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

January 17, 2006
January 19, 2006
November 19, 2013
July 27, 2015
July 27, 2015
April 2005
August 2007   (Final data collection date for primary outcome measure)
2-year Relapse Free Survival Rate [ Time Frame: 2 years ]
Relapse free survival
Complete list of historical versions of study NCT00278876 on Archive Site
  • 2-year Overall Survival Rate [ Time Frame: 2 years ]
  • 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. ]
    Number of patients who experienced toxicity from study treatment to evaluate the safety and tolerability of adjuvant imatinib
Overall survival, toxicities
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Adjuvant Imatinib in High-risk Gastrointestinal Stromal Tumor (GIST) With C-kit Mutation
Phase II Study of Imatinib Mesylate as Adjuvant Treatment in High-relapse Risk Localized Gastrointestinal Stromal Tumors With C-kit Mutation
The presence of c-kit mutation is an independent poor prognostic factor for relapse in addition to large size (> 5 cm) and high mitotic rate (> 5/50 high power field [HPF]) in localized gastrointestinal stromal tumor (GIST) patients who underwent complete surgical resection. In addition, the localized GIST which had exon 11 c-kit mutation and features of high-risk for relapse according to National Institute of Health (NIH) consensus guideline (tumor size > 10 cm or mitotic count > 10/50 HPF) also have high-risk of relapse. Until recently, there has been no effective therapy for advanced, unresectable GISTs. However, a new agent, imatinib mesylate, has shown promise in the metastatic setting, and c-kit exon 11 mutation is the strongest prognostic factor for better response and survival. It is reasonable to try imatinib in an earlier and minimal residual status especially for patients at higher risk of relapse and a higher probability of response to imatinib.
Not Provided
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Sarcoma
  • Gastrointestinal Stromal Tumors
Drug: Imatinib mesylate (Glivec)
Imatinib mesylate 400mg/day per oral (day 1-28) every 4 weeks
Experimental: imatinib mesylate
patients receiving adjuvant imatinib mesylate
Intervention: Drug: Imatinib mesylate (Glivec)
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
March 2011
August 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically proven diagnosis of GIST, with positive immunostaining for KIT (CD117)
  • Tumor size > 5 cm and mitotic rate > 5/50HPF(High Power Field), or tumor size > 10 cm irrespective of mitotic rate, or mitotic rate > 10/50 HPF irrespective of tumor size.
  • Presence of mutation in exon 11 of c-kit gene.
  • Surgery performed from 3 weeks to 8 weeks before administration of Imatinib mesylate.
  • No evidence of residual macroscopic and microscopic disease after surgery.
  • Absence of distant metastases
  • No prior radiation therapy, no prior chemotherapy, no prior therapy with Imatinib mesylate, or any other molecular targeted or biological therapy.
  • Age 18 yrs or older
  • ECOG(Eastern Cooperative Oncology Group electrocorticogram) performance status = 0-2
  • No New York Heart Association (NYHA) Class 3~4 cardiac problems
  • Absence of severe and/or uncontrolled concurrent medical disease (e.g., uncontrolled diabetes, uncontrolled chronic renal disease, uncontrolled liver disease, including chronic viral hepatitis judged at risk of reactivation, uncontrolled active infection, such as human immunodeficiency virus (HIV) infection, etc.).
  • No ongoing pregnancy or nursing..
  • No prior, or ongoing other malignancy, except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or adequately treated cancer with eradicative intent for which the patient has been continuously disease-free for 5 years.
  • No use of coumarin derivatives at the time of treatment start.
  • Adequate liver function, as defined by a serum bilirubin < 1.5 x the institutional upper limit of normal (IULN), aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2.5 IULN, obtained within 7 days prior to randomization.
  • Adequate renal function, as defined by a serum creatinine < 1.5 x IULN, obtained within 7 days prior to randomization.
  • Absolute neutrophil count (ANC) > 1.5 x 109/l and a platelet count > 100 x 109/l obtained within 7 days prior to randomization. Baseline hemoglobin > 9 g/dl (this may be achieved by transfusions if needed).
  • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
Not Provided
Not Provided
Yoon-Koo Kang, Asan Medical Center
Asan Medical Center
Not Provided
Principal Investigator: Yoon-Koo Kang, M.D., Ph.D. Asan Medical Center
Asan Medical Center
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP