EUCTR2012-002107-17-CZActive, not recruitingPhase 1
International Randomised Controlled Trial for the Treatment of Newly Diagnosed Ewing's Sarcoma Family of Tumours - Euro Ewing 2012
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- niversity of Birmingham
- Enrollment
- 600
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Randomisation R1:
- •* Any histologically and genetically confirmed ESFT of bone or soft
- •tissue, or round cell sarcomas which are 'Ewing's-like' but negative for EWSRl gene rearrangement
- •*Age >2 years and <50 years (from second birthday to 49 years 364
- •days) at the date of randomisation
- •*Randomisation = 45 days after diagnostic biopsy/surgery
- •* Patient assessed as medically fit to receive the treatment in either of
- •the Rl treatment arms
- •* No prior treatment for ESFT other than surgery
- •* Documented negative pregnancy test for female patients of
- •childbearing potential
- •* Patient agrees to use contraception during therapy and for 12 months
- •after last trial treatment (females) or 6 months after last trial treatment
- •(males), where applicable
- •*Written informed consent from the patient and/or the parent/legal
- •Randomisation 2:
- •*Age >5 years (from fifth birthday) at date of randomisation
- •* Localised tumour
- •* Metastatic disease and/or regional lymph node(s) involvement only at
- •diagnosis and at least partial response of the metastases and/or
- •regional lymph node(s)
- •* Consolidation chemotherapy as per protocol intended
- •* Patient assessed as medically fit to receive zoledronic acid if allocated
- •*Written informed consent from the patient and/or the parent/legal
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 470
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 130
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
Exclusion Criteria
- •Randomisation Rl
- •Contra-indication to the treatment in either of the Rl treatment arms
- •Second malignancy
- •Pregnant or breastfeeding women
- •Follow-up not possible due to social, geographic or psychological
- •Randomisation 2:
- •* 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
- •* Ewing's tumour of the maxilla or of the mandible
- •* Progression of the primary tumour or appearance of new lesions
Investigators
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