Clinical trial NCT00142350: A Study of 5-FUci Versus CPT-11 Plus CDDP Versus S-1 Alone in Advanced Gastric Cancer
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Cancer
Keywords: gastric cancer
5-fluorouracil
irinotecan
cisplatin
S-1
advanced or recurrent gastric cancer
Lead sponsor: Japan Clinical Oncology Group
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Labour and Welfare, Japan
name: Taiho Pharmaceutical Co., Ltd.
name: Yakult Honsha Co., LTD
First posted: 2005-09-02
Enrollment: 690
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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).

Eligibility criteria: Inclusion Criteria:

1. unresectable or recurrent histologically proved gastric cancer
2. adequate oral intake
3. age 20 or older and 75 or younger
4. Performance Status (ECOG):0, 1, 2
5. measurable or unmeasurable lesions
6. preserved organ functions
7. no severe medical condition
8. no prior chemotherapy for gastric cancer
9. written informed consent

Exclusion Criteria:

1. patient with marked infection or inflammation
2. patient with severe peritoneal metastasis
3. patient with massive pleural effusion
4. patient with metastasis to CNS
5. patient with diarrhea 4 or more times per day
6. patient severe medical condition
7. patient with other concurrent malignancy affecting on survival or adverse events
8. pregnant or nursing patient or with intent to bear baby
9. patient evaluated to be inadequate by a attending doctor
10. patient requiring nutritional support

Primary outcomes:
measure: overall survival
Secondary outcomes:
measure: time to treatment failure
measure: incidences of adverse events
measure: response rate
measure: non-hospitalized survival
Other outcomes:
Locations:
city: Nagoya,Chikusa-ku,Kanokoden,1-1
country: Japan
facility: Aichi Cancer Center Hospital
state: Aichi
city: Nagoya,Naka-ku,Sannomaru,4-1-1
country: Japan
facility: Nagoya Medical Center
state: Aichi
city: Okazaki,Kake-machi,Kuriyado,18
country: Japan
facility: Aichi Cancer Center,Aichi Hospital
state: Aichi
city: Higashitsukurimiti,2-1-1,Aomori
country: Japan
facility: Aomori Prefectural Central Hospital
state: Aomori
city: Chiba,Chuo-ku,Nitona-cho,666-2
country: Japan
facility: Chiba Cancer Center Hospital
state: Chiba
city: I-1326,Asahi
country: Japan
facility: Asahi General Hospital
state: Chiba
city: Kashiwa,Kashiwanoha,6-5-1
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Matsuyama,Horinouchi,13
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
state: Ehime
city: Fukuoka,Higashi-ku,Maidashi,3-1-1
country: Japan
facility: Kyushu University Hospital
state: Fukuoka
city: Fukuoka,Minami-ku,Notame,3-1-1
country: Japan
facility: National Kyushu Cancer Center
state: Fukuoka
city: kita 1 nishi 6,Chuo-ku,Sapporo
country: Japan
facility: Federation of national public service personnel mutual aid associations Tonan Hospital
state: Hokkaido
city: North-14 West-5 Kita-ku,Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Akashi,Kitaouji-cho,13-70
country: Japan
facility: Hyogo Medical Center for Adults
state: Hyogo
city: Kobe,Chuo-ku,Kusunoki-cho,7-5-2
country: Japan
facility: Kobe University Graduate School of Medicine
state: Hyogo
city: Nishi-ibarakigun,Tomobemachi,Koibuchi,6528
country: Japan
facility: Ibaraki Kenritsu Chuo Hospital & Cancer Center
state: Ibaraki
city: Morioka,Ueda,1-4-1
country: Japan
facility: Iwate Prefectural Central Hospital
state: Iwate
city: Sagamihara,Asamizodai,2-1-1
country: Japan
facility: Kitasato University East Hospital
state: Kanagawa
city: Yokohama,Asahi-ku,Nakao,1-1-2
country: Japan
facility: Kanagawa Cancer Center
state: Kanagawa
city: Yokohama,Hodogaya-ku,Okazawa-cho,56
country: Japan
facility: Yokohama Mucipical Citizen's Hospital
state: Kanagawa
city: Yokohama,Minami-ku,Urafunecho,4-57
country: Japan
facility: Yokohama City University Medical Center
state: Kanagawa
city: Kochi,Ike,2125-1
country: Japan
facility: Kochi Health Science Center
state: Kochi
city: Kumamoto,Honjo,5-16-10
country: Japan
facility: Kumamoto Regional Medical Center Hospital
state: Kumamoto
city: Kyoto,Sakyo-ku,Syogoinkawara,54
country: Japan
facility: Kyoto University Hospital
state: Kyoto
city: Sendai,Aoba-ku,Seiryo-machi,1-1
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Saku,Usuda,197
country: Japan
facility: Saku Central Hospital
state: Nagano
city: Takatsuki,Daigakucho,2-7
country: Japan
facility: Osaka Medical College
state: Osaka
city: Iruma-gun,Moroyama-machi,Morohongo,38
country: Japan
facility: Saitama Medical School Hospital
state: Saitama
city: Kita-adachi,Ina,Komuro,818
country: Japan
facility: Saitama Cancer Center
state: Saitama
city: Sunto-gun, Nagaizumi-cho, Shimonagakubo,1007
country: Japan
facility: Div. of Gastrointestinal Oncology, Shizuoka Cancer Center
state: Shizuoka
city: Utsunomiya,Yohnan,4-9-13
country: Japan
facility: Tochigi Cancer Center
state: Tochigi
city: Chuo-ku,Tsukiji,5-1-1
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Koto-ku,Ariake,3-10-6
country: Japan
facility: Cancer Institute Hospital
state: Tokyo
city: Shinagawa-ku,Hatanodai,1-5-8
country: Japan
facility: Showa University School of Medicine
state: Tokyo
city: Yamagata,Aoyagi,1800
country: Japan
facility: Yamagata Prefectural Central Hospital
state: Yamagata
Study officials:
affiliation: National Cancer Centr Hospital East
name: Atsushi Ohtsu, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.