Gastrointestinal stromal tumors (GISTs) are a form of sarcoma and the most common sarcoma tumors of the gastrointestinal tract. The limited clinical experience suggests that GIST patients may benefit from neo-adjuvant therapy from primary GIST. This is a prospective, multicenter, open, observational study in evaluation of safety and efficacy of imatinib compared with that of historical data for locally unresectable advanced GIST without metastasis. The study will include an up to 28-day screening period, followed by receiving imatinib mesylate (400 mg/day) for at least 6-12 months and followed up for 3 years after surgery.
Primary Objective * To observe the safety of imatinib compared with that of historical data for locally unresectable advanced GIST without metastasis. Secondary Objective * Progression-free survival (PFS) in resected patients during follow up * R0 resection rate * objective response rate, tumor shrinkage rate * Correlation of mutation status with response * Correlation of PK with response * Surgical morbidity and mortality and safety follow up * Quality of life * Overall survival (OS)
Study Type
OBSERVATIONAL
Enrollment
51
Chang Gung Memorial Hospital
Taoyuan District, Taiwan
progression free survival
Evidence of measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with CT scan.
Time frame: five years
R0 resection rate
all the participants
Time frame: three years
Objective response rate, tumor shrinkage rate
all the participants
Time frame: three years
Correlation of PK with response
check PK (trough level of imatinib)of all the participants at first month and every three months later to correlate with the response and check PK (peak level of imatinib) of all the participants who had adverse events
Time frame: three years
Surgical morbidity and mortality and safety follow up
surgical morbidity: morbidity related to surgical procedure surgical mortality: mortality related to surgical procedure safety: adverse events related imatinib according to NIH toxicity evaluation criteria
Time frame: five years
Overall survival (OS)
Overall survival (OS) will be measured from after administration of imatinib mesylate and death as the end point of the study, whatever the cause. Alive patients will be censored at the date of last follow-up. Causes of death will be recorded.
Time frame: five years
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