Descriptive Pharmacoepidemiological Study of Patients Treated With Iressa

Completed

• Conditions: Lung Cancer

• Registration Number: NCT01448187
• Lead Sponsor: AstraZeneca

Brief Summary

The aim of the study is to describe the characteristics of patients treated with Iressa (particularly age, gender, phenotype, histology and stage of disease, line of treatment and previous treatments, smoking history, conditions of initiation of treatment (presence of an EGFR-activating mutation) and to evaluate the impact of treatment on the health of the population concerned in terms of morbidity and mortality (clinical benefit, safety,...) and quality of life

Detailed Description

Descriptive pharmacoepidemiological study of patients treated with Iressa

Study Timeline

• Study First Submitted: 2011-09-26
• Study First Submitted QC: 2011-10-06
• Study First Posted: 2011-10-07
• Study Start: 2012-01
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-01
• Last Update Posted: 2016-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 361

Inclusion Criteria

• Patients treated with Iressa

Exclusion Criteria

• Patient included in a therapeutic trial comprising protocol use of Iressa
• Patient included in a therapeutic trial (Huriet-Serusclat Act)
• Patient refusing to participate in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The progression free survival	24 months
The Overall survival	24 months

Secondary Outcome Measures

Name	Time	Method
Description of Quality of life by Functional Assessment of Cancer Therapy - Lung including Life Stressor Checklist (FACT-L including LSC)	From baseline to 3 months
Description of Quality of life by Life Stressor Checklist - Lung (LSC-L)	From 18 months to 24 months

Trial Locations

Locations (2)

Research Site; 🇫🇷 Vienne, France

Reseacrh Site; 🇫🇷 Metz, France