Status:

COMPLETED

Iressa Case Control Study in Japan

Lead Sponsor:

AstraZeneca

Conditions:

Non-small Cell Lung Cancer

Eligibility:

All Genders

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

November 1 2003

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

February 1 2006

Estimated Enrollment :

6000 Patients enrolled

Trial Details

Trial ID

NCT00252759

Start Date

November 1 2003

End Date

February 1 2006

Last Update

January 28 2011

Active Locations (44)

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Page 1 of 11 (44 locations)

1

Research Site

Nagoya, Aichi-ken, Japan

2

Research Site

Okazaki, Aichi-ken, Japan

3

Research Site

Toyoake, Aichi-ken, Japan

4

Research Site

Imba-gun, Chiba, Japan