Induction Chemotherapy Followed by Concurrent Chemoradiotherapy in Patients With LA-NPC

Study Overview
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Brief Summary
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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.

Official Title
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Induction Chemotherapy With Nab-paclitaxel and Nedaplatin Followed by Concurrent Chemoradiotherapy in Patients With Locally Advanced Nasopharyngeal Carcinoma

Conditions
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Nasopharyngeal Carcinoma

Intervention / Treatment
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* Drug: Nab-paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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 1. Uncontrolled heart clinical symptoms or diseases.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nab-paclitaxel+Nedaplatin<br>induction chemotherapy by nab-paclitaxel and nedaplatin followed by concurrent chemoradiotherapy | Drug: Nab-paclitaxel<br>* induction chemotherapy with nab-paclitaxel and nedaplatin followed by concurrent chemoradiotherapy<br>* Other names: Paclitaxel for Injection (Albumin Bound);|
| Active Comparator: Paclitaxel+Nedaplatin<br>induction chemotherapy by paclitaxel and nedaplatin followed by concurrent chemoradiotherapy | Drug: Nab-paclitaxel<br>* induction chemotherapy with nab-paclitaxel and nedaplatin followed by concurrent chemoradiotherapy<br>* Other names: Paclitaxel for Injection (Albumin Bound);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | To be determined by measurement of target lesions according to RECIST criteria | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival(PFS) | From the date of enrollment to the date of either locally, regionally or distant failure or last follow-up | 3 years | 
| Overall survival（OS） | From the date of enrollment to the date of death is observed or to last follow-up visit | 3 years |