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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TERMINATED
PHASE3
230 participants
INTERVENTIONAL
2003-04-30
2007-04-30
Brief Summary
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Detailed Description
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Comparison: Single-agent weekly docetaxel versus weekly regimen of docetaxel-cisplatin combination for elderly advanced NSCLC.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Weekly docetaxel alone
Weekly docetaxel + cisplatin combination
Eligibility Criteria
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Inclusion Criteria
2. stage IV, or stage III disease ineligible for definitive radiotherapy
3. 70 years or older
4. ECOG PS 0-1
5. Ineligible for standard platinum(bolus infusion)-containing combination chemotherapy
6. No prior chemotherapy(containing gefitinib) for non-small cell lung cancer or other neoplasms
7. No prior surgery within 4 weeks before enrollment
8. No prior radiotherapy for primary tumor
9. No prior radiotherapy for metastatic lesions within 2 weeks before enrollment
10. Adequate organ function
11. Signed informed consent
Exclusion Criteria
2. Active another neoplasms
3. Severe SVC syndrome
4. Massive pericardial, pleural effusion, or ascites
5. Bone metastasis emergent for palliative radiotherapy or surgery
6. Uncontrollable systemic hypertension
7. Heart failure, Unstable angina, Myocardial infarction within 6 months
8. Uncontrollable diabetes
9. Active infection
10. Interstitial pneumonia/ Pulmonary fibrosis
11. Hypersensitivity for polysorbate 80
12. Systemic administration of corticosteroids
70 Years
ALL
No
Sponsors
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Ministry of Health, Labour and Welfare, Japan
OTHER_GOV
Japan Clinical Oncology Group
OTHER
Principal Investigators
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Akira Yokoyama, MD, PhD
Role: STUDY_CHAIR
Department of Internal Medicine, Niigata Cancer Center Hospital
Locations
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Aichi Cancer Center Hospital
Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, Japan
Aichi Cancer Center,Aichi Hospital
Okazaki,Kake-machi,Kuriyado,18, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama,Horinouchi,13, Ehime, Japan
Kyushu University Hospital
Higashi-ku,Maidashi,3-1-1, Fukuoka, Japan
Gifu Municipal Hospital
Gifu,Kashima-cho,7-1, Gifu, Japan
Gunma Prefectural Cancer Center
Ota,Takabayashi-nishi-cho,617-1, Gunma, Japan
National Nishigunma Hospital
Shibukawa,Kanai,2854, Gunma, Japan
National Hospital Organization, Dohoku National Hospital
Asahikawa,Hanasaki,7-4048, Hokkaido, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo,Shiroishi-ku,Kikusui,4-2-3-54, Hokkaido, Japan
Hyogo Medical Center for Adults
Akashi,Kitaouji-cho,13-70, Hyōgo, Japan
Hyogo College of Medicine
Nishinomiya,Mukogawa-cho,1-1, Hyōgo, Japan
Ibaraki Kenritsu Chuo Hospital & Cancer Center
Nishi-ibarakigun,Tomobemachi,Koibuchi,6528, Ibaraki, Japan
Kanagawa Cancer Center
Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, Japan
Yokohama Mucipical Citizen's Hospital
Yokohama,Hodogaya-ku,Okazawa-cho,56, Kanagawa, Japan
Kumamoto Regional Medical Center Hospital
Kumamoto,Honjo,5-16-10, Kumamoto, Japan
Niigata Cancer Center Hospital
Niigata,Kawagishi-cho, 2-15-3, Niigata, Japan
Osaka Prefectural Medical Center for Respiratory and Allergic Disease
Habikino,Habikino,3-7-1, Osaka, Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, Japan
Osaka City General Hospital
Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22, Osaka, Japan
Kinki University School of Medicine
Osaka-Sayama,Ohno-higashi,377-2, Osaka, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
Sakai,Nagasone,1180, Osaka, Japan
National Hospital Organization Toneyama National Hospital
Toyonaka,Toneyama,5-1-1, Osaka, Japan
Saitama Cancer Center
Kita-adachi,Ina,Komuro,818, Saitama, Japan
Sizuoka Cancer Center
Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007, Shizuoka, Japan
Tochigi Cancer Center
Utsunomiya,Yohnan,4-9-13, Tochigi, Japan
National Cancer Center Hospital
Chuo-ku,Tsukiji,5-1-1, Tokyo, Japan
International Medical Center of Japan
Shinjuku-ku,Toyama,1-21-1, Tokyo, Japan
Yamagata Prefectural Central Hospital
Yamagata,Aoyagi,1800, Yamagata, Japan
Countries
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References
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Tsukada H, Yokoyama A, Goto K, Shinkai T, Harada M, Ando M, Shibata T, Ohe Y, Tamura T, Saijo N; Lung Cancer Study Group of the Japan Clinical Oncology Group (JCOG). Randomized controlled trial comparing docetaxel-cisplatin combination with weekly docetaxel alone in elderly patients with advanced non-small-cell lung cancer: Japan Clinical Oncology Group (JCOG) 0207dagger. Jpn J Clin Oncol. 2015 Jan;45(1):88-95. doi: 10.1093/jjco/hyu176. Epub 2014 Nov 6.
Related Links
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Related Info
Other Identifiers
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C000000146
Identifier Type: -
Identifier Source: secondary_id
JCOG0207
Identifier Type: -
Identifier Source: org_study_id
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