Skip to main content
OpenTrials
Completed

NCT Number: NCT00171977

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastrointestinal Stromal Tumors Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue

Age range

20 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

imatinib mesylate

Drug

Other names: Gleevec/Glivec, STI571

Primary outcomes

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

    Time frame: 3 years

Secondary outcomes

  1. To evaluate overall survival, relapse free

    Time frame: 3 years

  2. Safety

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2004
Primary completion
2009
First posted
Sep 15, 2005
Registry last updated
Aug 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.