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Completed

NCT Number: NCT01448187

Descriptive Pharmacoepidemiological Study of Patients Treated With Iressa

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

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

Up to 130 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Aulnay-sous-Bois, France

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About this study

Descriptive pharmacoepidemiological study of patients treated with Iressa

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Acronym: EPIDAURE

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 7, 2011
Registry last updated
Jul 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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