
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
This study is looking at 3 different treatments for people with soft tissue
It is for people that are over 65 years old, and have sarcoma that both:
Soft tissue sarcomas are cancers that develop in the connective and supporting tissues of the body. These include tissues such as the muscle, nerves, fat, fibrous tissue and blood vessels.
Some people are diagnosed with soft tissue sarcoma. This means that the cancer has spread, and surgeons cannot fully remove it with surgery.
Doctors treat advanced soft tissue sarcoma with a chemotherapy drug called doxorubicin once every 3 weeks. This is also called palliative chemotherapy. The aim is that the chemotherapy will help people live longer and more comfortably, but not to cure the cancer.
Doxorubicin can have side effects. These side effects might include feeling or being sick or feeling very tired (fatigue). This means chemotherapy might interfere with day to day life (quality of life).
Doctors would like to improve the quality of life of people having treatment for advanced soft tissue sarcoma. They think that giving a smaller amount of doxorubicin more often or using another chemotherapy drug called cyclophosphamide with a steroid might help. But they aren’t sure. The researchers are using this study to try and find out.
The main aims of the trial are to:
The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this trial if all of the following apply.
Who can’t take part
Cancer related
You cannot join this study if any of these apply. You:
Medical conditions
You cannot join this study if any of these apply. You:
Other
You cannot join this study if any of these apply. You:
This is an international phase 3 study. The researchers need 185 people to take part.
It is a randomised trial. You are put into a group by a computer. Neither you nor your doctor will be able to decide which group you are in. There are 3 treatment groups.
You have 1 of the following:
For every ten people taking part in the study:
Group A
You have doxorubicin as a drip into your bloodstream.
You have doxorubicin every 3 weeks. You have treatment for up to 18 weeks as long as it is working, and the side effects are not too bad.
Group B
You have doxorubicin as a drip or as a slow injection into your bloodstream.
You have doxorubicin weekly. You have treatment for up to 37 weeks as long as it is working, and the side effects are not too bad.
Group C
You have cyclophosphamide and prednisolone as tablets. You take cyclophosphamide twice a day, in the morning and evening. And you take prednisolone once in the morning. You have your treatment for one week on and then one week off. You have treatment for as long as it is working, and the side effects are not too bad.
Tissue samples
The researchers ask for a sample of your cancer that was removed when you had a . You don’t need to give a new sample. The researchers use it to look at your specific type of soft tissue sarcoma.
Quality of life questionnaires
You fill in questionnaires about your wellbeing and quality of life before you start the study. And 3, 6, 9, 12, 24, 36 and 48 weeks after joining the study.
You fill the questionnaires in when you go to your clinic appointments. Each questionnaire takes about 20 minutes to fill in.
You see the trial doctor to have tests before you can take part. The tests include:
It can take up to 4 weeks to have these tests. It might mean you have to travel to hospital more than once to have them all.
You go to the hospital to have doxorubicin as an outpatient. You do not have to stay in hospital overnight. Your team will let you know how long it takes to have the doxorubicin.
You take your cyclophosphamide and prednisolone tablets at home.
During treatment you have some tests every 3 weeks, these include:
You might also have urine tests if your doctor thinks you need them.
You have a heart function test such as a heart scan (ECG) or MUGA scan 12 weeks and 24 weeks after you started treatment. You might have heart tests after this time if your doctor thinks you need them.
You have a every 12 weeks during treatment.
At the end of treatment, around 30 days after you had your last dose, you go to the hospital to see the study team. This is to see how you are getting on. You have some of the same tests as before.
Follow up
You see the study team every 12 weeks after you finish treatment and until your cancer starts growing again. This is to see how you are feeling and you have some tests, these include:
You might have urine tests or heart function tests.
The study team get in touch with you every 6 months until 2 years after treatment if your cancer grows. This is to see how your quality of life is.
The study team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
The most common side effects of doxorubicin are:
The most common side effects of cyclophosphamide are:
The most common side effects of prednisolone are:
We have more information about:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Sarah Pratap
European Organisation for Research and Treatment of Cancer (EORTC)
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.