Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00349492
Status:
COMPLETED
Last Update Posted:
2013-12-04
First Post:
2006-07-05
Brief Title:
A Study Comparing EtoposideCisplatin With IrinotecanCisplatin to Treat Extensive Disease Small Lung Cancer
Sponsor:
Clinical Research Center for Solid Tumor Korea
Organization:
Clinical Research Center for Solid Tumor Korea
Study Overview
Official Title:
Randomized Phase III Trial Comparing EtoposideCisplatin EP With IrinotecanCisplatin IP in Patients With Previously Untreated Extensive Disease ED Small Cell Lung Cancer SCLC
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:
This study is a randomized multi-center clinical trial Patients are stratified according to performance status ECOG 0 1 vs 2 and institution Patients are randomized to 1 of 2 treatment arms
Arm A Patients receive etoposide IV on days 1 2 3 and cisplatin IV on day 1 Courses repeat every 3 weeks Arm B Patients receive irinotecan IV on days 1 8 and cisplatin IV on day 1 Coursed repeated every 3 weeks
Treatment in both arms continues for 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 15 years
Arm A Patients receive etoposide IV on days 1 2 3 and cisplatin IV on day 1 Courses repeat every 3 weeks Arm B Patients receive irinotecan IV on days 1 8 and cisplatin IV on day 1 Coursed repeated every 3 weeks
Treatment in both arms continues for 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 15 years
Detailed Description:
None
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