A trial looking at treatment for Ewing's sarcoma family of tumours (Euro Ewing 2012)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Children's cancers

Ewing sarcoma

Sarcoma

Status:

Closed

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 Ewing’s sarcoma family of tumours Open a glossary item 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)

Euro Ewing 2012 trial diagram

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, bone marrow Open a glossary item 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.