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

Cancer type:

Oesophageal cancer

Status:

Results

Phase:

Phase 3

This trial looked at having radiotherapy after having a tube (stent) put in to help with swallowing. An oesophageal stent is a small expandable metal tube put into the food pipe (oesophagus) to keep it open. 

This trial was open for people to join between 2013 and 2018. The team published the results in 2021.

More about this trial

Many people with cancer of the food pipe have difficulty swallowing. This is because cancer in the food pipe can partly or completely block it and make it difficult to swallow. This can affect eating, drinking, physical activity and quality of life Open a glossary item.

When this trial was done, one of the treatments was to put a metal tube (stent Open a glossary item) inside the food pipe, where the blockage was. This keeps the food pipe open and makes swallowing easier. Sometimes the cancer grows over the tube and swallowing becomes difficult again. The means more hospital visits and stays.

Doctors wanted to find ways to keep the food pipe open for longer. They thought that having radiotherapy after having the stent fitted could help. But they weren’t sure so wanted to find out more. 

Everyone in the trial had an oesophageal stent. And then some people had radiotherapy and some didn’t. 

The main aims of this trial were to find out:

  • if adding radiotherapy helps to keep the food pipe open
  • how adding radiotherapy affects quality of life

Summary of results

Trial design
202 people took part in this trial. Everyone had a metal tube (stent) fitted. They were then put into one of two groups at random:

  • 102 had care as usual 
  • 97 had radiotherapy 

Results
The research team looked to see if adding radiotherapy helped. They compared the two groups. They looked at:

  •  whose swallowing got worse
  • how long people lived

At 12 weeks the results showed there wasn’t much of a difference between the two groups:

  • with swallowing
  • in how long people lived 

The team looked at the length of time before people developed bleeding from the cancer. They found this was about:

  • 49 weeks in people who had usual care
  • 62 weeks in people who had radiotherapy 

Side effects
The trial team looked at the more severe side effects of treatment. The most common for both groups were:

  • tiredness (fatigue)
  • difficulty swallowing
  • a drop in red blood cells (anaemia Open a glossary item)

Quality of life
The results aren’t available for the quality of life part of the trial. We hope to add them in when they become available. 

Conclusion
The trial team concluded that having radiotherapy after a stent isn’t recommended as part of routine care. The findings suggest that radiotherapy could be useful for people who have an increased risk of bleeding from the cancer. 

The team suggest more trials are done to find ways to help people with swallowing difficulties that oesophageal cancer can cause. They also found there were gaps in the support available to people and their families. They suggest that this also needs to be looked into. 

All trial results help doctors and researchers understand more about different cancers and the best way to treat them.

More detailed information
There is more information about this research in the reference below. 

Please note, this article is not in plain English. It has been written for health care professionals and researchers.

Journal articles
Palliative radiotherapy after oesophageal cancer stenting (ROCS): a multicentre, open-label, phase 3 randomised controlled trial
D Adamson and others 
The Lancet Gastroenterology and Hepatology. Volume 6, Issue 4, Pages 292 – 303. 

Where this information comes from    
We have based this summary on the information in the article above. This has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. We have not analysed the data ourselves. As far as we are aware, the link we list above is active and the article is free and available to view.

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
Professor 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

If you have questions about the trial please contact our cancer 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.

Last reviewed:

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