Three Cycles Versus Six Cycles of Adjuvant Chemotherapy for the Patients With High-risk Retinoblastoma After Enucleation: Prospective Randomized Control Study
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 179
- 试验地点
- 1
- 主要终点
- disease-free survival
研究概览
简要总结
The purpose of this study is to determine whether 3 cycles of chemotherapy(CEV) is not inferior to 6 cycles of chemotherapy(CEV) in the treatment of Stage I enucleated retinoblastoma.
详细描述
This study will be a phase Ⅲ open label interventional case series. Patients with unilateral Stage I enucleated retinoblastoma will be randomized to receive chemotherapy(CEV) of 3 cycles or 6 cycles every 21 days. Patients will be followed for 60 months.
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
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide written informed consent and comply with study assessments for the full duration of the study.
- •Definite pathology signs of retinoblastoma, Stage I base on International Retinoblastoma Staging System.
- •Received enucleation in the study eye.
- •Monocular retinoblastoma.
排除标准
- •Any previous disease in the study eye.
- •Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals).
- •History of chemical intervention for retinoblastoma in the study eye.
研究组 & 干预措施
3 cycles chemotherapy
Chemotherapy: vincristine 0.05 mg/kg (or 1.5 mg/m2 for children ≥ 3 years of age) on Day 1, carboplatin 18.6 mg/kg (or 560 mg/m2 for children ≥ 3 years of age) on Day 1, etoposide 5.0 mg/kg/day (or 150 mg/ m2 for children ≥ 3 years of age) on Days 1 and 2 and 2. Cycles were repeated every 21 days for three cycles.
干预措施: 3 cycles chemotherapy (Drug)
6 cycles chemotherapy
Chemotherapy: vincristine 0.05 mg/kg (or 1.5 mg/m2 for children ≥ 3 years of age) on Day 1, carboplatin 18.6 mg/kg (or 560 mg/m2 for children ≥ 3 years of age) on Day 1, etoposide 5.0 mg/kg/day (or 150 mg/ m2 for children ≥ 3 years of age) on Days 1 and 2 and 2. Cycles were repeated every 21 days for six cycles.
干预措施: 6 cycles chemotherapy (Drug)
结局指标
主要结局
disease-free survival
时间窗: five years
measure the disease-free survival rate for the two groups at five years
次要结局
- overall survival(five years)
- economic burden due to chemotherapy(during chemotherapy (9 weeks for 3-cycle group, and 18 weeks for 6-cycle group))
- safety: side effects of chemotherapy in the Treatment of Retinoblastoma(five years)
- quality of life (PedsQL4.0 scale) in the Treatment of Retinoblastoma(five years)
研究者
Huasheng Yang
Sun Yat-sen University
Sun Yat-sen University