Adjuvant Imatinib in High-risk Gastrointestinal Stromal Tumor (GIST) With C-kit Mutation

This study has been completed.
Information provided by (Responsible Party):
Yoon-Koo Kang, Asan Medical Center Identifier:
First received: January 17, 2006
Last updated: June 30, 2015
Last verified: June 2015
Results First Received: November 19, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Sarcoma
Gastrointestinal Stromal Tumors
Intervention: Drug: Imatinib mesylate (Glivec)

  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
Forty-eight patients were enrolled at four centers in South Korea between August 2005 and June 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One patient was excluded from the study before treatment initiation because of metastatic disease.

Reporting Groups
Imatinib Mesylate imatinib mesylate 400 mg daily for 2 years

Participant Flow:   Overall Study
    Imatinib Mesylate  
STARTED     47  
COMPLETED     38  

  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.
All enrolled patients were included for baseline analysis.

Reporting Groups
Imatinib Mesylate patients receiving adjuvant imatinib mesylate

Baseline Measures
    Imatinib Mesylate  
Number of Participants  
[units: participants]
[units: participants]
<=18 years     0  
Between 18 and 65 years     35  
>=65 years     12  
[units: years]
Mean (Standard Deviation)
  56.3  (10.0)  
[units: participants]
Female     23  
Male     24  
Region of Enrollment  
[units: participants]
Korea, Republic of     47  

  Outcome Measures
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1.  Primary:   2-year Relapse Free Survival Rate   [ Time Frame: 2 years ]

2.  Secondary:   2-year Overall Survival Rate   [ Time Frame: 2 years ]

3.  Secondary:   Toxicity Profile   [ Time Frame: Monitoring of adverse events will be continued for at least 28days following the last dose of study treatment, up to 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
phone: +82-2-3010-3210

No publications provided

Responsible Party: Yoon-Koo Kang, Asan Medical Center Identifier: NCT00278876     History of Changes
Other Study ID Numbers: AMC-ONCGI-0501, CSTI571BKR08
Study First Received: January 17, 2006
Results First Received: November 19, 2013
Last Updated: June 30, 2015
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)