Viewing Study NCT00154739



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Study NCT ID: NCT00154739
Status: COMPLETED
Last Update Posted: 2008-08-04
First Post: 2005-09-08

Brief Title: GemcitabineCisplatin Versus GemcitabineEpirubicin for Non-Small Cell Lung Cancer NSCLC
Sponsor: National Taiwan University Hospital
Organization: National Taiwan University Hospital

Study Overview

Official Title: A Phase II Randomized Trial of GemcitabineCisplatin Versus GemcitabineEpirubicin in Stage IIIBIV Non-Small Cell Lung Cancer
Status: COMPLETED
Status Verified Date: 2005-07
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 efficacy of gemcitabinecisplatin versus gemcitabineepirubicin in Stage IIIBIV NSCLC in terms of response rate and overall survival
Detailed Description: Most patients suffered from nausea vomiting and prolonged anorexia after cisplatin treatment Epirubicin is an anthracycline that was used widely in the treatment of cancer Our previous study of an epirubicin and paclitaxel combination in non-small cell lung cancer patients showed a response rate of 526 and good median survival However most patients suffered from paclitaxel-related neurotoxicity

Chemotherapy may increase an average of 1 to 2 months of median survival in inoperable non-small cell lung cancer patients treated with chemotherapy However chemotherapy may not provide a cure for these patients Reduction of side effects and enhancement of life quality of the patients are as important as life prolongation for these patients We designed a combination chemotherapy using gemcitabine with epirubicin in the treatment of inoperable non-small cell lung cancer The treatment will be compared to gemcitabine and cisplatin combination

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