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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01130961
First received: April 29, 2010
Last updated: October 6, 2010
Last verified: October 2010
History of Changes
  Purpose

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


Condition
Lung Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Prevalence of EGFR & KRAS mutation from laboratory result [ Time Frame: During Jan 2004- Dec 2008 or 5 years approx. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Tissue


Enrollment: 104
Study Start Date: October 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: MC MD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01130961     History of Changes
Other Study ID Numbers: NIS-OTH-IRE-2009/1
Study First Received: April 29, 2010
Last Updated: October 6, 2010
Health Authority: Thailand: Ethical Committee

Keywords provided by AstraZeneca:
Advanced NSCLC
Gefitinib
Thai patient

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

ClinicalTrials.gov processed this record on May 23, 2013