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

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: High resolution MRI scan (diagnostic test), mrTRG assessment (diagnostic test)
How long the study runs: Study runs about 249 months (dates as stated)
About the drug or intervention: High resolution MRI scan — diagnostic test: MRI reporting of tumour but not mrTRG in the control arm = standard of care · mrTRG assessment — diagnostic test: Watch and wait offered for good responders Consider further treatment for poor responders
Patient visit burden: Not specified by the sponsor

In plain English

This phase 3 study looks at rectal cancer that is locally advanced. It tests whether a measure called the Magnetic Resonance Tumour Regression Grade (mrTRG), taken from MRI (magnetic resonance imaging) scans, can act as a marker of how the tumour has responded to treatment. The study is sponsored by Imperial College London.

Who can take part

Rectal cancer that MRI scans show is locally advanced, with at least one of: tumour at mrT3c or beyond; mrEMVI positive; mr N1c; or mr CRM positive
A biopsy (tissue sample) has confirmed a cancer called adenocarcinoma in the rectum
Doctors have decided the patient needs chemoradiotherapy (CRT) or total neoadjuvant therapy (TNT) before surgery

Who may not be able to

Cancer that has spread to other parts of the body
Reasons why MRI, radiotherapy or chemotherapy cannot be given safely
Having the after-treatment MRI scan more than 10 weeks after finishing radiotherapy (if radiotherapy was given)
Another cancer in the past 5 years, if the risk of it coming back is more than 5%

What taking part involves

• Preoperative chemoradiotherapy (CRT) or total neoadjuvant therapy (TNT), as decided by the doctors
• MRI scans before and after treatment, so researchers can measure tumour response using mrTRG

Time commitment: Not stated — ask the trial team about the number of visits, how long the trial lasts, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study: Testing a treatment
Ages: 16 Years and over
Who: All
Number of participants: 441
Started: 2016-03
Last checked: 2024-10

Plain English Summary

What is this study?

• Testing a new treatment for rectal cancer
• NA - 441 participants
• 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

Who can take part?

• Ages 16 Years and over
• Diagnosed with rectal cancer

Where?

• Aberdeen - Aberdeen Royal Infirmary - NHS Grampion
• Basingstoke - Hampshire Hospitals NHS Foundation Trust
• Stoke-on-Trent - University Hospital of North Midlands NHS Trust - Royal Stoke
• Salisbury - Salisbury NHS Foundation Trust
• +6 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Rectal Cancer

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 16 Years and over
Who can join: All genders

Biomarkers mentioned

mrEMVI positiveCRM positive

Treatment history

Treatments you must have had:

✓ preoperative chemoradiotherapy (CRT) or total neoadjuvant therapy (TNT)

What the study is looking for

✓MRI defined that has grown locally rectal carcinoma i.e. one or more: greater than or equal to mrT3c; mrEMVI positive; mr...
✓Biopsy confirmed adenocarcinoma of radiologically defined rectum
✓Be deemed to require preoperative chemoradiotherapy (CRT) or total before surgery therapy (TNT)

Who cannot take part

✗that has spread disease
✗MRI, radiotherapy and/or drug treatment contraindications
✗A post-treatment MRI performed more than 10 weeks after the completion of radiotherapy if given
✗Previous cancer within preceding 5 years if risk of recurrence \>5%

See the full 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%