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.

Cancer type:

Children's cancers
Soft tissue sarcoma




Phase 3

This trial is looking at the treatment of children and young people with a type of soft tissue sarcoma called rhabdomyosarcoma. This trial is supported by Cancer Research UK.

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.

Rhabdomyosarcoma affects cells in muscle tissue. Children who have this cancer are usually treated with chemotherapysurgeryradiotherapy, or a combination of these treatments.

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)

Trial design

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 1 - Low risk group 
If you are in group 1, you have vincristine and actinomycin chemotherapy. Your chemotherapy will take about 6 months.

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.

Hospital visits

Before your treatment starts, a doctor will examine you and you will have various tests. These tests include

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

Side effects

All treatments have side effects. The most common side effects of chemotherapy include

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.

You can read about the particular side effects of vincristine, actinomycin, ifosfamide, doxorubicin, cyclophosphamide and vinorelbine by clicking on the drug names.

The side effects of radiotherapy include

  • Red, sore skin in the area being treated
  • Tiredness

We have more information about the side effects of radiotherapy and about having surgery to remove soft tissue sarcomas.

Recruitment start:

Recruitment end:

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr M. Jenney

Supported by

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

Other information

This is Cancer Research UK trial number CRUK/06/027.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:


Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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