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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
Hide Study Locations| United States, Alaska | |
| Providence Cancer Center | |
| Anchorage, Alaska, United States, 99508 | |
| United States, California | |
| Kaiser Foundation Hospital - San Rafael | |
| San Rafael, California, United States, 94903 | |
| Kaiser Permanente - Fremont | |
| Fremont, California, United States, 94538 | |
| Kaiser Permanente Medical Center - Hayward | |
| Hayward, California, United States, 94545 | |
| Kaiser Permanente Medical Center - Oakland | |
| Oakland, California, United States, 94611 | |
| Kaiser Permanente Medical Center - Redwood City | |
| Redwood City, California, United States, 94063 | |
| Kaiser Permanente Medical Center - Richmond | |
| Richmond, California, United States, 94801 | |
| Kaiser Permanente Medical Center - South San Francisco | |
| South San Francisco, California, United States, 94080 | |
| Kaiser Permanente Medical Center - Sacramento | |
| Sacramento, California, United States, 95825 | |
| Kaiser Permanente Medical Center - San Francisco Geary Campus | |
| San Francisco, California, United States, 94115 | |
| Kaiser Permanente Medical Center - Santa Clara Kiely Campus | |
| Santa Clara, California, United States, 95051 | |
| Kaiser Permanente Medical Center - Santa Rosa | |
| Santa Rosa, California, United States, 95403 | |
| Kaiser Permanente Medical Center - Santa Teresa | |
| San Jose, California, United States, 95119 | |
| Kaiser Permanente Medical Center - Roseville | |
| Roseville, California, United States, 95661 | |
| Kaiser Permanente Medical Center - Vallejo | |
| Vallejo, California, United States, 94589 | |
| Kaiser Permanente Medical Center - Walnut Creek | |
| Walnut Creek, California, United States, 94596 | |
| Kaiser Permanente Medical Facility - Stockton | |
| Stockton, California, United States, 95210 | |
| South Sacramento Kaiser-Permanente Medical Center | |
| Sacramento, California, United States, 95823 | |
| United States, Georgia | |
| Gwinnett Medical Center | |
| Lawrenceville, Georgia, United States, 30045 | |
| Charles B. Eberhart Cancer Center at DeKalb Medical Center | |
| Decatur, Georgia, United States, 30033 | |
| CCOP - Atlanta Regional | |
| Atlanta, Georgia, United States, 30342 | |
| Saint Joseph's Hospital of Atlanta | |
| Atlanta, Georgia, United States, 30342-1701 | |
| Southern Regional Medical Center | |
| Riverdale, Georgia, United States, 30274-2600 | |
| United States, Illinois | |
| Edward Hospital Cancer Center | |
| Naperville, Illinois, United States, 60540 | |
| Resurrection Medical Center | |
| Chicago, Illinois, United States, 60631 | |
| United States, Iowa | |
| Genesis Regional Cancer Center at Genesis Medical Center | |
| Davenport, Iowa, United States, 52803 | |
| Genesis Medical Center - West Campus | |
| Davenport, Iowa, United States, 52804 | |
| Covenant Cancer Treatment Center | |
| Waterloo, Iowa, United States, 50702 | |
| United States, Michigan | |
| Oncology Care Associates, PLLC | |
| Saint Joseph, Michigan, United States, 49085 | |
| United States, Minnesota | |
| Willmar Cancer Center at Rice Memorial Hospital | |
| Willmar, Minnesota, United States, 56201 | |
| United States, Nebraska | |
| UNMC Eppley Cancer Center at the University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198-6805 | |
| United States, New Jersey | |
| Frederick R. and Betty M. Smith Cancer Treatment Center | |
| Sparta, New Jersey, United States, 07871 | |
| United States, New York | |
| Tucker Center for Cancer Care at Orange Regional Medical Center | |
| Middletown, New York, United States, 10940-4199 | |
| United States, North Carolina | |
| Forsyth Regional Cancer Center at Forsyth Medical Center | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
| Adena Regional Medical Center | |
| Chillicothe, Ohio, United States, 45601 | |
| CCOP - Columbus | |
| Columbus, Ohio, United States, 43215 | |
| Genesis - Good Samaritan Hospital | |
| Zanesville, Ohio, United States, 43701 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| Community Hospital of Springfield and Clark County | |
| Springfield, Ohio, United States, 45505 | |
| Community Oncology Group at Cleveland Clinic Cancer Center | |
| Independence, Ohio, United States, 44131 | |
| Doctors Hospital at Ohio Health | |
| Columbus, Ohio, United States, 43228 | |
| Fairfield Medical Center | |
| Lancaster, Ohio, United States, 43130 | |
| Cleveland Clinic - Wooster | |
| Wooster, Ohio, United States, 44691 | |
| Good Samaritan Hospital Cancer Treatment Center | |
| Cincinnati, Ohio, United States, 45220 | |
| Grady Memorial Hospital | |
| Delaware, Ohio, United States, 43015 | |
| Grant Riverside Cancer Services | |
| Columbus, Ohio, United States, 43215 | |
| Licking Memorial Cancer Care Program at Licking Memorial Hospital | |
| Newark, Ohio, United States, 43055 | |
| Mount Carmel St. Ann's Cancer Center | |
| Westerville, Ohio, United States, 43081 | |
| Mount Carmel Health - West Hospital | |
| Columbus, Ohio, United States, 43222 | |
| Mercy Medical Center | |
| Springfield, Ohio, United States, 45504 | |
| Riverside Methodist Hospital Cancer Care | |
| Columbus, Ohio, United States, 43214-3998 | |
| Strecker Cancer Center at Marietta Memorial Hospital | |
| Marietta, Ohio, United States, 45750 | |
| United States, Pennsylvania | |
| Frankford Hospital Cancer Center - Torresdale Campus | |
| Philadelphia, Pennsylvania, United States, 19114 | |
| Hematology and Oncology Associates of Northeastern Pennsylvania | |
| Scranton, Pennsylvania, United States, 18510 | |
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19107-5541 | |
| United States, Vermont | |
| Fletcher Allen Health Care - University Health Center Campus | |
| Burlington, Vermont, United States, 05401 | |
| Mountainview Medical | |
| Berlin, Vermont, United States, 05602 | |
| 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 |