A trial looking at chemotherapy and radiotherapy for anal cancer (EXTRA)

Cancer type:

Anal cancer




Phase 2

This trial was looking at capecitabine (Xeloda) and mitomycin C with radiotherapy for anal cancer.

Doctors often treat cancer of the anus (anal cancer) with radiotherapy and chemotherapy at the same time. This is called chemoradiation. They commonly use the chemotherapy drugs 5-fluorouracil (5FU) and mitomycin C.

Capecitabine is another chemotherapy drug. One main benefits is that it is a capsule rather than an injection. It is converted into 5FU in the body, but works in a slightly different way. Because of this, doctors hoped it would work as well as 5FU, but would cause fewer side effects because it has less effect on normal cells.

In this trial patients had capecitabine and mitomycin C with radiotherapy. The aim of the trial was to find out how well this combination worked for anal cancer.

Summary of results

The research team found that capecitabine and mitomycin C with radiotherapy was a useful treatment for anal cancer.

The trial recruited 31 people with anal cancer. Most of the people taking part had stage 2 or 3 cancer. They all had capecitabine, mitomycin C and radiotherapy.

The research team looked at the results of 30 people, 4 weeks after finishing treatment and found that the cancer had

  • Gone away completely in 24 people
  • Got smaller in 5 people
  • Stayed the same in 1 person

And 6 months after treatment the cancer had

  • Gone away completely in 28 people
  • Got smaller in 1 person
  • Continued to grow in 1 person

The most common side effects included sore skin, a drop in blood cells, diarrhoea, constipation, feeling sick and tiredness.

The research team concluded that capecitabine and mitomycin C is a safe alternative to 5FU and mitomycin C and worked well for anal cancer. Another benefit is that patients can have their treatment as an outpatient rather than having to stay in hospital for chemotherapy.

The research team recommends that a larger phase 3 trial of this treatment is done.

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 Rob Glynne-Jones

Supported by

Colorectal Clinical Oncology Group (CCOG)
Experimental Cancer Medicine Centre (ECMC)
National Institute for Health Research Cancer Research Network (NCRN)

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 468

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

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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