Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial looking at radiotherapy for people with oesophageal cancer who have difficulty swallowing (ROCS)
This trial is looking at giving radiotherapy after having a tube (stent) put in. The trial is for people with cancer of the food pipe (oesophagus) who have difficulty swallowing.
Many people with cancer of the food pipe can have difficulty swallowing. The cancer blocking the food pipe causes this. This can affect your eating, physical activity and
One of the treatments for this is to put a metal tube (
Researchers think that radiotherapy after having the tube put in may help it last longer. And so the benefits of having it in place may last longer. In this trial, after having the tube put in, some people will have radiotherapy and some won’t.
The aims of this trial are to find out
- If having radiotherapy after having the tube put in is better than not having radiotherapy
- How the addition of radiotherapy affects quality of life
Who can enter
You may be able to enter this trial if
- You have oesophageal cancer
- You are unsuitable for, or don’t want to have, surgery
- You are unsuitable for, or don’t want to have, chemotherapy with radiotherapy (chemoradiation)
- You have a blockage in your food pipe (oesophagus) that needs a tube (stent) to keep it open
- Your doctor feels you are fit enough to go to the hospital for radiotherapy
- You are at least 16 years old
You cannot enter this trial if
- You have a type of oesophageal cancer called small cell (your doctor can tell you this)
- Your cancer is longer than 12cm (your doctor can tell you this)
- Your cancer is too close to your windpipe
- You are having any other treatment done at the same time when you have the stent put in (your doctor can tell you this)
- You have an abnormal opening (fistula) between your windpipe and your food pipe
- You have a pacemaker inside the area where you would need to have radiotherapy
- You have already had radiotherapy in the area to be treated
- You are pregnant
This is a phase 3 trial. It will recruit 496 people. It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
- People in group 1 have the tube (stent) put in
- People in group 2 have the tube put in and radiotherapy
You have the tube put in your food pipe during an endoscopy. When it is in the right position, it will expand to open up your food pipe.
You will usually be approached about the trial before the tube has been put in. But you can join the trial if the tube has been put in recently.
If you have radiotherapy, you will have either 1 week or 2 weeks of treatment as an
The trial team will ask you to fill out a few questionnaires before you start treatment, 2 weeks later and then every month for a year. 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. They want to know about your experience of taking part in the trial and the reasons for agreeing to this. You don’t have to agree to the interview if you don’t want to. You can still take part in the trial.
You see the doctor or a member of the trial team
- A week before being put into your group
- A week after having the tube put in
- 4 weeks after having the tube put in
- Every 4 weeks for the rest of your life
After having the tube put in your food pipe you may feel some pain at first, particularly when you swallow. But this will settle down.
Acid indigestion may also get worse after having the tube put in place.
The most common side effects of having radiotherapy include
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.
Dr Douglas Adamson
Dr Anthony Byrne
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
NIHR Health Technology Assessment (HTA) programme
Velindre NHS Trust