TRIAL DETAIL

Imatinib Mesylate (Gleevec; STI571) in Treating Patients With Primary Gastrointestinal Stromal Tumor That Has Been Completely Removed by Surgery (ACOSOG-Z9001)

Drug:	Imatinib
Trial Name:	Imatinib Mesylate (Gleevec; STI571) in Treating Patients With Primary Gastrointestinal Stromal Tumor That Has Been Completely Removed by Surgery (ACOSOG-Z9001)
NCT#:	NCT00041197
Conditions:	Gastrointestinal Stromal Tumor
Status:	Completed
Phase:	3	Start Date 06/01/2002	Age of Trial (yrs) 21.9
Treatment Phase:	Adjuvant
Drug Category:	KIT/PDGFRA inhibitor
Strategy:	Block KIT
Trial Type:	Specifically GIST and only GIST
Other Protocol IDs:	CDR0000069452, ACOSOG-Z9001, CAN-NCIC-SRC1, CALGB-ACOSOG-Z9001, SWOG-ACOSOG-Z9001, UWCC-UW-6303, UWCC-UW-03-8438-A-03
Sponsor:	ACS, NCI, NCIC, CALGB, SWOG
Patient Contact:
Contact email:
Contact Phone:
Randomized:	Randomized
IV or Oral:	Oral
Trial Notes:	This randomized trial (Z9001) compared patients taking imatinib (Gleevec) for one year after complete surgical removal of a primary tumor, to the same patient group that did not receive imatinib. On December 19th, 2008, the FDA approved adjuvant imatinib (preventative) for patients in the United States based on the results of this trial (results will continue to be updated as the trial matures). On May 7, 2009, imatinib received approval from the European Commission (EC) for adjuvant treatment of GIST. Patients assigned to the Gleevec arm had a recurrence-free survival (RFS) of 97% at the one year mark compared to 83% RFS for the patients on placebo. Patients will continue to be followed by protocol for up to 10 years. Note however, that patients in the imatinib arm AND the placebo arm may have taken imatinib after their active trial participation thus making the results more difficult to interpret.