Iressa Case Control Study in Japan

A Nested Case-control Study to Determine the Relative Risk of and Risk Factors for Interstitial Lung Disease in a Cohort of NSCLC Patients Treated With and Without Gefitinib

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00252759

Enrollment

6000

Registered

2005-11-15

Start date

2003-11-30

Completion date

2006-02-28

Last updated

2011-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Brief summary

The purposes of this study are: * To estimate the relative risk of ILD in advanced/recurrence NSCLC patients treated with gefitinib as compared to other chemotherapy treatment, and to assess the risk factors for ILD in advanced/recurrence NSCLC patients undergoing treatment * To provide an estimate of the incidence of ILD in a group of advanced/recurrence NSCLC patients undergoing treatment

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Advanced/recurrence NSCLC patients who have had one or more chemotherapy regimens. * Patients who are to be treated with gefitinib or chemotherapy * Cohort: All advanced/recurrence NSCLC patients participating in this post-marketing clinical study

Exclusion criteria

* Patients judged by the investigator(s) to have ILD (provisional cases) among those registered in the cohort OR Randomly selected patients without ILD (controls) for each provisional case * Case-control study: Patients enrolled in the case-control study; all consenting patients with ILD as cases and approximately 4 times as many consenting patients without ILD as controls randomly selected from the cohort

Countries

Japan

Outcome results