EUCTR2005-000217-35-ES进行中（未招募）不适用
RMS 2005: a protocol for non metastatic rhabdomyosarcoma
Dr Jose Sanchez de Toledo Codina0 个研究点目标入组 700 人开始时间: 2012年3月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 700
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
- •- A pathologically proven diagnosis of Rhabdomyosarcoma.
- •- No evidence of metastatic lesions.
- •- Age less than 21 years (20 years and 364 days) of age.
- •- Previously untreated except for primary surgery.
- •- No pre-existing illness preventing treatment, in particular renal function must be equivalent to grade 0-1 nephrotoxicity, no prior history of cardiac disease and normal shortening fraction (>
- •28%) and ejection fraction (> 47%).
- •- No previous malignant tumours.
- •- Interval between diagnostic surgery and chemotherapy no longer than 8 weeks.
- •- Diagnostic material available for pathology review.
- •- Available for long term follow up through the treatment centre.
- •- Written informed consent for treatment available.
- •- stratification according to the High Risk Arm
- •- age > 6 months (and < 21 years)
- •- not paratesticular alveolar RMS
- •- informed consent given for the randomised study
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 700
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Any negative response mentioned in the main inclusion criteria will be grounds for ineligibility of the patient.
研究者
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