Descriptive Pharmacoepidemiological Study of Patients Treated With Iressa

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01448187

Acronym

EPIDAURE

Enrollment

361

Registered

2011-10-07

Start date

2012-01-31

Completion date

2015-03-31

Last updated

2016-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

Lung cancer, France

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 130 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The Overall survival	24 months
The progression free survival	24 months

Secondary

Measure	Time frame
Description of Quality of life by Functional Assessment of Cancer Therapy - Lung including Life Stressor Checklist (FACT-L including LSC)	baseline
Description of Quality of life by Life Stressor Checklist - Lung (LSC-L)	From 3 months to 6 months

Countries

France

Outcome results