A trial looking at reduced dose chemotherapy for advanced bowel cancer (Focus 2; CR09)

Who can enter

You can enter this trial if you

• Have bowel cancer that has spread to another area of your body
• Cannot have surgery to cure your cancer
• Cannot have the full dose chemotherapy that is usually given for advanced bowel cancer
• Are well enough for reduced dose chemotherapy (performance status 0, 1 or 2)
• Have satisfactory blood test results

You cannot enter this trial if you

• Have had chemotherapy for advanced bowel cancer before
• Have a partial or complete blockage in your bowel (bowel obstruction)
• Have had chemotherapy after an operation (adjuvant chemotherapy) in the last 4 months
• Have had oxaliplatin before
• Have had chemoradiation for rectal cancer in the last month
• Are well enough for full dose chemotherapy
• Have any other serious illness
• Are pregnant

Trial design

This is a phase 3 randomised trial. To begin with 120 patients will be recruited. If all goes well, another 340 patients will be recruited, making 460 in total.

There are 4 treatment groups. 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 5FU alone through a drip into a vein. You have treatment over 2 days, once every 2 weeks for a total of 12 weeks (6 cycles).

• If you are in group 2 you will have 5FU and oxaliplatin through a drip into a vein. You have 5FU over 2 days, and oxaliplatin over 2 hours on the first day, once every 2 weeks for a total of 12 weeks (6 cycles).

• If you are in group 3 you will have capecitabine alone. Capecitabine is a tablet form of 5FU that you take twice a day for 2 weeks. Then you don’t take any for a week. You do this for a total of 12 weeks (4 cycles).

• If you are in group 4, you will have capecitabine and oxaliplatin. You take capecitabine tablets twice a day for 2 weeks, then take none for a week. And you have oxaliplatin on the first day through a drip into a vein over 2 hours, once every 3 weeks for a total of 12 weeks (4 cycles).

After 6 weeks the doctors will assess how well you are. This will be after either 2 or 3 cycles depending on which group you are in. If you are not having serious side effects, they may decide to increase the dose of chemotherapy you are having. But if you are feeling very unwell and having problems with side effects, they will not increase the dose.

After 12 weeks the doctors will assess how well the treatment is working. If it is working well, you will have more of the same treatment if your cancer starts to grow again. If the treatment is not working you may have different chemotherapy drugs. This is called second line treatment. Or you may have other treatments to help with the symptoms you are having. This is called supportive care.

Hospital visits

You will have some tests before you take part in the trial. These include

• Blood tests
• CT scan or MRI scan
• Physical examination

If you are in group 1 or 2 you will need a central line. This is put in before you start treatment, and will stay in place during the 12 weeks or more that you are having chemotherapy. You have chemotherapy through your central line for 2 days every 2 weeks.

You go to hospital to have a small pump attached to your central line for your chemotherapy. You don’t need to be in hospital overnight, you can go home with your pump attached. And then go back to the hospital 2 days later to have it disconnected.

If you are in group 3 you take chemotherapy tablets at home. You go to the hospital once every 3 weeks for blood tests. And to pick up the next 2 week supply of tablets.

If you are in group 4 you will go to the outpatients department for chemotherapy once every 3 weeks.

You will have blood tests at the start of each cycle (every 2 or 3 weeks, depending on which group you are in). You will have a CT scan after 12 weeks. After treatment, you will see the doctors every 12 weeks (3 months).

Side effects

All the chemotherapy drugs used in this trial have some side effects. But because you will have a lower dose than usual, the doctors hope you will have fewer side effects.

The side effects of full doses of 5FU, capecitabine and oxaliplatin include

• A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
• Feeling or being sick
• Sore mouth
• Diarrhoea
• Numbness and tingling in hands and feet (peripheral neuropathy) with oxaliplatin
• Soreness and redness on hands and feet (Palmar - plantar syndrome)

There is more information about 5FU, capecitabine and oxaliplatin on CancerHelp UK.