NCT00876031已完成3 期
A Randomised Phase-III Trial of the Cooperative Weichteilsarkom Study Group (CWS) for Localised High-risk Rhabdomyosarcoma and Localised Rhabdomyosarcoma-like Soft Tissue Sarcoma in Children, Adolescents, and Young Adults
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 195
- 试验地点
- 55
- 主要终点
- event free survival (EFS)
研究概览
简要总结
The purpose of this study is to investigate whether the addition of oral maintenance chemotherapy with O-TIE (Etoposide, Idarubicin, Trofosfamide) for 6 months improves the event free survival (EFS) in patients with localised high-risk RMS and RMS-like Soft Tissue Sarcoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written informed consent for registration, randomisation, data collection/transfer, and tumour material asservation available
- •pathologically (including molecular pathology) proven diagnosis of rhabdomyosarcoma (RMS) or RMS-like soft tissue sarcoma (STS) and tumour material available for pathology review
- •Rhabdomyosarcoma of the "High Risk" Group, i.e.:
- •RME, N0, M0, IRS II&III, >5 cm or >10 years in EXT, HN-PM, OTH, UG-BP
- •RME, N1, M0, any IRS-group, any size or age
- •RMA, NO, M0, any IRS-group, any size or age (exception: paratesticular RMA are not eligible) or
- •Rhabdomyosarcoma of the "Very High Risk" Group, i.e.:
- •RMA, N1, MO, IRS II&III, any size or age or
- •localised high-risk RMS-like Soft Tissue Sarcoma, i.e.:
- •EES, pPNET, UDS: any N, M0, any IRS-group, any size or age
- •SySa, any N, M0, any size or age (exception: SySa IRSI&II, not T2b, N0, M0 are not eligible)
- •no pre-existing illness preventing treatment (esp. those listed in the medicinal product information, e.g. cardiac, hepatic, metabolic, or renal dysfunction; hypersensitivity)
- •no previous malignant tumours
- •available for long term follow up through the treating centre
- •in remission (according to the CWS-2007-HR definition (see X7.1.8X)) at the time of randomisation after standard multimodal therapy e.g. according to the CWS-guidance
排除标准
- •pregnant or lactating women
- •other medical condition precluding treatment with protocol therapy (e.g. HIV, psychiatric disorder, etc.)
- •for sexually active females and males in Arm B (O-TIE treatment): refusal to use effective contraception (e.g. oral, IUD)
研究组 & 干预措施
O-TIE
Experimental
oral maintenance therapy with trofosfamide, idarubicin, and etoposide
干预措施: trofosfamide, idarubicin, etoposide (Drug)
结局指标
主要结局
event free survival (EFS)
时间窗: 3 years
次要结局
- Overall survival(5 years)
研究者
研究点 (55)
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