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CompletedNCT01448187EPIDAUREUpdated Jul 4, 2016

Descriptive Pharmacoepidemiological Study of Patients Treated With Iressa

An observational study in Lung Cancer, sponsored by AstraZeneca. Completed at 29 sites in France. Open to participants aged Up to 130 Years. Per ClinicalTrials.gov, last updated 2016-07-04.

Sponsored by AstraZeneca · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
361
Ages
Up to 130 Years
Sex
All
01

Study 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

Read the detailed description

Descriptive pharmacoepidemiological study of patients treated with Iressa

02

Conditions studied

  • Lung Cancer

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Keywords

  • Lung cancer, France
03

In context

Lung Neoplasms

7,334 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.

This study's enrollment of 361 is above the median of 190 across 1,547 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,492 studies on the registry; 265 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 176 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 130 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Hospital, clinic

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients treated with Iressa

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
361 participants (actual)
06

What researchers measure

Primary outcomes

  1. The Overall survival

    Time frame: 24 months

  2. The progression free survival

    Time frame: 24 months

Secondary outcomes

  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

07

Study locations

29 sites
  • 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
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 4, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01448187
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Oct 7, 2011
Start date
Jan 2012
Primary completion
Mar 2015
Completion
Mar 2015
Last update
Jul 4, 2016

Study contacts

Thierry BOUILLET, Dr
principal investigator · Bobigny
Elisabeth BRAMBILLA, Pr
principal investigator · Grenoble
Jacques CADRANEL, Pr
principal investigator · Paris
Jean-Francois MORERE, Pr
principal investigator · Bobigny
Maurice PEROL, Dr
principal investigator · Lyon
Virginie RONDEAU, PhD
principal investigator · Bordeaux

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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