Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
6000 participants
OBSERVATIONAL
2003-11-30
2006-02-28
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Principal Investigators
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AstraZeneca Japan Medical Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Nagoya, Aichi-ken, Japan
Research Site
Okazaki, Aichi-ken, Japan
Research Site
Toyoake, Aichi-ken, Japan
Research Site
Imba-gun, Chiba, Japan
Research Site
Kashiwa, Chiba, Japan
Research Site
Matsuyama, Ehime, Japan
Research Site
Fukuoka, Fukuoka, Japan
Research Site
Kitakyushu, Fukuoka, Japan
Research Site
Gifu, Gifu, Japan
Research Site
Hiroshima, Hiroshima, Japan
Research Site
Asahikawa, Hokkaido, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Akashi, Hyōgo, Japan
Research Site
Kobe, Hyōgo, Japan
Research Site
Kanazawa, Ishikawa-ken, Japan
Research Site
Isehara, Kanagawa, Japan
Research Site
Sagamihara, Kanagawa, Japan
Research Site
Yokohama, Kanagawa, Japan
Research Site
Kumamoto, Kumamoto, Japan
Research Site
Kyoto, Kyoto, Japan
Research Site
Sendai, Miyagi, Japan
Research Site
Nagasaki, Nagasaki, Japan
Research Site
Ōmura, Nagasaki, Japan
Research Site
Tenri, Nara, Japan
Research Site
Niigata, Niigata, Japan
Research Site
Okayama, Okayama-ken, Japan
Research Site
Ginowan, Okinawa, Japan
Research Site
Habikino, Osaka, Japan
Research Site
Izumisano, Osaka, Japan
Research Site
Osaka, Osaka, Japan
Research Site
Sakai, Osaka, Japan
Research Site
Sayama, Osaka, Japan
Research Site
Toyonaka, Osaka, Japan
Research Site
Tokyo, Ota, Japan
Research Site
Ōtsu, Shiga, Japan
Research Site
Sunto-gun, Shizuoka, Japan
Research Site
Bunkyo-ku, Tokyo, Japan
Research Site
Bunkyo, Tokyo, Japan
Research Site
Kiyose, Tokyo, Japan
Research Site
Minato-ku, Tokyo, Japan
Research Site
Mitaka, Tokyo, Japan
Research Site
Shinjuku, Tokyo, Japan
Research Site
Toshima-ku, Tokyo, Japan
Research Site
Toyama, Toyama, Japan
Countries
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References
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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.
Other Identifiers
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V-15-33
Identifier Type: -
Identifier Source: secondary_id
OZV1533
Identifier Type: -
Identifier Source: secondary_id
D791AL00002
Identifier Type: -
Identifier Source: org_study_id
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