Descriptive Pharmacoepidemiological Study of Patients Treated With Iressa (EPIDAURE)
This study is ongoing, but not recruiting participants.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01448187
First received: September 26, 2011
Last updated: August 21, 2013
Last verified: August 2013
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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 |
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) |
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
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 |
ClinicalTrials.gov processed this record on February 27, 2015