Gefitinib Usage and Outcomes in Routine Treatment

NCT01818947 | Completed

• 1 other identifier: NIS-OGB-IRE-2012/1
• Study Type: observational
• Target: 157
• Locations: 1 country
• Sites: 12

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

Conditions

Lung Cancer

Keywords

Lung cancer; epidermal growth factor receptor mutation; gefitinib; Iressa

Outcome Measures

Primary Outcomes (2)

• 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

• Assessment of Overall Survival (OS) in a 'Real World' population treated with gefitinib

  Retrospective population \[2009 to 2013\]

  6 months

Secondary Outcomes (6)

• 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

• 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

• Characteristics of patients treated with gefitinib for all patients and stratified by whether gefitinib discontinued treatment before or after three months

  6 months

• Description of treatment patterns in patients treated with gefitinib (prior chemo, treatment breaks, treatment on discontinuation)

  6 months

• Duration of treatment in patients stratified by age, gender, stage and performance status.

  6 months

Study Arms (1)

Gefitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

hospital clinic

You may qualify if:

• 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

You may not qualify if:

• Patient was treated privately (i.e. outside the NHS)
• Gefitinib was second-line therapy following treatment failure on a prior therapy

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (12)

Queen Elizabeth Hospital

Birmingham, United Kingdom

Location

Velindre Nhs Trust

Cardiff, United Kingdom

Location

Harrogate District Hospital

Harrogate, United Kingdom

Location

Leeds Teaching Hospitals

Leeds, United Kingdom

Location

Liverpool Heart and Chest Hospital

Liverpool, United Kingdom

Location

Mount Vernon Hospital Nhs Trust

London, United Kingdom

Location

Royal Marsden Hospital

London, United Kingdom

Location

University College Hospital

London, United Kingdom

Location

Christie Hospital Nhs Trust

Manchester, United Kingdom

Location

Nottingham University Hospitals Nhs Trust

Nottingham, United Kingdom

Location

Northern General Hospital

Sheffield, United Kingdom

Location

York District Hospital

York, United Kingdom

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Fiona Blackhall, MBCHB FRCP

  The Christie NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2013
• First Posted: March 27, 2013
• Study Start: June 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: January 23, 2014

Record last verified: 2014-01

Locations

GB (12)