RecruitingNAINTERVENTIONAL

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

The TRIGGER study is for people with a type of bowel cancer called locally advanced rectal cancer. It's the only study in the UK exploring a "watch and wait" approach for these patients. Researchers are using a special way to look at MRI scans after treatment, called mrTRG, to see if it can show how well the treatment has worked. If the scans show a very good response, some patients might be able to avoid surgery, which could lead to a better quality of life. For others, this information will help doctors decide the best next steps for their care. All participants are followed for five years, completing questionnaires about their quality of life.

At a glance

Status

Recruiting

Phase

Sponsor

Imperial College London

Enrolment target

441

Start

01 Mar 2016

Estimated completion

01 Dec 2036

Rectal Cancer

What is this study about?

The TRIGGER study is an important research project for people in the UK who have locally advanced rectal cancer. This type of cancer has grown into the deeper layers of the bowel wall or nearby tissues. Often, patients with this cancer have treatment like chemotherapy or radiotherapy before surgery.

This study is looking at a new way to understand how well that first treatment has worked. It uses a specific method to read MRI scans, called "mrTRG." The main goal is to see if this mrTRG score can help doctors decide on the best treatment plan for individual patients. For example, if the scan shows a really good response to the initial treatment, it might be possible for some patients to avoid a major operation and instead be carefully monitored – this is called "watch and wait." Avoiding surgery can significantly improve someone's quality of life.

On the other hand, if the scan shows that the cancer hasn't responded as well to treatment, doctors will use this information to plan further steps. This might involve more intensive treatments or closer monitoring. The study aims to confirm that using these scan results can help tailor treatments, potentially avoiding unnecessary surgery for some without affecting their chances of recovery, while ensuring others get the most effective follow-up care.

Key takeaways

Looks at a new way to use MRI scans to guide rectal cancer treatment.
Could help some patients avoid surgery if their treatment response is very good.
Aims to improve quality of life for patients with rectal cancer.
Does not involve new medications, but uses existing scans differently.
Participants are followed for five years with quality of life questionnaires.

Who may be eligible?

This study is for people who have been diagnosed with locally advanced rectal cancer. This means the cancer has spread into the deeper layers of the bowel wall or nearby tissues, or there's some spread to nearby lymph nodes, as shown on an MRI scan. Your doctor must have also decided that you need chemotherapy or radiotherapy before any potential surgery.

You would not be able to join the study if the cancer has already spread to other parts of your body (this is called metastatic disease). Also, if you can't have an MRI scan, radiotherapy, or chemotherapy for any reason, you wouldn't be able to participate. If you've had cancer in the last five years that has a high chance of coming back, or if your post-treatment MRI was done more than 10 weeks after finishing radiotherapy, you would also not be eligible. The study is open to anyone aged 16 or over, regardless of their sex.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have you been diagnosed with locally advanced rectal cancer?
Do you need chemotherapy or radiotherapy before any potential surgery?
Has your cancer not spread to other parts of your body?
Can you have an MRI? (e.g., no metal implants that prevent it)
Are you aged 16 or over?

Answer every question to see your result.

What does participation involve?

If you join the TRIGGER study, you will have regular MRI scans after your initial treatment for rectal cancer. These scans are already a standard part of care for many patients. The key difference in this study is how these scans are read. A specially trained doctor will assess your post-treatment MRI using the mrTRG method.

You will be randomly assigned to one of two groups. In one group, your doctors will make decisions about your next steps based on standard national guidelines. In the other group, the mrTRG result from your MRI scan will directly influence your care. If your scan shows a very good response (mrTRG 1 or 2), you might be offered the option to join a "watch and wait" programme, which means avoiding surgery. If the scan shows a less complete response (mrTRG 3-5), your local team will use this information to discuss and decide on the best next steps for your treatment and monitoring.

You will be followed for five years, and during this time, you'll be asked to complete questionnaires about your quality of life at the start of the study, and then again after three and five years. The study does not involve taking any new or experimental medications.

Potential risks and benefits

A potential benefit of joining this study is the chance to have your post-treatment MRI scans thoroughly reviewed using a new method, which might help tailor your treatment more precisely. For some, this could mean avoiding major surgery and its associated risks, leading to a better quality of life. For others, the detailed scan information could help your medical team make more informed decisions about your ongoing care. The main participation involves MRI scans and questionnaires, which are generally safe. However, like any medical study, there's always a possibility that the study findings might not directly benefit you personally. You are entirely free to withdraw from the study at any time without affecting your usual medical care.

Locations (10)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Aberdeen Royal Infirmary - NHS Grampion
Verified postcode
Aberdeen, United Kingdom· Recruiting
Hampshire Hospitals NHS Foundation Trust
Verified postcode
Basingstoke, United Kingdom· Recruiting
University Hospital of North Midlands NHS Trust - Royal Stoke
Verified postcode
Stoke-on-Trent, United Kingdom· Recruiting
Salisbury NHS Foundation Trust
Verified postcode
Salisbury, United Kingdom· Recruiting
Bristol Royal Infirmary
Verified postcode
Bristol, United Kingdom· Recruiting
Colchester General Hospital
Verified postcode
Colchester, United Kingdom· Recruiting
NHS Lanarkshire - Hairmyres Hospital
Verified postcode
East Kilbride, United Kingdom· Recruiting
Diana Princess of Wales Hospital
Verified postcode
Grimsby, United Kingdom· Recruiting
University Hospital of North Tees
Verified postcode
Stockton-on-Tees, United Kingdom· Recruiting
Royal Marsden NHS Foundation Trust
Verified postcode
Sutton, United Kingdom· Recruiting

Common questions

What is 'watch and wait'?

'Watch and wait' means that instead of having surgery, you are carefully monitored with regular scans and checks to see if the cancer comes back. It's only offered if your initial treatment has worked very well.

Will I have to take new medicines in this study?

No, this study does not involve any new or experimental medications. All decisions about chemotherapy or other standard treatments will be made by your existing medical team.

What is an mrTRG assessment?

This is a special way of looking at your MRI scan after treatment. Trained doctors use specific rules to grade how much of the original cancer is left, which helps in understanding your response to treatment.

How long will I be involved in the study?

You'll be followed for five years after your initial treatment. During this time, you'll complete a few questionnaires about your quality of life.

Why is this study important?

It's important because it could help doctors better decide who can avoid surgery for rectal cancer and still have excellent outcomes, greatly improving their quality of life. It also helps guide treatment for those who need more care.

How to find out more

Caroline Martin

cmartin1@imperial.ac.uk +44 (0) 7749 655 817 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.