Nedaplatin Versus Cisplatin in Induction Chemotherapy Combined With Concurrent Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma：a Prospective, Parallel, Randomized, Open Labeled, Phase III Non-Inferiority Clinical Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 352
- 试验地点
- 1
- 主要终点
- Progress-Free Survival (PFS)
研究概览
简要总结
To compare the effectiveness and toxicity of nedaplatin versus cisplatin in induction chemotherapy combined with concurrent chemoradiotherapy for locoregionally advanced nasopharyngeal carcinoma.
详细描述
This is a prospective, parallel, randomized, open labeled, phase III, non-inferiority clinical trial to compare the effectiveness and toxicity of nedaplatin versus cisplatin in induction chemotherapy combined with concurrent chemoradiotherapy for locoregionally advanced nasopharyngeal carcinoma patients in endemic area - nedaplatin, docetaxel and fluorouracil as induction chemotherapy regimen combined with nedaplatin as concurrent chemoradiotherapy (DNF-N) versus cisplatin, docetaxel and fluorouracil as induction chemotherapy regimen combined with cisplatin as concurrent chemoradiotherapy (DPF-P). All patients will receive radical intense modulate radiation therapy (IMRT). The primary endpoint is progress free survival (PFS).
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 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
- •Histologically confirmed keratinizing nasopharyngeal carcinoma (WHO I)
- •Age >65 or < 18 years
- •Treatment with palliative intent
- •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: Nedaplatin (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: Intensity modulated-radiotherapy (Radiation)
DPF-P
- Induction chemotherapy:
three cycles of intravenous docetaxel 60 mg/m² on day 1, intravenous cisplatin 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 cisplatin every 3 weeks, concurrently with intensity-modulated radiotherapy 3. Radiotherapy: radical intense modulated radiation therapy
干预措施: Docetaxel, cisplatin, fluorouracil (Drug)
DPF-P
- Induction chemotherapy:
three cycles of intravenous docetaxel 60 mg/m² on day 1, intravenous cisplatin 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 cisplatin every 3 weeks, concurrently with intensity-modulated radiotherapy 3. Radiotherapy: radical intense modulated radiation therapy
干预措施: Cisplatin (Drug)
DPF-P
- Induction chemotherapy:
three cycles of intravenous docetaxel 60 mg/m² on day 1, intravenous cisplatin 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 cisplatin every 3 weeks, concurrently with intensity-modulated radiotherapy 3. Radiotherapy: radical intense modulated radiation therapy
干预措施: Intensity modulated-radiotherapy (Radiation)
结局指标
主要结局
Progress-Free Survival (PFS)
时间窗: 3 years
Progress-free survival is calculated from the date of randomisation to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first.
次要结局
- Overall Survival(OS)(3 years)
- Locoregional Relapse-Free Survival(LRRFS)(3 years)
- Distant metastasis-Free Survival(DMFS)(3 years)
- Quality of life (QoL)(3 years)
- Objective Response Rate (ORR)(12 weeks after the interventions)
- Disease Control Rate (DCR)(12 weeks after the interventions)
研究者
Jin-Quan Liu
President of Affiliated Tumor Hospital of Guangzhou Medical University
Affiliated Cancer Hospital & Institute of Guangzhou Medical University