interpreted by trained radiologists to determine their treatment path. The trial includes a five-year follow-up with quality of life assessments.

Who should consider this trial

Good fit: Ideal candidates are patients with MRI-defined locally advanced rectal cancer who require preoperative chemoradiotherapy.

Not a fit: Patients with metastatic disease or contraindications to MRI, radiotherapy, or chemotherapy may not benefit from this trial.

Why it matters

Potential benefit: If successful, this approach could allow patients with good tumor responses to avoid unnecessary surgery, thereby improving their quality of life.

How similar studies have performed: Other studies have explored similar imaging biomarkers, but this specific approach in the context of rectal cancer management is novel.

Eligibility criteria

Show full inclusion / exclusion 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%

Where this trial is running

Aberdeen, Aberdeenshire and 9 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Rectal CancerMagnetic Resonance ImagingChemoradiotherapyChemotherapyDiagnostic Imaging
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.