A study looking at giving a biological therapy as well as combined chemotherapy and radiotherapy before surgery for cancer of the back passage (XERXES)

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 a fistula 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