|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | July 8, 2002 | ||||||||||||||||
| Last Updated Date | April 18, 2009 | ||||||||||||||||
| Start Date ICMJE | June 2002 | ||||||||||||||||
| Estimated Primary Completion Date | April 2018 (final data collection date for primary outcome measure) | ||||||||||||||||
| Current Primary Outcome Measures ICMJE |
Recurrence-free survival as measured by serial CT scans at 3-6 months [ Designated as safety issue: No ] | ||||||||||||||||
| Original Primary Outcome Measures ICMJE |
Recurrence-free survival as measured by serial CT scans at 3-6 months | ||||||||||||||||
| Change History | Complete list of historical versions of study NCT00041197 on ClinicalTrials.gov Archive Site | ||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
Overall survival as measured by serial doctor visits at 3-6 months [ Designated as safety issue: No ] | ||||||||||||||||
| Original Secondary Outcome Measures ICMJE |
Overall survival as measured by serial doctor visits at 3-6 months | ||||||||||||||||
| Descriptive Information | |||||||||||||||||
| Brief Title ICMJE | Imatinib Mesylate (Gleevec; STI571) in Treating Patients With Primary Gastrointestinal Stromal Tumor That Has Been Completely Removed by Surgery | ||||||||||||||||
| Official Title ICMJE | A Phase III Randomized Double-Blind Study of Adjuvant STI571 (Gleevec) Versus Placebo in Patients Following the Resection of Primary GastroIntestinal Stromal Tumor (GIST) | ||||||||||||||||
| Brief Summary | 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. |
||||||||||||||||
| Detailed Description | 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. |
||||||||||||||||
| Study Phase | Phase III | ||||||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control | ||||||||||||||||
| Condition ICMJE | Gastrointestinal Stromal Tumor | ||||||||||||||||
| Intervention ICMJE |
|
||||||||||||||||
| Study Arms / Comparison Groups |
|
||||||||||||||||
| Publications * | Dematteo RP, Ballman KV, Antonescu CR, Maki RG, Pisters PW, Demetri GD, Blackstein ME, Blanke CD, von Mehren M, Brennan MF, Patel S, McCarter MD, Polikoff JA, Tan BR, Owzar K; American College of Surgeons Oncology Group (ACOSOG) Intergroup Adjuvant GIST Study Team. Adjuvant imatinib mesylate after resection of localised, primary gastrointestinal stromal tumour: a randomised, double-blind, placebo-controlled trial. Lancet. 2009 Mar 28;373(9669):1097-104. Epub 2009 Mar 18. | ||||||||||||||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||||||||||||||
| Recruitment Information | |||||||||||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||||||||||
| Estimated Enrollment ICMJE | 732 | ||||||||||||||||
| Completion Date | |||||||||||||||||
| Estimated Primary Completion Date | April 2018 (final data collection date for primary outcome measure) | ||||||||||||||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
|
||||||||||||||||
| Gender | Both | ||||||||||||||||
| Ages | 18 Years and older | ||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
| Location Countries ICMJE | United States | ||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT ID ICMJE | NCT00041197 | ||||||||||||||||
| Responsible Party | David M. Ota, American College of Surgeons Oncology Group | ||||||||||||||||
| Study ID Numbers ICMJE | CDR0000069452, ACOSOG-Z9001, CAN-NCIC-SRC1, CALGB-ACOSOG-Z9001, SWOG-ACOSOG-Z9001, UWCC-UW-6303, UWCC-UW-03-8438-A-03 | ||||||||||||||||
| Study Sponsor ICMJE | American College of Surgeons | ||||||||||||||||
| Collaborators ICMJE |
|
||||||||||||||||
| Investigators ICMJE |
|
||||||||||||||||
| Information Provided By | National Cancer Institute (NCI) | ||||||||||||||||
| Verification Date | August 2008 | ||||||||||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||||||||||