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Sponsors and Collaborators: |
Maisonneuve-Rosemont Hospital Hippocrate Research & Development |
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Information provided by: | Maisonneuve-Rosemont Hospital |
ClinicalTrials.gov Identifier: | NCT00290485 |
The aim of this study is to demonstrate that the use of Gleevec in initially non-resectable gastrointestinal stromal tumors can lead to allow complete resection in 20% of cases.
Condition | Intervention | Phase |
---|---|---|
Gastrointestinal Stromal Tumors |
Drug: Imatinib mesylate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A Phase II Study on Preoperative Administration of Gleevec in Patients With Initially Non-Resectable Gastrointestinal Stromal Tumor |
Estimated Enrollment: | 50 |
Study Start Date: | August 2005 |
Gastrointestinal stromal tumor (GIST) is a specific, immunohistochemically KIT+ mesenchymal neoplasm of the gastrointestinal tract. The identification of KIT+ tumor has become more important after introduction of target treatment with KIT tyrosine kinase inhibitor Imatinib mesylate (Gleevec). Despite this progress, GIST patients presenting a tumor larger than 5 cm have a 10 year survival between 10% and 30%. Indeed, the risk of microscopic spreading of the tumor during surgery is very high since intra-abdominal organs are in close relation to each others. To improve survival, it seemed logical to use preoperative Gleevec to reduce tumor size and improve efficacy of the surgical procedure.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
GIST patient considered initially non-resectable as defined by one of the following:
Exclusion Criteria:
any of the following laboratory values:
Contact: Pierre Dubé, MD | (514) 252-3822 | pierredube@videotron.qc.ca |
Canada, Quebec | |
Maisonneuve-Rosemont Hospital | Recruiting |
Montreal, Quebec, Canada, h1t 2m4 | |
Contact: Pierre Dubé, MD (514) 252-3822 pierredube@videotron.qc.ca | |
Principal Investigator: Pierre Dubé, MD |
Study Chair: | Pierre Dubé, MD | Maisonneuve-Rosemont Hospital |
Study ID Numbers: | Q-CTG-01-V7.0-A1 |
Study First Received: | February 9, 2006 |
Last Updated: | April 6, 2006 |
ClinicalTrials.gov Identifier: | NCT00290485 |
Health Authority: | Canada: Health Canada |
non-resectable tumor high-risk tumor metastasis |
Response Evaluation Criteria in Solid Tumors (RECIST) Gleevec Imatinib mesylate |
Imatinib Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases |
Neoplasm Metastasis Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |