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

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

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.

Study Overview

• Status: Unknown
• Conditions: Nasopharyngeal Carcinoma
• Intervention / Treatment: Drug: Nab-paclitaxel

• Study Type: Interventional
• Enrollment (Anticipated): 92
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: wenmin ying, bachelor; Phone Number: 228 59125; Email: 18352770@qq.com
• Study Contact Backup: Name: xiaoyan li; Phone Number: 228 59125

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China
      • Recruiting
      • No. 156, North Road, Xierhuan Road
      • Contact: wenmin ying, bachelor; Phone Number: 15080015210

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fuzhou General Hospital
• Investigators: Study Chair: zhichao fu, M.D, Fuzhou General Hospital of Nanjing Military Regio，Department of Radiotherapy

Study record dates

Study Major Dates

• Study Start (Anticipated): July 9, 2019
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: July 9, 2019
• First Submitted That Met QC Criteria: July 9, 2019
• First Posted (Actual): July 11, 2019

Study Record Updates

• Last Update Posted (Actual): July 11, 2019
• Last Update Submitted That Met QC Criteria: July 9, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Albumin-Bound Paclitaxel
• Other Study ID Numbers: 20190515

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No