Hippocampus Avoidance During Intensity Modulated Radiotherapy for T4 Nasopharyngeal Carcinoma Patients:an Open, Prospective,Non-randomized Phase III Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- the dose-volume relationship between hippocampus and cognitive function
研究概览
简要总结
This is a prospective, non-randomized phase III study observing the cognitive function changes with conformal hippocampus avoidance during intensity modulated radiotherapy for T4 nasopharyngeal carcinoma patients.
详细描述
All patients received intensity modulated radiotherapy or Tomotherapy with or without chemotherapy. Before radiotherapy, the patients will receive brain MRI scanning and the brain MRI images will be fused with the head and neck CT scan images. The investigators develop the treatment plan with hippocampus avoidance. Cognitive function are evaluated before,during and after radiotherapy. 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologic confirmed nasopharyngeal carcinoma
- •ECOG performance scale 0-2
- •Tumor stage is T4N0-3M0-1 according to 8th American Joint Commission on Cancer edition
- •Adequate hepatic, renal and hematologic functions (hemoglobin ≥ 90g/L, platelets ≥ 100×10^9/L, neutrophils ≥ 1.5×10^9/L, serum transaminase < 2.5×the upper limit of normal(ULN), (If liver metastases, serum transaminase< 5×the ULN), creatinine clearance rate > 60ml/min.
- •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.
- •MRI contraindication -
结局指标
主要结局
the dose-volume relationship between hippocampus and cognitive function
时间窗: 1 year
To explore the relationship between cognitive impairment and exposure dose of hippocampus in patients with nasopharyngeal carcinoma.
次要结局
- cognitive function changes(1 year)
- memory function changes(1 year)
- quality of life(1 year)