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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 Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Stomach Neoplasms
Intervention Drug: Docetaxel and epirubicin
Enrollment 34
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment Group
Hide Arm/Group Description Salvage Chemotherapy with Docetaxel and Epirubicin for Advanced/Metastatic Gastric Cancer
Period Title: Overall Study
Started 34
Completed 32
Not Completed 2
Arm/Group Title Treatment Group
Hide Arm/Group Description Salvage Chemotherapy with Docetaxel and Epirubicin for Advanced/Metastatic Gastric Cancer
Overall Number of Baseline Participants 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 34 participants
53
(34 to 73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
Female
10
  29.4%
Male
24
  70.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 34 participants
34
1.Primary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group
Hide Arm/Group Description:
Salvage Chemotherapy with Docetaxel and Epirubicin for Advanced/Metastatic Gastric Cancer
Overall Number of Participants Analyzed 32
Median (95% Confidence Interval)
Unit of Measure: month
13.4
(7.0 to 19.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Group
Hide Arm/Group Description Salvage Chemotherapy with Docetaxel and Epirubicin for Advanced/Metastatic Gastric Cancer
All-Cause Mortality
Treatment Group
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Treatment Group
Affected / at Risk (%) # Events
Total   3/34 (8.82%)    
Infections and infestations   
sepsis  1/34 (2.94%) 
Respiratory, thoracic and mediastinal disorders   
pneumonia  2/34 (5.88%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment Group
Affected / at Risk (%) # Events
Total   16/34 (47.06%)    
Blood and lymphatic system disorders   
neutropenia  16/34 (47.06%)  16
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
Layout table for Results Point of Contact information
Name/Title: Dr. Jae Yong Cho
Organization: Gangnam Severance Hospital, Yonsei University College of Medicine
Phone: 82-2-2019-4363
EMail: chojy@yuhs.ac
Layout table for additonal information
Responsible Party: Jae Yong Cho, Yonsei University
ClinicalTrials.gov Identifier: NCT00375999    
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