EUCTR2012-002107-17-NL进行中（未招募）1 期
International Randomised Controlled Trial for the Treatment of Newly Diagnosed Ewing's Sarcoma Family of Tumours - Euro Ewing 2012
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 EWSR1 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 R1 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 guardian
- •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 guardian
- •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
排除标准
- •Randomisation R1
- •Contra-indication to the treatment in either of the R1 treatment arms
- •Second malignancy
- •Pregnant or breastfeeding women
- •Follow-up not possible due to social, geographic or psychological reasons
- •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 treatment.
- •*History of jaw fracture
- •* Ewing’s tumour of the maxilla or of the mandible
- •* Progression of the primary tumour or appearance of new lesions
研究者
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