Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial looking at chemotherapy or no chemotherapy after surgery for rectal cancer (Chronicle)
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This trial compared capecitabine (Xeloda) and oxaliplatin (Eloxatin) chemotherapy with no chemotherapy after surgery for rectal cancer. This trial was supported by Cancer Research UK.
Doctors often treat rectal cancer with radiotherapy and chemotherapy at the same time (chemoradiation), followed by surgery. This treatment usually works well, but sometimes the cancer starts to grow again.
Doctors thought that giving the chemotherapy drugs capecitabine and oxaliplatin after surgery may help to stop the cancer coming back. But they were not sure how well this would work. Chemotherapy has side effects and it is important that patients don’t have treatments they don’t need.
The aim of this trial was to find out how well chemotherapy worked after chemoradiation and surgery for rectal cancer.
Summary of results
This trial did not recruit very well and so closed early. Because of this, the trial team felt they could not come to any definite conclusions about the advantage or otherwise of having chemotherapy after rectal cancer surgery.
At the close of the trial 113 people had joined.
- 59 people had no chemotherapy after surgery (usual follow up)
- 54 people had capecitabine and oxaliplatin after surgery
After an average follow up of just over 3½ years, the researchers looked at the number of people whose rectal cancer had come back or who had sadly died since their treatment. Of these
- 16 people had no chemotherapy after surgery
- 12 people had chemotherapy after surgery
Because of the small numbers of people who took part, both of these results could have happened by chance. And so these results are not
The trial team couldn’t make a definite conclusion. They cannot say whether it helps to have chemotherapy after chemoradiation and surgery for rectal surgery. But say that their findings support the need for trials to find this out.
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 (
How to join a clinical trial
Dr R Glynne-Jones
Cancer Research UK
NIHR Clinical Research Network: Cancer
University College London (UCL)
This is Cancer Research UK trial number CRUK/03/009.