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NCT01818947 Clinical Trial

Gefitinib Usage and Outcomes in Routine Treatment

Lung Cancer Clinical Trial

Official title:
A Multicentre, Retrospective Chart Review Study to Characterise Gefitinib Usage and Outcomes in Routine Treatment

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01818947
Other study ID # NIS-OGB-IRE-2012/1
Secondary ID
Status Completed
Phase N/A
First received March 22, 2013
Last updated January 22, 2014
Start date June 2013
Est. completion date November 2013

Study information
Verified date January 2014
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United Kindom: Not Applicable for Observational and Retrospective Study
Study type Observational

Clinical Trial Summary

The purpose of this study is to understand real world gefitinib usage patterns, patient characteristics and outcomes and to present these for a Caucasian population

Description:

A multicentre, retrospective chart review study to characterise gefitinib usage and outcomes in routine treatment

Recruitment information / eligibility
Status Completed
Enrollment 157
Est. completion date November 2013
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients who received gefitinib first line in the UK Single Payment Access (SPA) scheme

- Locally advanced or metastatic EGFR mutation positive NSCLC

- Supplied with first pack of gefitinib prior to 1st January 2012

Exclusion Criteria:

- Patient was treated privately (i.e. outside the NHS)

- Gefitinib was second-line therapy following treatment failure on a prior therapy

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom Queen Elizabeth Hospital Birmingham
United Kingdom Velindre Nhs Trust Cardiff
United Kingdom Harrogate District Hospital Harrogate
United Kingdom Leeds Teaching Hospitals Leeds
United Kingdom Liverpool Heart and Chest Hospital Liverpool
United Kingdom Mount Vernon Hospital Nhs Trust London
United Kingdom Royal Marsden Hospital London
United Kingdom University College Hospital London
United Kingdom Christie Hospital Nhs Trust Manchester
United Kingdom Nottingham University Hospitals Nhs Trust Nottingham
United Kingdom Northern General Hospital Sheffield
United Kingdom York District Hospital York

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assessment of treatment duration, as a surrogate of Clinical Benefit (CB) in a 'Real World' population treated with gefitinib Retrospective population [2009 to 2013] 6 months No
Primary Assessment of Overall Survival (OS) in a 'Real World' population treated with gefitinib Retrospective population [2009 to 2013] 6 months No
Secondary Assessment of Overall Survival (OS) in the subgroup of patients of Caucasian ethnicity and in the subgroup of patients treated with gefitinib for at least 3 months Retrospective population [2009 to 2013] 6 months No
Secondary Assessment of Treatment duration in the subgroup of patients of Caucasian ethnicity and in the subgroup of patients treated with gefitinib for at least 3 months Retrospective population [2009 to 2013] 6 months No
Secondary Characteristics of patients treated with gefitinib for all patients and stratified by whether gefitinib discontinued treatment before or after three months Retrospective population [2009 to 2013] 6 months No
Secondary Description of treatment patterns in patients treated with gefitinib (prior chemo, treatment breaks, treatment on discontinuation) Retrospective population [2009 to 2013] 6 months No
Secondary Duration of treatment in patients stratified by age, gender, stage and performance status. Retrospective population [2009 to 2013] 6 months No
Secondary Overall Survival (OS) in patients stratified by age, gender, stage and performance status. Retrospective population [2009 to 2013] 6 months No
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