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

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. Identifier: NCT00278876
Recruitment Status : Completed
First Posted : January 19, 2006
Results First Posted : July 27, 2015
Last Update Posted : July 27, 2015
Information provided by (Responsible Party):
Yoon-Koo Kang, Asan Medical Center

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Sarcoma
Gastrointestinal Stromal Tumors
Intervention: Drug: Imatinib mesylate (Glivec)

  Participant Flow

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

  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.
All enrolled patients were included for baseline analysis.

Reporting Groups
Imatinib Mesylate patients receiving adjuvant imatinib mesylate

Baseline Measures
   Imatinib Mesylate 
Overall Participants Analyzed 
[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

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

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. Yoon-Koo Kang
Organization: Asan Medical Center
phone: +82-2-3010-3210

Responsible Party: Yoon-Koo Kang, Asan Medical Center Identifier: NCT00278876     History of Changes
Other Study ID Numbers: AMC-ONCGI-0501
First Submitted: January 17, 2006
First Posted: January 19, 2006
Results First Submitted: November 19, 2013
Results First Posted: July 27, 2015
Last Update Posted: July 27, 2015