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Euro Ewing 2012 - International Randomised Controlled Trial for the Treatment of Newly Diagnosed Ewing's Sarcoma Family of Tumours.
The Euro Ewing 2012 trial compared different chemotherapy regimens to determine which is more effective and / or has fewer side effects.
This trial closed to recruitment in 2019.
Stats
- The trial recruited over 600 patients.
- Over 90% consented to the use of their blood and tissue samples for biological research studies.
- We collected over 3,800 biological samples to process.
Results
The trial found that the USA treatment (VDC-IE) received by patients was more effective and less toxic, for all stages of newly diagnosed ES, than the European standard treatment (VIDE).
Results published in the Lancet journal.
A plain English summary, reviewed and edited by the EEC patient advocates
A version in Italian, translated by one of the EEC patient advocates.
The EEC would like to thank all the patients and researchers for their contribution to this important trial.
Abstracts and protocols
Trials (2020) International randomised controlled trial for the treatment of newly diagnosed EWING sarcoma family of tumours - Protocol.
Information for Health Professionals
- Background
The objective of the induction/consolidation chemotherapy randomisation (R1) is to compare the VIDE strategy (VIDE induction and VAI/VAC consolidation) with the VDC/IE strategy (compressed VDC/IE induction and IE/VC consolidation). The event-free survival (EFS) of the two chemotherapy regimens will be compared, and also the relative toxicity experienced by patients both before and after local control of the primary tumour.
The objective of the zoledronic acid randomisation (R2) is to determine whether the addition of zoledronic acid to consolidation chemotherapy, as assigned at R1, is associated with improved clinical outcome in patients with localised ESFT or with pulmonary and/or pleural metastases only at diagnosis.
The objective of the biological studies associated with this trial is to identify informative prognostic biomarkers for assessment of disease status and response at diagnosis and throughout the disease course. Whether they are predictive of response to therapy and may be used to improve stratification of patients and whether they might predict those patients that may not tolerate a particular therapy will be explored.
- Protocols
Patient information and the trial protocol can be found on the CRCTU website.
Information for Parents and Carers
- Why is this trial running?
The trial is comparing two treatments, known as A and B.
- Treatment arm A is the chemotherapy that is the standard treatment used in Europe.
- 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.
We are also testing 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. 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.
- What treatments might I receive?
Treatment arm A
In the first part of the trial, 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.
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.
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.
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.
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.
- Can I choose which treatment I receive?
No. Euro Ewing 2012 is a randomised trial so you will be randomly assigned by computer. This means that the results of the trial are not biased in any way.
- Where did the trial run?
The trial opened at 112 sites across ten countries: UK, France, Spain, Belgium, Czech Republic, Netherlands, Denmark, Switzerland, Hungary and Republic of Ireland.
- How many patients took part?
Over 600 patients were recruited from across Europe between 2013 and 2019.
If you have any questions about this trial:
- Read more at Cancer Research UK.
- Contact the Clinical Trials Unit at the University of Birmingham: ee2012@trials.bham.ac.uk.
- The Trial Office cannot give advice on personal clinical questions.
Glossary of treatments
- Busulfan
Busulfan is a type of chemotherapy drug. It is a treatment for polycythaemia vera, essential thrombocythaemia and myelofibrosis. They are all part of a group of conditions called myeloproliferative neoplasms or myeloproliferative disorders.
- IE/VC
IE/VC is short for a treatment that uses four chemotherapy drugs called:
and
- Melphalan
Melphalan is a type of chemotherapy. It is a treatment for a number of different cancer types. You usually have it in combination with other drugs before a stem cell or bone marrow transplant. You may also have it if you can’t have a transplant.
- VAC
VAC is short for a combination of three chemotherapy drugs called:
- Vincristine
- Actinomycin D
- Cyclophosphamide
- VAI
VAI is short for a combination of three chemotherapy drugs called:
- Vincristine
- Actinomycin D
- Ifosfamide
- VDC/IE
VDC/IE is short for a treatment that uses five chemotherapy drugs called:
- Vincristine
- Doxorubicin
- Cyclophosphamide
and
- Ifosfamide
- Etoposide
- VIDE
VIDE is short for a combination of four chemotherapy drugs called:
Vincristine
Ifosfamide
Doxorubicin
Etoposide- Zoledronic acid
Zoledronic acid is a type of drug known as a bisphosphonate Open a glossary item. It is also called Zometa. You might have zoledronic acid to:
- prevent problems with the bones such as breaks in the bones (fractures) in myeloma and cancers that have spread to the bone (advanced cancers)
- lower the chance of breast cancer coming back after surgery in certain situations
- prevent bone loss for people having aromatase inhibitors
- lower high levels of calcium in the blood (hypercalcaemia), which can happen in secondary bone cancer
Recruitment by 2018
While the trial data was not analysed until the study closed, progress with the trial up to September 2018 is summarised below.
Euro Ewing 2012 - recruitment by country
| Country | Number of patients (Randomisation 1) | Number of patients (Randomisation 2) |
|---|---|---|
| UK | 204 | 69 |
| France | 157 | 39 |
| Spain | 119 | 60 |
| Czech Republic | 15 | 13 |
| Belgium | 11 | 5 |
| Hungary | 7 | 2 |
| Netherlands | 5 | 0 |
| Republic of Ireland | 3 | 2 |
| Total | 521 | 190 |
Euro Ewing 2012 - gender of patients
| Gender | Number of patients |
|---|---|
| Male | 293 |
| Female | 228 |
Euro Ewing 2012 - age of patients
| Age | Number of patients |
|---|---|
| Under 14 years | 211 |
| 14-25 years | 228 |
| Over 25 years | 82 |