Conditions: Gastrointestinal Stromal Tumor (GIST)
Keywords: Imatinib Protein Kinase Inhibitors Gastrointestinal Stromal Tumors Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Adjuvant PERSIST PERSIS-5
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 91
Healthy volunteers: no

Brief summary:
This is a Phase II, non-randomized, open-label, multi-center study conducted in the USA. The purpose of this trial is to evaluate the use of long term adjuvant imatinib mesylate in patients at significant risk for recurrence following complete resection of primary GIST.

Detailed description:
This is a Phase II, non-randomized, open-label, multi-center study conducted in the USA. The primary endpoint is to evaluate the use of long term adjuvant imatinib mesylate in patients at significant risk for recurrence following complete resection of primary GIST. A total of 85 adult patients, 18 years of age and older will be enrolled.Participants will take 400 mg of imatinib mesylate daily by mouth for a total of 5 years. At the conclusion of the treatment period, patients will be followed for 2 years for survival, status of response and antineoplastic treatments and quality of life.

Arms:
arm 1: All subjects received in tablet form imatinib (STI571) 400 mg once daily.

Interventions: intervention 1: imatinib mesylate
Intervention descriptions: intervention 1: imatinib mesylate was supplied in 100 and 400 mg tablets

Protocol document: