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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00142350
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : September 12, 2016
Ministry of Health, Labour and Welfare, Japan
Taiho Pharmaceutical Co., Ltd.
Yakult Honsha Co., LTD
Information provided by:
Japan Clinical Oncology Group

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

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: continuous infusion of 5-fluorouracil Drug: combination of irinotecan and cisplatin Drug: oral administration of S-1 Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Enrollment : 690 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2000
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Primary Outcome Measures :
  1. overall survival

Secondary Outcome Measures :
  1. time to treatment failure
  2. incidences of adverse events
  3. response rate
  4. non-hospitalized survival

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00142350

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Aichi Cancer Center Hospital
Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi, Japan, 464-8681
Nagoya Medical Center
Nagoya,Naka-ku,Sannomaru,4-1-1, Aichi, Japan, 460-0001
Aichi Cancer Center,Aichi Hospital
Okazaki,Kake-machi,Kuriyado,18, Aichi, Japan, 444-0011
Aomori Prefectural Central Hospital
Higashitsukurimiti,2-1-1,Aomori, Aomori, Japan, 030-0911
Chiba Cancer Center Hospital
Chiba,Chuo-ku,Nitona-cho,666-2, Chiba, Japan, 260-8717
Asahi General Hospital
I-1326,Asahi, Chiba, Japan, 289-2511
National Cancer Center Hospital East
Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan, 277-8577
National Hospital Organization Shikoku Cancer Center
Matsuyama,Horinouchi,13, Ehime, Japan, 790-0007
Kyushu University Hospital
Fukuoka,Higashi-ku,Maidashi,3-1-1, Fukuoka, Japan, 812-8582
National Kyushu Cancer Center
Fukuoka,Minami-ku,Notame,3-1-1, Fukuoka, Japan, 811-1395
Federation of national public service personnel mutual aid associations Tonan Hospital
kita 1 nishi 6,Chuo-ku,Sapporo, Hokkaido, Japan, 060-0001
Hokkaido University Hospital
North-14 West-5 Kita-ku,Sapporo, Hokkaido, Japan, 060-8648
Hyogo Medical Center for Adults
Akashi,Kitaouji-cho,13-70, Hyogo, Japan, 673-8558
Kobe University Graduate School of Medicine
Kobe,Chuo-ku,Kusunoki-cho,7-5-2, Hyogo, Japan, 650-0017
Ibaraki Kenritsu Chuo Hospital & Cancer Center
Nishi-ibarakigun,Tomobemachi,Koibuchi,6528, Ibaraki, Japan, 309-1793
Iwate Prefectural Central Hospital
Morioka,Ueda,1-4-1, Iwate, Japan, 020-0066
Kitasato University East Hospital
Sagamihara,Asamizodai,2-1-1, Kanagawa, Japan, 228-8520
Kanagawa Cancer Center
Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, Japan, 241-0815
Yokohama Mucipical Citizen's Hospital
Yokohama,Hodogaya-ku,Okazawa-cho,56, Kanagawa, Japan, 240-8555
Yokohama City University Medical Center
Yokohama,Minami-ku,Urafunecho,4-57, Kanagawa, Japan, 232-0024
Kochi Health Science Center
Kochi,Ike,2125-1, Kochi, Japan, 781-8555
Kumamoto Regional Medical Center Hospital
Kumamoto,Honjo,5-16-10, Kumamoto, Japan, 860-0811
Kyoto University Hospital
Kyoto,Sakyo-ku,Syogoinkawara,54, Kyoto, Japan, 606-8507
Tohoku University Hospital
Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, Japan, 980-8574
Saku Central Hospital
Saku,Usuda,197, Nagano, Japan, 384-0301
Osaka Medical College
Takatsuki,Daigakucho,2-7, Osaka, Japan, 569-0801
Saitama Medical School Hospital
Iruma-gun,Moroyama-machi,Morohongo,38, Saitama, Japan, 350-0495
Saitama Cancer Center
Kita-adachi,Ina,Komuro,818, Saitama, Japan, 362-0806
Div. of Gastrointestinal Oncology, Shizuoka Cancer Center
Sunto-gun, Nagaizumi-cho, Shimonagakubo,1007, Shizuoka, Japan, 411-8777
Tochigi Cancer Center
Utsunomiya,Yohnan,4-9-13, Tochigi, Japan, 320-0834
National Cancer Center Hospital
Chuo-ku,Tsukiji,5-1-1, Tokyo, Japan, 104-0045
Cancer Institute Hospital
Koto-ku,Ariake,3-10-6, Tokyo, Japan, 135-8550
Showa University School of Medicine
Shinagawa-ku,Hatanodai,1-5-8, Tokyo, Japan, 142-8666
Yamagata Prefectural Central Hospital
Yamagata,Aoyagi,1800, Yamagata, Japan, 990-2292
Sponsors and Collaborators
Japan Clinical Oncology Group
Ministry of Health, Labour and Welfare, Japan
Taiho Pharmaceutical Co., Ltd.
Yakult Honsha Co., LTD
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Study Chair: Atsushi Ohtsu, MD National Cancer Centr Hospital East

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00142350     History of Changes
Other Study ID Numbers: JCOG9912
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: September 12, 2016
Last Verified: September 2016

Keywords provided by Japan Clinical Oncology Group:
gastric cancer
advanced or recurrent gastric cancer

Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs