Clinical trial NCT01448187: Descriptive Pharmacoepidemiological Study of Patients Treated With Iressa
Official title: Descriptive Pharmacoepidemiological Study of Patients Treated With Iressa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: Lung cancer, France
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-10-07
Enrollment: 361
Sex: ALL
Maximum age (years): 130
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospital, clinic

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

Eligibility criteria: 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

Primary outcomes:
measure: The Overall survival
timeFrame: 24 months
measure: The progression free survival
timeFrame: 24 months
Secondary outcomes:
measure: Description of Quality of life by Functional Assessment of Cancer Therapy - Lung including Life Stressor Checklist (FACT-L including LSC)
timeFrame: baseline
measure: Description of Quality of life by Functional Assessment of Cancer Therapy - Lung including Life Stressor Checklist (FACT-L including LSC)
timeFrame: From baseline to 3 months
measure: Description of Quality of life by Life Stressor Checklist - Lung (LSC-L)
timeFrame: From 3 months to 6 months
measure: Description of Quality of life by Life Stressor Checklist - Lung (LSC-L)
timeFrame: From 6 months to 12 months
measure: Description of Quality of life by Life Stressor Checklist - Lung (LSC-L)
timeFrame: From 12 months to 18 months
measure: Description of Quality of life by Life Stressor Checklist - Lung (LSC-L)
timeFrame: From 18 months to 24 months
Other outcomes:
Locations:
city: Aulnay Sous Bois
country: France
facility: Research Site
city: Bayonne
country: France
facility: Research Site
city: Bordeaux
country: France
facility: Research Site
city: Bron
country: France
facility: Research Site
city: Carcassonne
country: France
facility: Research Site
city: Chalon Sur Saone
country: France
facility: Research Site
city: Cholet
country: France
facility: Research Site
city: Clamart
country: France
facility: Research Site
city: Colmar
country: France
facility: Research Site
city: Corbeil Essonnes
country: France
facility: Research Site
city: Creteil
country: France
facility: Research Site
city: Epernay
country: France
facility: Research Site
city: La Source
country: France
facility: Research Site
city: Macon
country: France
facility: Research Site
city: Marseille
country: France
facility: Research Site
city: Metz
country: France
facility: Reseacrh Site
city: Mont de Marsan
country: France
facility: Research Site
city: Niort
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Pierre Benite
country: France
facility: Research Site
city: Quimper
country: France
facility: Research Site
city: Reims
country: France
facility: Research Site
city: Rouen
country: France
facility: Research Site
city: St Herblain
country: France
facility: Research Site
city: St Nazaire
country: France
facility: Research Site
city: St Omer
country: France
facility: Research Site
city: Strasbourg
country: France
facility: Research Site
city: Toulon
country: France
facility: Research Site
city: Vienne
country: France
facility: Research Site
Study officials:
affiliation: Bobigny
name: Thierry BOUILLET, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Grenoble
name: Elisabeth BRAMBILLA, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: Paris
name: Jacques CADRANEL, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: Bobigny
name: Jean-Francois MORERE, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: Lyon
name: Maurice PEROL, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Bordeaux
name: Virginie RONDEAU, PhD
role: PRINCIPAL_INVESTIGATOR
References: