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Docetaxel and Epirubicin in Advanced Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00375999
Recruitment Status : Completed
First Posted : September 14, 2006
Results First Posted : March 3, 2014
Last Update Posted : March 3, 2014
Sponsor:
Information provided by (Responsible Party):
Jae Yong Cho, Yonsei University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Stomach Neoplasms
Intervention: Drug: Docetaxel and epirubicin

  Participant Flow

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

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 
Overall Participants Analyzed 
[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 ]
  Show Outcome Measure 1


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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
First Submitted: September 13, 2006
First Posted: September 14, 2006
Results First Submitted: January 14, 2014
Results First Posted: March 3, 2014
Last Update Posted: March 3, 2014