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

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Bowel (colorectal) cancer
Rectal cancer

Status:

Closed

Phase:

Phase 2

This trial is looking at having cetuximab (Erbitux), capecitabine (Xeloda) and irinotecan (Campto) with radiotherapy before surgery for rectal cancer that has spread into the surrounding tissues. This trial is supported by Cancer Research UK.

Doctors often use radiotherapy to shrink rectal cancer before surgery. You may have chemotherapy at the same time. This is called chemoradiation. As well as killing some 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 is a chemotherapy drug doctors often use in chemoradiation for rectal cancer. Irinotecan 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 is a type of biological therapy. We know from research that cetuximab can help radiotherapy work.

In this trial, everybody will have cetuximab, irinotecan, capecitabine and radiotherapy. The aims of the trial are to find out

  • How much this treatment helps to shrink rectal cancer
  • What the side effects are

Who can enter

You can enter this trial if you

  • Have type of rectal cancer called adenocarcinoma that has spread outside the rectum into the surrounding tissues
  • Are able to have surgery (your doctor can advise you about this)
  • Are able to have radiotherapy (your doctor can advise you about this)
  • Are well enough for treatment (performance status 0 or 1)
  • Have satisfactory blood test results
  • Are willing to use reliable contraception if there is a chance that you or your partner could become pregnant

You cannot enter this trial if you

  • Have rectal cancer that has spread to other parts of the body
  • Have cancer that is close to the anus Open a glossary item
  • Have a blockage in the rectum (rectal obstruction)
  • Have already had chemotherapy
  • Have an infection of the pelvis Open a glossary item
  • Have another medical condition that cannot be controlled with medication
  • Are taking St John’s Wort
  • Are pregnant or breastfeeding

Trial design

This is a national study. It will recruit about 80 people around the UK. Everybody taking part will have cetuximab, irinotecan, capecitabine and radiotherapy, followed by surgery.

You have 6 treatments of cetuximab. The first treatment is 1 week before you start radiotherapy. You have cetuximab each week until the end of radiotherapy. You have cetuximab through a drip in a vein (intravenous infusion Open a glossary item). The first treatment takes 2 hours. Following treatments may only take 1 hour.

You have 4 treatments of irinotecan. The first treatment is in the second week, which is the same week you start radiotherapy. You have irinotecan each week for 3 more weeks. You have irinotecan through a drip in a vein. This takes 1 hour.

Capecitabine is a tablet. You have several tablets of capecitabine to take twice a day. You take these tablets Monday to Friday only, for 5 weeks. You do not take the tablets on the weekends. You are given enough capecitabine each week to take home. You start taking the tablets when you start radiotherapy.

You have radiotherapy Monday to Friday for 5 weeks.

You will have surgery 8 weeks after you finish radiotherapy.

If you take part in this trial, the researchers will ask your permission to take extra blood samples, and samples of tissues from when you had a biopsy Open a glossary item and when you have surgery. These samples will be stored safely and may be used in the future, but for research purposes only. This is because studying these samples may help researchers learn more about rectal cancer.

If you don’t wish to give these extra samples for research, you don’t have to. You can still take part in the trial.

Hospital visits

You will see the doctor and have some tests before you take part in this trial.

These tests include

You have chemoradiation as an outpatient Open a glossary item. In week 1 you go to the hospital for 1 day. In weeks 2 to 6 you go to the hospital every day, Monday to Friday to have your radiotherapy. One day each week, in weeks 2 to 6, you will have chemotherapy as well as radiotherapy.

You will have your operation to remove your rectal cancer 8 weeks after radiotherapy.

Two weeks before your operation you will have

  • Blood tests
  • MRI of the pelvis

After your chemoradiation you see your doctors at

  • 6 months
  • 1 year
  • 2 years
  • 3 years

Side effects

The most common side effects of cetuximab, irinotecan and capecitabine are

The most common side effects of radiotherapy to the rectum are

There is more about the side effects of cetuximab, irinotecan, capecitabine and radiotherapy on CancerHelp UK.

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 Simon Gollins

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University College London (UCL)

Other information

This is Cancer Research UK trial number CRUK/07/043.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 2129

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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