Gastrointestinal Stromal Tumor (GIST)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients pathologically diagnosed as GIST 2.Patients with KIT positive by immunohistological study 3.Patients who were macroscopically 4.Intermediate or High risk (including clinically malignant) classified by Fletcher category 5.Age: &#8805;>=20 & <75 6.Patients who have no previous treatment 7.Patients who could start adjuvant treatment within 2-12 weeks 8.PS(ECOG):0-2 9.Patients who To be able to take orally 10.Patients who Maintain major organ function (2 weeks after surgery & 30 days before submission) 11.Patients who acquire agreement by written document
Exclusion criteria
Exclusion criteria: 1.Patients who have a medical history of active double cancers without cis in the past 5 years 2.Patients who have active infectious disease by bacteria and/or fungus 3.Patients who have heart disease of NYHA class III or IV 4.Patients who are pregnant, lactating, or with the intention of becoming pregnant (including men) 5.Patients who have mental disorder and considered inappropriate for registration to this study 6.Patients who were judged to be unacceptable for enrollment by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence-Free Survival (RFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Accomplishment rate of treatment 2.Overall survival (OS) 3.To examine factors for Imatinib treatment continuation 4.Relationship between mutation and survival term (RFS, OS) 5.Occurrence rate of adverse events | — |
Countries
Japan