A trial looking at radiotherapy for people with oesophageal cancer who have difficulty swallowing (ROCS)

Cancer type:

Oesophageal cancer

Status:

Open

Phase:

Phase 3

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.

More about this trial

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 quality of life.

One of the treatments for this is to put a metal tube (stent) inside your food pipe, where the blockage is. This keeps the food pipe open and makes swallowing easier. Unfortunately after some time the cancer may grow over the tube and swallowing becomes difficult again.

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

Trial design

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

ROCS trial diagram

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 outpatient. This will depend on the hospital you go to and what they normally do. You have radiotherapy daily, from Monday to Friday.

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.

Hospital visits

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

A member of the trial team will also call you half way between the four weekly visits.

Side effects

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

Location

Basildon
Brighton
Bristol
Canterbury
Cardiff
Coventry
Doncaster
Dundee
Eastbourne
London
Merthyr Tydfil
Middlesbrough
Newport
Nottingham
Nuneaton
Sheffield
Southampton
Southend on Sea
St Leonards-on-sea
Sutton in Ashfield
Taunton
Warwick
Weston Super Mare
Worthing

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

Dr Douglas Adamson
Dr Anthony Byrne

Supported by

Cardiff University
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
NIHR Health Technology Assessment (HTA) programme
Velindre NHS Trust

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

10160

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

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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