Descriptive Pharmacoepidemiological Study of Patients Treated With Iressa
EPIDAURE
1 other identifier
observational
361
1 country
29
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2012
Typical duration for all trials
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2011
CompletedFirst Posted
Study publicly available on registry
October 7, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedJuly 4, 2016
July 1, 2016
3.2 years
September 26, 2011
July 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The Overall survival
24 months
The progression free survival
24 months
Secondary Outcomes (6)
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 Functional Assessment of Cancer Therapy - Lung including Life Stressor Checklist (FACT-L including LSC)
From baseline to 3 months
Description of Quality of life by Life Stressor Checklist - Lung (LSC-L)
From 3 months to 6 months
Description of Quality of life by Life Stressor Checklist - Lung (LSC-L)
From 6 months to 12 months
Description of Quality of life by Life Stressor Checklist - Lung (LSC-L)
From 12 months to 18 months
- +1 more secondary outcomes
Eligibility Criteria
Hospital, clinic
You may qualify if:
- Patients treated with Iressa
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (29)
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-Saône, France
Research Site
Cholet, France
Research Site
Clamart, France
Research Site
Colmar, France
Research Site
Corbeil-Essonnes, France
Research Site
Créteil, France
Research Site
Épernay, France
Research Site
La Source, France
Research Site
Marseille, France
Research Site
Mâcon, France
Reseacrh Site
Metz, France
Research Site
Mont-de-Marsan, France
Research Site
Niort, France
Research Site
Paris, France
Research Site
Pierre-Bénite, France
Research Site
Quimper, France
Research Site
Reims, France
Research Site
Rouen, France
Research Site
Saint-Herblain, France
Research Site
Saint-Nazaire, France
Research Site
Saint-Omer, France
Research Site
Strasbourg, France
Research Site
Toulon, France
Research Site
Vienne, France
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2011
First Posted
October 7, 2011
Study Start
January 1, 2012
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
July 4, 2016
Record last verified: 2016-07