NCT02245997已完成早期 1 期
Local Control With Reduced-dose Radiotherapy for High-Risk Neuroblastoma
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- assess local control rates treatment response
研究概览
简要总结
The purpose of this study is to give 12T a smaller dose of radiation in order to decrease these late side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have a diagnosis of neuroblastoma (International Classification of Disease for Oncology [ICD-O] morphology 9500/3) confirmed by MSKCC pathologic review
- •Patients must have high-risk neuroblastoma as defined by the COG Risk Stratification Schema
- •o Patients with International agreement on staging (INSS) stage 4 are eligible with the following:
- •MYCN amplification, regardless of age or additional biologic features
- •Age >18 months, regardless of biologic features OR
- •Age 1-18 months, with any of the 3 following unfavorable biologic OR features: MYCN amplification, unfavorable pathology, and/or DNA index = 1
- •o Patients with INSS stage 3 are eligible with the following:
- •MYCN amplification, regardless of age or additional biologic features OR
- •Age > 18 months with unfavorable pathology, regardless of MYCN status
- •o Patients with INSS stage 2a or 2b are eligible with the following:
- •MYCN amplification, regardless of age or additional biologic features
- •o Patients with INSS stage 4s are eligible with the following:
- •MYCN amplification, regardless of additional biologic features Patients must have undergone chemotherapy and surgery for high-risk neuroblastoma prior to enrollment on trial.
- •Age at time of enrollment of ≥1 month and ≤18 years
- •Female patients of childbearing potential must have a negative pregnancy test within 14 days of radiation start.
- •Female patients who are lactating must agree to stop breast-feeding.
- •Sexually active patients of childbearing potential must agree to use effective contraception.
排除标准
- •Patients with gross residual tumor after surgical resection
- •Patients who have received prior radiotherapy at or adjacent to the primary tumor bed
- •Patients with any concurrent medical or psychiatric condition or disease which, in the investigator's judgment, would make them inappropriate candidates for entry into this study.
结局指标
主要结局
assess local control rates treatment response
时间窗: 3 yeas
will be assessed via imaging (CT+/- MRI and MIBG) and clinical evidence at the primary site post completion of treatment. The baseline scan will be the pre-irradiation CT scan. Local failure is defined as a relapse in the primary tumor bed or adjacent lymph nodes.
次要结局
- Assessment of toxicity(3 years)
- event-free survival(3 years)
研究者
研究点 (1)
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