A trial looking at chemotherapy or no chemotherapy after surgery for rectal cancer (Chronicle)

Cancer type:

Bowel (colorectal) cancer
Rectal cancer

Status:

Results

Phase:

Phase 3

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 statistically significant Open a glossary item.

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 (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 R Glynne-Jones

Supported by

Cancer Research UK
NIHR Clinical Research Network: Cancer
University College London (UCL)

Other information

This is Cancer Research UK trial number CRUK/03/009.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 340

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

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

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