A trial looking at chemotherapy before surgery for people with cancer of the foodpipe (oesophagus) (OE05 trial)

Who can enter

You can enter this trial if you

• Have adenocarcinoma of the oesophagus that is stage 2B or stage 3, or
• Have stage 4 oesophageal cancer that has only spread to your diaphragm or to the lining of your lungs (the pleura), and not to any other part of your body, or
• Have cancer just above or at the area where the oesophagus meets the stomach (type 1 or type 2 cancer of the oesophago-gastric junction)

In addition to that, you must also

• Be well enough to have chemotherapy and surgery (performance status 0 or 1)
• Have satisfactory blood test results

You cannot enter this trial if you

• Have stage 1 cancer of the oesophagus
• Have stage 4 cancer of the oesophagus that has spread to another part of your body, apart from the diaphragm or pleura
• Have cancer just below the area where the oesophagus meets the stomach (type 3 cancer of the oesophago-gastric junction)
• Have had treatment for your oesophageal cancer before
• Have had any other cancer in the past, except for basal cell skin cancer or carcinoma in situ of the cervix
• Have severe ringing in your ears (tinnitus) - you can take part if you have mild tinnitus, or tinnitus that comes and goes
• Have a serious heart condition, or have had angina or a heart attack in the last 6 months
• Have HIV, Hepatitis B or Hepatitis C
• Have any other serious medical condition
• You are pregnant or breast feeding

Trial design

This is a randomised trial. It will recruit 842 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 cisplatin and 5 fluorouracil (5FU) chemotherapy (‘CF’). You have cisplatin through a drip into a vein and a 4 day infusion of 5FU once every 3 weeks (one cycle). You will have two cycles over 6 weeks. You will have an operation 4 to 6 weeks after you finish chemotherapy.

If you are in group 2, you will have epirubicin, cisplatin and capecitabine (Xeloda)chemotherapy (‘ECX’). You have epirubicin and cisplatin through a drip into a vein once every 3 weeks (one cycle). You have 4 cycles over 12 weeks (3 months). At the same time, you take capecitabine tablets twice a day for the whole 12 weeks. You will have an operation 4 to 6 weeks after you finish chemotherapy.

You will fill out a questionnaire before, during and after your chemotherapy course. You will also complete the questionnaire at various points after your operation. It will ask you how you are feeling, and about any side effects you have had. This is called a quality of life questionnaire.

The researchers will ask your permission to get a sample of your tumour that was taken when you had a biopsy. And to take another sample when you have surgery. They will also ask for 2 extra blood samples. This is so that they can try to find substances they can measure in the body to help them tell how treatment is working. They call these substances biomarkers. If you don’t want to give these samples for research, you don’t have to. You can still take part in the trial.

Hospital visits

You will need to go to the hospital for tests before you have chemotherapy. These tests include

• CT scan
• Ultrasound scan of your oesophagus
• Blood tests
• Physical examination
• Nutritional assessment

You may also have a hearing test, a bone scan and a PET scan. You will have blood tests before each cycle of chemotherapy. And another CT scan between finishing chemotherapy and having your operation.

If you are in group 1, you may be in hospital for 4 days when you have 5FU. You have this twice. But you may be able to have chemotherapy at home through a central line.

If you are in group 2, you will be in hospital overnight to have the epirubicin and cisplatin chemotherapy, on 4 occasions (once every 3 weeks). You will take the capecitabine tablets at home.

You will have an operation to remove part of your oesophagus (an oesophagectomy) and probably some lymph nodes as well. This is a major operation, and you may be in intensive care or the high dependency unit for a while after your operation. You are likely to be in hospital for a couple of weeks altogether. There is more information about ‘having your operation’ for oesophageal cancer on the main oesophageal cancer section of CancerHelp UK.

After your operation you will see the doctors

• Every 3 months for a year, then
• Every 6 months for 2 years, then
• Once a year after that

Side effects

All chemotherapy drugs have some side effects. The most common side effects of the drugs used in this trial are

• A drop in blood cells causing an increased risk of infection, bleeding and bruising problems, tiredness and shortness of breath
• Feeling or being sick
• Diarrhoea
• Sore mouth (mucositis)
• Kidney damage with cisplatin
• Hair loss with epirubicin and 5FU

There is more information about the side effects of cisplatin, fluorouracil (5FU), epirubicin and capecitabine in the chemotherapy section of CancerHelp UK.