Post-Marketing Clinical Study of Postoperative Adjuvant Therapy With Imatinib Mesylate in Patients With Gastrointestinal Stromal Tumors (GIST)

Phase 4CompletedNCT00171977

Novartis Pharmaceuticals64 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gastrointestinal Stromal Tumors

Interventions

Imatinib MesylateDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 74 Years

Medical Language ↔ Plain English

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.

Locations (1)

Novartis Investigative Site

Tokyo, Japan

Outcomes

Primary Outcomes

To evaluate the relapse-free survival (RFS) in patients receiving postoperative adjuvant therapy

Time frame: 3 years

Secondary Outcomes

To evaluate overall survival, relapse free

Time frame: 3 years

Safety

Time frame: 3 years

Data from ClinicalTrials.gov

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