NCT01130961

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2010

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 26, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

October 7, 2010

Status Verified

October 1, 2010

Enrollment Period

10 months

First QC Date

April 29, 2010

Last Update Submit

October 6, 2010

Conditions

Lung Cancer

Keywords

Advanced NSCLCGefitinibThai patient

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (3)

  • 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.

  • Overall survival

    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

    During Jan 2004- Dec 2008 or 5 years approx.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • Involvement in the planning and/or conduct of the study
  • Participation in another clinical study during the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Bangkok, Thailand

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissue

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Virote Sriuranpong, MD., PhD.

    Chulalongkorn Hospital, Bangkok, Thailand

    PRINCIPAL INVESTIGATOR

  • Vichien Srimuninnimit, MD.

    Siriraj Hospital, Bangkok, Thailand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 29, 2010

First Posted

May 26, 2010

Study Start

October 1, 2009

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

October 7, 2010

Record last verified: 2010-10

Locations

TH(1)