Gefitinib Usage and Outcomes in Routine Treatment
- Conditions
- Lung Cancer
- Registration Number
- NCT01818947
- Lead Sponsor
- AstraZeneca
- Brief 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
- Detailed Description
A multicentre, retrospective chart review study to characterise gefitinib usage and outcomes in routine treatment
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 157
- 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
- Patient was treated privately (i.e. outside the NHS)
- Gefitinib was second-line therapy following treatment failure on a prior therapy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of treatment duration, as a surrogate of Clinical Benefit (CB) in a 'Real World' population treated with gefitinib 6 months Retrospective population \[2009 to 2013\]
Assessment of Overall Survival (OS) in a 'Real World' population treated with gefitinib 6 months Retrospective population \[2009 to 2013\]
- Secondary Outcome Measures
Name Time Method 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 6 months Retrospective population \[2009 to 2013\]
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 6 months Retrospective population \[2009 to 2013\]
Characteristics of patients treated with gefitinib for all patients and stratified by whether gefitinib discontinued treatment before or after three months 6 months Retrospective population \[2009 to 2013\]
Description of treatment patterns in patients treated with gefitinib (prior chemo, treatment breaks, treatment on discontinuation) 6 months Retrospective population \[2009 to 2013\]
Duration of treatment in patients stratified by age, gender, stage and performance status. 6 months Retrospective population \[2009 to 2013\]
Overall Survival (OS) in patients stratified by age, gender, stage and performance status. 6 months Retrospective population \[2009 to 2013\]
Trial Locations
- Locations (12)
York District Hospital
π¬π§York, United Kingdom
Royal Marsden Hospital
π¬π§London, United Kingdom
Harrogate District Hospital
π¬π§Harrogate, United Kingdom
Liverpool Heart and Chest Hospital
π¬π§Liverpool, United Kingdom
Mount Vernon Hospital Nhs Trust
π¬π§London, United Kingdom
Northern General Hospital
π¬π§Sheffield, United Kingdom
Velindre Nhs Trust
π¬π§Cardiff, United Kingdom
Leeds Teaching Hospitals
π¬π§Leeds, United Kingdom
Nottingham University Hospitals Nhs Trust
π¬π§Nottingham, United Kingdom
University College Hospital
π¬π§London, United Kingdom
Queen Elizabeth Hospital
π¬π§Birmingham, United Kingdom
Christie Hospital Nhs Trust
π¬π§Manchester, United Kingdom