Table 1.
Randomisation 1 | Randomisation 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 |