Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
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.
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.
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
- Have a blockage in the rectum (rectal obstruction)
- Have already had chemotherapy
- Have an infection of the
- Have another medical condition that cannot be controlled with medication
- Are taking St John’s Wort
- Are pregnant or breastfeeding
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 (
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
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.
You will see the doctor and have some tests before you take part in this trial.
These tests include
- Physical examination
- MRI scan of the pelvis
- Chest X-ray
- Blood tests including CEA
- Ultrasound scan or CT scan of the liver
You have chemoradiation as an
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
The most common side effects of cetuximab, irinotecan and capecitabine are
- Tiredness (fatigue)
- Sore mouth
- Feeling sick
- Loss of appetite
- Hair loss
- A drop in blood cells causing an increased risk of infection, bruising and bleeding problems
- Sore hands and feet (plantar palmar syndrome)
- Skin rash
The most common side effects of radiotherapy to the rectum are
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.
Dr Simon Gollins
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University College London (UCL)
This is Cancer Research UK trial number CRUK/07/043.