Clinical trial NCT00252759: Iressa Case Control Study in Japan
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-11-15
Enrollment: 6000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients

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


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Research Site
state: Aichi
city: Okazaki
country: Japan
facility: Research Site
state: Aichi
city: Toyoake
country: Japan
facility: Research Site
state: Aichi
city: Imba-gun
country: Japan
facility: Research Site
state: Chiba
city: Kashiwa
country: Japan
facility: Research Site
state: Chiba
city: Matsuyama
country: Japan
facility: Research Site
state: Ehime
city: Kitakyushu
country: Japan
facility: Research Site
state: Fukuoka
city: Asahikawa
country: Japan
facility: Research Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Research Site
state: Hokkaido
city: Akashi
country: Japan
facility: Research Site
state: Hyogo
city: Kobe
country: Japan
facility: Research Site
state: Hyogo
city: Kanazawa
country: Japan
facility: Research Site
state: Ishikawa
city: Isehara
country: Japan
facility: Research Site
state: Kanagawa
city: Sagamihara
country: Japan
facility: Research Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Research Site
state: Kanagawa
city: Sendai
country: Japan
facility: Research Site
state: Miyagi
city: Omura
country: Japan
facility: Research Site
state: Nagasaki
city: Tenri
country: Japan
facility: Research Site
state: Nara
city: Ginowan
country: Japan
facility: Research Site
state: Okinawa
city: Habikino
country: Japan
facility: Research Site
state: Osaka
city: Izumisano
country: Japan
facility: Research Site
state: Osaka
city: Osakasayama
country: Japan
facility: Research Site
state: Osaka
city: Sakai
country: Japan
facility: Research Site
state: Osaka
city: Toyonaka
country: Japan
facility: Research Site
state: Osaka
city: Tokyo
country: Japan
facility: Research Site
state: Ota
city: Otsu
country: Japan
facility: Research Site
state: Shiga
city: Sunto-gun
country: Japan
facility: Research Site
state: Shizuoka
city: Bunkyo-ku
country: Japan
facility: Research Site
state: Tokyo
city: Bunkyo
country: Japan
facility: Research Site
state: Tokyo
city: Kiyose
country: Japan
facility: Research Site
state: Tokyo
city: Minato-ku
country: Japan
facility: Research Site
state: Tokyo
city: Mitaka
country: Japan
facility: Research Site
state: Tokyo
city: Shinjuku
country: Japan
facility: Research Site
state: Tokyo
city: Toshima-ku
country: Japan
facility: Research Site
state: Tokyo
city: Fukuoka
country: Japan
facility: Research Site
city: Gifu
country: Japan
facility: Research Site
city: Hiroshima
country: Japan
facility: Research Site
city: Kumamoto
country: Japan
facility: Research Site
city: Kyoto
country: Japan
facility: Research Site
city: Nagasaki
country: Japan
facility: Research Site
city: Niigata
country: Japan
facility: Research Site
city: Okayama
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Toyama
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Japan Medical Director, MD
role: STUDY_DIRECTOR
References:
citation: 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.