Management of Advanced Non-Small Cell Lung Cancer (NSCLC) and Clinical Outcomes in Patients Who Received Gefitinib in Thailand

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01130961
• Other study ID #: NIS-OTH-IRE-2009/1
• Status: Completed
• Phase: N/A
• First received: April 29, 2010
• Last updated: October 6, 2010
• Start date: October 2009
• Est. completion date: August 2010

Study information

• Verified date: October 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Involvement in the planning and/or conduct of the study

• Participation in another clinical study during the last 3 months

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
Thailand	Research Site	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		median time from the first date of treatment until date of disease progression during Jan 2004- Dec 2008 or 5 years approx.	No
Secondary	Time to maximum response		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.	No
Secondary	Overall survival		time from the first date of treatment until date of patients dead during Jan 2004- Dec 2008 or 5 years approx.	No
Secondary	Prevalence of EGFR & KRAS mutation from laboratory result		During Jan 2004- Dec 2008 or 5 years approx.	No