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

Phase 2

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Drug: Nab-paclitaxel

• Registration Number: NCT04015661
• Lead Sponsor: Fuzhou General Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-07
• Study Start: 2019-07-09
• Study First Submitted: 2019-07-09
• Study First Submitted QC: 2019-07-09
• Last Update Submitted: 2019-07-09
• Study First Posted: 2019-07-11
• Last Update Posted: 2019-07-11
• Primary Completion: 2020-12-01
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 92

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nab-paclitaxel+Nedaplatin	Nab-paclitaxel	induction chemotherapy by nab-paclitaxel and nedaplatin followed by concurrent chemoradiotherapy
Paclitaxel+Nedaplatin	Nab-paclitaxel	induction chemotherapy by paclitaxel and nedaplatin followed by concurrent chemoradiotherapy

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	3 years	To be determined by measurement of target lesions according to RECIST criteria

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

No. 156, North Road, Xierhuan Road; 🇨🇳 Fuzhou, Fujian, China