"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 rhabdomyosarcoma (EpSSG RMS 2005 STS 2006 04)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
More about this trial
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.
Some of the children in this trial will have treatment according to an internationally agreed protocol (called EpSSG RMS 2005). These protocols have been established as a result of earlier trials. The researchers want to follow a large number of children so that they can learn more about existing treatments and their side effects. This will hopefully lead to improvements in treatment in the future.
Many children with rhabdomyosarcoma can be cured. But there are some children whose rhabdomyosarcoma is more difficult to treat. This trial also aims to find out if this group of children and young people will benefit from
- Adding doxorubicin to the existing chemotherapy drugs
- Having chemotherapy for a further 6 months
Who can enter
You can enter this trial if you
- Have rhabdomyosarcoma
- Are well enough to take part in this trial
- Have satisfactory blood test results
- Are less than 21 years of age
You cannot enter this trial if you
- Have already had treatment for your rhabdomyosarcoma (except your first operation)
- Have had any other type of cancer before
- Have had your operation to diagnose your rhabdomyosarcoma over 2 months ago (you will need to start treatment in this trial within 8 weeks of your operation)
This European trial has 5 different treatment groups. Your doctor will decide whether you have rhabdomyosarcoma that is
- Low risk
- Standard risk
- High risk
- Very high risk
This depends on a number of factors including
- Your age
- Where in the body the rhabdomyosarcoma is
- Whether it has spread to lymph nodes
- How large it is
- The type of rhabdomyosarcoma
There is also a group for people whose rhabdomyosarcoma has spread (metastasised) to another part of the body.
Whichever group you are in, you may first of all have surgery to remove all, or as much of the rhabdomyosarcoma as possible.
Group 2 - Standard risk group
If you are in group 2, you have vincristine, actinomycin and ifosfamide. You may also have surgery and, or radiotherapy. The doctor will discuss treatment with you in detail. Your treatment will take about 6 months.
Group 3 - High risk group
If you are in group 3, you will have ifosfamide, vincristine and actinomycin chemotherapy. You may also have further surgery or radiotherapy. Treatment up to this point will take about 6 months.
If there is no sign of your rhabdomyosarcoma (it is in remission), you will be put into one of two groups by a computer. Neither you nor your doctor will be able to decide which group you are in. This is called randomisation.
People in one group will not have any more chemotherapy. People in the other group will have a further 6 months of chemotherapy, using the drugs cyclophosphamide and vinorelbine. This is called maintenance chemotherapy.
Group 4 - Very high risk group
If you are in group 4, you have ifosfamide, vincristine, actinomycin and doxorubicin. You may then have further surgery and radiotherapy, followed by maintenance chemotherapy with cyclophosphamide and vinorelbine. Your treatment will last for about 1 year.
Group 5 - Metastatic group
This trial now includes people whose rhabdomyosarcoma has spread (metastasised) to another part of the body. This part of the trial is called EpSSG RMS MET 2008.
If you are in this group you will have ifosfamide, vincristine, actinomycin and doxorubicin for about 6 months to begin with. You will then have vinorelbine and cyclophosphamide as maintenance treatment for about a year.
Before your treatment starts, a doctor will examine you and you will have various tests. These tests include
- Blood tests
- Bone marrow test
- A test to check that the heart is healthy (echocardiogram)
- MRI scan or CT scan of your cancer
- Chest X-ray
- Bone scan
Some of these tests will be repeated during your treatment.
If you have doxorubicin and the extra 6 months of chemotherapy, it is likely that you will spend longer periods of time in hospital. This is because the treatment will be more intensive and you are at a greater risk of infection.
After your treatment has finished, you will continue to see a doctor as an outpatient. You will be examined, have a chest X-ray and a CT scan, or ultrasound scan, or MRI scan. These appointments will be
- Every 3 months for the first year after your treatment has finished
- Every 4 months for the second and third year
- Every year for the fourth and fifth year
All treatments have side effects. 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
If you have doxorubicin and the extra 6 months of chemotherapy, you are more at risk of developing an infection. The extra 6 months of chemotherapy also means that you are more at risk of being unable to have children (infertility) in the future. Doxorubicin may cause heart problems in the short or long term. You will be monitored closely to try to prevent this from happening.
The side effects of radiotherapy include
- Red, sore skin in the area being treated
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 M. Jenney
Cancer Research UK
Cancer Research UK Children's Cancer Trials Team
Children’s Cancer and Leukaemia Group (CCLG)
University of Birmingham
NIHR Clinical Research Network: Cancer
This is Cancer Research UK trial number CRUK/06/027.