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

Primary Purpose

Nasopharyngeal Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Nab-paclitaxel
Sponsored by
Fuzhou General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • No. 156, North Road, Xierhuan RoadRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nab-paclitaxel+Nedaplatin

Paclitaxel+Nedaplatin

Arm Description

induction chemotherapy by nab-paclitaxel and nedaplatin followed by concurrent chemoradiotherapy

induction chemotherapy by paclitaxel and nedaplatin followed by concurrent chemoradiotherapy

Outcomes

Primary Outcome Measures

Objective response rate (ORR)
To be determined by measurement of target lesions according to RECIST criteria

Secondary Outcome Measures

Progression-Free Survival(PFS)
From the date of enrollment to the date of either locally, regionally or distant failure or last follow-up
Overall survival（OS）
From the date of enrollment to the date of death is observed or to last follow-up visit

Full Information

First Posted
July 9, 2019
Last Updated
July 9, 2019
Sponsor
Fuzhou General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04015661
Brief Title
Induction Chemotherapy Followed by Concurrent Chemoradiotherapy in Patients With LA-NPC
Official Title
Induction Chemotherapy With Nab-paclitaxel and Nedaplatin Followed by Concurrent Chemoradiotherapy in Patients With Locally Advanced Nasopharyngeal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 9, 2019 (Anticipated)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
June 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fuzhou General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nab-paclitaxel+Nedaplatin
Arm Type
Experimental
Arm Description
induction chemotherapy by nab-paclitaxel and nedaplatin followed by concurrent chemoradiotherapy
Arm Title
Paclitaxel+Nedaplatin
Arm Type
Active Comparator
Arm Description
induction chemotherapy by paclitaxel and nedaplatin followed by concurrent chemoradiotherapy
Intervention Type
Drug
Intervention Name(s)
Nab-paclitaxel
Other Intervention Name(s)
Paclitaxel for Injection (Albumin Bound)
Intervention Description
induction chemotherapy with nab-paclitaxel and nedaplatin followed by concurrent chemoradiotherapy
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
To be determined by measurement of target lesions according to RECIST criteria
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Progression-Free Survival(PFS)
Description
From the date of enrollment to the date of either locally, regionally or distant failure or last follow-up
Time Frame
3 years
Title
Overall survival（OS）
Description
From the date of enrollment to the date of death is observed or to last follow-up visit
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
wenmin ying, bachelor
Phone
228 59125
Email
18352770@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
xiaoyan li
Phone
228 59125
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zhichao fu, M.D
Organizational Affiliation
Fuzhou General Hospital of Nanjing Military Regio，Department of Radiotherapy
Official's Role
Study Chair
Facility Information:
Facility Name
No. 156, North Road, Xierhuan Road
City
Fuzhou
State/Province
Fujian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
wenmin ying, bachelor
Phone
15080015210

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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