Viewing Study NCT00173524



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Last Modification Date: 2024-10-26 @ 9:16 AM
Study NCT ID: NCT00173524
Status: UNKNOWN
Last Update Posted: 2009-05-19
First Post: 2005-09-12

Brief Title: PharmacoEconomic Assessment IRESSA in the Treatment of Non-Small-Cell Lung Cancer NSCLC
Sponsor: National Taiwan University Hospital
Organization: National Taiwan University Hospital

Study Overview

Official Title: PharmacoEconomic Assessment IRESSA in the Treatment of Non-Small-Cell Lung Cancer NSCLC A Cost-Effectiveness Analysis and Cost-Utility Analysis
Status: UNKNOWN
Status Verified Date: 2009-04
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: The objective of this pharmacoeconomics PE study is to evaluate the cost- effectiveness analysis and cost-utility analysis of IRESSA as first line treatment of NSCLC from the society perspective based on resources and outcomes from patients who met the inclusion criteria for this naturalistic study comparing to existing first line platinum-based regimen chemotherapy
Detailed Description: Patients with late-stage NSCLC are often symptomatic with specific pulmonary problems eg cough breathlessness hemoptysis and general symptoms eg fatigue weight loss that can cause extreme distress to the patient Therefore improvements in disease-related symptoms and quality of life QoL are the key desired outcomes of medical management7 Effective palliative low-toxicity with reasonable treatment cost for patients with advanced NSCLC are needed Recently more and more countries consider evidence of economic value along with clinical efficacy

The epidermal growth factor receptor EGFR is a promising target for anticancer therapy because it is expressed or highly expressed in a variety of tumors including NSCLC 89 Furthermore high levels of EGFR expression have been associated with a poor prognosis in lung cancer patients in several studies 10-12 EGFR-targeted cancer therapies are currently being developed strategies include inhibition of the intracellular tyrosine kinase domain of the receptor by small molecules such as gefitinib Iressa ZD1839 AstraZeneca Wilmington DE13 Iressa is an orally active selective EGFR tyrosine kinase inhibitor that blocks signal transduction pathways implicated in the proliferation and survival of cancer cells

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