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| ID | Type | Description | Link |
|---|---|---|---|
| V-15-32 |
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In this study, among the patients with non-small cell lung cancer, those with metastasis or recurrence and previous treatment with chemotherapy will receive gefitinib or docetaxel, and we will compare the effectiveness and safety of gefitinib with docetaxel.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gefitinib or Docetaxel | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the overall survival with these treatments as the primary outcome. |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the followings as the secondary outcome variables: | ||
| - Progression-free survival (PFS) | ||
| - Time to treatment failure (TTF) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca Japan Medical Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Nagoya | Aichi-ken | Japan | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18779611 | Derived | Maruyama R, Nishiwaki Y, Tamura T, Yamamoto N, Tsuboi M, Nakagawa K, Shinkai T, Negoro S, Imamura F, Eguchi K, Takeda K, Inoue A, Tomii K, Harada M, Masuda N, Jiang H, Itoh Y, Ichinose Y, Saijo N, Fukuoka M. Phase III study, V-15-32, of gefitinib versus docetaxel in previously treated Japanese patients with non-small-cell lung cancer. J Clin Oncol. 2008 Sep 10;26(26):4244-52. doi: 10.1200/JCO.2007.15.0185. |
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| - Objective tumour response (CR, PR) and the disease control rate (CR, PR, SD [≥12 weeks]) based on the RECIST guidelines |
| - Lung cancer subscale (LCS) |
| - QOL according to FACT-L questionnaire |
| - Frequency and severity of adverse events. |
| Determine the followings as the exploratory outcome variables: |
| - Biomarkers related to expression, activation and dimerisation of EGFR and other ErbB family receptors and associated pathways including downstream signalling pathways |
| - Biomarkers related to somatic (non-inheritable) mutation analyses of genes of the ErbB family, their signalling pathways and associated pathways which are thought to be influenced by gefitinib in tumour cells. |
| Okazaki |
| Aichi-ken |
| Japan |
| Research Site | Hirosaki | Aomori | Japan |
| Research Site | Kashiwa | Chiba | Japan |
| Research Site | Matsuyama | Ehime | Japan |
| Research Site | Fukuoka | Fukuoka | Japan |
| Research Site | Gifu | Gifu | Japan |
| Research Site | Asahikawa | Hokkaido | Japan |
| Research Site | Sapporo | Hokkaido | Japan |
| Research Site | Akashi | Hyōgo | Japan |
| Research Site | Kobe | Hyōgo | Japan |
| Research Site | Naka-gun | Ibaraki | Japan |
| Research Site | Isehara | Kanagawa | Japan |
| Research Site | Sagamihara | Kanagawa | Japan |
| Research Site | Yokohama | Kanagawa | Japan |
| Research Site | Kumamoto | Kumamoto | Japan |
| Research Site | Sendai | Miyagi | Japan |
| Research Site | Nagasaki | Nagasaki | Japan |
| Research Site | Ōmura | Nagasaki | Japan |
| Research Site | Niigata | Niigata | Japan |
| Research Site | Beppu | Oita Prefecture | Japan |
| Research Site | Okayama | Okayama-ken | 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 | Iwata | Shizuoka | Japan |
| Research Site | Sunto-gun | Shizuoka | Japan |
| Research Site | Bunkyo-ku | Tokyo | Japan |
| Research Site | Chūō | Tokyo | Japan |
| Research Site | Kiyose | Tokyo | Japan |
| Research Site | Minato-ku | Tokyo | Japan |
| Research Site | Shinjuku | Tokyo | Japan |
| Research Site | Sumida City | Tokyo | Japan |
| Research Site | Toshima-ku | Tokyo | Japan |
| Research Site | Yamagata | Yamagata | Japan |
| Research Site | Ube | Yamaguchi | Japan |
| Research Site | Kanazawa | Japan |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077156 | Gefitinib |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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