Non-small Cell Lung Cancer Clinical Trial
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
| Verified date | January 2011 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Japan: Ministry of Health, Labor and Welfare |
| Study type | Observational |
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
| Status | Completed |
| Enrollment | 6000 |
| Est. completion date | February 2006 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
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 |
Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Japan | Research Site | Akashi | Hyogo |
| Japan | Research Site | Asahikawa | Hokkaido |
| Japan | Research Site | Bunkyo | Tokyo |
| Japan | Research Site | Bunkyo-ku | Tokyo |
| Japan | Research Site | Fukuoka | |
| Japan | Research Site | Gifu | |
| Japan | Research Site | Ginowan | Okinawa |
| Japan | Research Site | Habikino | Osaka |
| Japan | Research Site | Hiroshima | |
| Japan | Research Site | Imba-gun | Chiba |
| Japan | Research Site | Isehara | Kanagawa |
| Japan | Research Site | Izumisano | Osaka |
| Japan | Research Site | Kanazawa | Ishikawa |
| Japan | Research Site | Kashiwa | Chiba |
| Japan | Research Site | Kitakyushu | Fukuoka |
| Japan | Research Site | Kiyose | Tokyo |
| Japan | Research Site | Kobe | Hyogo |
| Japan | Research Site | Kumamoto | |
| Japan | Research Site | Kyoto | |
| Japan | Research Site | Matsuyama | Ehime |
| Japan | Research Site | Minato-ku | Tokyo |
| Japan | Research Site | Mitaka | Tokyo |
| Japan | Research Site | Nagasaki | |
| Japan | Research Site | Nagoya | Aichi |
| Japan | Research Site | Niigata | |
| Japan | Research Site | Okayama | |
| Japan | Research Site | Okazaki | Aichi |
| Japan | Research Site | Omura | Nagasaki |
| Japan | Research Site | Osaka | |
| Japan | Research Site | Osakasayama | Osaka |
| Japan | Research Site | Otsu | Shiga |
| Japan | Research Site | Sagamihara | Kanagawa |
| Japan | Research Site | Sakai | Osaka |
| Japan | Research Site | Sapporo | Hokkaido |
| Japan | Research Site | Sendai | Miyagi |
| Japan | Research Site | Shinjuku | Tokyo |
| Japan | Research Site | Sunto-gun | Shizuoka |
| Japan | Research Site | Tenri | Nara |
| Japan | Research Site | Tokyo | Ota |
| Japan | Research Site | Toshima-ku | Tokyo |
| Japan | Research Site | Toyama | |
| Japan | Research Site | Toyoake | Aichi |
| Japan | Research Site | Toyonaka | Osaka |
| Japan | Research Site | Yokohama | Kanagawa |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Japan,
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