Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00041197
Status:
COMPLETED
Last Update Posted:
2013-07-16
First Post:
2002-07-08
Brief Title:
Imatinib Mesylate in Treating Patients With Primary Gastrointestinal Stromal Tumor That Has Been Completely Removed By Surgery
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Randomized Double-Blind Study of Adjuvant STI571 Gleevec Versus Placebo in Patients Following the Resection of Primary Gastrointestinal Stromal Tumor GIST
Status:
COMPLETED
Status Verified Date:
2013-06
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:
This randomized phase III trial is studying imatinib mesylate to see how well it works compared to placebo in treating patients with primary gastrointestinal stromal tumor that has been completely removed by surgery Imatinib mesylate may interfere with the growth of tumor cells and may be an effective treatment for patients with primary gastrointestinal stromal tumor that has been completely removed by surgery
Detailed Description:
PRIMARY OBJECTIVES
I To determine whether patients with resected primary gastrointestinal stromal tumor GIST who are randomized to the STI571 imatinib mesylate Arm have longer recurrence-free survival as compared to the patients randomized to the placebo Arm
SECONDARY OBJECTIVES
I To ascertain whether patients with resected primary GIST who are randomized to the STI571 Arm have longer survival as compared to the patients randomized to the placebo Arm
II To obtain from patients with GIST tumor tissue before therapy with STI571 and if the patient develops recurrence blood specimens before therapy with STI571 and serum specimens before therapy with STI571 after completing therapy with STI571 and if the patient develops recurrence for scientific correlative analyses
III To assess the safetyefficacy of oral STI571 therapy in the adjuvant setting
OUTLINE Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive oral imatinib mesylate Gleevec STI571 once daily Treatment continues for 1 year in the absence of unacceptable toxicity Patients who develop a recurrence during the year of initial treatment receive imatinib mesylate Gleevec STI571 at an increased dose Patients who develop a recurrence after the year of initial treatment restart imatinib mesylate Gleevec STI571 and continue taking the drug at the discretion of the principal investigator
ARM II Patients receive oral placebo once daily Treatment continues for 1 year in the absence of unacceptable toxicity Patients who develop a recurrence at any time discontinue placebo and crossover to arm I Treatment on arm I continues at the discretion of the principal investigator
Patients are followed every 3 months for 2 years then every 6 months for 10 years
I To determine whether patients with resected primary gastrointestinal stromal tumor GIST who are randomized to the STI571 imatinib mesylate Arm have longer recurrence-free survival as compared to the patients randomized to the placebo Arm
SECONDARY OBJECTIVES
I To ascertain whether patients with resected primary GIST who are randomized to the STI571 Arm have longer survival as compared to the patients randomized to the placebo Arm
II To obtain from patients with GIST tumor tissue before therapy with STI571 and if the patient develops recurrence blood specimens before therapy with STI571 and serum specimens before therapy with STI571 after completing therapy with STI571 and if the patient develops recurrence for scientific correlative analyses
III To assess the safetyefficacy of oral STI571 therapy in the adjuvant setting
OUTLINE Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive oral imatinib mesylate Gleevec STI571 once daily Treatment continues for 1 year in the absence of unacceptable toxicity Patients who develop a recurrence during the year of initial treatment receive imatinib mesylate Gleevec STI571 at an increased dose Patients who develop a recurrence after the year of initial treatment restart imatinib mesylate Gleevec STI571 and continue taking the drug at the discretion of the principal investigator
ARM II Patients receive oral placebo once daily Treatment continues for 1 year in the absence of unacceptable toxicity Patients who develop a recurrence at any time discontinue placebo and crossover to arm I Treatment on arm I continues at the discretion of the principal investigator
Patients are followed every 3 months for 2 years then every 6 months for 10 years
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 |
|---|---|---|---|
| U10CA076001 | NIH | None | httpsreporternihgovquickSearchU10CA076001 |
| Z9001 | None | None | None |
| CDR0000069452 | None | None | None |