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Sponsored by: |
Asan Medical Center |
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Information provided by: | Asan Medical Center |
ClinicalTrials.gov Identifier: | NCT00278876 |
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 (> 5/50HPF) in localized 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 NIH consensus guideline (tumor size > 10 cm or mitotic count > 10/50HPF) 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 | Intervention | Phase |
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GIST Sarcoma |
Drug: Imatinib mesylate (Glivec) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Phase II Study of Imatinib Mesylate as Adjuvant Treatment in High-Relapse Risk Localized Gastrointestinal Stromal Tumors With c-Kit Mutation |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Korea, Republic of | |
Asan Medical Center | |
Seoul, Korea, Republic of | |
Seoul Samsung Medical Center | |
Seoul, Korea, Republic of | |
Seoul National University Hospital | |
Seoul, Korea, Republic of | |
National Cancer Center | |
Goyang, Korea, Republic of |
Principal Investigator: | Yoon-Koo Kang, M.D., Ph.D. | Asan Medical Center |
Study ID Numbers: | AMC-ONCGI-0501, CSTI571BKR08 |
Study First Received: | January 17, 2006 |
Last Updated: | November 28, 2007 |
ClinicalTrials.gov Identifier: | NCT00278876 History of Changes |
Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
GIST Imatinib Adjuvant therapy Kit mutation |
Imatinib Soft Tissue Sarcomas Malignant Mesenchymal Tumor Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases |
Adjuvants, Immunologic Sarcoma Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors Protein Kinase Inhibitors |
Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |
Imatinib Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors |