A Multicenter, Randomized, Double-blind, Prospective Study to Evaluate the Efficacy and Safety of Vincristine, Dactinomycin/Cyclophosphamide Combination Therapy Combined With Liposomal Doxorubicin/Doxorubicin/Pharmorubicin/Pirarubicin in 0.5-14 Year Old Children With Nephroblastoma.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
This study aims to estimate the efficacy and side effects of study drugs in children with nephroblastoma who are treated with combination therapy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6 months old to 14 years old.
- •No smoking history.
- •Pathologically confirmed nephroblastoma.
- •Informed consent and assent has been obtained before any study assessment is performed.
- •Good compliance.
- •Need to be applied to anthracycline chemotherapy according to the diagnosis and treatment recommendations for Chinese children with nephroblastoma (current version CCCG-WT-2016).
- •Need to be applied to doxorubicin according to the diagnosis and treatment recommendations for children with nephroblastoma (CCCG-WT-2016).
排除标准
- •Patients with cardiovascular disease in addition to nephroblastoma.
- •Patients with digestive, neurological, circulatory, renal or liver disease, blood disorders or growth abnormalities unrelated to the tumor.
- •Patients have been treated with chemotherapy or cardiotoxic nephrotoxic drugs in the past 4 weeks.
- •Patients have participated in other clinical trials in the past 4 weeks.
- •Patients with mediastinal disease.
- •Patients who have undergone mediastinal radiotherapy due to other tumors or received other treatments that may cause heart damage.
研究组 & 干预措施
liposomal doxorubicin
Drugs: liposome doxorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide
干预措施: Vincristine (Drug)
liposomal doxorubicin
Drugs: liposome doxorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide
干预措施: Oxytetracycline/ Cyclophosphamide (Drug)
liposomal doxorubicin
Drugs: liposome doxorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide
干预措施: Liposomal doxorubicin (Drug)
doxorubicin
Drug: doxorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide
干预措施: Vincristine (Drug)
doxorubicin
Drug: doxorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide
干预措施: Oxytetracycline/ Cyclophosphamide (Drug)
doxorubicin
Drug: doxorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide
干预措施: Doxorubicin (Drug)
pharmorubicin
Drug: pharmorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide
干预措施: Vincristine (Drug)
pharmorubicin
Drug: pharmorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide
干预措施: Pharmorubicin (Drug)
pharmorubicin
Drug: pharmorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide
干预措施: Oxytetracycline/ Cyclophosphamide (Drug)
pirarubicin
Drug: pirarubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide
干预措施: Vincristine (Drug)
pirarubicin
Drug: pirarubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide
干预措施: Oxytetracycline/ Cyclophosphamide (Drug)
pirarubicin
Drug: pirarubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide
干预措施: Pirarubicin (Drug)
结局指标
主要结局
Progression free survival (PFS)
时间窗: 5 years
Time to treatment failure (TTF)
时间窗: 5 years
Five-year Event free survival (5-year EFS)
时间窗: 5 years
次要结局
- Overall survival (OS)(5 years)