Lung CancerNCT01818947
Gefitinib Usage and Outcomes in Routine Treatment
An observational study of Lung Cancer, run by AstraZeneca at 12 sites in United Kingdom.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- How many people
- 157 participants
- Where
- 12 sitesUnited Kingdom
- Study dates
- Jun 2013to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: hospital clinic
Who may be able to join
- 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
Who cannot join
- Patient was treated privately (i.e. outside the NHS)
- Gefitinib was second-line therapy following treatment failure on a prior therapy
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United Kingdom12 sites
Queen Elizabeth Hospital
Birmingham
Velindre Nhs Trust
Cardiff
Harrogate District Hospital
Harrogate
Leeds Teaching Hospitals
Leeds
Liverpool Heart and Chest Hospital
Liverpool
Mount Vernon Hospital Nhs Trust
London
Royal Marsden Hospital
London
University College Hospital
London
Christie Hospital Nhs Trust
Manchester
Nottingham University Hospitals Nhs Trust
Nottingham
Northern General Hospital
Sheffield
York District Hospital
York
About this study
Official title: A Multicentre, Retrospective Chart Review Study to Characterise Gefitinib Usage and Outcomes in Routine Treatment
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
Read the detailed description
A multicentre, retrospective chart review study to characterise gefitinib usage and outcomes in routine treatment
- Conditions
- Lung Cancer
- Keywords
- Lung cancer, epidermal growth factor receptor mutation, gefitinib, Iressa
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Gefitinib | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of treatment duration, as a surrogate of Clinical Benefit (CB) in a 'Real World' population treated with gefitinib
Retrospective population [2009 to 2013]
Measured: 6 months
Assessment of Overall Survival (OS) in a 'Real World' population treated with gefitinib
Retrospective population [2009 to 2013]
Measured: 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
Retrospective population [2009 to 2013]
Measured: 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
Retrospective population [2009 to 2013]
Measured: 6 months
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]
Measured: 6 months
Description of treatment patterns in patients treated with gefitinib (prior chemo, treatment breaks, treatment on discontinuation)
Retrospective population [2009 to 2013]
Measured: 6 months
Duration of treatment in patients stratified by age, gender, stage and performance status.
Retrospective population [2009 to 2013]
Measured: 6 months
Overall Survival (OS) in patients stratified by age, gender, stage and performance status.
Retrospective population [2009 to 2013]
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Study startJun 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fiona Blackhall, MBCHB FRCP, Principal investigator, The Christie NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01818947
- Sponsor's protocol ID
- NIS-OGB-IRE-2012/1
- Status last verified
- Jan 2014
- First submitted
- 22 Mar 2013
- Last updated
- 23 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Retrospective Chart Review Study to Characterise Gefitinib Usage and Outcomes in Routine Treatment
- ClinicalTrials.gov ID
- NCT01818947
- Acronym / sponsor ID
- NIS-OGB-IRE-2012/1
- Conditions
- Lung Cancer
- Keywords
- Lung cancer, epidermal growth factor receptor mutation, gefitinib, Iressa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 27 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gefitinib | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hospital clinic
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patient was treated privately (i.e. outside the NHS)
- Gefitinib was second-line therapy following treatment failure on a prior therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of treatment duration, as a surrogate of Clinical Benefit (CB) in a 'Real World' population treated with gefitinib
Time frame: 6 months
Retrospective population [2009 to 2013]
Assessment of Overall Survival (OS) in a 'Real World' population treated with gefitinib
Time frame: 6 months
Retrospective population [2009 to 2013]
6 secondary outcomes
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
Time frame: 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
Time frame: 6 months
Characteristics of patients treated with gefitinib for all patients and stratified by whether gefitinib discontinued treatment before or after three months
Time frame: 6 months
Description of treatment patterns in patients treated with gefitinib (prior chemo, treatment breaks, treatment on discontinuation)
Time frame: 6 months
Duration of treatment in patients stratified by age, gender, stage and performance status.
Time frame: 6 months
Overall Survival (OS) in patients stratified by age, gender, stage and performance status.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fiona Blackhall, MBCHB FRCP principal investigator
The Christie NHS Foundation Trust
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by AstraZeneca at 12 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of treatment duration, as a surrogate of Clinical Benefit (CB) in a 'Real World' population treated with gefitinib (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2014.