Descriptive Pharmacoepidemiological Study of Patients Treated With Iressa (EPIDAURE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01448187
First received: September 26, 2011
Last updated: August 21, 2013
Last verified: August 2013
  Purpose

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
Lung Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Descriptive Pharmacoepidemiological Study of Patients Treated With Iressa

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The Overall survival [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • The progression free survival [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Description of Quality of life by Functional Assessment of Cancer Therapy - Lung including Life Stressor Checklist (FACT-L including LSC) [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Description of Quality of life by Life Stressor Checklist - Lung (LSC-L) [ Time Frame: From 3 months to 6 months ] [ Designated as safety issue: No ]
  • Description of Quality of life by Life Stressor Checklist - Lung (LSC-L) [ Time Frame: From 6 months to 12 months ] [ Designated as safety issue: No ]
  • Description of Quality of life by Life Stressor Checklist - Lung (LSC-L) [ Time Frame: From 12 months to 18 months ] [ Designated as safety issue: No ]
  • Description of Quality of life by Life Stressor Checklist - Lung (LSC-L) [ Time Frame: From 18 months to 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: January 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Detailed Description:

Descriptive pharmacoepidemiological study of patients treated with Iressa

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01448187     History of Changes
Other Study ID Numbers: NIS-OFR-IRE-2011/1
Study First Received: September 26, 2011
Last Updated: August 21, 2013
Health Authority: France: French Data Protection Authority
France: National Consultative Ethics Committee for Health and Life Sciences

Keywords provided by AstraZeneca:
Lung cancer, France

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 29, 2014