A trial looking at docetaxel chemotherapy for advanced cancer of the stomach, the oesophagus or the junction of the stomach and oesophagus (COUGAR-02)

Who can enter

You can enter this trial if

• You have adenocarcinoma of the stomach, adenocarcinoma of the oesophagus, or adenocarcinoma at the junction of the stomach and food pipe (oesophagus)
• You have advanced cancer
• Your cancer has continued to grow or has come back within 6 months of treatment with drugs such as cisplatin and 5FU, or chemotherapy that included a drug called raltitrexed 
• You are well enough for treatment (performance status 0,1 or 2)
• You have satisfactory blood results
• You are prepared to use a reliable, barrier contraception (for example, condoms) while you are taking part in the trial and for 3 months after treatment, if there is any chance you or your partner could become pregnant
• You are at least 18 years old

You cannot enter this trial if you

• Have cancer that has spread to your brain or the tissue covering your brain and spinal cord
• Have had treatment with docetaxel or a similar chemotherapy drug (such as Taxol) in the past
• Have nerve damage (peripheral neuropathy) unless it is very mild
• Have had any other cancer in the past (apart from successfully treated basal cell skin cancer or carcinoma in situ of the cervix)
• Have any other medical condition that the doctors think will affect the treatment in this trial
• Are pregnant or breastfeeding

Trial design

This is a randomised trial. It will recruit up to 180 people into 2 groups. The people taking part are put into treatment groups by computer. Neither you, nor your doctor, will be able to decide which group you are in.

If you are in group 1 you will see the doctors at the hospital every 3 weeks for the first 18 weeks, and every 6 weeks after that. They will ask you about any symptoms you have and about how you are feeling. The doctors will treat your symptoms with medicines and other treatments such as radiotherapy.

If you are in group 2 you will have treatment for your symptoms, in the same way as group 1. And you will have the chemotherapy drug docetaxel. Each 3 week period is one cycle of treatment. You will have docetaxel through a drip into a vein on the first day of each cycle. This will take about 1 hour. You will have up to 6 cycles of treatment, but the exact number will depend on how well the treatment works, and on any side effects you have.

You will be asked to fill in a questionnaire as part of this trial. This is called a quality of life questionnaire. This will ask how you have been feeling generally. You will fill in the questionnaire

• Before you start the treatment
• Every 3 weeks for 18 weeks
• Every 6 weeks after that

Hospital visits

You will have a physical examination and some tests before you can take part in this trial. These include blood tests and a CT scan.

Everyone taking part will come to the hospital to see the doctor every 3 weeks for the first 18 weeks. You will have a physical examination and a blood test at each visit. If you are in group 2, you will also have chemotherapy at each of these visits. And you will have another CT scan after the 3rd and 6th cycle of chemotherapy.

After 18 weeks, everyone taking part will see the doctor every 6 weeks until the end of the first year, and every 3 months after that.

Side effects

The most common side effects of docetaxel chemotherapy are

• Diarrhoea
• A drop in blood cells causing an increased risk of infection, bleeding or bruising problems, tiredness and shortness of breath
• Tiredness
• Feeling or being sick
• Hair loss
• Swelling of hands or feet because of fluid retention
• Numbness or tingling in the hands or feet (peripheral neuropathy)
• Rash
• Aching muscle and joints

You can find out more about docetaxel on CancerHelp UK.