TPC vs PF as Induction Chemotherapy Combined With CCRT for Stage IVa-b Nasopharyngeal Carcinoma, a Prospective,Parallel, Randomized, Open Labeled, Multicenter Phase III Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 241
- 试验地点
- 1
- 主要终点
- Failure-free survival calculated from randomisation to locoregional failure, distant failure, or death from any cause
研究概览
简要总结
The purpose of this study is to compare the survival and toxicity of TPC (TAXOL, DDP AND CAPECITABINE ) VS PF (cisplatin and 5-Fluorouracil) as induction chemotherapy combined with concurrent chemoradiotherapy (CCRT) for stage IVa-b nasopharyngeal carcinoma patients in endemic area.
详细描述
This is a prospective, parallel, randomized, open labeled, multicenter phase III clinical trial to compare the survival and toxicity of TPC VS PF as induction chemotherapy combined with CCRT for stage IVa-b nasopharyngeal carcinoma patients in endemic area.The primary endpoint is failure free survival (FFS）.The secondary endpoints are overall survival(OS）,progression-free survival（PFS）, local-regionally relapse free survival(LRFS), distant metastasis free survival（DMFS)and toxicities.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •WHO II or III pathological type
- •stage Ⅳa or Ⅳb (UICC 7th edition)
- •no anticancer treatment before
- •no malignant history
- •both gender, 18-60 years old
- •enough liver function: TBIL≤ULN；AST/ALT≤2.5×ULN；ALP≤5×ULN
- •enough kidney function: Clcr≥80 mL/min
- •enough hemo: ANC≥2×109/L, PLT≥100×109/L and HB≥9g/dL
- •no sever heart, lung disfunction
排除标准
- •previous anticancer treatment
- •distant metastasis
- •pregnant or breasting female
- •can not access to followup
- •enrolled in other therapeutic clinical trial
- •sever infection and internal disease
- •sever disfunction of heart, lung, kidney, liver, etc
- •TBIL>ULN；AST/ALT>2.5×ULN；ALP>5×ULN
- •with factors that will affect the administration, distribution,metabolism or evacuation.
- •using immunosuppressive agents after organ transplantation
- •other malignant history
结局指标
主要结局
Failure-free survival calculated from randomisation to locoregional failure, distant failure, or death from any cause
时间窗: up to 5 years
次要结局
- Local-regionally relapse free survival calculated from randomisation to locoregional failure(up to 5 years)
- Progression free survival calculated from randomisation to disease progression or death from any cause(up to 5 years)
- Overall survival calculated from randomisation to death from any cause(up to 5 years)
- Distant metastasis free survival calculated from randomisation to distant failure(up to 5 years)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(up to 5 years)
研究者
XIANG YANQUN
PROFESSOR
Sun Yat-sen University