Lung Cancer Clinical Trial
— EPIDAUREOfficial title:
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
| Status | Completed |
| Enrollment | 361 |
| Est. completion date | March 2015 |
| Est. primary completion date | March 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 130 Years |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The Overall survival | 24 months | Yes | |
| Primary | The progression free survival | 24 months | Yes | |
| Secondary | Description of Quality of life by Functional Assessment of Cancer Therapy - Lung including Life Stressor Checklist (FACT-L including LSC) | baseline | No | |
| Secondary | 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 | No | |
| Secondary | Description of Quality of life by Life Stressor Checklist - Lung (LSC-L) | From 3 months to 6 months | No | |
| Secondary | Description of Quality of life by Life Stressor Checklist - Lung (LSC-L) | From 6 months to 12 months | No | |
| Secondary | Description of Quality of life by Life Stressor Checklist - Lung (LSC-L) | From 12 months to 18 months | No | |
| Secondary | Description of Quality of life by Life Stressor Checklist - Lung (LSC-L) | From 18 months to 24 months | No |
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