Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00455936
Status:
COMPLETED
Last Update Posted:
2010-10-25
First Post:
2007-04-03
Brief Title:
First-line Gefitinib Versus Chemotherapy for Lung Adenocarcinoma in Never Smoker
Sponsor:
National Cancer Center Korea
Organization:
National Cancer Center Korea
Study Overview
Official Title:
A Randomized Phase III Study of Gefitinib IRESSATM Versus Standard Chemotherapy Gemcitabine Plus Cisplatin as First-line Treatment for in Never Smokers Advance or Metastatic Adenocarcinoma of Lung
Status:
COMPLETED
Status Verified Date:
2010-03
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:
The investigators will conduct the randomized trial to determine the role of Gefitinib monotherapy as first-line setting in adenocarcinoma patients with no history of smoking as compared with the standard combination chemotherapy
This is a randomized open label parallel group phase III study in never-smokers with advanced or metastatic adenocarcinoma of lung
After stratification by gender performance status and disease stage patients will be randomized to one of the two treatment arms to receive either gefitinib or standard chemotherapy until clinical or objective disease progression unacceptable toxicity or patients refusal whichever is sooner The chemotherapy will be administered for no more than nine cycles
This is a randomized open label parallel group phase III study in never-smokers with advanced or metastatic adenocarcinoma of lung
After stratification by gender performance status and disease stage patients will be randomized to one of the two treatment arms to receive either gefitinib or standard chemotherapy until clinical or objective disease progression unacceptable toxicity or patients refusal whichever is sooner The chemotherapy will be administered for no more than nine cycles
Detailed Description:
Gefitinib Iressa TM Arm - Gefitinib administration 250mg tablet once daily every 3 weeks
standard chemotherapy arm - gemcitabine 1250mgm2 for 30 minutes on day 1 and 8 of a 3 week cycle plus cisplatin 80mgm2 on day 1 of a 3 week cycle
standard chemotherapy arm - gemcitabine 1250mgm2 for 30 minutes on day 1 and 8 of a 3 week cycle plus cisplatin 80mgm2 on day 1 of a 3 week cycle
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 |
|---|---|---|---|
| D7913L00054 | OTHER_GRANT | AstraZeneca | None |