NCT02143388已完成3 期
Concurrent Cisplatin Chemoradiation With or Without Capecitabine as Adjuvant Chemotherapy in Local Advanced High Risk Nasopharyngeal Carcinoma: Randomized Control Clinical Trial
Zhao Chong1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2014年3月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Failure free survival
研究概览
简要总结
This is an randomized controlled, multicenter 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 high risk nasopharyngeal carcinoma.
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 7th)
- •Meet at least one factor below :1 primary tumor SUVmax>10 in 18F-FDG PET/CT;2 primary tumor volume>30cm3;3 mutiple metastatic cervical lymph node with at least one's short diameter>4cm; 4 T4N2M0; 5 T1-4N3M0;6 EBV-DNA>2×10E4 copy/l
- •Range from 18～70 years old
- •WBC count ≥ 4×109/L，Hemoglobin ≥ 100g/L， platelet count ≥ 100×109/L
- •ALT or AST < 2.5×ULN、bilirubin < 1.5×ULN
- •OSerum creatinine < 1.5×ULN
排除标准
- •Central nervous system metastases
- •Suitable for local treatment
- •Uncontrolled seizure disorder or other serious neurologic disease
- •Clinically significant cardiac or respiratory disease
- •Drug or alcohol addition
- •Do not have full capacity for civil acts
- •Severe complication, active infection
- •Concurrent immunotherapy or hormone therapy for other diseases
- •Pregnancy or lactation
研究组 & 干预措施
Concurrent chemoradiation + adjuvant chemotherapy
Experimental
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
Active Comparator
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
Failure free survival
时间窗: 3-year
Defined as the time from date of recruitment to documented relapse or death from any cause.
次要结局
- Acute Toxicity(18 months)
研究者
Zhao Chong
MD
Sun Yat-sen University
研究点 (1)
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