A study looking cetuximab, chemoradiotherapy and surgery for rectal cancer (XERXES)

Cancer type:

Bowel (colorectal) cancer

Rectal cancer

Status:

Results

Phase:

Phase 1/2

This study looked at having cetuximab as well as chemoradiotherapy Open a glossary item before surgery for cancer of the back passage (rectal cancer).

It was open for people to join between 2011 and 2012. The team published the results in 2020.

More about this trial

Doctors often treat rectal cancer with chemotherapy and radiotherapy at the same time (chemoradiotherapy) followed by surgery. When this study was done, they often used the chemotherapy drug capecitabine.

Researchers wanted to find out if having cetuximab (Erbitux) as well could help stop the cancer coming back. Cetuximab is a type of targeted cancer treatment called a monoclonal antibody.

The people in this study had either:

capecitabine and radiotherapy
cetuximab, capecitabine and radiotherapy

The main aims of the study were to find out:

more about the side effects
if it is useful to have cetuximab as well as chemoradiotherapy and surgery

Summary of results

There were 2 parts to this study – phase 1 and phase 2.

The 12 people in phase 1 all had cetuximab before chemoradiotherapy, and then surgery. Everyone in this group had their operation as planned.

The 10 people in phase 2 were put into a treatment group at random. There were:

5 people in group A - chemoradiotherapy and then surgery
5 people in group B - cetuximab, chemoradiotherapy, more cetuximab and then surgery

Not everyone in this group went on to have surgery:

3 out of 5 people in group A had surgery
4 out of 5 people in group B had surgery

The study team looked at how many people’s cancer had gone completely after their operation. They call this complete response. They found it was:

1 person in phase 1
2 people in phase 2, group A
1 person in phase 2, group B

Part way through the study, other research showed that cetuximab worked best for people with specific genetic changes. The team decided to stop this study early as they weren’t testing for genetic changes. So fewer people joined the study than originally planned.

Side effects
Most people had at least one side effect from treatment. But many of these were mild or didn’t last long.

The most common side effects included:

diarrhoea
feeling sick (nausea)
extreme tiredness (fatigue)
rash

More people who had cetuximab had diarrhoea, nausea and a rash than people who only had chemoradiotherapy.

We have more information about cetuximab in our Cancer drugs section.

We have more information about chemoradiotherapy in our Bowel cancer section.

Conclusion
It’s hard to draw any firm conclusions because of the small number of people in each group. But the study team concluded that cetuximab:

may work alongside chemoradiotherapy and surgery for rectal cancer
didn’t cause too many side effects

They suggested that other studies are done to find out more.

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

Please note, the information we link to here is not in plain English. It has been written for healthcare professionals and researchers.

A Phase I/ II Feasibility Study of Intravenous Cetuximab in Combination with 5 days Weekly Oral Capecitabine and Preoperative Radiotherapy in Rectal Cancer (XERXES)
R Glynne-Jones and others
Archives of Clinical and Biomedical Research, 2020. Volume 4, issue 4, pages 394-412

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.