Iressa Case Control Study in Japan - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00252759

Purpose

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

Condition	Phase
Non-Small Cell Lung Cancer	Phase IV

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: ZD1839

Study Type:	Observational
Study Design:	Prospective
Official Title:	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

Further study details as provided by AstraZeneca:

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00252759

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Japan Medical Director, MD

AstraZeneca

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	D791AL00002, V-15-33, OZV1533
Study First Received:	November 14, 2005
Last Updated:	December 14, 2007
ClinicalTrials.gov Identifier:	NCT00252759
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Lung Diseases, Interstitial
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Gefitinib
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 14, 2009