A study looking at a new way of MRI scan reporting before surgery for rectal cancer (Beyond TME)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This study is looking at a new and more detailed way of reporting MRI scans before surgery for rectal cancer. It is for people who have rectal cancer that has grown into surrounding tissues or has come back after treatment.
More about this trial
Doctors usually treat rectal cancer with surgery. Sometimes people need more extensive surgery to remove their tumour. This is called exenterative surgery. It usually involves removing other organs within the area between your hipbones (your pelvis) in order to remove the entire tumour.
Before you have exenterative surgery, you have an MRI scan to see how far the cancer has grown. And a to show that it hasn’t spread outside of the pelvis to another part of the body.
The researchers in this study are looking at a new and more detailed way of reporting the MRI scan. They hope this will give the surgeon carrying out your exenterative surgery more information about the tumour.
The aims of the study are to find out if the new way of MRI scan reporting
- results in improved surgical planning and how well people do after surgery
- is accurate in checking how far the cancer has spread before surgery
Joining this study will not change your treatment, and you may not get any direct benefit from taking part. The researchers hope that the information they collect will help to improve MRI reporting before exenterative surgery for rectal cancer in the future.
Who can enter
The following bullet points list the entry conditions for this study. If you are unsure about any of these speak with your doctor or the study team. They will be able to advise you.
You may be able to join this study if all of the following apply.
- You have rectal cancer that has grown into surrounding tissues or come back after treatment
- You have had an MRI scan, a CT scan and possibly a PET-CT scan to assess the cancer
- You are having treatment at the Royal Marsden Hospital in London or Surrey
- You are at least 18 years old
You cannot join this study if any of these apply. You
- Have rectal cancer that has spread to another part of the body and it isn’t possible to remove it with an operation
- Can’t have an MRI for any reason, for example, you have certain types of metal surgical clips, metal pins or plates or a pacemaker
- Have
anal cancer - Have diabetes that isn’t well controlled with medication
Trial design
The researchers need about 210 people to take part. The study is for people having treatment at the Royal Marsden Hospital in London or Surrey. The researchers expect about one third (70 people) will go on to have exenterative surgery.
If you are going to have surgery this will go ahead as usual. Your doctor can tell you more about this and how long you stay in hospital afterwards.
After surgery, specialist doctors will look at the removed bowel cancer section to confirm how far the cancer has spread. Depending on this, you may need further treatment such as chemotherapy or radiotherapy. Your doctor can tell you more if this applies to you.
The researchers will compare the laboratory findings with the information in the detailed MRI scan report. This will help them to work out how accurate the new way of MRI reporting is.
The study team will also ask to keep a tissue sample from your surgery to check for cancer gene changes ().
If you do not have surgery, you may or may not be offered other treatments such as radiotherapy or chemotherapy and these will go ahead as usual.
For those having surgery, the study team will ask you to fill out a questionnaire when you are first seen and then at
- 1 year
- 2 years
- 3 years
This questionnaire will ask how you’ve been feeling. This is called a .
Hospital visits
You won’t have any extra hospital visits or tests as a result of taking part in this study.
The study team will follow everyone up who joined once a year for up to 3 years. They will check your medical notes to see how you are getting on.
Side effects
The researchers don’t expect there to be any side effects as a result of taking part in this study.
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.
Chief Investigator
Dr Gina Brown
Supported by
Pelican Cancer Foundation
The Royal Marsden NHS Foundation Trust
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040