A trial looking at chemotherapy for people with rectal cancer (Copernicus)

You may be able to enter this trial if you

• Have rectal cancer that can be removed with surgery
• Have cancer that can be measured on CT scan or MRI scan
• Are able to have chemotherapy
• Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
• Have satisfactory blood test results
• Are willing to use reliable contraception during treatment and for 6 months afterwards if there is any chance that you or your partner could become pregnant
• Are at least 18 years old

You cannot enter this trial if you

• Have cancer that has spread (metastases)
• Have problems absorbing tablets due to chronic diarrhoea or inflammatory bowel disease
• Have problems with your heart that are a cause for concern
• Have any other medical conditions that are a cause for concern
• Are unable to have an MRI scan
• Have had radiotherapy to the area between your hip bones (your pelvis) before
• Have had treatment on another cancer trial in the last 30 days
• Have had any other cancer, apart from carcinoma in situ of the cervix, non melanoma skin cancer or carcinoma in situ that was successfully treated at least 5 years ago
• Are pregnant or breastfeeding

This trial will recruit 62 people from the UK. Everyone taking part has the same treatment.

You have chemotherapy once every 2 weeks. Each 2 week period is called a cycle of treatment. On the first day of each cycle, you have oxaliplatin and folinic acid through a drip into a vein over 2 hours. You then have an injection of 5FU into a vein. This will take a few minutes. After this, you have an infusion of 5FU continuously over the next 46 hours.  You then have a break from treatment until the next cycle starts.

Most hospitals can give you a portable pump so that you can go home with the 5FU infusion. But to use a pump, you also need to have a central line or a PICC line. Your doctor will discuss this with you before you start your treatment.

After 4 cycles of chemotherapy you have 5 doses (fractions) of radiotherapy. You then have surgery to remove your rectal cancer. Once you have recovered from surgery, you have 8 more cycles of chemotherapy.

If you agree to take part in this study, the researchers will ask for a sample of tissue taken when you were diagnosed and another when you have surgery. Researchers will also ask for extra blood samples. If you do not want to give these samples for this study, you don’t have to. You can still take part in the trial.   

You will see the doctors and have some tests before you start treatment. The tests include

• Physical examination
• Blood tests
• Heart trace (ECG)
• MRI scan
• CT scan

On the first day of each chemotherapy cycle you have a physical examination and blood tests.

You come to hospital every day for 5 days when you have radiotherapy.

Before your surgery you have an MRI scan. One month after your surgery you see the doctors and have a blood test.

You see the trial doctors 1 and 6 months after completing your chemotherapy. You have a CT scan 6 months after completing your chemotherapy.

The most common side effects of oxaliplatin and fluorouracil (5FU) are

• A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
• Feeling or being sick
• Tiredness (fatigue)
• Numbness and tingling in your hands and feet (peripheral neuropathy)
• Diarrhoea
• Constipation
• A sore mouth
• Loss of appetite
• Sore hands and feet

The most common side effects of radiotherapy are

• Tiredness (fatigue)
• Feeling sick
• Diarrhoea
• Sore skin in the treatment area
• Passing urine more often

There is more information about oxaliplatin and fluorouracil (5FU) in our drugs section. We have more information about radiotherapy for bowel cancer.