Descriptive Pharmacoepidemiological Study of Patients Treated With Iressa (EPIDAURE)

July 1, 2016 updated by: AstraZeneca
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

Study Overview

Status

Completed

Conditions

Detailed Description

Descriptive pharmacoepidemiological study of patients treated with Iressa

Study Type

Observational

Enrollment (Actual)

361

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Aulnay Sous Bois, France
        • Research Site
      • Bayonne, France
        • Research Site
      • Bordeaux, France
        • Research Site
      • Bron, France
        • Research Site
      • Carcassonne, France
        • Research Site
      • Chalon Sur Saone, France
        • Research Site
      • Cholet, France
        • Research Site
      • Clamart, France
        • Research Site
      • Colmar, France
        • Research Site
      • Corbeil Essonnes, France
        • Research Site
      • Creteil, France
        • Research Site
      • Epernay, France
        • Research Site
      • La Source, France
        • Research Site
      • Macon, France
        • Research Site
      • Marseille, France
        • Research Site
      • Metz, France
        • Reseacrh Site
      • Mont de Marsan, France
        • Research Site
      • Niort, France
        • Research Site
      • Paris, France
        • Research Site
      • Pierre Benite, France
        • Research Site
      • Quimper, France
        • Research Site
      • Reims, France
        • Research Site
      • Rouen, France
        • Research Site
      • St Herblain, France
        • Research Site
      • St Nazaire, France
        • Research Site
      • St Omer, France
        • Research Site
      • Strasbourg, France
        • Research Site
      • Toulon, France
        • Research Site
      • Vienne, France
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 130 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Hospital, clinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Overall survival
Time Frame: 24 months
24 months
The progression free survival
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Description of Quality of life by Functional Assessment of Cancer Therapy - Lung including Life Stressor Checklist (FACT-L including LSC)
Time Frame: baseline
baseline
Description of Quality of life by Functional Assessment of Cancer Therapy - Lung including Life Stressor Checklist (FACT-L including LSC)
Time Frame: From baseline to 3 months
From baseline to 3 months
Description of Quality of life by Life Stressor Checklist - Lung (LSC-L)
Time Frame: From 3 months to 6 months
From 3 months to 6 months
Description of Quality of life by Life Stressor Checklist - Lung (LSC-L)
Time Frame: From 6 months to 12 months
From 6 months to 12 months
Description of Quality of life by Life Stressor Checklist - Lung (LSC-L)
Time Frame: From 12 months to 18 months
From 12 months to 18 months
Description of Quality of life by Life Stressor Checklist - Lung (LSC-L)
Time Frame: From 18 months to 24 months
From 18 months to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Thierry BOUILLET, Dr, Bobigny
  • Principal Investigator: Elisabeth BRAMBILLA, Pr, Grenoble
  • Principal Investigator: Jacques CADRANEL, Pr, Paris
  • Principal Investigator: Jean-Francois MORERE, Pr, Bobigny
  • Principal Investigator: Maurice PEROL, Dr, Lyon
  • Principal Investigator: Virginie RONDEAU, PhD, Bordeaux

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

March 1, 2015

Study Completion (ACTUAL)

March 1, 2015

Study Registration Dates

First Submitted

September 26, 2011

First Submitted That Met QC Criteria

October 6, 2011

First Posted (ESTIMATE)

October 7, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

July 4, 2016

Last Update Submitted That Met QC Criteria

July 1, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-OFR-IRE-2011/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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