"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial looking at the treatment of children and young people with non rhabdomyosarcoma soft tissue sarcomas (EpSSG NRSTS 2005, STS 2006 03)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is trying to find the best treatment for children and young people with non rhabdomyosarcoma soft tissue sarcomas.
This trial is for children and young people up to and including the age of 20. We use the term ‘you’ in this summary, but of course if you are a parent, we are referring to your child.
More about this trial
Soft tissue sarcomas are a type of cancer of the supporting tissues of the body. For example, muscle, nerve or fat tissues. Doctors find it useful to sort the types of soft tissue sarcomas into groups.
Children with soft tissue sarcoma are usually put into one of two groups - rhabdomyosarcoma and non rhabdomyosarcoma. Non rhabdomyosarcoma includes a variety of different sub types. Children with non rhabdomyosarcoma are usually treated with surgery and sometimes chemotherapy or radiotherapy, or both.
In this trial, doctors want to treat a large group of children with non rhabdomyosarcoma according the same treatment protocol (called EpSSG). This protocol has been established as a result of earlier trials. Doctors hope to collect more information about non rhabdomyosarcoma, its treatment and side effects. This will hopefully lead to improvements in treatment in the future.
Who can enter
You can enter this trial if
- You have been diagnosed with non rhabdomyosarcoma soft tissue sarcoma
- You are under 21 years old
- You are well enough to have treatment as part of this trial
- You have satisfactory blood test results
- You have had any other cancer in the past
- A sample of your cancer removed when you had surgery or a
biopsyis available to be looked at by the researchers
You cannot enter this trial if you
- Have non rhabdomyosarcoma soft tissue sarcoma that has spread elsewhere in the body
- Have already had treatment, apart from initial surgery
This European trial will recruit about 250 children and young people with non rhabdomyosarcoma soft tissue sarcoma. If you take part, your treatment will depend on a number of factors, including
- The size of your sarcoma
- How much of the sarcoma had been removed during surgery
- The sub type of your non rhabdomyosarcoma
There are many different treatment groups in this trial and so it is not possible to describe them all in detail here. Your doctor will tell you more about your individual treatment plan.
To summarise, everyone in this trial will have surgery to remove their sarcoma, or as much of it as possible. You may have chemotherapy before surgery, after surgery, or both. You will probably have the chemotherapy drugs ifosfamide and doxorubicin (Adriamycin).
If you have ifosfamide and doxorubicin, you have these drugs over about 3 days in week one. Then no chemotherapy for 2 weeks. This 3 week period is called a ‘cycle’ of chemotherapy. You will have 3, 4 or 5 cycles, depending on your treatment group.
You may have radiotherapy to the area where you had your operation. You have radiotherapy every day from Monday to Friday for about 5 to 6 weeks.
Before you start treatment, a doctor will examine you and you may have some of the following tests.
- A biopsy of the sarcoma
- Blood tests
- Urine tests
- Bone marrow test
- CT scan or MRI scan of the sarcoma
- Chest X-ray
- CT scan of your chest, stomach and
- Bone scan
- Ultrasound scan of the stomach
You may have some of these tests again during and after your treatment.
After your treatment finished, you will continue to see a doctor as an outpatient. At each appointment, you will be examined, have a chest X-ray and a scan. These appointments will be
- Every 3 months for the first year after treatment
- Every 4 months for second and third year
- Every 6 months for the fourth and fifth year
- Every year for the next 5 years
All treatments have side effects. The most common side effects of having an operation include pain and the risk of infection. We have more information about having surgery to remove soft tissue sarcomas.
The most common side effects of chemotherapy include
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Feeling or being sick
- Loss of appetite
- Dry and sore mouth
The side effects of radiotherapy include
- Red, sore skin in the area being treated
You can also read more about the side effects of radiotherapy.
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr B. Brennan
Central Manchester University Hospitals NHS Foundation Trust
Children's Cancer and Leukaemia Group (CCLG)
NIHR Clinical Research Network: Cancer