Randomized Trial of Concurrent Cisplatin Chemoradiotherapy Plus Capecitabine Adjuvant Chemotherapy vs Concurrent Cisplatin Chemoradiotherapy Alone for Patients With Local Advanced Nasopharyngeal Carcinoma at High Risk of Distant Metastasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 294
- 试验地点
- 1
- 主要终点
- Distant metastasis-free survival
研究概览
简要总结
This is a randomized,controlled,prospective phase III clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy in Local Advanced Nasopharyngeal Carcinoma at High Risk of Distant Metastasis.Exploring an Individualized comprehensive treatment plan which is reasonable,effective,low toxicity and fitting with Modern radiotherapy techniques for Local Advanced Nasopharyngeal Carcinoma at High Risk of Distant Metastasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II/III)
- •Clinical stage III~IVb(UICC/AJCC 7th)
- •No distant metastasis
- •Karnofsky Performance Status Scale≥70
- •WBC count ≥ 4×109/L, neutrophil differential count≥ 1.5×109/L, Hemoglobin ≥ 90g/L, platelet count ≥ 100×109/L
- •ALT or AST ≤2.5×ULN,bilirubin ≤2.5×ULN, Serum creatinine ≤1.5×ULN or Serum creatinine clearance≥60ml/min
- •Sign the informed consent.
排除标准
- •Angle of sexual squamous cell carcinomas and basal cell layout, squamous cell carcinomas
- •Younger than 18 years old or older than 70 years old
- •Are receiving other drugs treanment
- •kidney disease
- •Have suffered from other tumor or now suffering from other tumor
- •Have recieved chemotherapy or radiotherapy
- •Pregnancy or lactation
- •unstable heart disease need timely treatment
- •Severe cerebrovascular disease/canker/psychosis/uncontrolled diabetes
研究组 & 干预措施
Concurrent chemoradiation + adjuvant chemotherapy
IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy
干预措施: IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy (Drug)
Concurrent chemoradiation
IMRT combine with cisplatin concurrent chemotherapy
干预措施: IMRT combine with cisplatin concurrent chemotherapy (Drug)
结局指标
主要结局
Distant metastasis-free survival
时间窗: Five year
Defined as the time from date of recruitment to documented distant metastasis or death from any cause.
次要结局
- Locoregional relapse-free survival(Five year)
- Overall survival(Five year)
- Acute toxicity(three months after corresponding treatment)
- Failure-free survival(Five year)
- Late toxicity(Five year)
研究者
Zhao Chong
PhD
Sun Yat-sen University