A Study of 5-FUci Versus CPT-11 Plus CDDP Versus S-1 Alone in Advanced Gastric Cancer
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)
2 other identifiers
interventional
690
1 country
34
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 gastric-cancer
Started Nov 2000
Typical duration for phase_3 gastric-cancer
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2000
CompletedFirst Submitted
Initial submission to the registry
September 1, 2005
CompletedFirst Posted
Study publicly available on registry
September 2, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedSeptember 12, 2016
September 1, 2016
September 1, 2005
September 8, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall survival
Secondary Outcomes (4)
time to treatment failure
incidences of adverse events
response rate
non-hospitalized survival
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Japan Clinical Oncology Grouplead
- Ministry of Health, Labour and Welfare, Japancollaborator
- Taiho Pharmaceutical Co., Ltd.collaborator
- Yakult Honsha Co., LTDcollaborator
Study Sites (34)
Aichi Cancer Center Hospital
Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, 464-8681, Japan
Nagoya Medical Center
Nagoya,Naka-ku,Sannomaru,4-1-1, Aichi-ken, 460-0001, Japan
Aichi Cancer Center,Aichi Hospital
Okazaki,Kake-machi,Kuriyado,18, Aichi-ken, 444-0011, Japan
Aomori Prefectural Central Hospital
Higashitsukurimiti,2-1-1,Aomori, Aomori, 030-0911, Japan
Chiba Cancer Center Hospital
Chiba,Chuo-ku,Nitona-cho,666-2, Chiba, 260-8717, Japan
Asahi General Hospital
I-1326,Asahi, Chiba, 289-2511, Japan
National Cancer Center Hospital East
Kashiwa,Kashiwanoha,6-5-1, Chiba, 277-8577, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama,Horinouchi,13, Ehime, 790-0007, Japan
Kyushu University Hospital
Fukuoka,Higashi-ku,Maidashi,3-1-1, Fukuoka, 812-8582, Japan
National Kyushu Cancer Center
Fukuoka,Minami-ku,Notame,3-1-1, Fukuoka, 811-1395, Japan
Federation of national public service personnel mutual aid associations Tonan Hospital
Kita 1 Nishi 6,Chuo-ku,Sapporo, Hokkaido, 060-0001, Japan
Hokkaido University Hospital
North-14 West-5 Kita-ku,Sapporo, Hokkaido, 060-8648, Japan
Hyogo Medical Center for Adults
Akashi,Kitaouji-cho,13-70, Hyōgo, 673-8558, Japan
Kobe University Graduate School of Medicine
Kobe,Chuo-ku,Kusunoki-cho,7-5-2, Hyōgo, 650-0017, Japan
Ibaraki Kenritsu Chuo Hospital & Cancer Center
Nishi-ibarakigun,Tomobemachi,Koibuchi,6528, Ibaraki, 309-1793, Japan
Iwate Prefectural Central Hospital
Morioka,Ueda,1-4-1, Iwate, 020-0066, Japan
Kitasato University East Hospital
Sagamihara,Asamizodai,2-1-1, Kanagawa, 228-8520, Japan
Kanagawa Cancer Center
Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, 241-0815, Japan
Yokohama Mucipical Citizen's Hospital
Yokohama,Hodogaya-ku,Okazawa-cho,56, Kanagawa, 240-8555, Japan
Yokohama City University Medical Center
Yokohama,Minami-ku,Urafunecho,4-57, Kanagawa, 232-0024, Japan
Kochi Health Science Center
Kochi,Ike,2125-1, Kochi, 781-8555, Japan
Kumamoto Regional Medical Center Hospital
Kumamoto,Honjo,5-16-10, Kumamoto, 860-0811, Japan
Kyoto University Hospital
Kyoto,Sakyo-ku,Syogoinkawara,54, Kyoto, 606-8507, Japan
Tohoku University Hospital
Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, 980-8574, Japan
Saku Central Hospital
Saku,Usuda,197, Nagano, 384-0301, Japan
Osaka Medical College
Takatsuki,Daigakucho,2-7, Osaka, 569-0801, Japan
Saitama Medical School Hospital
Iruma-gun,Moroyama-machi,Morohongo,38, Saitama, 350-0495, Japan
Saitama Cancer Center
Kita-adachi,Ina,Komuro,818, Saitama, 362-0806, Japan
Div. of Gastrointestinal Oncology, Shizuoka Cancer Center
Sunto-gun, Nagaizumi-cho, Shimonagakubo,1007, Shizuoka, 411-8777, Japan
Tochigi Cancer Center
Utsunomiya,Yohnan,4-9-13, Tochigi, 320-0834, Japan
National Cancer Center Hospital
Chuo-ku,Tsukiji,5-1-1, Tokyo, 104-0045, Japan
Cancer Institute Hospital
Koto-ku,Ariake,3-10-6, Tokyo, 135-8550, Japan
Showa University School of Medicine
Shinagawa-ku,Hatanodai,1-5-8, Tokyo, 142-8666, Japan
Yamagata Prefectural Central Hospital
Yamagata,Aoyagi,1800, Yamagata, 990-2292, Japan
Related Publications (3)
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.
PMID: 27843586DERIVEDTakahari 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.
PMID: 24668328DERIVEDBoku 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.
PMID: 19818685DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Atsushi Ohtsu, MD
National Cancer Centr Hospital East
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 1, 2005
First Posted
September 2, 2005
Study Start
November 1, 2000
Study Completion
January 1, 2007
Last Updated
September 12, 2016
Record last verified: 2016-09