Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor
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|ClinicalTrials.gov Identifier: NCT00112632|
Recruitment Status : Completed
First Posted : June 3, 2005
Last Update Posted : March 8, 2012
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving imatinib mesylate before surgery may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with locally advanced gastrointestinal stromal tumor.
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Stromal Tumor||Drug: imatinib mesylate Procedure: conventional surgery Procedure: neoadjuvant therapy||Phase 2|
- Determine radiographic objective response rates in patients with locally advanced gastrointestinal stromal tumor treated with neoadjuvant imatinib mesylate.
- Determine histological response in patients treated with this drug.
- Determine R0-resectability and organ-preserving resectability in these patients after treatment with this drug.
- Correlate radiographic imaging and metabolic imaging with histological response in patients treated with this drug.
- Determine the safety and tolerability of this drug in these patients.
OUTLINE: This is a nonrandomized, open-label, multicenter study.
Patients receive oral imatinib mesylate once or twice daily for 4-6 months in the absence of disease progression or unacceptable toxicity. Within 2-3 weeks after completion of imatinib mesylate, patients with responding or stable disease undergo surgical resection.
After completion of study treatment, patients are followed at 4 weeks, 6 months, and then at 1 year.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Masking:||None (Open Label)|
|Official Title:||Open-Label Trial of Neoadjuvant Imatinib Mesylate (Glivec) in Patients With Locally Advanced Malignant Gastrointestinal Stromal Tumors (GIST) Expressing c-Kit or Platelet-Derived Growth Factor Receptor-alpha|
|Study Start Date :||February 2005|
- Overall tumor response (complete response, partial response, stable disease, and progression of disease)
- Time to progression of disease
- Overall survival
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 ClinicalTrials.gov identifier (NCT number): NCT00112632
|Allgemeines Krankenhaus - Universitatskliniken|
|Vienna, Austria, A-1090|
|Robert Roessle Comprehensive Cancer Center - Charite Campus Buch|
|Berlin, Germany, D-13122|
|Bonn, Germany, D-53105|
|Medizinische Universitaetsklinik I at the University of Cologne|
|Cologne, Germany, D-50924|
|University Medical Center Hamburg - Eppendorf|
|Hamburg, Germany, D-20246|
|Klinikum der Universitaet Muenchen - Grosshadern Campus|
|Munich, Germany, D-81377|
|Klinikum Rechts Der Isar - Technische Universitaet Muenchen|
|Munich, Germany, D-81675|
|Southwest German Cancer Center at Eberhard-Karls-University|
|Tuebingen, Germany, D-72076|
|Wiesbaden, Germany, D-65199|
|Study Chair:||Thomas Licht, MD||Technische Universität München|