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A Study of 5-FUci Versus CPT-11 Plus CDDP Versus S-1 Alone in Advanced Gastric Cancer

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
continuous infusion of 5-fluorouracil
combination of irinotecan and cisplatin
oral administration of S-1
Sponsored by
Japan Clinical Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring gastric cancer, 5-fluorouracil, irinotecan, cisplatin, S-1, advanced or recurrent gastric cancer

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aichi Cancer Center Hospital
  • Nagoya Medical Center
  • Aichi Cancer Center,Aichi Hospital
  • Aomori Prefectural Central Hospital
  • Chiba Cancer Center Hospital
  • Asahi General Hospital
  • National Cancer Center Hospital East
  • National Hospital Organization Shikoku Cancer Center
  • Kyushu University Hospital
  • National Kyushu Cancer Center
  • Federation of national public service personnel mutual aid associations Tonan Hospital
  • Hokkaido University Hospital
  • Hyogo Medical Center for Adults
  • Kobe University Graduate School of Medicine
  • Ibaraki Kenritsu Chuo Hospital & Cancer Center
  • Iwate Prefectural Central Hospital
  • Kitasato University East Hospital
  • Kanagawa Cancer Center
  • Yokohama Mucipical Citizen's Hospital
  • Yokohama City University Medical Center
  • Kochi Health Science Center
  • Kumamoto Regional Medical Center Hospital
  • Kyoto University Hospital
  • Tohoku University Hospital
  • Saku Central Hospital
  • Osaka Medical College
  • Saitama Medical School Hospital
  • Saitama Cancer Center
  • Div. of Gastrointestinal Oncology, Shizuoka Cancer Center
  • Tochigi Cancer Center
  • National Cancer Center Hospital
  • Cancer Institute Hospital
  • Showa University School of Medicine
  • Yamagata Prefectural Central Hospital

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

time to treatment failure
incidences of adverse events
response rate
non-hospitalized survival

Full Information

First Posted
September 1, 2005
Last Updated
September 8, 2016
Sponsor
Japan Clinical Oncology Group
Collaborators
Ministry of Health, Labour and Welfare, Japan, Taiho Pharmaceutical Co., Ltd., Yakult Honsha Co., LTD
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1. Study Identification

Unique Protocol Identification Number
NCT00142350
Brief Title
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

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
November 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Japan Clinical Oncology Group
Collaborators
Ministry of Health, Labour and Welfare, Japan, Taiho Pharmaceutical Co., Ltd., Yakult Honsha Co., LTD

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
gastric cancer, 5-fluorouracil, irinotecan, cisplatin, S-1, advanced or recurrent gastric cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
690 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
continuous infusion of 5-fluorouracil
Intervention Type
Drug
Intervention Name(s)
combination of irinotecan and cisplatin
Intervention Type
Drug
Intervention Name(s)
oral administration of S-1
Primary Outcome Measure Information:
Title
overall survival
Secondary Outcome Measure Information:
Title
time to treatment failure
Title
incidences of adverse events
Title
response rate
Title
non-hospitalized survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atsushi Ohtsu, MD
Organizational Affiliation
National Cancer Centr Hospital East
Official's Role
Study Chair
Facility Information:
Facility Name
Aichi Cancer Center Hospital
City
Nagoya,Chikusa-ku,Kanokoden,1-1
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Nagoya Medical Center
City
Nagoya,Naka-ku,Sannomaru,4-1-1
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
Aichi Cancer Center,Aichi Hospital
City
Okazaki,Kake-machi,Kuriyado,18
State/Province
Aichi
ZIP/Postal Code
444-0011
Country
Japan
Facility Name
Aomori Prefectural Central Hospital
City
Higashitsukurimiti,2-1-1,Aomori
State/Province
Aomori
ZIP/Postal Code
030-0911
Country
Japan
Facility Name
Chiba Cancer Center Hospital
City
Chiba,Chuo-ku,Nitona-cho,666-2
State/Province
Chiba
ZIP/Postal Code
260-8717
Country
Japan
Facility Name
Asahi General Hospital
City
I-1326,Asahi
State/Province
Chiba
ZIP/Postal Code
289-2511
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Kashiwa,Kashiwanoha,6-5-1
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
National Hospital Organization Shikoku Cancer Center
City
Matsuyama,Horinouchi,13
State/Province
Ehime
ZIP/Postal Code
790-0007
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka,Higashi-ku,Maidashi,3-1-1
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
National Kyushu Cancer Center
City
Fukuoka,Minami-ku,Notame,3-1-1
State/Province
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Federation of national public service personnel mutual aid associations Tonan Hospital
City
kita 1 nishi 6,Chuo-ku,Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0001
Country
Japan
Facility Name
Hokkaido University Hospital
City
North-14 West-5 Kita-ku,Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Hyogo Medical Center for Adults
City
Akashi,Kitaouji-cho,13-70
State/Province
Hyogo
ZIP/Postal Code
673-8558
Country
Japan
Facility Name
Kobe University Graduate School of Medicine
City
Kobe,Chuo-ku,Kusunoki-cho,7-5-2
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Ibaraki Kenritsu Chuo Hospital & Cancer Center
City
Nishi-ibarakigun,Tomobemachi,Koibuchi,6528
State/Province
Ibaraki
ZIP/Postal Code
309-1793
Country
Japan
Facility Name
Iwate Prefectural Central Hospital
City
Morioka,Ueda,1-4-1
State/Province
Iwate
ZIP/Postal Code
020-0066
Country
Japan
Facility Name
Kitasato University East Hospital
City
Sagamihara,Asamizodai,2-1-1
State/Province
Kanagawa
ZIP/Postal Code
228-8520
Country
Japan
Facility Name
Kanagawa Cancer Center
City
Yokohama,Asahi-ku,Nakao,1-1-2
State/Province
Kanagawa
ZIP/Postal Code
241-0815
Country
Japan
Facility Name
Yokohama Mucipical Citizen's Hospital
City
Yokohama,Hodogaya-ku,Okazawa-cho,56
State/Province
Kanagawa
ZIP/Postal Code
240-8555
Country
Japan
Facility Name
Yokohama City University Medical Center
City
Yokohama,Minami-ku,Urafunecho,4-57
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Facility Name
Kochi Health Science Center
City
Kochi,Ike,2125-1
State/Province
Kochi
ZIP/Postal Code
781-8555
Country
Japan
Facility Name
Kumamoto Regional Medical Center Hospital
City
Kumamoto,Honjo,5-16-10
State/Province
Kumamoto
ZIP/Postal Code
860-0811
Country
Japan
Facility Name
Kyoto University Hospital
City
Kyoto,Sakyo-ku,Syogoinkawara,54
State/Province
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai,Aoba-ku,Seiryo-machi,1-1
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Saku Central Hospital
City
Saku,Usuda,197
State/Province
Nagano
ZIP/Postal Code
384-0301
Country
Japan
Facility Name
Osaka Medical College
City
Takatsuki,Daigakucho,2-7
State/Province
Osaka
ZIP/Postal Code
569-0801
Country
Japan
Facility Name
Saitama Medical School Hospital
City
Iruma-gun,Moroyama-machi,Morohongo,38
State/Province
Saitama
ZIP/Postal Code
350-0495
Country
Japan
Facility Name
Saitama Cancer Center
City
Kita-adachi,Ina,Komuro,818
State/Province
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
Div. of Gastrointestinal Oncology, Shizuoka Cancer Center
City
Sunto-gun, Nagaizumi-cho, Shimonagakubo,1007
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Tochigi Cancer Center
City
Utsunomiya,Yohnan,4-9-13
State/Province
Tochigi
ZIP/Postal Code
320-0834
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo-ku,Tsukiji,5-1-1
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Cancer Institute Hospital
City
Koto-ku,Ariake,3-10-6
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Showa University School of Medicine
City
Shinagawa-ku,Hatanodai,1-5-8
State/Province
Tokyo
ZIP/Postal Code
142-8666
Country
Japan
Facility Name
Yamagata Prefectural Central Hospital
City
Yamagata,Aoyagi,1800
State/Province
Yamagata
ZIP/Postal Code
990-2292
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
27843586
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.
Results Reference
derived
PubMed Identifier
24668328
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.
Results Reference
derived
PubMed Identifier
19818685
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.
Results Reference
derived
Links:
URL
http://www.jcog.jp/
Description
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A Study of 5-FUci Versus CPT-11 Plus CDDP Versus S-1 Alone in Advanced Gastric Cancer

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