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Descriptive Pharmacoepidemiological Study of Patients Treated With Iressa (EPIDAURE)

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ClinicalTrials.gov Identifier: NCT01448187
Recruitment Status : Completed
First Posted : October 7, 2011
Last Update Posted : July 4, 2016
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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

Condition or disease
Lung Cancer

Detailed Description:
Descriptive pharmacoepidemiological study of patients treated with Iressa

Study Design
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Study Type : Observational
Actual Enrollment : 361 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Descriptive Pharmacoepidemiological Study of Patients Treated With Iressa
Study Start Date : January 2012
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. The Overall survival [ Time Frame: 24 months ]
  2. The progression free survival [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Description of Quality of life by Functional Assessment of Cancer Therapy - Lung including Life Stressor Checklist (FACT-L including LSC) [ Time Frame: baseline ]
  2. 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 ]
  3. Description of Quality of life by Life Stressor Checklist - Lung (LSC-L) [ Time Frame: From 3 months to 6 months ]
  4. Description of Quality of life by Life Stressor Checklist - Lung (LSC-L) [ Time Frame: From 6 months to 12 months ]
  5. Description of Quality of life by Life Stressor Checklist - Lung (LSC-L) [ Time Frame: From 12 months to 18 months ]
  6. Description of Quality of life by Life Stressor Checklist - Lung (LSC-L) [ Time Frame: From 18 months to 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   up to 130 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Hospital, clinic
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01448187


Locations
France
Research Site
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
Reseacrh Site
Metz, France
Research 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
Sponsors and Collaborators
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
More Information
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Additional Information:
NIS-OFR-IRE-2011_1CSR_Synopsis.pdf  This link exits the ClinicalTrials.gov site

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01448187     History of Changes
Other Study ID Numbers: NIS-OFR-IRE-2011/1
First Posted: October 7, 2011    Key Record Dates
Last Update Posted: July 4, 2016
Last Verified: July 2016

Keywords provided by AstraZeneca:
Lung cancer, France