A trial of chemoradiotherapy with or without cetuximab for oesophageal cancer (SCOPE1)

Cancer type:

Oesophageal cancer

Status:

Results

Phase:

Phase 2/3

This trial was looking at a drug called cetuximab alongside chemotherapy and radiotherapy for cancer of the food pipe (oesophageal cancer). The trial was supported by Cancer Research UK.

If oesophageal cancer has not spread to other parts of your body, your doctors may suggest that you have a combination of chemotherapy and radiotherapy. This is called chemoradiotherapy.

This trial looked at having cetuximab as well as chemoradiotherapy. Cetuximab is a type of biological therapy, called a monoclonal antibody.

The aims of the trial were to

  • See if adding cetuximab to chemoradiotherapy helped people with oesophageal cancer
  • Learn  more about the side effects

Summary of results

The trial team found that adding cetuximab to chemoradiotherapy did not help people with oesophageal cancer and caused more side effects.

The trial recruited 258 people with oesophageal cancer that hadn’t spread to other parts of the body. Their average age was 67. It was a randomised trial. The people taking part were put into 1 of 2 treatment groups at random. Neither they nor their doctor could choose which group they were in.

Everybody had the chemotherapy drugs cisplatin and capecitabine as well as 5 weeks of radiotherapy. Half the people taking part also had cetuximab.

The committee set up to monitor the safety of the trial (the data monitoring committee) analysed some early results from the first 180 people recruited to the trial.

They looked at how many people were alive with no signs of cancer in their food pipe or elsewhere in their body 12 weeks after finishing treatment. They found this was

  • 79 out of 119 people who had chemoradiotherapy and cetuximab
  • 93 out of 121 people who had chemoradiotherapy only

As these results showed that adding cetuximab was not helping, they stopped recruiting people to the trial. But the trial team continued to follow up the people who had already joined.

They found that on average, the overall length of time people lived was

  • Just over 22 months in the group of people who had chemoradiotherapy and cetuximab
  • Over 25 months in the group who had chemoradiotherapy alone

They also found that people who had cetuximab had more side effects, particularly skin problems. And more people in the cetuximab group stopped having chemoradiotherapy because of side effects or illness than in the chemoradiotherapy only group.

The trial team concluded that adding cetuximab to chemoradiotherapy cannot be recommended as treatment for oesophageal cancer.

We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.

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 Tom Crosby

Supported by

Cancer Research UK
Department of Health
Health and Care Research Wales
Medical Research Council (MRC)
Merck Serono UK
National Institute for Health Research Cancer Research Network (NCRN)
Velindre NHS Trust
Wales Cancer Trials Unit

Other information

This is Cancer Research UK trial number CRUK/07/003.

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

797

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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