NCT03183271已完成不适用
Phase II Clinical Study on Proton Therapy Boost (Hadrontherapy) for Locally Advanced HEAD AND NECK TUMORS
CNAO National Center of Oncological Hadrontherapy2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2012年7月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Local response
研究概览
简要总结
The aim of this research project is to test the local response and the acute toxicity (which can be observed within 90 days).
详细描述
Local response and acute toxicity are primary endpoints of the trial. At CNAO a proton boost is delivered on the PTV1rx (area at high risk of relapse) up to at least 70 Gy [RBE] in 2-3 Gy [RBE] per fractions for 8-15 total fractions.
PTV2 rx (area at low or intermediate risk of relapse) will be irradiated with photon IMRT up to a total dose of 50-60 Gy [RBE].
Secondary endpoints of the trial are local control, relapse free survival, overall survival, tumor specific survival, intermediate and long term toxicity.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic/cytologic diagnosis of primary epithelial malignant or neuroendocrine tumour
- •Inoperable tumour, locally advanced stage
- •Seated in rhinopharynx, nasal and paranasal sinuses, hypopharynx, larynx, oral cavity and oropharynx
- •At least one lesion measured according to the RECIST criteria
- •Enrollment for irradiation with IMRT up to 50-60 Gy RBE] on the PTV1rx and PTV2 rx to be followed at CNAO with irradiation with proton boost on thePTV1rx.
排除标准
- •Metastasis
- •Previous radiotherapy
- •Any metallic implants or other conditions such to prevent an adequate imaging of target volume
- •Unavailability of previous IMRT first phase radiotherapy plans
结局指标
主要结局
Local response
时间窗: 90 days
RECIST criteria
Acute toxicity
时间窗: 90 days
According to CTCAE v4.0
次要结局
- Local control(5 years)
- Disease free survival(5 years)
- Overall survival(5 years)
- Late toxicity(5 years)
研究者
研究点 (2)
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