A Phase II Study of Adjuvant STI571 (Gleevec TM) Therapy in Patients Following Completely Resected High-risk Primary GastroIntestinal Stromal Tumor (GIST)
PRIMARY OBJECTIVES:
I. To ascertain whether patients with completely resected high-risk primary GIST who undergo
adjuvant treatment with STI571 have prolonged survival compared to historical controls.
SECONDARY OBJECTIVES:
I. To determine the 2 and 5-year prevalence of recurrence in patients treated with adjuvant
STI571 following complete resection of high-risk primary GIST.
II. To obtain from patients with GIST: tumor tissue (before therapy with STI571 and at the
time of recurrence), blood specimens (before therapy with STI571), and serum specimens
(before therapy with STI571, after completing therapy with STI571, and at the time of
recurrence) for scientific correlative analyses.
III. To assess the toxicity of oral STI571 therapy when used in the adjuvant setting.
OUTLINE:
Patients receive oral imatinib mesylate daily beginning within 84 days of surgical
resection. Treatment continues for 1 year in the absence of disease recurrence or
unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 10 years.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determination whether patients with completely resected high-risk primary GIST who undergo adjuvant treatment with imatinib mesylate have prolonged survival compared to historical controls
Up to 5 years
No
Ronald DeMatteo
Principal Investigator
American College of Surgeons
United States: Food and Drug Administration
NCI-2012-03079
NCT00025246
September 2001
Name | Location |
---|---|
American College of Surgeons Oncology Group | Durham, North Carolina 27705 |