Induction Chemotherapy With Nab-paclitaxel and Nedaplatin Followed by Concurrent Chemoradiotherapy in Patients With Locally Advanced Nasopharyngeal Carcinoma
试验速览
- 阶段
- 2 期
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
Nasopharyngeal carcinoma (NPC) is a malignant tumor that originates in nasopharyngeal epithelial cells. It is common in southern China and Southeast Asia, but the incidence rate is low in most parts of the world. According to the World Health Organization survey, 80% of nasopharyngeal carcinomas occur in China, with high incidence in southern China, as high as 30-50/100,000, such as Guangdong, Guangxi, Hunan, and Fujian. In 2015, Chinese cancer statistics showed that there were about 60,600 new cases of nasopharyngeal carcinoma in China, and the number of deaths was about 34,100. Radiation therapy is the main treatment for nasopharyngeal carcinoma. Early stage I and IIa achieved a 5-year survival rate (OS) of 90% and 84%, respectively . However, the treatment outcomes of most patients with locally advanced nasopharyngeal carcinoma are not ideal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age, 18-75 years old.
- •Patients with newly histologically confirmed NPC.
- •WHO Type Ⅱ and Ⅲ.
- •Tumor staged as Ⅲ-ⅣA (according to the 8th AJCC edition).
- •No serious organ dysfunction of heart, lung, liver, kidney.
- •No distant metastasis.
- •Hematological examinations:WBC≥3.5×109/L, NEUT#≥1.5×109/L, PLT≥90×109/L, HB≥90g/L.
- •Normal liver function test：Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) <1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤1.5×ULN，creatinine clearance ≥60 ml/min.
- •Patients must be given written informed consent.
排除标准
- •age >75 years or <18years.
- •Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
- •History of previous radiotherapy and chemotherapy.
- •Known or suspected to be allergic to platinum and Nab-paclitaxel.
- •Pregnancy or lactation.
- •Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial.
- •Peripheral sensory neuropathy> grade
- •Uncontrolled heart clinical symptoms or diseases.
研究组 & 干预措施
Nab-paclitaxel+Nedaplatin
induction chemotherapy by nab-paclitaxel and nedaplatin followed by concurrent chemoradiotherapy
干预措施: Nab-paclitaxel (Drug)
Paclitaxel+Nedaplatin
induction chemotherapy by paclitaxel and nedaplatin followed by concurrent chemoradiotherapy
干预措施: Nab-paclitaxel (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: 3 years
To be determined by measurement of target lesions according to RECIST criteria
次要结局
- Progression-Free Survival(PFS)(3 years)
- Overall survival（OS）(3 years)