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| Sponsor: | European Organization for Research and Treatment of Cancer - EORTC |
|---|---|
| Collaborators: |
Italian Sarcoma Group Federation Nationale des Centres de Lutte Contre le Cancer Grupo Espanol de Investigacion en Sarcomas |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00103168 |
Purpose
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving imatinib mesylate after surgery may kill any remaining tumor cells. It is not yet known whether imatinib mesylate is more effective than observation only in treating gastrointestinal stromal tumor.
PURPOSE: This randomized phase III trial is studying imatinib mesylate to see how well it works compared to observation only in treating patients who have undergone surgery for localized gastrointestinal stromal tumor.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastrointestinal Stromal Tumor |
Drug: imatinib mesylate Procedure: adjuvant therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Intermediate and High Risk Localized, Completely Resected, Gastrointestinal Stromal Tumors (GIST) Expressing KIT Receptor: A Controlled Randomized Trial on Adjuvant Imatinib Mesylate (Glivec) Versus No Further Therapy After Complete Surgery |
| Estimated Enrollment: | 750 |
| Study Start Date: | December 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center, risk category (high vs intermediate), tumor site (gastric vs other), and resection level (R0 vs R1). Patients are randomized to 1 of 2 arms.
After completion of study treatment, patients in arm I are followed every 3 months for 2 years. All patients are then followed every 4 months for 3 years and at least annually thereafter.
PROJECTED ACCRUAL: A total of 750 patients will be accrued for this study within 5 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed gastrointestinal stromal tumor
Meets 1 of the following criteria:
At high-risk of relapse, defined by 1 of the following criteria:
At intermediate-risk of relapse, defined by 1 of the following criteria:
Must have undergone complete resection of the primary tumor at least 2 weeks, but no more than 3 months, before study entry
Meets criteria for 1 of the following resection levels:
R1, defined by 1 of the following criteria:
No residual macroscopic disease after surgery
No distant metastases*, including any of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent therapeutic anticoagulation with coumarin derivatives
Contacts and Locations
Show 50 Study Locations| Investigator: | Paolo G. Casali, MD | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
| Investigator: | Axel Le Cesne, MD | Institut Gustave Roussy |
| Investigator: | Andres Poveda, MD | Instituto Valenciano De Oncologia |
More Information
| ClinicalTrials.gov Identifier: | NCT00103168 History of Changes |
| Other Study ID Numbers: | CDR0000410825, EORTC-62024, ISG-62024, FRE-FNCLCC-EORTC-62024, GEIS-EORTC-62024, EUDRACT-2004-001810-16 |
| Study First Received: | February 7, 2005 |
| Last Updated: | December 13, 2009 |
| Health Authority: | Unspecified |
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gastrointestinal stromal tumor |
|
Gastrointestinal Stromal Tumors Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Adjuvants, Immunologic Imatinib |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |