A trial looking at radiotherapy and chemotherapy before surgery for locally advanced rectal cancer (RICE NWCOG-2)

The trial team found the best dose of capecitabine and irinotecan to give with radiotherapy and learned about side effects.

The trial recruited 47 people, but 1 person decided not to go ahead. Of the 46 who had treatment, the first 3 had a low dose of irinotecan and capecitabine. As they didn’t have any bad side effects, the next 3 people had a higher dose and so on, for 4 different doses. This is called a dose escalation study. The side effects included

• Diarrhoea
• Tiredness
• A drop in blood cells causing an increased risk of infection
• Feeling or being sick

Of these 46 people, 43 had their cancer measured. The cancer had

• Shrunk in 18 people
• Stayed the same in 25 people

Of these 43 people, 34 had cancer cells in some of their lymph nodes. Doctors found that of these 34 people

• Fewer lymph nodes contained cancer after treatment in 30 people
• The number of lymph nodes containing cancer stayed the same in 4 people

The research team concluded that irinotecan and capecitabine with radiotherapy worked well. And that this combination should be further studied in a larger trial with more people.

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 ) and published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.