Using MRI to assess tumor response in rectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Aberdeen Royal Infirmary - NHS Grampion
  Aberdeen, Aberdeenshire, United Kingdom Recruiting
• Hampshire Hospitals NHS Foundation Trust
  Basingstoke, Hampshire, United Kingdom Recruiting
• University Hospital of North Midlands NHS Trust - Royal Stoke
  Stoke-on-Trent, Staffordshire, United Kingdom Recruiting
• Salisbury NHS Foundation Trust
  Salisbury, Wiltshire, United Kingdom Recruiting
• Bristol Royal Infirmary
  Bristol, United Kingdom Recruiting
• Colchester General Hospital
  Colchester, United Kingdom Recruiting

Study contacts

• Principal investigator: Gina Brown, MD — Imperial College London
• Study coordinator: Caroline Martin
• Email: cmartin1@imperial.ac.uk
• Phone: +44 (0) 7749 655 817

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.