A trial looking at chemoradiotherapy with or without cetuximab for cancer of the food pipe (oesophagus) (SCOPE1)

This trial is looking at chemoradiotherapy combined with a new drug called cetuximab as a treatment for cancer of the food pipe (oesophageal cancer).

If your cancer has not spread to other parts of your body, your doctors may suggest that you have a combination of chemotherapy and radiotherapy (chemoradiotherapy). This trial will look at giving cetuximab as well as chemoradiotherapy.

Cetuximab is a type of biological therapy, called a monoclonal antibody. Doctors have tested it in people with bowel cancer and head and neck cancers and the results have been promising. They hope that cetuximab will help chemoradiotherapy to work better for people with oesophageal cancer. But they are not sure yet how well it will work.

The aim of this trial is to find out how well chemoradiotherapy and cetuximab works for oesophageal cancer. And to find out more about the side effects.

Recruitment

Start 16/01/2008

End 01/03/2011

Phase

Phase 3

Who can enter

You can enter this trial if you

Have stage 1, 2 or 3 oesophageal cancer and your doctors think you should have combined chemotherapy and radiotherapy (chemoradiotherapy) to try and cure your cancer
Have a cancer that is less than 10 cm long in total
Are well enough for treatment (performance status 0, or 1)
Have satisfactory blood test results
Have satisfactory heart and lung function
Are able to take tablets by mouth
Are prepared to use reliable contraception while you are taking part in the trial if there is any chance that you or your partner could become pregnant
Are at least 18 years old

You cannot enter this trial if you

Have had treatment in the past for oesophageal cancer (you may still be able to take part if you had laser treatment or photodynamic therapy (PDT) for high grade dysplasia or carcinoma in situ)
Have stage 4 oesophageal cancer that has spread to other parts of your body, apart from to your lymph nodes
Have cancer in the lower part of your oesophagus which has grown more than 2 cm into your stomach
Have had surgery in the last 4 weeks
Have had treatment with a monoclonal antibody in the last 4 weeks
Have had radiotherapy in the last 3 months
Have had treatment for cancer in the past which the doctors think will affect whether you can have this treatment, or affect the results of this trial
Have a heart condition that is not controlled by medication (for example high blood pressure, angina or heart failure)
Have severe hearing difficulties, or have lost feeling or movement in part of your body (your doctor can tell you more about this)
Are taking any medicines or have another medical condition which the doctors think will affect your treatment or the results of this trial
Have had any other cancer in the last 5 years
Are pregnant

Trial design

This is a randomised trial. It will recruit 420 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 have cisplatin, capecitabine and radiotherapy. You have cisplatin through a drip into a vein once every 3 weeks. Each 3 weeks of treatment is one cycle. You will have 4 cycles of cisplatin over 12 weeks. You take capecitabine tablets twice a day for 12 weeks. At the same time, you will have radiotherapy for 5 weeks. This will start in week 7.

If you are in group 2 you will have the same treatment as those in group 1. So you will have cisplatin, capecitabine and radiotherapy as above. But you will also have cetuximab through a drip into a vein once every week for the 12 week treatment period.

You will be asked to fill out a questionnaire before you start the treatment, and then again after

6 weeks
3 months
6 months
Every year after that

This will ask you how you have been feeling and about any side effects you have had. It is called a quality of life questionnaire.

Hospital visits

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

Physical examination
A test to look inside your oesophagus (endoscopic ultrasound)
CT scan
Blood tests
Heart trace (ECG)
Kidney function test

If you are in group 1 you will go to the hospital outpatients and have treatment every 3 weeks. If you are in group 2 you will go to the hospital outpatients and have treatment once every week.

As well as this, everyone taking part will see the doctors and have a blood test every 3 weeks for the first 6 weeks of treatment (2 cycles), and then every week after that until the end of treatment.

At the start of week 7, everyone taking part will go to the hospital daily, from Monday to Friday, for 5 weeks, for radiotherapy treatment. You will not need to stay in hospital overnight as part of this trial.

3 months after the end of treatment you will see the doctors and have an endoscopy and CT scan. You will see the doctors every 3 months for the first year, every 4 months for the second year, and then every year for at least 3 years.

Side effects

All chemotherapy drugs have side effects. The most common side effects of cisplatin and capecitabine are

Feeling or being sick
A drop in blood cells causing an increased risk of infection, bleeding or bruising problems, tiredness and shortness of breath
Reduced kidney function with cisplatin (you will have lots of fluids to stop this happening)
Numbness of tingling in your hands and feet
Reduced hearing of high pitched sounds with cisplatin
Sore mouth
Hair loss
Redness or soreness on hands and feet (plantar palmar or hand - foot syndrome)
Diarrhoea

The most common side effect of cetuximab is