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

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ClinicalTrials.gov Identifier: NCT01130961
Recruitment Status : Completed
First Posted : May 26, 2010
Last Update Posted : October 7, 2010
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
The purpose of this study is to determine progression-free survival of lung cancer patients who received gefitinib in clinical practice in Thailand.

Condition or disease
Lung Cancer

Study Type : Observational
Actual Enrollment : 104 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Study Start Date : October 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Gefitinib
U.S. FDA Resources




Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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. ]
  2. 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. ]
  3. Prevalence of EGFR & KRAS mutation from laboratory result [ Time Frame: During Jan 2004- Dec 2008 or 5 years approx. ]

Biospecimen Retention:   Samples With DNA
Tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01130961


Locations
Thailand
Research Site
Bangkok, Thailand
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Virote Sriuranpong, MD., PhD. Chulalongkorn Hospital, Bangkok, Thailand
Principal Investigator: Vichien Srimuninnimit, MD. Siriraj Hospital, Bangkok, Thailand

Responsible Party: MC MD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01130961     History of Changes
Other Study ID Numbers: NIS-OTH-IRE-2009/1
First Posted: May 26, 2010    Key Record Dates
Last Update Posted: October 7, 2010
Last Verified: October 2010

Keywords provided by AstraZeneca:
Advanced NSCLC
Gefitinib
Thai patient

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gefitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action