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The aim of the Euro Ewing 2012 trial is to compare different chemotherapy regimens to determine which is more effective and/or has fewer side effects.
***Important update - 8 May 2019***
The R1 stage of the Euro Ewing 2012 trial has now closed to recruitment.
Why is this trial being run?
The trial is comparing two treatments, known as treatment arms A and B.
Treatment arm A is the chemotherapy that is the standard treatment used in Europe whereas treatment arm B is the chemotherapy that is used in the USA. The trial is being run as we do not know which treatment is best.
A second reason for running the trial is to test if a drug called zoledronic acid can improve treatment for Ewing sarcoma. Zoledronic acid has been widely used for the treatment of other bone diseases and cancers that start in or spread to the bone, so we think that it may offer benefit for patients with Ewing sarcoma without worsening the side effects of the chemotherapy. We do not know whether this is the best treatment for patients with Ewing sarcoma.
Can I take part in the trial?
If you have been recently diagnosed with Ewing sarcoma for the first time, you may be able to take part in the trial. Your doctor will explain whether you are able to take part. Your doctor will review your diagnostic tests and medical notes to see if you are eligible to take part in the trial.
What treatment will I receive?
Treatment arm A
In the first part of the trial, if you are given treatment arm A you will receive a type of chemotherapy called VIDE, followed by surgery and/or radiotherapy, then more chemotherapy.
After surgery and/ or radiotherapy, you will have the opportunity to take part in the second part of the trial which tests zoledronic acid.
The doctors will see how well you have responded to the treatment so far and then decide which treatment would be best for you. They will look at the risk of your sarcoma coming back or starting to grow again and put you into one of the following groups where half of the patients will receive zoledronic acid:
- Standard risk group
- Medium risk group
- High risk group
If you are in the standard risk group, you have either:
- Vincristine, actinomycin D, cyclophosphamide and zoledronic acid or
- 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 or
- 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
Zoledronic acid (a bisphosphonate drug)
VAC
VAI
Busulfan
Melphalan
Treatment arm B
If you are given treatment arm B you will receive a type of chemotherapy called VDC/IE, followed by surgery and/or radiotherapy, then more chemotherapy.
After surgery and/ or radiotherapy, you will have the opportunity to take part in the second part of the trial.
The doctors will see how well you have responded to the treatment so far and then decide which treatment would be best for you. They will look at the risk of your sarcoma coming back or starting to grow again and you will receive one of the following treatments, where half of the patients will receive zoledronic acid:
- 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
VDC/IE
IE/VC
Busulfan
Melphalan
Zoledronic acid (a bisphosphonate drug)
For more detailed information can be found on Cancer Research UK
Can I choose which treatment arm I receive?
No. Euro Ewing 2012 is a randomised trial so you will be randomly assigned to a treatment arm by a computer. This is done so that neither you or your doctor will be able to influence which treatment arm you receive and means that the results of the trial are not biased in any way.
Randomised trials
Computer randomisation
Where is the trial running?
The trial is open at 112 sites across ten countries: UK, France, Spain, Belgium, Czech Republic, Netherlands, Denmark, Switzerland, Hungary and Republic of Ireland.
How many patients will take part?
At least 600 patients will be recruited from across Europe between 2013 and 2019.
How can I find out more information?
Read more at Cancer Research UK
How can I take part in the trial?
***Important update - 8 May 2019***
The R1 stage of the Euro Ewing 2012 trial has now closed to recruitment.
If you have any questions about this trial, please contact the Cancer Research UK Clinical Trials Unit at the University of Birmingham ee2012@trials.bham.ac.uk
***The Trial Office cannot give advice on personal clinical questions***