Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial looking at treatment for Ewing's sarcoma family of tumours (Euro Ewing 2012)
Cancer type:
Children's cancers
Ewing's sarcoma
Sarcoma
Status:
Open
Phase:
Phase 3
This trial is looking at treatment for the Ewing’s sarcoma family of tumours. Cancer Research UK supports this study.
This study is for both adults and children. 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
Treatment for the 
usually includes chemotherapy. You may have treatment that includes the drugs vincristine, ifosfamide, doxorubicin and etoposide. Doctors call this VIDE. Or you may have vincristine, doxorubicin, cyclophosphamide, ifosfamide and etoposide, which is called VDC/IE.
This is to shrink the cancer before having surgery. If the doctor can’t completely remove your sarcoma with surgery, you may also have radiotherapy.
As with any cancer there is a risk that your sarcoma may come back or start to grow again. To try and reduce this risk doctors give more chemotherapy after surgery.
In this trial the researchers want to compare VIDE with VDC/IE to find out which is best to use before surgery. They also want to compare different types of chemotherapy after surgery to find out which is the best.
Who can enter
You may be able to join this trial if all of the following apply.
- You have been diagnosed with either Ewing’s sarcoma, primitive neuroectodermal tumour, soft tissue Ewing’s tumour or Askin tumour
- Your doctor feels you are fit enough to take part in the trial
- You are willing to use reliable contraception during treatment and for a year afterwards if you are a woman, or 6 months afterwards if you are a man
- You are between 2 and 50 years old
You cannot join this trial if any of these apply.
- You have already had treatment for your cancer, apart from surgery
- You have another type of cancer
- You are not able to have any of the drugs used in this trial
- You are pregnant or breastfeeding
Trial design
This is an international phase 3 trial. The researchers need about 600 people to join the trial.
There are 2 parts in this trial. After the 1st part of the trial, if you don’t want to continue with the 2nd part you don’t have to.
Before starting treatment, you have a central line put in. This is a plastic tube that goes into a large vein near your heart. You have your drugs through it and blood samples can be taken from it.
The first part of this trial is randomised
- People in group A have vincristine, ifosfamide, doxorubicin and etoposide (VIDE)
- People in group B have vincristine, cyclophosphamide, doxorubicin, ifosfamide and etoposide (VDC/IE)
After chemotherapy the trial team will assess how your sarcoma has responded. You then have surgery, radiotherapy or both.
They will then look at the risk of your sarcoma coming back or starting to grow again and put you into 1 of the following groups.
- Standard risk group
- Medium risk group
- High risk group
You have more chemotherapy and you are put into treatment groups at random again, according to what your risk is or if your sarcoma has spread to your lungs.
Those who had VIDE in the first part of the trial will have one of the following.
If you are in the standard risk group, you have either
- Vincristine, actinomycin D, cyclophosphamide and zoledronic acid
- Vincristine, actinomycin D and cyclophosphamide
If you are in the medium risk group, you have either
- Vincristine, actinomycin D, ifosfamide, busulfan, melphalan and zoledronic acid
- Vincristine, actinomycin D, ifosfamide, busulfan and melphalan
If you are in the high risk group, or your sarcoma has spread to the lungs, you have either
- Vincristine, actinomycin D and ifosfamide and zoledronic acid
- Vincristine, actinomycin D and ifosfamide
Those who had VDC/IE in the first part of the trial will have one of the following
- Ifosfamide, etoposide, vincristine, cyclophosphamide and zoledronic acid
- Ifosfamide, etoposide, vincristine and cyclophosphamide
- Ifosphamide, vincristine, actinomycin D, busulfan, melphalan and zoledronic acid
- Ifosphamide, vincristine, actinomycin D, busulfan and melphalan
If you agree to take part in this trial, the researchers will ask for a sample of your cancer, and blood from when you were diagnosed and during your treatment. If you don’t want to give the bone marrow and blood samples during treatment you don’t have to. You can still take part in the trial.
Hospital visits
You see the doctor to have some tests before taking part in this trial. These tests include
- A physical examination
- Blood tests
- A small tissue sample (
biopsy ) of your sarcoma - Bone marrow test
- CT scan, MRI scan, PET-CT scan, bone scan or x-ray (your doctor will decide which of these you need to have)
- Heart scan (
ECHO )
You have a physical examination and blood tests after each treatment of chemotherapy. You have the scan and heart scan as needed. You have another bone marrow test done if your sacoma had alredy spread to the bone marrow when you joined the study.
At the end of treatment you have a MRI scan and another 6 months later if needed.
After treatment your doctor will tell you how often they need to see you.
Side effects
The most common side effects of the drugs used in this trial are
- Hair loss
- Feeling or being sick
- A drop in blood cells causing an increased risk of infection, bruising and bleeding
- Sore mouth
- Diarrhoea
- Tummy (abdominal) pain
- Loss of appetite
- Tiredness
- Aches and pains in the legs
- Changes to the way your kidneys, liver, heart and lungs works
- Rash or reddening of the skin
- Muscle and joint pain
- Swelling of your hands, feet and ankles
Your doctor will talk to you about the possible side effects before you agree to take part in the trial.
We have specific information on the side effects of vincristine, etoposide, actinomycin D, ifosfamide, doxorubicin, cyclophosphamide, and zoledronic acid.
Location
Aberdeen
Belfast
Birmingham
Bristol
Cambridge
Cardiff
Edinburgh
Glasgow
Leeds
Leicester
Liverpool
London
Manchester
Newcastle upon Tyne
Nottingham
Oxford
Sheffield
Southampton
Sutton
Wirral
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
Professor Bernadette Brennan
Supported by
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University of Birmingham
Other information
This is Cancer Research UK number CRUK/11/050.
Questions about cancer? Contact our information nurses
Freephone 0808 800 4040
Last review date
CRUK internal database number:
9183
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
Last reviewed:
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