A trial looking at chemotherapy or no chemotherapy after surgery for rectal cancer (Chronicle)

Please note this trial is no longer recruiting patients.

This trial is looking at capecitabine (Xeloda) and oxaliplatin chemotherapy (Eloxatin) or no chemotherapy after surgery for rectal cancer.

Doctors often treat rectal cancer with radiotherapy and chemotherapy at the same time (chemo radiation), followed by surgery. This treatment usually works well, but sometimes the cancer starts to grow again.

Doctors think that giving the chemotherapy drugs capecitabine and oxaliplatin after surgery may help stop the cancer coming back. But they are not sure yet how well this will work. Chemotherapy has side effects and it is important that patients don’t have treatments they don’t need.

The aim of this trial is to find out how well chemotherapy works after chemo radiation and surgery for rectal cancer.

Recruitment

Start 01/11/2004

End 30/04/2008

Phase

Phase 3

Who can enter

You can enter this trial if you

Have stage 1, 2 or 3 rectal cancer
Have had chemotherapy and radiotherapy (chemo radiation) followed by surgery to remove all your rectal cancer
Had surgery less than 3 months ago (you must be able to start chemotherapy within 3 months of your operation)
Are well enough for chemotherapy (performance status 0 or 1)
Have satisfactory blood test results
Are at least 18 years old

You cannot enter this trial if you

Have had the chemotherapy drug oxaliplatin in the past
Have had any other cancer in the past, apart from carcinoma in situ of the cervix or non melanoma skin cancer that was effectively treated at least 10 years ago
Have any other serious medical condition
Are pregnant or breastfeeding

Trial design

This is a randomised trial. It will recruit 800 patients into 2 groups. The people taking part will be put into treatment 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 will have routine follow up after chemo radiation and surgery. You will not have any extra chemotherapy after your operation.

If you are in group 2, you will have oxaliplatin and capecitabine after your operation. You have oxaliplatin through a drip into a vein, once every 3 weeks (one cycle). You also take capecitabine tablets twice a day for 2 weeks out of every 3. You will have 6 cycles of chemotherapy. So you have treatment for 18 weeks in total.

Hospital visits

You will go to the hospital to have some tests before you take part in this trial. These tests include

Blood tests
Physical examination
CT scan
Chest X-ray
Heart trace (ECG)

If you are in group 2, you will also have blood tests every 3 weeks, before each cycle of chemotherapy.

You will see the doctors

Every 3 months until 2 years, then
Every 6 months until 5 years, then
Every year after that

You will have a chest X-ray and a CT scan or ultrasound scan and every 6 months until 2 years, and at 3 years.

Side effects

The most common side effects of capecitabine and oxaliplatin are

A drop in blood cells causing an increased risk of infection, bleeding or bruising, tiredness and shortness of breath
Feeling or being sick
Diarrhoea
Sore mouth (mucositis)
Soreness or redness of hands or feet (palmar-plantar syndrome) with capecitabine
Numbness and tingling in hands and feet (peripheral neuropathy) with oxaliplatin

There is more information about the side effects of capecitabine and oxaliplatin on CancerHelp UK.