Ewing Sarcoma
Conditions
Interventions
2 differrent standard chemoinduction regimens are being compared
postchemo zoldronic acid for 7 cycles are being compared to observation
Sponsors
European Organisation for Research in Treatment of Cancer (EORTC)
Eligibility
Age
2 Years to 99 Years
Inclusion criteria
Inclusion criteria: Randomisation 1 - Any histologically and genetically confirmed ESFT of bone or soft tissue, or round cell sarcomas *Ewing*s-like* but negative for EWSR1 gene rearrangement. - Age >2 years and 5 years - 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) - Consolidation chemotherapy as per protocol intended -Medically fit to receive zoledronic acid
Exclusion criteria
Exclusion criteria: Randomisation 1 -Contra-indication to the treatment in R1 -Second malignancy -Pregnant or breast feeding women Randomisation 2 -History of dental surgery 6 months preceding start of zoledronic acid, or planned dental surgery during treatment or within 6 months after the end of treatment. -Ewing*s tumour of the maxilla or of the mandible -Progression of the primary tumour or appearance of new lesions - History of Jaw fracture
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) * Adverse events and toxicity, defined by NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0 * Histological response of the primary tumour to induction chemotherapy if surgery is performed as local control * Response of primary tumour, regional lymfph nodes and/or metastases * Achievement of local control at the end of treatment * Growth parameters and jaw/ear osteonecrosis (R2 only) | — |
Countries
Netherlands
Outcome results
None listed