Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00173888
Status:
COMPLETED
Last Update Posted:
2012-12-06
First Post:
2005-09-08
Brief Title:
Docetaxel Plus Cisplatin Followed by Gemcitabine Versus Gemcitabine Plus Cisplatin Followed by Docetaxel for Non-Small Cell Lung Cancer NSCLC
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
A Randomized Phase II Study of Weekly Docetaxel Plus Cisplatin Followed by Gemcitabine Versus Gemcitabine Plus Cisplatin Followed by Weekly Docetaxel in the Treatment of Advanced Non-small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2012-12
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 purpose of this study is to evaluate the 1-year treatment failure rate of two sequential chemotherapy regimens weekly docetaxel plus cisplatin followed by gemcitabine and gemcitabine plus cisplatin followed by weekly docetaxel
Detailed Description:
Lung cancer is the leading cause of cancer death in men and women worldwide Shifting trends in the incidence of lung cancer closely follow the patterns of cigarette smoking although other carcinogens have been implicated Despite intensive treatment over the past several decades the 5-year lung-cancer survival rate remains a dismal 8-14
Chemotherapy is the primary therapy to patients with stage IIIBIV disease and most investigators believe that treatment with a combination of two agents is the best first-line treatment for stage IV NSCLC In the late 1970s and 1980s studies were conducted using combinations of agents Outcomes were improved and these agents were eventually incorporated into clinical practice
Weekly docetaxel is being studied in combination with other commonly used NSCLC chemotherapeutic agents including carboplatin navelbine and gemcitabine These combinations are being studied in both first- and second-line settings Second line chemotherapy with docetaxel may affect survival TAX 318 1 year survival 37 vs 11 However the optimal sequence of chemotherapy was rarely explored Weekly docetaxel may offer better tolerability vs 3-weekly schedule when combining docetaxel to cisplatin Based upon these studied we choose weekly docetaxel in combination with cisplatin as our regimen We expected the regimen would be effective and well tolerated
Chemotherapy is the primary therapy to patients with stage IIIBIV disease and most investigators believe that treatment with a combination of two agents is the best first-line treatment for stage IV NSCLC In the late 1970s and 1980s studies were conducted using combinations of agents Outcomes were improved and these agents were eventually incorporated into clinical practice
Weekly docetaxel is being studied in combination with other commonly used NSCLC chemotherapeutic agents including carboplatin navelbine and gemcitabine These combinations are being studied in both first- and second-line settings Second line chemotherapy with docetaxel may affect survival TAX 318 1 year survival 37 vs 11 However the optimal sequence of chemotherapy was rarely explored Weekly docetaxel may offer better tolerability vs 3-weekly schedule when combining docetaxel to cisplatin Based upon these studied we choose weekly docetaxel in combination with cisplatin as our regimen We expected the regimen would be effective and well tolerated
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