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

Phase 3

Completed

Conditions: Ewing Sarcoma
10028389

Registration Number: NL-OMON50678

Lead Sponsor: European Organisation for Research in Treatment of Cancer (EORTC)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 5

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 <50 years
- Randomisation <=45 days after diagnostic biopsy/surgery
- Patient medically fit to receive the randomised treatment
- No prior treatment other than surgery

Randomisation 2
-Age >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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Event-free survival</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Overall Survival (OS)<br /><br>* Adverse events and toxicity, defined by NCI Common Terminology Criteria for<br /><br>Adverse Events (CTCAE) v4.0<br /><br>* Histological response of the primary tumour to induction chemotherapy if<br /><br>surgery is performed as local control<br /><br>* Response of primary tumour, regional lymfph nodes and/or metastases<br /><br>* Achievement of local control at the end of treatment<br /><br>* Growth parameters and jaw/ear osteonecrosis (R2 only)</p><br>