NCT02945878Unknown不适用
Predictive Factors of Acute Oral Mucositis Induced by Intensity-Modulated Radiation Therapy With Concurrent Chemotherapy for Local Advanced Nasopharyngeal Carcinoma
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- gradings of oral mucositis
研究概览
简要总结
This is a prospective, observational study to analyze the clinical and dosimetric factors about the radiation oral mucositis caused by radical chemo-radiotherapy for nasopharyngeal carcinoma patients and try to find the indicators for acute radiation oral mucositis.
详细描述
All patients received 1 - 3 concurrent chemotherapy during the intensity modulated radiotherapy. Before radiotherapy, three types of mouth mucosa are contoured in all treatment plans. Oral mucosa grades are recorded before and during treatment. Dose-volume Histograms are got to analyze the associated factors.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically conformed Initial nasopharyngeal carcinoma
- •Patients can feed through the mouth.
- •ECOG (Eastern Cooperative Oncology Group) : 0-
- •No history of chemo-radiotherapy, immuno-therapy or biotherapy.
- •Normal hemodynamic indices before the recruitment (including white blood cell count>4.0×109/L, neutrophil count>1.5×109/L, platelet count >100×109/L, hemoglobin≥90g/l, normal liver/kidney function).
- •Informed consent signed.
排除标准
- •History of malignant tumors.
- •Any severe complications contraindicated chemotherapy or radiotherapy.
- •Medical history of central nervous system, cognitive or psychological diseases;
- •Pregnant or nursing women.
- •Patients with mental disease cannot complete the questionaire.
- •Patients refused the informed consent.
结局指标
主要结局
gradings of oral mucositis
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (1)
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