ISRCTN92192408进行中（未招募）3 期
International randomised controlled trial for the treatment of newly diagnosed Ewing's sarcoma family of tumours (ESFT)
niversity of Birmingham (UK)0 个研究点目标入组 640 人开始时间: 2013年11月4日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 640
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
- •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)
- •4. Localised tumour with initial tumour volume <200ml with resection after chemotherapy and early radiotherapy, and good histological response to induction chemoradiotherapy (<10% viability)
- •5. Localised tumour with initial tumour volume <200ml and surgery at diagnosis
- •6. Localised tumour with initial tumour volume <200ml with resection after chemotherapy alone and extracorporeal irradiation of the primary tumour at surgery
- •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
- •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)
- •3. Localised tumour with initial tumour volume =200ml with surgery after chemotherapy and early radiotherapy, irrespective of histological response
- •4. Localised tumour with initial tumour volume =200ml and surgery at diagnosis
- •5. Localised tumour with initial tumour volume =200ml with extracorporeal irradiation of the primary tumour at surgery, and no progression under induction chemotherapy
- •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
- •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
排除标准
- •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
- •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
研究者
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