ISRCTN92192408
Active, not recruiting
Phase 3
International randomised controlled trial for the treatment of newly diagnosed Ewing's sarcoma family of tumours (ESFT)
niversity of Birmingham (UK)0 sites640 target enrollmentNovember 4, 2013
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Ewing's sarcoma
- Sponsor
- niversity of Birmingham (UK)
- Enrollment
- 640
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
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)
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •1\. No evidence of metastatic disease
Exclusion Criteria
- •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
- •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
- •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
Outcomes
Primary Outcomes
Not specified
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