- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01267695
Perioperative Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor
February 2, 2015 updated by: Ziyu Li, Peking University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Beijing, China, 100142
- Peking University School of Oncology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of disease recurrence at 2 years
Time Frame: 4 years
|
4 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rates of objective response (complete, partial, and stable)
Time Frame: 2 years
|
2 years
|
Determine the safety and tolerability of this drug in these patients.
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Eisenberg BL, Harris J, Blanke CD, Demetri GD, Heinrich MC, Watson JC, Hoffman JP, Okuno S, Kane JM, von Mehren M. Phase II trial of neoadjuvant/adjuvant imatinib mesylate (IM) for advanced primary and metastatic/recurrent operable gastrointestinal stromal tumor (GIST): early results of RTOG 0132/ACRIN 6665. J Surg Oncol. 2009 Jan 1;99(1):42-7. doi: 10.1002/jso.21160.
- Seshadri RA, Rajendranath R. Neoadjuvant imatinib in locally advanced gastrointestinal stromal tumors. J Cancer Res Ther. 2009 Oct-Dec;5(4):267-71. doi: 10.4103/0973-1482.59905.
- Saied GM, Kensarah AM. Six months neoadjuvant imatinib improves resectability potential of gastric stromal tumors in Egyptian patients. Int J Surg. 2010;8(2):105-8. doi: 10.1016/j.ijsu.2009.09.016. Epub 2009 Nov 24.
- Machlenkin S, Pinsk I, Tulchinsky H, Ziv Y, Sayfan J, Duek D, Rabau M, Walfisch S. The effect of neoadjuvant Imatinib therapy on outcome and survival after rectal gastrointestinal stromal tumour. Colorectal Dis. 2011 Oct;13(10):1110-5. doi: 10.1111/j.1463-1318.2010.02442.x.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
December 27, 2010
First Submitted That Met QC Criteria
December 27, 2010
First Posted (Estimate)
December 28, 2010
Study Record Updates
Last Update Posted (Estimate)
February 3, 2015
Last Update Submitted That Met QC Criteria
February 2, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Neoplasms, Connective Tissue
- Gastrointestinal Stromal Tumors
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Imatinib Mesylate
Other Study ID Numbers
- WJP-320.6700.09010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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