NCT00252759

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2003

Typical duration for all trials

Geographic Reach
1 country

44 active sites

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

November 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 15, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

January 28, 2011

Status Verified

January 1, 2011

First QC Date

November 14, 2005

Last Update Submit

January 27, 2011

Conditions

Non-small Cell Lung Cancer

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (44)

Research Site

Nagoya, Aichi-ken, Japan

Location

Research Site

Okazaki, Aichi-ken, Japan

Location

Research Site

Toyoake, Aichi-ken, Japan

Location

Research Site

Imba-gun, Chiba, Japan

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Research Site

Kashiwa, Chiba, Japan

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Research Site

Matsuyama, Ehime, Japan

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Research Site

Fukuoka, Fukuoka, Japan

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Research Site

Kitakyushu, Fukuoka, Japan

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Research Site

Gifu, Gifu, Japan

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Research Site

Hiroshima, Hiroshima, Japan

Location

Research Site

Asahikawa, Hokkaido, Japan

Location

Research Site

Sapporo, Hokkaido, Japan

Location

Research Site

Akashi, Hyōgo, Japan

Location

Research Site

Kobe, Hyōgo, Japan

Location

Research Site

Kanazawa, Ishikawa-ken, Japan

Location

Research Site

Isehara, Kanagawa, Japan

Location

Research Site

Sagamihara, Kanagawa, Japan

Location

Research Site

Yokohama, Kanagawa, Japan

Location

Research Site

Kumamoto, Kumamoto, Japan

Location

Research Site

Kyoto, Kyoto, Japan

Location

Research Site

Sendai, Miyagi, Japan

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Research Site

Nagasaki, Nagasaki, Japan

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Research Site

Ōmura, Nagasaki, Japan

Location

Research Site

Tenri, Nara, Japan

Location

Research Site

Niigata, Niigata, Japan

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Research Site

Okayama, Okayama-ken, Japan

Location

Research Site

Ginowan, Okinawa, Japan

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Research Site

Habikino, Osaka, Japan

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Research Site

Izumisano, Osaka, Japan

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Research Site

Osaka, Osaka, Japan

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Research Site

Sakai, Osaka, Japan

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Research Site

Sayama, Osaka, Japan

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Research Site

Toyonaka, Osaka, Japan

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Research Site

Tokyo, Ota, Japan

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Research Site

Ōtsu, Shiga, Japan

Location

Research Site

Sunto-gun, Shizuoka, Japan

Location

Research Site

Bunkyo-ku, Tokyo, Japan

Location

Research Site

Bunkyo, Tokyo, Japan

Location

Research Site

Kiyose, Tokyo, Japan

Location

Research Site

Minato-ku, Tokyo, Japan

Location

Research Site

Mitaka, Tokyo, Japan

Location

Research Site

Shinjuku, Tokyo, Japan

Location

Research Site

Toshima-ku, Tokyo, Japan

Location

Research Site

Toyama, Toyama, Japan

Location

Related Publications (1)

  • Kawata T, Higashimori M, Itoh Y, Tomkinson H, Johnson MG, Tang W, Nyberg F, Jiang H, Tanigawara Y. Gefitinib exposure and occurrence of interstitial lung disease in Japanese patients with non-small-cell lung cancer. Cancer Chemother Pharmacol. 2019 May;83(5):849-858. doi: 10.1007/s00280-019-03788-4. Epub 2019 Feb 14.

    PMID: 30762084DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • AstraZeneca Japan Medical Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 14, 2005

First Posted

November 15, 2005

Study Start

November 1, 2003

Study Completion

February 1, 2006

Last Updated

January 28, 2011

Record last verified: 2011-01

Locations

JP(44)