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Sponsors and Collaborators: |
American College of Surgeons National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00025246 |
RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.
PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with gastrointestinal stromal tumor that was completely removed during surgery.
Condition | Intervention | Phase |
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Gastrointestinal Stromal Tumor |
Drug: imatinib mesylate Procedure: adjuvant therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Study of Adjuvant STI571 Therapy in Patients Following Completely Resected High-Risk Primary Gastrointestinal Stromal Tumor (GIST) |
Study Start Date: | September 2001 |
OBJECTIVES:
OUTLINE: Patients receive oral imatinib mesylate daily beginning within 84 days of surgical resection. Treatment continues for 1 year in the absence of disease recurrence or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 10 years.
PROJECTED ACCRUAL: A total of 89 patients will be accrued for this study.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed high-risk primary gastrointestinal stromal tumor
High-risk is defined as any of the following:
Complete gross tumor resection performed within the past 70 days
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
No other prior malignancy within the past 5 years except:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Ronald DeMatteo, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000068942, ACOSOG-Z9000, CWRU-020313 |
Study First Received: | October 11, 2001 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00025246 History of Changes |
Health Authority: | United States: Federal Government |
gastrointestinal stromal tumor |
Imatinib Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases |
Adjuvants, Immunologic Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors Protein Kinase Inhibitors |
Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |
Imatinib Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors |