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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sarcoma Gastrointestinal Stromal Tumors Drug: Imatinib mesylate (Glivec) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Imatinib Mesylate as Adjuvant Treatment in High-relapse Risk Localized Gastrointestinal Stromal Tumors With C-kit Mutation
Study Start Date : April 2005
Actual Primary Completion Date : August 2007
Actual Study Completion Date : March 2011

Arm Intervention/treatment
Experimental: imatinib mesylate
patients receiving adjuvant imatinib mesylate
Drug: Imatinib mesylate (Glivec)
Imatinib mesylate 400mg/day per oral (day 1-28) every 4 weeks

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

Secondary Outcome Measures :
  1. 2-year Overall Survival Rate [ Time Frame: 2 years ]
  2. 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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00278876

Korea, Republic of
National Cancer Center
Goyang, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Seoul Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Asan Medical Center
Principal Investigator: Yoon-Koo Kang, M.D., Ph.D. Asan Medical Center

Responsible Party: Yoon-Koo Kang, Professor, Asan Medical Center Identifier: NCT00278876     History of Changes
Other Study ID Numbers: AMC-ONCGI-0501
First Posted: January 19, 2006    Key Record Dates
Results First Posted: July 27, 2015
Last Update Posted: July 27, 2015
Last Verified: June 2015

Keywords provided by Yoon-Koo Kang, Asan Medical Center:
Adjuvant therapy
Kit mutation

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action