Induction Chemotherapy With Nedaplatin, Docetaxel and 5-Fluorouracil Followed by Concurrent Nedaplatin and Radiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: a Single Arm, Open Label, Multicenter, Phase II Clinical Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- objective response rate (ORR)
研究概览
简要总结
To evaluate the efficacy of induction chemotherapy with nedaplatin, docetaxel and 5-Fluorouracil followed by concurrent nedaplatin combined with radical radiotherapy in locally advanced nasopharyngeal carcinoma.
详细描述
This is a prospective, phase II clinical trial to evaluate the efficacy and safety of induction chemotherapy with nedaplatin, docetaxel and 5-Fluorouracil followed by concurrent nedaplatin combined with radical radiotherapy in locally advanced nasopharyngeal carcinoma patients. This is a multicenter study. All patients will be enrolled in endemic area. All patients will receive radical intense modulate radiation therapy (IMRT). The primary endpoint is objective response rate (ORR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III
- •Original clinical staged as III-IVa (except T3-4N0) according to the 8th edition American Joint Committee on Cancer staging system
- •No evidence of distant metastasis (M0)
- •Age between 18-65
- •WBC≥4×10^9/ l, platelet ≥ 100×10^9/ l and hemoglobin ≥ 90g/l
- •With normal liver function test (TBIL、ALT、AST ≤ 2.5×uln)
- •With normal renal function test (creatinine ≤ 1.5×uln or ccr ≥ 60ml/min)
- •Satisfactory performance status: KARNOFSKY scale (KPS) > 70
- •Patients must give signed informed consent
排除标准
- •Treatment with palliative intent
- •The primary tumor or lymph node has undergone chemotherapy or surgery (except operations for diagnostic purposes)
- •Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer
- •History of previous radiotherapy, chemotherapy, or surgery (except diagnostic) to the primary tumor or nodes
- •History of previous radiotherapy
- •Pregnancy or lactation
- •Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, acute exacerbation of chronic obstructive pulmonary disease or other respiratory illness requiring admission to hospital, active hepatitis, and mental disturbance.
研究组 & 干预措施
DNF-N
- Induction chemotherapy:
three cycles of intravenous docetaxel 60 mg/m² on day 1, intravenous nedaplatin 60 mg/m² on day 1, and continuous intravenous fluorouracil 600 mg/m² per day from day 1 to day 5, every 3 weeks 2. Concurrent chemoradiotherapy:
three cycles of 100 mg/m² nedaplatin every 3 weeks, concurrently with intensity-modulated radiotherapy 3. Radiotherapy: radical intense modulated radiation therapy
干预措施: Docetaxel, nedaplatin, fluorouracil (Drug)
DNF-N
- Induction chemotherapy:
three cycles of intravenous docetaxel 60 mg/m² on day 1, intravenous nedaplatin 60 mg/m² on day 1, and continuous intravenous fluorouracil 600 mg/m² per day from day 1 to day 5, every 3 weeks 2. Concurrent chemoradiotherapy:
three cycles of 100 mg/m² nedaplatin every 3 weeks, concurrently with intensity-modulated radiotherapy 3. Radiotherapy: radical intense modulated radiation therapy
干预措施: IMRT (Radiation)
DNF-N
- Induction chemotherapy:
three cycles of intravenous docetaxel 60 mg/m² on day 1, intravenous nedaplatin 60 mg/m² on day 1, and continuous intravenous fluorouracil 600 mg/m² per day from day 1 to day 5, every 3 weeks 2. Concurrent chemoradiotherapy:
three cycles of 100 mg/m² nedaplatin every 3 weeks, concurrently with intensity-modulated radiotherapy 3. Radiotherapy: radical intense modulated radiation therapy
干预措施: Nedaplatin (Drug)
结局指标
主要结局
objective response rate (ORR)
时间窗: at the end of radiotherapy(±1week）
CR+PR
次要结局
- Overall Survival(OS)(3 years)
- Distant metastasis-Free Survival(DMFS)(3 years)
- Progress-Free Survival (PFS)(3 years)
- Locoregional Relapse-Free Survival(LRRFS)(3 years)
- Quality of life (QoL)(3 years)
研究者
Jin-Quan Liu
Section Chief
Affiliated Cancer Hospital & Institute of Guangzhou Medical University