Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004100
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
1999-12-10
Brief Title:
Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
Sponsor:
Istituto Nazionale per lo Studio e la Cura dei Tumori
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Gemcitabine and Vinorelbine vs Standard Chemotherapy Containing Cisplatin for Stage IIIBIV Non-Small Cell Lung Cancer
Status:
UNKNOWN
Status Verified Date:
2008-06
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die It is not yet known which regimen of chemotherapy is more effective for non-small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of two regimens of chemotherapy in treating patients who have stage IIIB or stage IV non-small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of two regimens of chemotherapy in treating patients who have stage IIIB or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES I Compare gemcitabine plus vinorelbine vs standard chemotherapy containing cisplatin in terms of the effect on the quality of life of patients with stage IIIB or IV non-small cell lung cancer II Compare the effect of these regimens on the overall survival of these patients III Compare the toxic effects of these regimens in these patients IV Compare the effect of these regimens on the rate of objective response in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to center stage of disease IIIB vs IV and performance status 0 vs 1 vs 2 Patients are randomized to one of two treatment arms Arm I Patients receive cisplatin IV on day 1 and either gemcitabine IV or vinorelbine IV on days 1 and 8 Arm II Patients receive gemcitabine IV and vinorelbine IV on days 1 and 8 Treatment repeats every 21 days for up to 6 courses Quality of life is assessed prior to therapy and before each course of chemotherapy to the fourth course
PROJECTED ACCRUAL A total of 500 patients will be accrued for this study
OUTLINE This is a randomized multicenter study Patients are stratified according to center stage of disease IIIB vs IV and performance status 0 vs 1 vs 2 Patients are randomized to one of two treatment arms Arm I Patients receive cisplatin IV on day 1 and either gemcitabine IV or vinorelbine IV on days 1 and 8 Arm II Patients receive gemcitabine IV and vinorelbine IV on days 1 and 8 Treatment repeats every 21 days for up to 6 courses Quality of life is assessed prior to therapy and before each course of chemotherapy to the fourth course
PROJECTED ACCRUAL A total of 500 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-99016 | None | None | None |
| ITA-GEMVIN | None | None | None |
| CAN-NCIC-BR14 | None | None | None |