Back to resultsStudy of Docetaxel and Cisplatin Combined With Nimotuzumab As First-Line Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
Primary Purpose
Nasopharyngeal Carcinoma
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Docetaxel and Cisplatin and Nimotuzumab
Sponsored by
About this trial
This is an interventional treatment trial for Nasopharyngeal Carcinoma
Eligibility Criteria
Inclusion Criteria:
- biopsy proved nasopharyngeal carcinoma;
- stage IVc according to Union for International Cancer Control (UICC) edition VIII,or recurrent disease after chemotherapy and/or radiotherapy;
- 18 years or older; without other malignancy;
- proper functioning of the major organs.
Exclusion Criteria:
- allergic to docetaxel or cisplatin or Nimotuzumab ;
- female within gestation period or lactation;
- patients received drug of other clinical trail within 3 months
Sites / Locations
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University,Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Docetaxel and Cisplatin and Nimotuzumab
Arm Description
Outcomes
Primary Outcome Measures
overall survival
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03708822
Brief Title
Study of Docetaxel and Cisplatin Combined With Nimotuzumab As First-Line Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
Official Title
Open-Label, Multicenter, Phase Ⅱ Study of Docetaxel and Cisplatin Combined With Nimotuzumab As First-Line Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
December 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The purpose of this single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of docetaxel and cisplatin combined with Nimotuzumab in the treatment of recurrent and metastatic nasopharyngeal carcinoma
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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Docetaxel and Cisplatin and Nimotuzumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Docetaxel and Cisplatin and Nimotuzumab
Intervention Description
All patients enrolled in the study will accept docetaxel combined with cisplatin and Nimotuzumab as their firstline chemotherapy
Primary Outcome Measure Information:
Title
overall survival
Time Frame
5-years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
biopsy proved nasopharyngeal carcinoma;
stage IVc according to Union for International Cancer Control (UICC) edition VIII,or recurrent disease after chemotherapy and/or radiotherapy;
18 years or older; without other malignancy;
proper functioning of the major organs.
Exclusion Criteria:
allergic to docetaxel or cisplatin or Nimotuzumab ;
female within gestation period or lactation;
patients received drug of other clinical trail within 3 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qingqing Cai, PhD
Phone
0086-20-87342823
Email
caiqq@sysucc.org.cn
Facility Information:
Facility Name
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University,
City
Guangzhou
ZIP/Postal Code
51000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhihua Li, PhD
12. IPD Sharing Statement
Learn more about this trial
Study of Docetaxel and Cisplatin Combined With Nimotuzumab As First-Line Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
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