"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A study looking at giving a biological therapy as well as combined chemotherapy and radiotherapy before surgery for cancer of the back passage (XERXES)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This study is looking at giving the drug cetuximab as well as chemoradiation before surgery for cancer of the back passage (rectal cancer).
We know from research that cancer of the back passage (rectum) can be successfully treated with radiotherapy and chemotherapy before surgery. This combination of treatment works well for many people, but for some, the cancer comes back after a time.
A drug called cetuximab may help reduce the risk of the cancer coming back. Cetuximab is a type of biological therapy called a monoclonal antibody. Monoclonal antibodies can seek out cancer cells by looking for particular proteins on the cell’s surface.
People taking part in this study will have capecitabine chemotherapy with their radiotherapy, with or without cetuximab. The main aim of this study is to see if people do better with cetuximab, and which treatment plan works best. Researchers also hope to learn more about the safety and side effects of the combination of cetuximab, capecitabine and radiotherapy.
Who can enter
You can enter this study if
- You have cancer of the back passage (rectum) that is called adenocarcinoma of the rectum
- Your cancer is within 15 cm of the opening of your back passage
- Your doctor has a sample of your cancer that can be tested at the end of the study to see if the cells are
EGFR positive - You need to have a combination of chemotherapy and radiotherapy (chemoradiation) to shrink your cancer before it can be removed with surgery
- You are well enough to have surgery
- You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- You have satisfactory blood test results
- You are willing and able to take the tablets given to you in the study correctly, and take part in all the study tests and visits
- You are willing to use reliable contraception during the study treatment and for 6 months afterwards if there is a risk that you or your partner could become pregnant
- You are at least 18 years old
You cannot enter this study if
- You have any condition that would mean you couldn’t have radiotherapy, for example you have
ulcerative colitis , are taking sulphasalazine, have an abnormal opening in the body called afistula or areas of back passage (rectal) tissue that have stuck together - You have any condition that would stop you having capecitabine chemotherapy, for example a heart condition that is a cause for concern – you can check this with your doctor
- You have already had radiotherapy to the area between your hip bones (your pelvis), or your back passage
- You have already had chemotherapy for rectal cancer
- You have had surgery anywhere in your pelvis, for example to remove your womb (hysterectomy) or your bladder (cystectomy)
- You are opening your bowels more than 6 times a day, or you are unable to control your bowels and no one would be able to assess your diarrhoea (if you have a
stoma you can still take part) - You would have too much of your
small bowel in the way when you have radiotherapy to your back passage – you can check this with your doctor - The top of your cancer is above the level of the part of your spine called the sacrum – your doctor will be able to tell you this
- You have, or are developing, a blockage (obstruction) in your bowel
- You have an infection in your pelvis
- You have a metal reinforcing tube (stent) in your back passage to stop the cancer blocking it off
- You have a condition where your body does not make enough of an
enzyme called dihydropyrimidine dehydrogenase (you can ask your doctor about this) - You have a condition that would stop you absorbing tablets properly
- Your cancer has spread to a distant part of your body, for example to your lungs, or you have had any other cancer in the last 5 years
- You are taking medication as part of another clinical trial
- You are pregnant or breastfeeding
- You have any other condition that would make you unwell if you took part, or affect the results of the study - you can check this with your doctor
Trial design
This study is in 2 parts. Part 1 was completed a while ago. Part 2 is randomised. The people taking part are put into 2 groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
If you are in group 1, you have cetuximab through a drip into vein, once a week for 4 weeks. You then have radiotherapy and capecitabine chemotherapy (chemoradiation) every weekday for 5 weeks. After this, you have cetuximab once a week, for 5 more weeks.
If you are in group 2 you will just have the chemoradiation.
After you finish treatment, you have your surgery as planned, which is not part of the study.
The team will also ask for permission to study the tissue removed for your diagnosis (biopsy). If you are having cetuximab in the study, the team would also like to take 2 fresh tissue samples during your first course of cetuximab. And a sample of tissue from your surgery.
Everyone will also give a number of blood samples.
Hospital visits
Before you start the study you will see the doctor and have some tests. These tests include
Everyone will come to hospital every weekday for 5 weeks for chemoradiation.
If you are having cetuximab in group 1, you will also come to the hospital once a week for 4 weeks before chemoradiation. And then once a week for 5 weeks after chemoradiation.
After your study treatment and before your surgery, you will have another MRI scan.
If you are having cetuximab, you will have an extra biopsy under
- 4 hours after your first dose
- About 3 weeks after this
You will give a study blood sample whenever you have a biopsy, and also
- Before your first radiotherapy treatment, then at
- 2 hours
- 4 hours
- 24 hours
- 48 hours
Everyone taking part in the main study will see the study team for a check up at
- 3 months
- 6 months
- 12 months
- 24 months
- 36 months
Side effects
Side effects of capecitabine include
- Rash or slight burning feeling on the palms of your hands or the soles of your feet (hand foot syndrome)
- Feeling or being sick
- Diarrhoea
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Taste changes
- Chest pain
- Weakness
- Drowsiness
- Dehydration
- Hair loss
Capecitabine may affect, or be affected by, other medication. If you take phenytoin, drugs to thin your blood, vitamin B6 (pyridoxine) or antiviral treatment you must tell your study doctor.
Side effects of cetuximab include
- Pain, tenderness or cracking of finger or toenails
- Rash, spots and inflamed hair follicles
- Severe tiredness (fatigue)
- Mouth ulcers
- Feeling or being sick
- Constipation
- Tummy pain
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
Side effects of rectal radiotherapy include
- Soreness in the area being treated (until about a month afterwards), and around the area until about 2 weeks after treatment
- Tiredness
- Diarrhoea
- Needing to pass urine often
- Possible sexual problems including vaginal dryness or difficulty getting an erection
You can find out more about the side effects of capecitabine, cetuximab and rectal 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.
Chief Investigator
Dr R Glynne-Jones
Supported by
Experimental Cancer Medicine Centre (ECMC)
Merck Pharmaceuticals
NIHR Clinical Research Network: Cancer
University College London (UCL)
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040