A Study of 5-FUci Versus CPT-11 Plus CDDP Versus S-1 Alone in Advanced Gastric Cancer
September 8, 2016 updated by: Japan Clinical Oncology Group
Randomized Phase III Study of 5-FU Continuous Infusion (5-FUci) Versus CPT-11 Plus CDDP (CP) Versus S-1 Alone (S-1) in Advanced Gastric Cancer (JCOG9912)
To investigate the superiority of a combination of irinotecan and cisplatin and the non-inferiority of S-1 compared to continuous infusion of 5-FU in advanced gastric cancer
Study Overview
Status
Completed
Conditions
Detailed Description
From the results of our previous phase III study (JCOG9205), continuous infusion of 5-fluorouracil has remained to be a control arm of this study.
This study investigates the superiority of a combination of irinotecan plus cisplatin and non-inferiority of S-1, a oral fluoropyrimidine, compared to continuous infusion of 5-fluorouracil at the point of overall survival, and the planned number of enrolled patients is 690 (230/arm).
Study Type
Interventional
Enrollment
690
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Aichi
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Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi, Japan, 464-8681
- Aichi Cancer Center Hospital
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Nagoya,Naka-ku,Sannomaru,4-1-1, Aichi, Japan, 460-0001
- Nagoya Medical Center
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Okazaki,Kake-machi,Kuriyado,18, Aichi, Japan, 444-0011
- Aichi Cancer Center,Aichi Hospital
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Aomori
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Higashitsukurimiti,2-1-1,Aomori, Aomori, Japan, 030-0911
- Aomori Prefectural Central Hospital
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Chiba
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Chiba,Chuo-ku,Nitona-cho,666-2, Chiba, Japan, 260-8717
- Chiba Cancer Center Hospital
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I-1326,Asahi, Chiba, Japan, 289-2511
- Asahi General Hospital
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Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan, 277-8577
- National Cancer Center Hospital East
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Ehime
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Matsuyama,Horinouchi,13, Ehime, Japan, 790-0007
- National Hospital Organization Shikoku Cancer Center
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Fukuoka
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Fukuoka,Higashi-ku,Maidashi,3-1-1, Fukuoka, Japan, 812-8582
- Kyushu University Hospital
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Fukuoka,Minami-ku,Notame,3-1-1, Fukuoka, Japan, 811-1395
- National Kyushu Cancer Center
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Hokkaido
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North-14 West-5 Kita-ku,Sapporo, Hokkaido, Japan, 060-8648
- Hokkaido University Hospital
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kita 1 nishi 6,Chuo-ku,Sapporo, Hokkaido, Japan, 060-0001
- Federation of national public service personnel mutual aid associations Tonan Hospital
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Hyogo
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Akashi,Kitaouji-cho,13-70, Hyogo, Japan, 673-8558
- Hyogo Medical Center for Adults
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Kobe,Chuo-ku,Kusunoki-cho,7-5-2, Hyogo, Japan, 650-0017
- Kobe University Graduate School of Medicine
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Ibaraki
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Nishi-ibarakigun,Tomobemachi,Koibuchi,6528, Ibaraki, Japan, 309-1793
- Ibaraki Kenritsu Chuo Hospital & Cancer Center
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Iwate
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Morioka,Ueda,1-4-1, Iwate, Japan, 020-0066
- Iwate Prefectural Central Hospital
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Kanagawa
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Sagamihara,Asamizodai,2-1-1, Kanagawa, Japan, 228-8520
- Kitasato University East Hospital
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Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, Japan, 241-0815
- Kanagawa Cancer Center
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Yokohama,Hodogaya-ku,Okazawa-cho,56, Kanagawa, Japan, 240-8555
- Yokohama Mucipical Citizen's Hospital
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Yokohama,Minami-ku,Urafunecho,4-57, Kanagawa, Japan, 232-0024
- Yokohama City University Medical Center
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Kochi
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Kochi,Ike,2125-1, Kochi, Japan, 781-8555
- Kochi Health Science Center
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Kumamoto
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Kumamoto,Honjo,5-16-10, Kumamoto, Japan, 860-0811
- Kumamoto Regional Medical Center Hospital
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Kyoto
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Kyoto,Sakyo-ku,Syogoinkawara,54, Kyoto, Japan, 606-8507
- Kyoto University Hospital
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Miyagi
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Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, Japan, 980-8574
- Tohoku University Hospital
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Nagano
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Saku,Usuda,197, Nagano, Japan, 384-0301
- Saku Central Hospital
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Osaka
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Takatsuki,Daigakucho,2-7, Osaka, Japan, 569-0801
- Osaka Medical College
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Saitama
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Iruma-gun,Moroyama-machi,Morohongo,38, Saitama, Japan, 350-0495
- Saitama Medical School Hospital
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Kita-adachi,Ina,Komuro,818, Saitama, Japan, 362-0806
- Saitama Cancer Center
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Shizuoka
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Sunto-gun, Nagaizumi-cho, Shimonagakubo,1007, Shizuoka, Japan, 411-8777
- Div. of Gastrointestinal Oncology, Shizuoka Cancer Center
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Tochigi
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Utsunomiya,Yohnan,4-9-13, Tochigi, Japan, 320-0834
- Tochigi Cancer Center
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Tokyo
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Chuo-ku,Tsukiji,5-1-1, Tokyo, Japan, 104-0045
- National Cancer Center Hospital
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Koto-ku,Ariake,3-10-6, Tokyo, Japan, 135-8550
- Cancer Institute Hospital
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Shinagawa-ku,Hatanodai,1-5-8, Tokyo, Japan, 142-8666
- Showa University School of Medicine
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Yamagata
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Yamagata,Aoyagi,1800, Yamagata, Japan, 990-2292
- Yamagata Prefectural Central Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- unresectable or recurrent histologically proved gastric cancer
- adequate oral intake
- age 20 or older and 75 or younger
- Performance Status (ECOG):0, 1, 2
- measurable or unmeasurable lesions
- preserved organ functions
- no severe medical condition
- no prior chemotherapy for gastric cancer
- written informed consent
Exclusion Criteria:
- patient with marked infection or inflammation
- patient with severe peritoneal metastasis
- patient with massive pleural effusion
- patient with metastasis to CNS
- patient with diarrhea 4 or more times per day
- patient severe medical condition
- patient with other concurrent malignancy affecting on survival or adverse events
- pregnant or nursing patient or with intent to bear baby
- patient evaluated to be inadequate by a attending doctor
- patient requiring nutritional support
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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overall survival
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Secondary Outcome Measures
Outcome Measure |
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response rate
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time to treatment failure
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incidences of adverse events
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non-hospitalized survival
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Atsushi Ohtsu, MD, National Cancer Centr Hospital East
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kurokawa Y, Boku N, Yamaguchi T, Ohtsu A, Mizusawa J, Nakamura K, Fukuda H. Inter-institutional heterogeneity in outcomes of chemotherapy for metastatic gastric cancer: correlative study in the JCOG9912 phase III trial. ESMO Open. 2016 Feb 8;1(1):e000031. doi: 10.1136/esmoopen-2015-000031. eCollection 2016.
- Takahari D, Boku N, Mizusawa J, Takashima A, Yamada Y, Yoshino T, Yamazaki K, Koizumi W, Fukase K, Yamaguchi K, Goto M, Nishina T, Tamura T, Tsuji A, Ohtsu A. Determination of prognostic factors in Japanese patients with advanced gastric cancer using the data from a randomized controlled trial, Japan clinical oncology group 9912. Oncologist. 2014 Apr;19(4):358-66. doi: 10.1634/theoncologist.2013-0306. Epub 2014 Mar 25.
- Boku N, Yamamoto S, Fukuda H, Shirao K, Doi T, Sawaki A, Koizumi W, Saito H, Yamaguchi K, Takiuchi H, Nasu J, Ohtsu A; Gastrointestinal Oncology Study Group of the Japan Clinical Oncology Group. Fluorouracil versus combination of irinotecan plus cisplatin versus S-1 in metastatic gastric cancer: a randomised phase 3 study. Lancet Oncol. 2009 Nov;10(11):1063-9. doi: 10.1016/S1470-2045(09)70259-1. Epub 2009 Oct 7.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2000
Study Completion
January 1, 2007
Study Registration Dates
First Submitted
September 1, 2005
First Submitted That Met QC Criteria
September 1, 2005
First Posted (Estimate)
September 2, 2005
Study Record Updates
Last Update Posted (Estimate)
September 12, 2016
Last Update Submitted That Met QC Criteria
September 8, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Stomach Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Cisplatin
- Fluorouracil
- Irinotecan
Other Study ID Numbers
- JCOG9912
- C000000062
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.