Hemoglobin, Neutrophil to Lymphocyte Ratio and Platelet Count Improve Prognosis Prediction of TNM Staging System in Nasopharyngeal Carcinoma: A Prospective Multi-institutional Observation Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 720
- 试验地点
- 6
- 主要终点
- 5-year overall survival
研究概览
简要总结
RATIONALE
- In patients with nasopharyngeal carcinoma, there is sometimes a discrepancy between actual clinical outcome and TNM stages because it is an anatomy-based system in which functional factors are not concerned.
- Hemoglobin, neutrophil to lymphocyte ratio and platelet count were proved to improve prognosis prediction of TNM staging system in our previous retrospective study.
PURPOSE To validate that the prognostic index based on complete blood count and TNM system had higher prediction efficiency on survival in nasopharyngeal carcinoma than TNM system alone.
详细描述
Totally 720 patients with non-metastatic nasopharyngeal carcinoma will be include and will be divided into 3 groups (Low Risk, Intermediate Risk and High Risk Groups) according to their prognostic index, which is on basis of blood cell count indexes and TNM stage. The 3 groups of patients will undergo a radical radiotherapy or chemoradiotherapy and be followed until death or the end of the study. Comparison on survivals of the 3 groups will be made to validate the accuracy of the prognostic index. And comparison on prediction efficacy between prognostic index and TNM staging system will be made.
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
- •Nasopharyngeal cancer patients diagnosed by pathology or cytology
- •UICC/AJCC 2010 Stage T1-4 N0-3 M0
- •Male or female patients with age between 18 and 75 years old
- •Karnofsky Performance Scores ≥ 60
- •Expected survival ≥ 3 months
- •Without dysfunction of heart, lung, liver, kidney and hematopoiesis
排除标准
- •Karnofsky Performance Status Score < 70'
- •Radiotherapy uncompleted (≥ 1 fraction missing)
- •Distant metastases before or during radiotherapy
- •Without weekly complete blood count during radiotherapy
- •Application of colony stimulating factor such as erythropoietin
- •Signs of infection before radiotherapy.
结局指标
主要结局
5-year overall survival
时间窗: 5 years after diagnosis
The period until any event (death, local recurrence or distant metastasis) is detected.
次要结局
- 5-year recurrence-free survival(5 years after diagnosis)
- 5-year disease-free survival(5 years after diagnosis)
- 5-year distant-free survival(5 years after diagnosis)
研究者
Yun-fei Xia
Department of Radiation Oncology, Sun Yat-sen University Cancer Center
Sun Yat-sen University