A trial looking at gefitinib for people with advanced cancer of the food pipe (oesophagus) - COG Trial

You can enter this trial if

• You have oesophageal cancer that has started to grow again after chemotherapy (the original cancer may have been where the oesophagus meets the stomach or just above - cancer of the oesophago-gastric junction)
• Your cancer can be measured on a CT scan
• You are well enough to take part (performance status 0,1 or 2)
• You are able to take tablets (either whole or dissolved in liquid)
• You have satisfactory blood test results
• You are willing to use reliable contraception if there is a chance that you or your partner could become pregnant
• You are at least 18 years old

You cannot enter this trial if you

• Have already had more than 2 courses of chemotherapy and 1 course of chemotherapy and radiotherapy combined (chemoradiation)
• Have had chemotherapy in the last 6 weeks 
• Have had radiotherapy to treat your cancer in the last 4 weeks
• Have cancer that has spread to the brain (if you have had radiotherapy to the brain and your condition is stable, you may be able to take part)
• Have or have had another type of cancer that could affect your taking part in this trial
• Have a condition called interstitial lung disease - you can check this with your doctor (If you have long term or stable disease you may still be able to take part)
• Have any other medical condition that would make it difficult for you to take part
• Are allergic to gefitinib or any of the other ingredients in the product
• Are taking any other drugs to treat your cancer, or hormone treatments (not including contraceptive pills) or as part of another clinical trial
• Are pregnant

This trial will recruit 450 people in total. It is a randomised trial. You will be put into one of two treatment groups by a computer. Neither you nor your doctor will be able to choose which group you are in, or be told which group you are in. This is called a double blind trial.

One group will take gefitinib tablets, and the other will take dummy tablets (placebo tablets). You take 2 tablets of gefitinib or placebo each day for 3 months. After this, if your doctors feel that the treatment is helping and you don’t have any serious side effects, you may be able to continue with it.

You will fill out 2 questionnaires

• Before you start treatment
• Every 4 weeks for the next 3 months

The questionnaires will ask about how you have been feeling, any changes to your daily activities and any pain you may have. These are called quality of life questionnaires.

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

• Physical examination
• Blood tests
• CT scan

You will go to the hospital every 4 weeks for the first 4 months, and then every 8 weeks for as long as you are taking part in this study. During these visits you will have blood tests and a CT scan.

All treatments have side effects. As gefitinib is a relatively new drug there may be some side effects that doctors don’t know about yet. In trials so far, the most common side effects are

• Diarrhoea
• Feeling or being sick
• Skin rash which can look like acne and may be red and itchy

There is more information about the side effects of gefitinib on CancerHelp UK.