Wednesday, November 07, 2018 The CCTG SRC1 (ACOSOG Z9007) A Phase III Randomized Double-Blind Study of Adjuvant STI571 (Gleevec) Versus Placebo in Patients Following the Resection of Primary Gastrointestinal Stromal Tumors (GIST) has been permanently closed and no further ethics approvals or folow up data are required. The notification of permanent trial closure has posted on the CCTG website in the "Toolbox" here: https://www.ctg.queensu.ca/trials/permanent_closure/permanent-trial-closure/ and also on the SRC.1 trial page. Eligibility: Patient must have a diagnosis of primary GIST confirmed histologially by central pathology review. The patient's tumor must stain positive for the Kit receptor tyrosine kinase on immunohistochemistry as determined by the Central Pathologist using the Dako anti-CD 117 antibody (Dako Corp., Carpinteria, CA). The patient must have undergone complete gross resection (includes R0 [negative microscopic margins] and R1 [positive microscopic margins] resections) of a primary GIST within 70 days prior to registration. Tumor size must be > 3 cm in maximum dimension. Post-operative chemotherapy, radiation therapy or investigational treatment will cause the patient to be ineligible, as will prior therapy with STI-571. Patients will not be eligible for randomization if they have New York Heart Association Class 3 or 4 cardiac disease, or if they are taking full-dose warfarin. Objectives: To ascertain whether patients with resected primary GIST who are randomized to the STI571 Arm have longer recurrence-free survival and overall survival as compared to the patients randomized to the Placebo Arm. To obtain from patients with GIST: tumor tissue (before therapy with STI571 and if the patient develops recurrence), blood specimens (before therapy with STI571), and serum specimens (before therapy with STI571, after completing therapy with STI571, and if the patient develops recurrence) for scientific correlative analyses. To assess the safety/efficacy of oral STI571 therapy in the adjuvant setting. If you have any questions please contact the study coordinator: Marina Djurfeldt
