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Trial of Adjuvant Chemotherapy for Gastric Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00296322
First Posted: February 27, 2006
Last Update Posted: August 14, 2013
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.
Collaborators:
Ulsan University Hospital
Hallym University Medical Center
Information provided by (Responsible Party):
Yoon-Koo Kang, Asan Medical Center
Results First Submitted: July 19, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Stomach Cancer
Intervention: Drug: cisplatin, mitomycin-C, doxifluridine

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Although this study was originally designed to include 528 patients, a total 521 patients could be enrolled.

Reporting Groups
  Description
Mitomycin and Short-term Fluoropyrimidine Mitomycin-C 20mg/m2 intravenously (3-6 weeks after surgery) Doxifluridine 460-600mg/m2/day per oral for 3 months (started 4 weeks after surgery)
iceMFP Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine

Participant Flow:   Overall Study
    Mitomycin and Short-term Fluoropyrimidine   iceMFP
STARTED   258   263 
COMPLETED   237   184 
NOT COMPLETED   21   79 



  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.
No text entered.

Reporting Groups
  Description
Mitomycin and Short-term Fluoropyrimidine Mitomycin-C 20mg/m2 intravenously (3-6 weeks after surgery) Doxifluridine 460-600mg/m2/day per oral for 3 months (started 4 weeks after surgery)
iceMFP Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine
Total Total of all reporting groups

Baseline Measures
   Mitomycin and Short-term Fluoropyrimidine   iceMFP   Total 
Overall Participants Analyzed 
[Units: Participants]
 258   263   521 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   212   224   436 
>=65 years   46   39   85 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.87  (10.093)   52.23  (11.016)   53.04  (10.591) 
Gender 
[Units: Participants]
     
Female   82   88   170 
Male   176   175   351 
Region of Enrollment 
[Units: Participants]
     
Korea, Republic of   258   263   521 


  Outcome Measures
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1.  Primary:   Relapse-free Survival   [ Time Frame: 3 years ]

2.  Secondary:   Toxicity Profile (According to NCI CTC Version 2.0)   [ Time Frame: up to 1 year ]

3.  Secondary:   Overall Survival   [ Time Frame: 3 years ]


  Serious Adverse Events


  Other Adverse Events


  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. Yoon-Koo Kang
Organization: Asan Medical Center, University of Ulsan College of Medicine
phone: +82-2-3010-3230
e-mail: ykkang@amc.seoul.kr



Responsible Party: Yoon-Koo Kang, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00296322     History of Changes
Other Study ID Numbers: AMC-ONCGI-0102
First Submitted: February 24, 2006
First Posted: February 27, 2006
Results First Submitted: July 19, 2012
Results First Posted: September 6, 2012
Last Update Posted: August 14, 2013