Gastrointestinal Stromal Tumors
Conditions
Keywords
GIST, Imatinib, Postoperative Adjuvant
Brief summary
This is a multicenter, post-marketing, clinical study evaluating the safety and efficacy of postoperative adjuvant therapy with Imatinib Mesylate in high-risk patients after curative resection of newly diagnosed GIST.Patients will be evaluated for relapse -free survival as measured by the confirmation of tumor recurrence and survival for 3 years after surgery for their primary tumors.
Interventions
DRUGImatinib Mesylate
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* underwent macroscopically curative resection; * immunohistochemically confirmed KIT (CD117)-positive tumors; * judged as being high-risk according to the criteria for risk classification
Exclusion criteria
* synchronous double cancer or metachronous double cancer with a disease-free period of ≤5 years; * received therapy with Imatinib Mesylate prior to study entry; * cardiac problem of Grade 3 or higher (New York Heart Association (NYHA) criteria) Other protocol-defined inclusion /
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the relapse-free survival (RFS) in patients receiving postoperative adjuvant therapy | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate overall survival, relapse free | 3 years |
| Safety | 3 years |
Countries
Japan
Outcome results
None listed