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

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

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

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:

  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

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
overall survival

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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.

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

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.

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