Effect of Neoadjuvant Chemotherapy Followed by Concurrent Chemo-radiotherapy on Nutritional Status in Locoregionally Advanced Nasopharyngeal Carcinoma Patients: Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Change in Body weight
研究概览
简要总结
This is an prospective，open-label, none-interventional, observational， multicenter phase II clinical trial. The purpose of this study is to observe the effect of neoadjuvant chemotherapy followed by concurrent chemoradiation therapy(CCRT) on nutritional status in locoregionally advanced nasopharyngeal carcinoma(NPC) patients, analyse the changes of patients' nutrition status during the treatment and the connection between nutrition changes and curative effects, evaluate nutritional risks under the neoadjuvant chemotherapy and CCRT and provide data and basis for further study。
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II)
- •All genders，range from 18～65 years old
- •Karnofsky performance status(KPS) ≥ 80
- •Clinical stage III~IVb(UICC 7th)
- •Without significant digestive system disease，nutritional and metabolic diseases or endocrine disease
- •Without significant cardiac，respiratory，kidney or liver disease
- •Not received radiotherapy, chemotherapy and other anti-tumor treatment(including immunotherapy)
- •white blood cell(WBC) count ≥ 4×109/L, neutrophile granulocyte(NE) count ≥ 1.5×109/L, Hemoglobin(HGB) ≥ 10g/L, platelet(PLT) count ≥ 100×109/L
- •alanine aminotransferase (ALT) or aspartate aminotransferase(AST) < 1.5×upper limit of normal(ULN), bilirubin < 1.5×ULN, alanine aminotransferase (CCR) ≥ 30ml/min
- •Inform consent form
排除标准
- •Distance metastases
- •Second malignancy within 5 years
- •Drug or alcohol addition
- •Do not have full capacity for civil acts
- •Active systemic infections
- •Chronic consumptions
- •Mental disorder
- •Pregnancy or lactation
- •Concurrent immunotherapy or hormone therapy for other diseases
- •Severe complication, eg, uncontrolled hypertension
研究组 & 干预措施
NC+CCRT
Patients treated with neoadjuvant chemotherapy(NC) (cisplatin and docetaxel) and CCRT (cisplatin)
干预措施: cisplatin and docetaxel (Drug)
结局指标
主要结局
Change in Body weight
时间窗: baseline and 36 months
次要结局
- Number of Participants With Abnormal Laboratory Values(36 months)
- Acute Toxicity(3 months)
- Three-year locoregional relapse free survival rate(36 months)
- Three-year distance metastasis free survival rate(36 months)
- Three-year overall survival rate(36 months)
- Adverse Events That Are Related to Treatment(36 months)
- Tumor regressive rate after treatment(36 months)
- Late toxicity(36 months)
- Three-year disease free survival rate(36 months)
研究者
Zhao Chong
MD
Sun Yat-sen University