Back to resultsNedaplatin Combined With Gemcitabine in the Treatment of Recurrent and/or Metastatic Nasopharyngeal Carcinoma : a Single Arm and Phase Ⅱ Clinical Trail
Primary Purpose
Recurrent and Metastatic Nasopharyngeal Carcinoma
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
nedaplatin and gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent and Metastatic Nasopharyngeal Carcinoma
Eligibility Criteria
Inclusion Criteria:
- biopsy proved nasopharyngeal carcinoma; stage IVc according to Union for International Cancer Control (UICC) edition VII,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 nedaplatin and/or gemcitabine; female within gestation period or lactation; patients received drug of other clinical trail within 3 months.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
nedaplatin combined with gemcitabine
Arm Description
Outcomes
Primary Outcome Measures
overall survival
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02789189
Brief Title
Nedaplatin Combined With Gemcitabine in the Treatment of Recurrent and/or Metastatic Nasopharyngeal Carcinoma : a Single Arm and Phase Ⅱ Clinical Trail
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Terminated
Study Start Date
June 2016 (undefined)
Primary Completion Date
September 4, 2019 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
5. Study Description
Brief Summary
The purpose of this single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of nedaplatin combined with gemcitabine 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
Recurrent and Metastatic 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
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
nedaplatin combined with gemcitabine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
nedaplatin and gemcitabine
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
No
Eligibility Criteria
Inclusion Criteria:
biopsy proved nasopharyngeal carcinoma; stage IVc according to Union for International Cancer Control (UICC) edition VII,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 nedaplatin and/or gemcitabine; female within gestation period or lactation; patients received drug of other clinical trail within 3 months.
12. IPD Sharing Statement
Learn more about this trial
Nedaplatin Combined With Gemcitabine in the Treatment of Recurrent and/or Metastatic Nasopharyngeal Carcinoma : a Single Arm and Phase Ⅱ Clinical Trail
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