A Randomized Phase III Study of Sodium Thiosulfate for the Prevention of Cisplatin-Induced Ototoxicity in Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 131
- 试验地点
- 76
- 主要终点
- Incidence of Hearing Loss
研究概览
简要总结
RATIONALE: Sodium thiosulfate may reduce or prevent hearing loss in young patients receiving cisplatin for cancer. It is not yet known whether sodium thiosulfate is more effective than no additional treatment in preventing hearing loss.
PURPOSE: This randomized phase III trial is studying sodium thiosulfate to see how well it works in preventing hearing loss in young patients receiving cisplatin for newly diagnosed germ cell tumor, hepatoblastoma, medulloblastoma, neuroblastoma, osteosarcoma, or other malignancy.
详细描述
OBJECTIVES:
Primary
- To compare the efficacy of sodium thiosulfate vs observation in preventing hearing loss in young patients receiving cisplatin for the treatment of newly diagnosed germ cell tumor, hepatoblastoma, medulloblastoma, neuroblastoma, osteosarcoma, or other malignancy.
Secondary
- To compare the mean change in hearing thresholds for key frequencies in these patients.
- To compare the incidences of cisplatin-related grade 3 and 4 nephrotoxicity and grade 3 and 4 cytopenia in these patients.
- To compare the event-free survival and overall survival of these patients.
- To evaluate the association of two key gene mutations (TPMT and COMT) with the development of cisplatin-induced hearing loss in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
STS Arm (sodium thiosulfate treatment)
Patients receive sodium thiosulfate IV (dosage 16 g/m2 or 533 mg per kg for patients whose therapeutic protocol administers cisplatin on a per kg basis due to young age or small body) over 15 minutes beginning 6 hours after the completion of each cisplatin infusion. Treatment with sodium thiosulfate continues until the completion of cisplatin therapy.
干预措施: sodium thiosulfate (Drug)
STS Arm (sodium thiosulfate treatment)
Patients receive sodium thiosulfate IV (dosage 16 g/m2 or 533 mg per kg for patients whose therapeutic protocol administers cisplatin on a per kg basis due to young age or small body) over 15 minutes beginning 6 hours after the completion of each cisplatin infusion. Treatment with sodium thiosulfate continues until the completion of cisplatin therapy.
干预措施: examination (Procedure)
Observation Arm (No sodium thiosulfate treatment)
Patients do not receive sodium thiosulfate.
干预措施: examination (Procedure)
结局指标
主要结局
Incidence of Hearing Loss
时间窗: 4 weeks after last dose of cisplatin
Hearing loss defined by comparing hearing sensitivity at follow up evaluation relative to baseline measurements using ASHA criteria.
次要结局
- Change in Hearing Thresholds For Key Frequencies at 500 hz(4 weeks after last dose of cisplatin)
- Change in Hearing Thresholds For Key Frequencies at 1000 hz(4 weeks after last dose of cisplatin)
- Change in Hearing Thresholds For Key Frequencies at 2000 hz(4 weeks after last dose of cisplatin)
- Change in Hearing Thresholds For Key Frequencies at 4000 hz(4 weeks after last dose of cisplatin)
- Change in Hearing Thresholds For Key Frequencies at 8000 hz(4 weeks after last dose of cisplatin)
- Event-Free Survival (EFS)(4 years after enrollment)
- Overall Survival (OS)(4 Years after enrollment)
- Hearing Loss Among Patients Carrying/Not-carrying Two Key Gene Mutations (TPMT and COMT)(4 weeks after the last dose of cisplatin)