NCT03588403Unknown不适用
Comparison of Tomotherapy Versus Intensity-modulated Radiotherapy for Patients With Nasopharyngeal Carcinoma: a Prospective,Phase II Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- QoL(quality of life)
研究概览
简要总结
Tomotherapy is a new radiation planning and delivery technology which may allow for delivery of higher radiation doses with less damage to normal tissues. The investigators aim to compare the treatment efficacy and quality of life between tomotherapy and intensity-modulated radiotherapy for patients with nasopharyngeal carcinoma
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with newly histologically confirmed non-keratinizing carcinoma.
- •Tumor staged T1-4N0-3M0 （according to the 8th AJCC staging system）
- •Performance status: KPS>70
- •With normal liver function test (ALT, AST <1.5ULN)
- •Renal: creatinine clearance >60ml/min
- •Without hematopathy,marrow: WBC >4*109/L, HGB>80G/L, and PLT>100*109/L.
- •Written informed consent
排除标准
- •WHO type I squamous cell carcinoma or adenocarcinoma
- •Age >65 or <18
- •Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin)
- •Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume)
- •Patient is pregnant or lactating
- •Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance.
结局指标
主要结局
QoL(quality of life)
时间窗: 2 years
Changes in quality of life were assessed by EORTC QLQ-C30
次要结局
- Adverse Events(5 years)
- PFS (progression free survival)(2 years)
- OS (overall survival)(2 years)
- LRRFS(Locoregional failure-free survival)(2 years)
研究者
Chen Xiaozhong
chief phisician
Zhejiang Cancer Hospital
研究点 (1)
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