A Study Comparing Irinotecan and Cisplatin (IP) With Etoposide and Cisplatin (EP) Following EP/TRT for LD-SCLC
NCT ID: NCT00144989
Last Updated: 2016-09-22
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
PHASE3
281 participants
INTERVENTIONAL
2002-09-30
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Etoposide and cisplatin after chemoradiotherapy
Etoposide and cisplatin after chemoradiotherapy
Etoposide and cisplatin after chemoradiotherapy
2
Irinotecan and cisplatin after chemoradiotherapy
Irinotecan and cisplatin after chemoradiotherapy
Irinotecan and cisplatin after chemoradiotherapy
Interventions
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Etoposide and cisplatin after chemoradiotherapy
Etoposide and cisplatin after chemoradiotherapy
Irinotecan and cisplatin after chemoradiotherapy
Irinotecan and cisplatin after chemoradiotherapy
Eligibility Criteria
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Inclusion Criteria
2. limited disease
3. age 20-70 years old
4. performance status of 0-1
5. measurable disease
6. no prior treatment for small-cell lung cancer
7. no history of chemotherapy
8. adequate organ functions
9. written informed consent
Exclusion Criteria
2. active concomitant malignancy
3. pregnant or lactating women
4. interstitial pneumonia/active lung fibrosis on chest x-ray, watery diarrhea, intestinal obstruction or paralysis, uncontrolled heart disease or a history of myocardial infarction within the previous 6 months, uncontrolled diabetes mellitus, active infection, psychological disease deemed unacceptable for inclusion to the study, long-term steroid treatment.
20 Years
70 Years
ALL
No
Sponsors
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Ministry of Health, Labour and Welfare, Japan
OTHER_GOV
Haruhiko Fukuda
OTHER
Responsible Party
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Haruhiko Fukuda
JCOG Data Center
Principal Investigators
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Yutaka Nishiwaki, MD
Role: STUDY_CHAIR
National Cancer Center Hospital East
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-shi,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
Kobe City General Hospital
Kobe,Chuo-ku,Minatojimanakamachi,4-6, 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
Tohoku University Hospital
Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, Japan
Niigata Cancer Center Hospital
Niigata,Kawagishi-cho,2-15-3, Niigata, Japan
Okayama University Hospital
Okayama,Shikata-cho,2-5-1, Okayama-ken, Japan
Osaka Prefectural Medical Center for Respiratory and Allergic Disease
Habikino,Habikino,3-7-1, Osaka, Japan
Rinku General Medical Center
Izumisano,rinku-ohrai-kita,2-23, Osaka, Japan
Graduate School of Medicine, Osaka City University
Osaka,Abeno-ku,Asahi-machi,1-5-7, 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
Osaka General Medical Center
Osaka,Sumiyoshi-ku,Bandai-higashi,3-1-56, 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
Cancer Institute Hospital
Koto-ku,Ariake,3-10-6, Tokyo, Japan
Toranomon Hospital
Minato-ku,Toranomon,2-2-2, 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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Kubota K, Hida T, Ishikura S, Mizusawa J, Nishio M, Kawahara M, Yokoyama A, Imamura F, Takeda K, Negoro S, Harada M, Okamoto H, Yamamoto N, Shinkai T, Sakai H, Matsui K, Nakagawa K, Shibata T, Saijo N, Tamura T; Japan Clinical Oncology Group. Etoposide and cisplatin versus irinotecan and cisplatin in patients with limited-stage small-cell lung cancer treated with etoposide and cisplatin plus concurrent accelerated hyperfractionated thoracic radiotherapy (JCOG0202): a randomised phase 3 study. Lancet Oncol. 2014 Jan;15(1):106-13. doi: 10.1016/S1470-2045(13)70511-4. Epub 2013 Dec 3.
Related Links
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Related Info
Other Identifiers
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C000000095
Identifier Type: -
Identifier Source: secondary_id
JCOG0202-MF
Identifier Type: -
Identifier Source: org_study_id
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