Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
A study comparing different types of surgery to treat cancer of the food pipe (ROMIO pilot)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
More about this trial
If you have cancer of the food pipe found at an early stage, you may have surgery, or surgery with chemotherapy. Surgery to treat cancer of the food pipe is a major operation as it usually involves removing some of the food pipe and using the stomach to replace it.
There are now 3 ways of carrying out this operation. Each aims to cure food pipe cancer, but we don’t yet know which is the best.
Researchers in this study want to compare the 3 types of surgery in a large trial. But before they can do this they need to test it on a small scale, to work out how practical it would be to recruit lots of people later on. So this pilot study will recruit and treat people with cancer of the foodpipe from hospitals in Bristol and Plymouth.
The aim of the main trial is to compare how well each type of surgery works in terms of recovery, health related
Who can enter
If you are suitable for this study, your specialist will ask if you would like to take part. People taking part will
- Be cared for by doctors at either University Hospitals Bristol NHS Foundation Trust or Plymouth Hospitals NHS Trust
- Have adenocarcinoma of the food pipe, or squamous cell cancer of the food pipe or where the food pipe meets the stomach (gastro oesophageal junction), or very abnormal cells in one of these areas (high grade dysplasia)
- Be due to have all or part of their food pipe removed, either as a first treatment or after chemotherapy to shrink their cancer
- Have cancer (or an area of high grade dysplasia) more than 5 cm below the muscle at the bottom of their throat called the cricopharyngeus – you can ask your doctor about this
- Have cancer (or area of high grade dysplasia) in less than 4 cm of the wall of their stomach – you can ask your doctor about this
- Have cancer that has not grown into other organs or body structures, though it may have grown into the membrane covering the outside of the oesophagus, the tissue covering the lungs or heart, or the muscle at the bottom of the ribcage and there may be cancer cells in 1 or 2 nearby lymph nodes (stage T4a, N1, M0)
- Be fit enough to have surgery under a
- Be at least 18 years old
You cannot enter this study if you
- Have cancer that has spread to another part of your body (stage 4 cancer)
- Have cancer that has grown into the gastro oesophageal junction from the top of your stomach (type 3 gastro oesophageal junction cancer), and you are due to have your stomach removed
- Are due to have chemotherapy and radiotherapy together (chemoradiation)
- Have had an operation to open up your chest or tummy (abdomen) before
- Have had any other cancer that may affect the treatment in this study
- Are taking part in any other trial that would interfere with this one – you can ask your doctor about this
- Are pregnant
This study will recruit 36 people. It is randomised. The people taking part will be put into different groups by a computer.
If you are a patient taking part in Plymouth, you will be put into one of 2 groups by a computer. If you are a patient in Bristol you will be put into one of 3 groups by a computer. Each group has a different type of surgery to treat their cancer of the food pipe. Neither you nor your doctor will be able to decide which group you are in. All of the surgery in the study is
If you are in group 1, you will have traditional ‘open’ surgery. Open surgery is where the surgeon makes 2 cuts in your chest and tummy (abdomen).
If you are in group 2, you will have a combination of open surgery and keyhole surgery. The surgeon will make up to 5 small cuts in your tummy and a cut in your chest.
If you are in group 3 you have keyhole surgery (this is open to Bristol patients only). With this surgery you have small cuts in your tummy and chest.
The team will audio and video record your surgery. This will help them to check that all the operations were done in a similar way. They will also audio record any appointments where the study is discussed.
You fill out a questionnaire before your surgery and then 2 days, 6 days, 6 weeks, 3 months, 6 months and 12 months after your surgery. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study. The team may also ask to interview you about your experiences of the study.
Whichever group you are in, you are likely to stay in hospital for between 8 and 14 days. You will be contacted by the study team about 9 times in the 3 years after your surgery, so they can see how you are getting on.
The team will pay travel expenses for any hospital visits that you make just for the study.
There should be no extra risk to you during this study because all 3 operations are standard procedures.
About 4 in 10 people (40%) have a complication with each of the operations. This can lead to a longer hospital stay or the need for a second operation. The study team will talk through these risks with you.
If you feel distressed in the interview about your experiences, you will be able to stop at any time.
How to join a clinical trial
Dr Chris Metcalfe
Professor Jane Blazeby
Clinical Trials and Evaluation Unit Bristol and Bristol Randomised Trials Collaboration
NIHR Health Technology Assessment (HTA) programme
National Institute for Health Research Cancer Research Network (NCRN)
University of Bristol