Lung CancerNCT01130961
Management of Advanced Non-Small Cell Lung Cancer (NSCLC) and Clinical Outcomes in Patients Who Received Gefitinib in Thailand
An observational study of Lung Cancer, run by AstraZeneca at 1 site in Thailand.
Trial summary
The purpose of this study is to determine progression-free survival of lung cancer patients who received gefitinib in clinical practice in Thailand. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer
- How many people
- 104 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2009to Aug 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Lung cancer patients admitted in Chulalongkorn and Siriraj hospitals between January 2004 and December 2008 and treated with gefitinib for at least 3 months
Who may be able to join
- Diagnosed as having lung cancer based on histological/cytological findings
- Admitted to the hospital between January 2004 and December 2008
- Treated with gefitinib for at least 3 months
Who cannot join
- Involvement in the planning and/or conduct of the study
- Participation in another clinical study during the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Management of Advanced Non-Small Cell Lung Cancer and Clinical Outcomes in Patients Who Received Gefitinib (IRESSA) in Tertiary Care Setting in Thailand
The purpose of this study is to determine progression-free survival of lung cancer patients who received gefitinib in clinical practice in Thailand.
- Conditions
- Lung Cancer
- Keywords
- Advanced NSCLC, Gefitinib, Thai patient
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: median time from the first date of treatment until date of disease progression during Jan 2004- Dec 2008 or 5 years approx.
Secondary outcomes (3)
Time to maximum response
Measured: Median time from the first date of treatment until the date that the disease can be maximum controlled during Jan 2004- Dec 2008 or 5 years approx.
Overall survival
Measured: time from the first date of treatment until date of patients dead during Jan 2004- Dec 2008 or 5 years approx.
Prevalence of EGFR & KRAS mutation from laboratory result
Measured: During Jan 2004- Dec 2008 or 5 years approx.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2010 (estimated)
- Study startOct 2009
- Primary completionAug 2010
- Study completionAug 2010
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Virote Sriuranpong, MD., PhD., Principal investigator, Chulalongkorn Hospital, Bangkok, ThailandVichien Srimuninnimit, MD., Principal investigator, Siriraj Hospital, Bangkok, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01130961
- Sponsor's protocol ID
- NIS-OTH-IRE-2009/1
- Status last verified
- Oct 2010
- First submitted
- 29 Apr 2010
- Last updated
- 7 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Advanced Non-Small Cell Lung Cancer and Clinical Outcomes in Patients Who Received Gefitinib (IRESSA) in Tertiary Care Setting in Thailand
- ClinicalTrials.gov ID
- NCT01130961
- Acronym / sponsor ID
- NIS-OTH-IRE-2009/1
- Conditions
- Lung Cancer
- Keywords
- Advanced NSCLC, Gefitinib, Thai patient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 26 May 2010 (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 determine progression-free survival of lung cancer patients who received gefitinib in clinical practice in Thailand.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Lung cancer patients admitted in Chulalongkorn and Siriraj hospitals between January 2004 and December 2008 and treated with gefitinib for at least 3 months
Key inclusion criteria (3 listed)
- Diagnosed as having lung cancer based on histological/cytological findings
- Admitted to the hospital between January 2004 and December 2008
- Treated with gefitinib for at least 3 months
Key exclusion criteria (2 listed)
- Involvement in the planning and/or conduct of the study
- Participation in another clinical study during the last 3 months
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
Progression-free survival
Time frame: median time from the first date of treatment until date of disease progression during Jan 2004- Dec 2008 or 5 years approx.
3 secondary outcomes
Time to maximum response
Time frame: Median time from the first date of treatment until the date that the disease can be maximum controlled during Jan 2004- Dec 2008 or 5 years approx.
Overall survival
Time frame: time from the first date of treatment until date of patients dead during Jan 2004- Dec 2008 or 5 years approx.
Prevalence of EGFR & KRAS mutation from laboratory result
Time frame: During Jan 2004- Dec 2008 or 5 years approx.
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 7 Oct 2010.
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
Virote Sriuranpong, MD., PhD. principal investigator
Chulalongkorn Hospital, Bangkok, Thailand
Vichien Srimuninnimit, MD. principal investigator
Siriraj Hospital, Bangkok, Thailand
1 site 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 1 site in Thailand.
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 7 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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?
Progression-free survival (time frame: median time from the first date of treatment until date of disease progression during Jan 2004- Dec 2008 or 5 years approx.). 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 7 Oct 2010.