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Table 1 Inclusion and exclusion criteria

From: International randomised controlled trial for the treatment of newly diagnosed EWING sarcoma family of tumours – EURO EWING 2012 Protocol

Randomisation 1Randomisation 2
Inclusion criteria
• Any histologically and genetically confirmed Ewing sarcoma family of tumours (ESFT) of bone or soft tissue, or round cell sarcomas ‘Ewing’s-like’ but negative for EWSR1 gene rearrangement
(Prior to protocol version 3.0, this read as ‘Histologically confirmed ESFT of bone or soft tissue, and Localised or pulmonary and/or pleural metastatic disease’.)
• Age of more than 2 years and less than 50 years
• Randomisation not more than 45 days after diagnostic biopsy/surgery
• Patient medically fit to receive trial treatment
• No prior treatment other than surgery
• Localised tumour
OR
metastatic disease and/or regional lymph node(s) involvement only at diagnosis and at least partial response of metastases and/or regional lymph node(s)
(Prior to protocol version 3.0, this read as ‘Localised tumour OR Pulmonary and/or pleural metastatic disease only at diagnosis and at least partial response of the lung metastases and no progression of the primary tumour during induction chemotherapy’.)
• Age of more than 5 years
• Consolidation chemotherapy as per protocol intended
• Medically fit to receive zoledronic acid
Exclusion criteria
• Contra-indication to the treatment in randomisation 1 (R1)
• Second malignancy
• Pregnant or breastfeeding women
• History of dental surgery 6 months preceding the start of zoledronic acid or planned dental surgery during treatment or within 6 months after the end of treatment
• History of jaw fracture
• Ewing’s tumour of the maxilla or of the mandible
• Progression of the primary tumour or appearance of new lesions