Iressa Case Control Study in Japan

Completed

• Conditions: Non-small Cell Lung Cancer

• Registration Number: NCT00252759
• Lead Sponsor: AstraZeneca

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-11
• Study First Submitted: 2005-11-14
• Study First Submitted QC: 2005-11-14
• Study First Posted: 2005-11-15
• Study Completion: 2006-02
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-27
• Last Update Posted: 2011-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Research Site; 🇯🇵 Toyama, Japan