Perioperative Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Strom⦠(NCT01267695) | Clinical Trial Compass
CompletedPhase 2
Perioperative Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor
China20 participantsStarted 2010-05
Plain-language summary
Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Perioperative imatinib mesylate may shrink the tumor and may reduce the chance of relapse after surgery. This phase II trial is studying the effectiveness of perioperative imatinib mesylate in treating patients with locally advanced gastrointestinal stromal tumor.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Criteria:
* DISEASE CHARACTERISTICS:
* Histologically confirmed gastrointestinal stromal tumor
* Locally advanced disease: tumour size \>5 cm and mitotic count \>5/HPF; tumour size \>10 cm; mitotic count \>10/HPF
* Potentially resectable disease: Multivisceral resection may be necessary to get sufficient margins
* Documented c-kit (CD117) expression by immunohistochemical analysis of either initial core specimen or, if recurrent disease, from original tumor block
* At least 1 site of measurable disease
* No known brain metastases
* PATIENT CHARACTERISTICS:
Age:18 and over Performance status:ECOG 0-3 Life expectancy:Not specified
* Platelet count \> 100,000/mm3
* Absolute neutrophil count \> 1,500/mm3 Hepatic
* AST and ALT \< 2.5 times upper limits of normal (ULN) (5 times ULN if hepatic metastases are present)
* Bilirubin \< 1.5 times ULN
* No chronic active hepatitis
* No cirrhosis
* No other chronic liver disease Renal
* Creatinine \< 1.5 times ULN
* No chronic renal disease Cardiovascular
* No New York Heart Association class III-IV cardiac disease
* No congestive heart failure
* No myocardial infarction within the past 6 months Immunology
* No active uncontrolled infection
* No known HIV positivity Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment
* Must be medically fit to undergo surgery
* No other primary malignancy withinā¦