A trial to see if an MRI biomarker can decide treatment after chemoradiotherapy for people with rectal cancer (TRIGGER trial)

Cancer type:

Bowel (colorectal) cancer
Rectal cancer

Status:

Open

Phase:

Other

This trial is for people who are having chemotherapy with radiotherapy (chemoradiotherapy) before surgery for rectal (bowel) cancer.

More about this trial

Chemoradiotherapy before surgery is a treatment for rectal cancer. The aim of this treatment is to shrink the cancer making surgery more likely to be successful.

There can be differences in how well the chemoradiotherapy works. Doctors know this from looking at bowel tissue taken out after surgery. In some people the chemoradiotherapy completely gets rid of the cancer (a good response) and in other people the cancer stays the same or even grows (a poor response).

In this trial doctors want to look at a smarter way of reading the results of an MRI scan after chemoradiotherapy. They are looking at a biomarker called the mrTRG (MRI tumour regression grade). They want to see if it is possible to choose treatment based on the mrTRG results.

They hope to test this in a large phase 3 clinical trial but first they need to know that it is safe and acceptable to patients. So they are starting with a smaller trial. This is called a feasibility trial.

The aims of the trial are to see if mrTRG can

  • tell how well the chemoradiotherapy has worked
  • help  to make decisions about treatment

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.

You may be able to join this trial if all of the following apply. You

  • Have been diagnosed with a locally advanced adenocarcinoma of the rectum
  • Are due to have chemoradiotherapy including a standard dose and length of radiotherapy
  • Are willing to use reliable contraception during treatment and for up to 12 months afterwards if there is any possibility that you or your partner could become pregnant
  • Are aged 18 years or older

You cannot join this trial if any of these apply. You

  • Have rectal cancer that has spread elsewhere in the body
  • Are not able to have an MRI scan because, for example, you have a pacemaker or metal in your body
  • Are not able to have chemoradiotherapy
  • Are going to have a non standard dose of radiotherapy
  • Are allergic to or unable to have any of the chemotherapy drugs that could be used in the trial (fluorouracil, capecitabine, oxaliplatin or folinic acid)
  • Are having or planning to have any other type of chemotherapy drug or experimental drug during the time you are in this trial
  • Have had any other cancer in the last 5 years, unless it was non melanoma skin cancer or a very early stage cancer and has been successfully treated
  • Are pregnant or breastfeeding

Trial design

The researchers need 90 people to take part in this feasibility trial.

The trial has 2 steps.

Step 1
This is just before you start your chemoradiotherapy.

Blood and tissue samples
The researchers will ask you if a sample of your rectal cancer taken when you were diagnosed can sent to a central laboratory at the Royal Marsden Hospital in London. You’ll also have some extra blood tests. 

They use the cancer sample to find out more about the type of bowel cancer you have. The blood samples are for other bowel cancer research and won’t be used in your own treatment.

Quality of life
The doctors would like to know more about your quality of life at the start of your treatment. You complete 3 short questionnaires that have questions about how your bowels work and your general health.

The doctors will also ask to collect information about your health after you have taken part in the trial.

You do not have to do step 1 if you don’t want to, you can still take part in step 2 of the trial. Or you can choose to only do step 1 of this trial.

Step 2
This starts after you finish your chemoradiotherapy. 

This part of the trial is randomised. In the last 2 weeks of your chemoradiotherapy you will be put into 1 of 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

  • One group has current standard treatment Open a glossary item (the control group)
  • The other group will be split depending on whether people had a good or a poor response to chemoradiotherapy (the intervention group)

You have a 2 out of 3 chance of being in the intervention group.

Trigger trial diagram

Control group
After completing your chemoradiotherapy you have

  • an MRI scan after 4 to 6 weeks
  • surgery after 6 to 8 weeks

4 to 8 weeks after your surgery you have 6 months of chemotherapy (called adjuvant chemotherapy). 

You have a combination of chemotherapy drugs called CapOx or FolFox or you may just have one drug. This is either capecitabine or fluorouracil (5 FU).

Intervention group
Everyone in this group has an MRI scan 4 to 6 weeks after finishing their chemoradiotherapy. Using the mrTRG (MRI tumour regression grade) the doctors decide if you have had a good or a poor response to the treatment.

Intervention group- good response
You have chemotherapy for 6 months. You start 6 to 8 weeks after finishing your chemoradiotherapy.

You have a combination of chemotherapy drugs called CapOx or FolFox or you may just have one drug. This is either capecitabine or fluorouracil (5 FU).

You then have follow up appointments

  • every 3 months for the first 2 years
  • every 6 months until 5 years after your finished the chemoradiotherapy

At most of these visits you have blood tests, an MRI scan and a flexible sigmoidoscopy. At some visits you have a CT scan as well as the MRI scan and a colonoscopy instead of the sigmoidoscopy.

If any of these tests show your cancer is no longer shrinking or it has started to re grow you have surgery.

Intervention group – poor response
You have 3 months of chemotherapy. You start 6 to 8 weeks after finishing your chemoradiotherapy.

You have a combination of chemotherapy drugs called CapOx or FolFox or you may just have one drug. This is either capecitabine or fluorouracil (5 FU).

After 3 months you have an MRI scan. What happens next depends on how well the treatment has worked.

A poor response, you have about 3 to 4 weeks to recover from the chemotherapy. Then you have surgery and 4 to 8 weeks later another 3 months of chemotherapy.

A good response, you discuss with your doctor whether to have surgery or not. You have another 3 months of chemotherapy if you choose not to have surgery.

You then have follow up appointments

  • every 3 months for the first 2 years
  • every 6 months until 5 years after your finished the chemoradiotherapy

At most of these visits you have blood tests, an MRI scan and a flexible sigmoidoscopy. At some visits you have a CT scan as well as the MRI scan and a colonoscopy instead of the sigmoidoscopy. 

You have surgery if any of these tests show your cancer is no longer shrinking or it has started to re grow.

Blood and tissue samples
The doctors will ask if a sample of your cancer can sent to a central laboratory at the Royal Marsden Hospital in London if you have surgery. They use this for research to understand more about bowel cancer and how your genes Open a glossary item can influence how successful treatment is.

They ask everyone to have extra blood tests. They use these for the same research as above. Where possible they take the extra blood samples at the same time as any routine blood tests you have.

You do not have to give these samples if you don’t want to. You can still take part in the trial.

Hospital visits

How often you need to go to hospital for your chemotherapy treatment will depend on what chemotherapy drugs you have.

You have FolFox, oxaliplatin and fluorouracil (5 FU) as a drip into the vein. Capecitabine is a tablet.

How often you see the doctors after treatment depends on which group you are in

  • control group – you see the doctors every year for 3 years
  • intervention group – if you have surgery you see the doctors every year for 3 years
  • intervention group- no surgery – you have follow up as described in Trial design

At some of these follow up appointments they will ask you to complete a quality of life questionnaire. These include questions about your health and about how your bowels are working.

Side effects

The most common side effects of CapOx and FolFox include

We have more information about the side effects of

We also have information about surgery for rectal cancer.

Location

Basingstoke
Colchester
London
Salisbury
Stockton-on-Tees

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Gina Brown

Supported by

NIHR Clinical Research Network: Cancer
Pelican Cancer Foundation
The Royal Marsden NHS Foundation Trust

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

13872

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

Last reviewed:

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