Local Control With Reduced-dose Radiotherapy for High-Risk Neuroblastoma
试验速览
- 阶段
- 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.
研究组 & 干预措施
patients with high-risk neuroblastoma
Patients undergo external beam radiation therapy using IMRT or proton beam RT twice daily for 5-6 weekdays (10-12 treatments). Patients will be evaluated by physical exams, CT scan or MRI of the primary site, and MIBG at, 6, 12, 18 and 24 months (+/- 6 weeks).
干预措施: External beam radiotherapy (Radiation)
patients with high-risk neuroblastoma
Patients undergo external beam radiation therapy using IMRT or proton beam RT twice daily for 5-6 weekdays (10-12 treatments). Patients will be evaluated by physical exams, CT scan or MRI of the primary site, and MIBG at, 6, 12, 18 and 24 months (+/- 6 weeks).
干预措施: proton beam RT (Radiation)
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)