Nasopharyngeal Carcinoma
Conditions
Brief summary
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.
Interventions
DRUGNab-paclitaxel
induction chemotherapy with nab-paclitaxel and nedaplatin followed by concurrent chemoradiotherapy
Sponsors
Fuzhou General Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age, 18-75 years old. 2. Patients with newly histologically confirmed NPC. 3. WHO Type Ⅱ and Ⅲ. 4. Tumor staged as Ⅲ-ⅣA (according to the 8th AJCC edition). 5. No serious organ dysfunction of heart, lung, liver, kidney. 6. No distant metastasis. 7. Hematological examinations:WBC≥3.5×109/L, NEUT#≥1.5×109/L, PLT≥90×109/L, HB≥90g/L. 8. 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. 9. Patients must be given written informed consent.
Exclusion criteria
1. age \>75 years or \<18years. 2. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes. 3. History of previous radiotherapy and chemotherapy. 4. Known or suspected to be allergic to platinum and Nab-paclitaxel. 5. Pregnancy or lactation. 6. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial. 7. Peripheral sensory neuropathy\> grade 1. 8. Uncontrolled heart clinical symptoms or diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | 3 years | To be determined by measurement of target lesions according to RECIST criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival(PFS) | 3 years | From the date of enrollment to the date of either locally, regionally or distant failure or last follow-up |
| Overall survival（OS） | 3 years | From the date of enrollment to the date of death is observed or to last follow-up visit |
Countries
China
Contacts
Primary Contactwenmin ying, bachelor
Backup Contactxiaoyan li
Outcome results
None listed