Clinical trial NCT01818947: Gefitinib Usage and Outcomes in Routine Treatment
Official title: A Multicentre, Retrospective Chart Review Study to Characterise Gefitinib Usage and Outcomes in Routine Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: Lung cancer
epidermal growth factor receptor mutation
gefitinib
Iressa
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-03-27
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hospital clinic

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

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of treatment duration, as a surrogate of Clinical Benefit (CB) in a 'Real World' population treated with gefitinib
timeFrame: 6 months
measure: Assessment of Overall Survival (OS) in a 'Real World' population treated with gefitinib
timeFrame: 6 months
Secondary outcomes:
measure: 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
timeFrame: 6 months
measure: 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
timeFrame: 6 months
measure: Characteristics of patients treated with gefitinib for all patients and stratified by whether gefitinib discontinued treatment before or after three months
timeFrame: 6 months
measure: Description of treatment patterns in patients treated with gefitinib (prior chemo, treatment breaks, treatment on discontinuation)
timeFrame: 6 months
measure: Duration of treatment in patients stratified by age, gender, stage and performance status.
timeFrame: 6 months
measure: Overall Survival (OS) in patients stratified by age, gender, stage and performance status.
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Cardiff
country: United Kingdom
facility: Velindre Nhs Trust
city: Harrogate
country: United Kingdom
facility: Harrogate District Hospital
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital
city: London
country: United Kingdom
facility: Mount Vernon Hospital Nhs Trust
city: London
country: United Kingdom
facility: Royal Marsden Hospital
city: London
country: United Kingdom
facility: University College Hospital
city: Manchester
country: United Kingdom
facility: Christie Hospital Nhs Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals Nhs Trust
city: Sheffield
country: United Kingdom
facility: Northern General Hospital
city: York
country: United Kingdom
facility: York District Hospital
Study officials:
affiliation: The Christie NHS Foundation Trust
name: Fiona Blackhall, MBCHB FRCP
role: PRINCIPAL_INVESTIGATOR
References: