A trial looking at cetuximab, capecitabine and irinotecan with radiotherapy before surgery for cancer of the rectum (EXCITE)

Cancer type:

Bowel (colorectal) cancer

Rectal cancer

Status:

Results

Phase:

Phase 2

This trial looked at cetuximab, capecitabine and irinotecan with radiotherapy before surgery for rectal cancer that has spread into the surrounding tissues. It was supported by Cancer Research UK.

More about this trial

Doctors often use radiotherapy to shrink rectal cancer (bowel cancer) before surgery. You may have chemotherapy at the same time. This is called chemoradiation.

As well as killing cancer cells, some chemotherapy drugs can make cancer cells more sensitive to radiotherapy. Having chemotherapy with radiotherapy is often better at shrinking a cancer than radiotherapy alone.

Capecitabine (Xeloda) is a chemotherapy drug doctors often use in chemoradiation for rectal cancer. Irinotecan (Campto) is another chemotherapy drug that is used for bowel cancer. We know from research that using irinotecan and capecitabine together may work better than capecitabine alone.

Cetuximab (Erbitux) is a type of targeted cancer drug. We know from research that cetuximab can help radiotherapy work.

In this trial, everybody had cetuximab, irinotecan, capecitabine and radiotherapy. The aims of the trial were to find out:

how much this combination of treatment helps to shrink rectal cancer
what the side effects are

Summary of results

This trial showed that the combination of cetuximab, irinotecan, capecitabine and radiotherapy before surgery, could be a useful treatment for rectal cancer.

This trial recruited 82 people with rectal cancer. They all had cancer that had spread into the tissues around the rectum, but had not spread to another part of the body.

Of the 82 people in the trial:

80 had cetuximab, irinotecan, capecitabine and radiotherapy (this combination is called chemoradiation)
76 went on to have surgery, about 8 weeks after chemoradiation
4 had scans that showed their cancer had gone completely and decided not to have surgery

When you have an operation to remove cancer, the doctors look at the area around the operation site to see if there are any cancer cells there. They call this the margin.

When the doctors looked at the margin around the operation site in the people taking part in this trial, they found that:

67 people had no cancer (a clear margin)
8 people had a very small amount of cancer, which could only be seen under a microscope
1 person had a small area of cancer that could be seen by the doctor

They looked at how well the treatment worked, and found that:

in 3 out of 10 people (30%), the cancer had either gone completely or nearly gone
in nearly 7 out of 10 people (67%), there was no signs of the cancer growing 3 years after treatment
8 out of 10 people (80%) were living 3 years after treatment

The research team also compared the genetic changes (mutations) in samples of cancer taken before and after treatment, in 52 of the people who took part.

They found that some cancers had fewer genetic changes, and that some had new ones.

Overall, 24 people (46%) had genetic changes that were different in the cancer cells after treatment. This could be because the treatment had affected the genes in the cancer cells. Or because different areas of the same cancer have different genetic changes, so it depends where the sample is taken from.

About half of the people taking part had serious side effects. The most common serious side effects were diarrhoea, a rash and tiredness.

The research team concluded that this combination of treatment is useful before surgery, as many people had no signs of cancer in the tissues around the operation site (a clear margin). They also suggest that work should be done to make sure any genetic changes are identified accurately in biopsy samples.

We have based this summary on information from the research team. 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 who did the research. We have not analysed the data ourselves.