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

Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04015661
• Other study ID #: 20190515
• Status: Recruiting
• Phase: Phase 2
• Start date: July 9, 2019
• Est. completion date: June 1, 2022

Study information

• Verified date: July 2019
• Source: Fuzhou General Hospital
• Contact: wenmin ying, bachelor
• Phone: 228 59125
• Email: 18352770[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: June 1, 2022
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age, 18-75 years old.

2. Patients with newly histologically confirmed NPC.

3. WHO Type ? and ?.

4. Tumor staged as ?-?A (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.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Drug:
• Nab-paclitaxel
induction chemotherapy with nab-paclitaxel and nedaplatin followed by concurrent chemoradiotherapy

Locations

Country	Name	City	State
China	No. 156, North Road, Xierhuan Road	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fuzhou General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR)	To be determined by measurement of target lesions according to RECIST criteria	3 years
Secondary	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
Secondary	Overall survival(OS)	From the date of enrollment to the date of death is observed or to last follow-up visit	3 years