Post-Marketing Clinical Study of Postoperative Adjuvant Therapy With Imatinib Mesylate in Patients With Gastrointestinal Stromal Tumors (GIST)
- Registration Number
- NCT00171977
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
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 / exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Imatinib Mesylate Imatinib Mesylate 400 mg once per day
- Primary Outcome Measures
Name Time Method To evaluate the relapse-free survival (RFS) in patients receiving postoperative adjuvant therapy 3 years
- Secondary Outcome Measures
Name Time Method To evaluate overall survival, relapse free 3 years Safety 3 years
Trial Locations
- Locations (1)
Novartis Investigative Site
🇯🇵Tokyo, Japan