EUCTR2005-000217-35-IE进行中（未招募）1 期
European Paediatric Soft Tissue Sarcoma Study Group EpSSG RMS 2005. A protocol for non metastatic rhabdomyosarcoma. - RMS 2005
Children's Health Ireland at Crumlin0 个研究点目标入组 600 人开始时间: 2009年7月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 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
入选标准
- •Observational study
- •Patients with pathologically confirmed rhabdomyosarcoma
- •Age 0 to < 21 years
- •Previously untreated except for primary surgery
- •Diagnostic material available for pathology review
- •Interval between diagnostic surgery and start of chemotherapy no longer than 8 weeks
- •No previous malignant tumours
- •No evidence of metastatic disease (except for those patients eligible for the metastatic arm of the observational study)
- •Available for long term follow up through the treatment centre
- •Written informed consent
- •Investigational study (randomised trial)
- •Eligible for the protocol and stratified to the High Risk Group
- •Age > 6 months (younger children are eligible for the protocol study treatment but they will not enter in the randomised trial)
- •Informed consent given for the randomised study.
- •Additional criterion for the second randomisation: patient in complete remission or with minimal abnormalities at the end of standard treatment.
- •Adults >21 years with RMS may be eligible for registration and standard treatment on study but not for randomisation.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 120
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Failure to meet the stated inclusion criteria.
- •(NB. patients with evidence of metastatic disease and fulfilling all other inclusion criteria are eligible for the metastatic arm of the protocol)
研究者
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