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| Sponsor: | American College of Surgeons |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) NCIC Clinical Trials Group Cancer and Leukemia Group B Southwest Oncology Group |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00041197 |
Purpose
RATIONALE: Imatinib mesylate (Gleevec; STI571) may interfere with the growth of tumor cells and may be an effective treatment for patients with primary gastrointestinal stromal tumor that has been completely removed by surgery.
PURPOSE: This randomized phase III trial is studying imatinib mesylate (Gleevec; STI571) to see how well it works compared to placebo in treating patients with primary gastrointestinal stromal tumor that has been completely removed by surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastrointestinal Stromal Tumor |
Drug: imatinib mesylate Other: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
| Official Title: | A Phase III Randomized Double-Blind Study of Adjuvant STI571 (Gleevec) Versus Placebo in Patients Following the Resection of Primary GastroIntestinal Stromal Tumor (GIST) |
| Estimated Enrollment: | 732 |
| Study Start Date: | June 2002 |
| Estimated Primary Completion Date: | April 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm I: Experimental
Patients receive oral imatinib mesylate (Gleevec; STI571) once daily for 1 year.
|
Drug: imatinib mesylate
Given orally
|
|
Arm II: Placebo Comparator
Patients receive oral placebo once daily for 1 year.
|
Other: placebo
Given orally
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, double-blind, placebo-controlled, crossover, multicenter study. Patients are stratified according to tumor size (3 cm but less than 6 cm vs 6 cm to less than 10 cm vs 10 cm or greater). Patients are randomized to 1 of 2 treatment arms.
Patients are followed every 3 months for 2 years and then every 6 months for 8 years.
PROJECTED ACCRUAL: A total of 732 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Prior complete gross resection of a primary GIST within the past 14-70 days
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
No other malignancy within the past 5 years except:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 57 Study Locations| Study Chair: | Ronald DeMatteo, MD | Memorial Sloan-Kettering Cancer Center |
| Study Chair: | Martin E. Blackstein, MD | Mount Sinai Hospital - Toronto |
| Study Chair: | Christopher W. Ryan, MD | University of Chicago |
| Study Chair: | John T. Vetto, MD, FACS | OHSU Knight Cancer Institute |
More Information
| Responsible Party: | American College of Surgeons Oncology Group ( David M. Ota ) |
| Study ID Numbers: | CDR0000069452, ACOSOG-Z9001, CAN-NCIC-SRC1, CALGB-ACOSOG-Z9001, SWOG-ACOSOG-Z9001, UWCC-UW-6303, UWCC-UW-03-8438-A-03 |
| Study First Received: | July 8, 2002 |
| Last Updated: | April 18, 2009 |
| ClinicalTrials.gov Identifier: | NCT00041197 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
gastrointestinal stromal tumor |
|
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 |