NCT03837808招募中3 期
A Randomized Phase III Non-inferiority Study of Radiotherapy Plus Concurrent Nimotuzumab Versus Cisplatin in Stage II-III Nasopharyngeal Carcinoma
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 384 人开始时间: 2019年4月11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
- 招募中
- 发起方
- 入组人数
- 384
- 试验地点
- 1
- 主要终点
- Progress-free survival (PFS)
研究概览
简要总结
This is a Phase III trial to study the effectiveness of nimotuzumab versus cisplatin combined with intensity-modulated radiation therapy (IMRT) in treating patients with stage II-III nasopharyngeal carcinoma.
详细描述
Scheme:
Eligible stage II and III NPC patients will first be stratified by institution, then randomized to 2 arms at 1:1 ratio.
-
Arm Cisplatin: cisplatin 40mg/m2/week in concurrent with IMRT
-
Arm nimotuzumab: nimotuzumab 200mg/week in concurrent with IMRT
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
- •Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III
- •histologically confirmed positive EGFR expression
- •Stage II and III NPC patients（according to the 8th AJCC edition）
- •Male and no pregnant female
- •Age between 18-65
- •Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL
- •Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) <2.0×upper limit of normal (ULN)
- •Adequate renal function: creatinine clearance ≥60 ml/min
- •Satisfactory performance status: Karnofsky scale (KPS) > 70
- •Without radiotherapy or chemotherapy
- •Patients must give signed informed consent
排除标准
- •Evidence of relapse or distant metastasis
- •History of prior malignancy or previous treatment for NPC
- •Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance.
- •Pregnancy or lactation
研究组 & 干预措施
Nimotuzumab
Experimental
nimotuzumab 200mg/week in concurrent with IMRT
干预措施: Nimotuzumab (Drug)
Cisplatin
Active Comparator
cisplatin 40mg/m2/week in concurrent with IMRT
干预措施: Cisplatin (Drug)
结局指标
主要结局
Progress-free survival (PFS)
时间窗: 2 years
Progress-free survival is calculated from the date of randomization to the date of the first progress at any site.
次要结局
- Overall Survival (OS)(2 years)
- Locoregional Relapse-Free Survival (LRRFS)(2 years)
- Distant Metastasis-Free Survival (DMFS)(2 years)
- Number of participants with adverse events(up to 2 years)
研究者
Ming-Yuan Chen
Principal Investigator
Sun Yat-sen University
研究点 (1)
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