A Multicenter Study to Evaluate a Risk-adapted Strategy for Treatment of Extra Cranial Non Seminomateous Malignant Germ Cell Tumour in Children and Adolescent
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 10
- 主要终点
- Progression-free survival
研究概览
简要总结
The main objective is to assess the benefit-risk ratio of a risk-adapted strategy for treatment of extra cranial NSMGCT in children and adolescent.
详细描述
Two different situations will be considered:
- in NSMGCT patients treated with cisplatin-based chemotherapy, the objective is to maintain a 2-year progression-free survival rate >80% despite a limitation of the number of course of chemotherapy (≤4) after the achievement of a clinical and biological response (primary endpoint);
- in children over 10 years with testicular or extragonadal NSMGCT, the objective is to improve the overall survival by systematically classifying the patients in high-risk group to allow a dose intensification.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Extra cranial non seminomateous malignant germ cell tumour (NSMGCT) except pure immature teratoma.
- •Age ≤ 18 years.
- •Affiliation with a social security scheme.
- •Signed informed consent by parents
- •Effective contraception during the study if relevant .
排除标准
- •Previous chemotherapy
- •Contraindications to study treatments
- •Patient who cannot follow medical surveillance due to geographical, social, or psychological reasons
- •Pregnant and breast feeding women
研究组 & 干预措施
3 courses of Velbe-Bleomycin-Cisplatin
3 VBP (Velbe-Bleomycin-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses
干预措施: Velbe-Bleomycin-Cisplatin (Drug)
4 courses of Velbe-Bleomycin-Cisplatin
4 VBP (Velbe-Bleomycin-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses
干预措施: Velbe-Bleomycin-Cisplatin (Drug)
3 courses Vepeside-ifosfamide-Cisplatin
3 VIP (Vepeside-ifosfamide-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses
干预措施: Vepeside-ifosfamide-Cisplatin (Drug)
4 courses Vepeside-ifosfamide-Cisplatin
4 VIP (Vepeside-ifosfamide-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses
干预措施: Vepeside-ifosfamide-Cisplatin (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 24 months
次要结局
- Overall survival(Within 10 years after the first inclusion, from the date of inclusion to the date of death due to any cause)
- complete remission rate after 1st line treatment (chemotherapy and surgery)(3 weeks after the end of treatment (CT + surgery))