Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003053
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Stage I II or IIIA Non-small Cell Lung Cancer That Has Been Surgically Removed
Sponsor:
European Institute of Oncology
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Adjuvant Treatment of Non Small Cell Lung Cancer
Status:
UNKNOWN
Status Verified Date:
2008-01
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 Combining more than one drug may kill more tumor cells
PURPOSE Randomized phase III trial to compare cisplatin and etoposide with no chemotherapy in treating patients who have stage I stage II or stage IIIA non-small cell lung cancer that has been surgically removed
PURPOSE Randomized phase III trial to compare cisplatin and etoposide with no chemotherapy in treating patients who have stage I stage II or stage IIIA non-small cell lung cancer that has been surgically removed
Detailed Description:
OBJECTIVES
Assess the efficacy of the combination of cisplatin and etoposide after radical surgery in prolonging the relapse free and overall survival for stages I II and IIIA non-small cell lung cancer
OUTLINE This a randomized study treatment vs no treatment Patients are stratified according to sex and to stage of disease I vs II vs IIIA
Patient receives cisplatin and etoposide on days 1-3 every 28 days for 3 cycles Patient may receive radiation therapy after surgery at the discretion of the physician
PROJECTED ACCRUAL Approximately 750 patients will be accrued over 3 years
Assess the efficacy of the combination of cisplatin and etoposide after radical surgery in prolonging the relapse free and overall survival for stages I II and IIIA non-small cell lung cancer
OUTLINE This a randomized study treatment vs no treatment Patients are stratified according to sex and to stage of disease I vs II vs IIIA
Patient receives cisplatin and etoposide on days 1-3 every 28 days for 3 cycles Patient may receive radiation therapy after surgery at the discretion of the physician
PROJECTED ACCRUAL Approximately 750 patients will be accrued over 3 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-97010 | None | None | None |
| CNR-NICO-01 | None | None | None |