Euro Ewing 2012

• Research type

  Research Study

• Full title

  International Randomised Controlled Trial for the Treatment of Newly Diagnosed Ewing's Sarcoma Family of Tumours

• IRAS ID

  96956

• Contact name

  Bernadette Brennan

• Sponsor organisation

  University of Birmingham

• Eudract number

  2012-002107-17

• Research summary

  The treatment for Ewing's sarcoma consists of three phases: induction chemotherapy, local control (surgery and/or radiotherapy) and consolidation chemotherapy. The Euro Ewing 2012 trial is an international, phase III, open-label, randomised controlled trial which asks several research questions simultaneously. All patients are randomised at trial entry to receive either the current European treatment strategy or the American equivalent. The European strategy consists of VIDE induction chemotherapy and VAI/VAC (risk-adapted) consolidation chemotherapy, whilst the American strategy consists of compressed VDC/IE induction chemotherapy and IE/VC consolidation chemotherapy. The objective is to compare these two strategies with respect to clinical outcome and toxicity. There are three options for randomisation at R2 depending on the patient's disease status at diagnosis and response following induction chemotherapy. Patients fall into one of the following groups: 1) localised disease and good histological response/small tumour volume - these patients are eligible for R2zol 2) localised disease and poor histological response/large tumour volume - these patients are eligible for R2loc 3) pulmonary/pleural metastases at diagnosis - these patients are eligible for R2pulm The objectives of the R2zol randomisation is to determine whether the addition of zoledronic acid to consolidation chemotherapy is associated with improved clinical outcome. The objective of the R2loc and R2pulm randomisations is to compare high-dose chemotherapy (busulfan and melphalan) and stem cell transplantation support with the assigned consolidation chemotherapy from the R1 randomisation.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  12/NW/0827

• Date of REC Opinion

  1 Feb 2013

• REC opinion

  Further Information Favourable Opinion