Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
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Docetaxel and Epirubicin in Advanced Gastric Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jae Yong Cho, Yonsei University
ClinicalTrials.gov Identifier:
NCT00375999
First received: September 13, 2006
Last updated: January 14, 2014
Last verified: January 2014
History of Changes
Results First Received: January 14, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Stomach Neoplasms
Intervention: Drug: Docetaxel and epirubicin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Treatment Group Salvage Chemotherapy with Docetaxel and Epirubicin for Advanced/Metastatic Gastric Cancer

Participant Flow:   Overall Study
    Treatment Group  
STARTED     34  
COMPLETED     32  
NOT COMPLETED     2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Treatment Group Salvage Chemotherapy with Docetaxel and Epirubicin for Advanced/Metastatic Gastric Cancer

Baseline Measures
    Treatment Group  
Number of Participants  
[units: participants]
 		  34  
Age  
[units: years]
Median ( Full Range ) 		  53  
  ( 34 to 73 )  
Gender  
[units: participants]
 		 
Female     10  
Male     24  
Region of Enrollment  
[units: participants]
 		 
Korea, Republic of     34  



  Outcome Measures

1.  Primary:   Overall Survival   [ Time Frame: One year ]
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  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Jae Yong Cho
Organization: Gangnam Severance Hospital, Yonsei University College of Medicine
phone: 82-2-2019-4363
e-mail: chojy@yuhs.ac


Publications of Results:


Responsible Party: Jae Yong Cho, Yonsei University
ClinicalTrials.gov Identifier: NCT00375999     History of Changes
Other Study ID Numbers: 2004-232
Study First Received: September 13, 2006
Results First Received: January 14, 2014
Last Updated: January 14, 2014
Health Authority: Korea, Republic of: Yonsei University