Perioperative Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor

Study Overview
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Brief Summary
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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.

Detailed Description
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Open-label trial in patients with locally advanced GISTs admitted to Department of Surgery, Beijing Cancer Hospital and Institute between April 2010 and May 2013 was carried out prospectively. Patients were planned to be treated with imatinib for duration of 6 months followed by surgical resection. Postoperative imatinib was planned to be administrated for 1.5 years. The primary end point was recurrent free survival (RFS) at 2 years; the secondary end points included objective response rate (ORR), surgical outcomes and drug safety.

Official Title
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Perioperative Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor

Conditions
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Gastrointestinal Stromal Tumor

Intervention / Treatment
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* Drug: imatinib mesylate
* Procedure: conventional surgery


Participation Criteria
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Eligibility Criteria
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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 within the past 5 years except basal cell skin cancer, carcinoma in situ of the cervix, or a primary malignancy that is not currently clinically significant and does not require active intervention No gastrointestinal obstruction or major bleeding episode requiring immediate surgical intervention No uncontrolled diabetes No other severe or uncontrolled medical disease No significant history of noncompliance to medical regimens PRIOR CONCURRENT THERAPY: No concurrent anticancer biologic agents More than 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) unless disease is rapidly progressing No concurrent anticancer chemotherapy At least 28 days since prior radiotherapy More than 2 weeks since prior major surgery except tumor biopsy Other At least 28 days since prior investigational drugs At least 28 days since prior imatinib mesylate No concurrent therapeutic doses of warfarin Concurrent low-molecular weight heparin or mini-dose warfarin (1 mg per day) prophylaxis is allowed

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: imatinib mesylate|Patients receive oral imatinib mesylate once daily for 6 months in the absence of disease progression or unacceptable toxicity. Patients with disease progression or unacceptable toxicity are considered for immediate surgical resection. Within 2-6 weeks after completion of imatinib mesylate, patients with responding or stable disease undergo surgical resection. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for one and a half years.|
|Procedure: conventional surgery|All the patients should receive elective surgery with R0 resection.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of disease recurrence at 2 years |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of objective response (complete, partial, and stable) |  | 2 years | 
| Determine the safety and tolerability of this drug in these patients. |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastrointestinal Stromal Tumor, Imatinib mesylate, Perioperative therapy