Euro Ewing 2012

Phase 3

• Conditions: Ewing's sarcoma; Cancer

• Registration Number: ISRCTN92192408
• Lead Sponsor: niversity of Birmingham (UK)

Brief Summary

2020 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31952545 protocol (added 20/01/2020) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36522207/ (added 16/12/2022)

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-04
• Last Update Posted: 29 April 2024
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 640

Inclusion Criteria

R1
1. Histologically confirmed ESFT of bone or soft tissue
2. Localised or pulmonary and/or pleural metastatic disease
3. Age >2 years and <50 years (from second birthday to 49 years and 364 days) at the date of diagnostic biopsy
4. Randomisation =45 days after diagnostic biopsy/surgery
5. Patient assessed as medically fit to receive the treatment in either of the R1 treatment arms
6. No prior treatment for ESFT other than surgery
7. Documented negative pregnancy lactation test for female patients of childbearing potential
8. Patient agrees to use contraception during therapy and for 12 months after last trial treatment (females) or 5 months after last trial treatment (males), where applicable
9. Written informed consent from the patient and/or parent/legal guardian

R2zol
1. No evidence of metastatic disease
2. Age >5 years (from fifth birthday) at date of randomization
3. Localised tumour of any tumour volume with surgery after chemotherapy alone, and good histological response to induction chemotherapy (<10% viability)
OR
4. Localised tumour with initial tumour volume <200ml with resection after chemotherapy and early radiotherapy, and good histological response to induction chemoradiotherapy (<10% viability)
OR
5. Localised tumour with initial tumour volume <200ml and surgery at diagnosis
OR
6. Localised tumour with initial tumour volume <200ml with resection after chemotherapy alone and extracorporeal irradiation of the primary tumour at surgery
OR
7. Localised unresected tumour with initial tumour volume <200ml and at least a partial radiological response to induction chemotherapy (=50% regression of evaluable soft tissue component)
8. Consolidation chemotherapy as per protocol intended
9. Patient assessed medically fit to receive zoledronic acid if allocated
10. Written informed consent from the patient and/or parent/legal guardian

R2loc
1. No evidence of metastatic disease
2. Localised tumour of any tumour volume with surgery after chemotherapy alone, and poor histological response to induction chemotherapy (=10% viability)
OR
3. Localised tumour with initial tumour volume =200ml with surgery after chemotherapy and early radiotherapy, irrespective of histological response
OR
4. Localised tumour with initial tumour volume =200ml and surgery at diagnosis
OR
5. Localised tumour with initial tumour volume =200ml with extracorporeal irradiation of the primary tumour at surgery, and no progression under induction chemotherapy
OR
6. Localised unresected tumour with initial tumour volume <200ml treated by radiation therapy alone as local therapy and with poor radiological response to induction chemotherapy (<50% regression of evaluable soft tissue component) but no progression under induction chemotherapy
7. Consolidation chemotherapy as per protocol intended
8. Patient assessed medically fit to receive the treatment in either of the R2loc treatment arms
9. Written informed consent from the patient and/or parent/legal guardian

R2pulm
1. Pulmonary and/or pleural metastatic disease only at diagnosis
2. Partial response of the lung metastatses and no progression of the primary tumour during induction chemotherapy
3. Consolidation chemotherapy as per protocol intended
4. Patient assessed medically fit to receive the treatment in either of the R2pulm treatment arms
5. Written informed consent from the patient and/or the parent/legal guardian

Exclusion Criteria

R1
1. Extrapulmonary metastatic disease
2. Contra-indication to the treatment in either of the R1 treatment arms
3. Second Malignancy
4. Pregnant or breastfeeding women
5. Follow-up not possible due to social, geographic or psychological reasons

R2zol
1. History of dental surgery (extraction or jaw surgery) in the 6 months preceding the start of zoledronic acid treatment, or planned dental surgery within the treatment period or within 6 months after the end of treatment
2. Ewing?s tumour of the maxilla or of the mandible
3. Progression of the primary tumour or appearance of new lesions

R2loc
1. Radiotherapy required encompassing spine, a significant volume of digestive tract or lungs (such patients should be discussed during a web conference before randomisation for technique, volume, and dose validation with the national radiotherapy committee)
2. Progression of the primary tumour or appearance of new lesions

R2pulm
1. Radiotherapy required encompassing spine, a significant volume of digestive tract or lungs (such patients should be discussed during a web conference before randomisation for technique, volume, and dose validation with the national radiotherapy committee)
2. Progression of the primary tumour or appearance of new lesions

Study & Design

• Study Type: Interventional
• Study Design: Not specified