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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01267695
Recruitment Status : Completed
First Posted : December 28, 2010
Last Update Posted : February 3, 2015
Information provided by (Responsible Party):
Ziyu Li, Peking University

Brief 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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Stromal Tumor Drug: imatinib mesylate Procedure: conventional surgery Phase 2

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Perioperative Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor
Study Start Date : May 2010
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Intervention Details:
  • 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.
    Other Names:
    • Gleevec
    • STI-571
    • NSC #716051
  • Procedure: conventional surgery
    All the patients should receive elective surgery with R0 resection.

Primary Outcome Measures :
  1. Rate of disease recurrence at 2 years [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. Rates of objective response (complete, partial, and stable) [ Time Frame: 2 years ]
  2. Determine the safety and tolerability of this drug in these patients. [ Time Frame: 3 years ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No



    • 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

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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01267695

Peking University School of Oncology
Beijing, China, 100142
Sponsors and Collaborators
Peking University

Additional Information:
Responsible Party: Ziyu Li, vice director of Department of Gastrointestinal Surgery,Peking University Cancer Hospital and Institute, Peking University Identifier: NCT01267695     History of Changes
Other Study ID Numbers: WJP-320.6700.09010
First Posted: December 28, 2010    Key Record Dates
Last Update Posted: February 3, 2015
Last Verified: February 2015

Keywords provided by Ziyu Li, Peking University:
Gastrointestinal Stromal Tumor
Imatinib mesylate
Perioperative therapy

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action