Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112632
Status:
COMPLETED
Last Update Posted:
2012-03-08
First Post:
2005-06-02
Brief Title:
Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor
Sponsor:
Technical University of Munich
Organization:
Technical University of Munich
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
PURPOSE This phase II trial is studying how well imatinib mesylate works in treating patients with locally advanced gastrointestinal stromal tumor
Detailed Description:
OBJECTIVES
Primary
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
Secondary
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
Primary
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
Secondary
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20507 | None | None | None |
| KRDI-TUM-GIST-CST1571-BDE43 | None | None | None |