A Study of 5-FU Versus MTX+5-FU in Gastric Cancer With Peritoneal Metastasis

February 2, 2009 updated by: Japan Clinical Oncology Group

Randomized Phase III Study of 5-FU Continuous Infusion (5FUci) Versus MTX+5-FU Sequential Therapy (MF) in Gastric Cancer With Peritoneal Metastasis (JCOG0106-MF, MF/5FU)

To develop effective chemotherapy regimen against gastric cancer with peritoneal metastasis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Peritoneal metastasis is common in advanced gastric cancer and is considered an incurable disease state. Peritoneal metastasis may cause serious complications, such as intestinal obstruction, massive ascites, and hydronephrosis associated with the clinical presentation of abdominal pain and fullness, vomiting, constipation, malnutrition and renal dysfunction.5-FU continuous infusion remains the mainstay for chemotherapy against gastric cancer. On the other, sequential MTX+5-FU was reported to be effective in advanced gastric cancer with peritoneal metastasis in some phase II studies. Therefore, the randomized phase III study of 5-FU versus sequential MTX+5-FU in gastric cancer with peritoneal metastasis was conducted.

Study Type

Interventional

Enrollment

160

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

  • Japan
    • Aichi
      • 1-1,Kanokoden,Chikusa-ku,Nagoya, Aichi, Japan, 464-8681
        • Aichi Cancer Center Hospital
      • 18,Kuriyado,Kake-machi,Okazaki, Aichi, Japan, 444-0011
        • Aichi Cancer Center,Aichi Hospital
      • 4-1-1,Sannomaru,Naka-ku,Nagoya, Aichi, Japan, 460-0001
        • Nagoya Medical Center
    • Aomori
      • 2-1-1,Higashitsukurimiti,Aomori, Aomori, Japan, 030-0911
        • Aomori Prefectural Central Hospital
    • Chiba
      • 6-5-1,Kashiwanoha,Kashiwa, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East
      • 666-2,Nitona-cho,Chuo-ku,Chiba, Chiba, Japan, 260-8717
        • Chiba Cancer Center Hospital
      • I-1326,Asahi, Chiba, Japan, 289-2511
        • Asahi General Hospital
    • Ehime
      • 13,Horinouchi,Matsuyama, Ehime, Japan, 790-0007
        • National Hospital Organization Shikoku Cancer Center
    • Fukuoka
      • 3-1-1,Maidashi,Higashi-ku, Fukuoka, Japan, 812-8582
        • Kyushu University Hospital
      • 3-1-1,Notame,Minami-ku,Fukuoka, 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
      • 13-70,Kitaouji-cho,Akashi, Hyogo, Japan, 673-8558
        • Hyogo Medical Center for Adults
      • 7-5-2,Kusunoki-cho,Chuo-ku,Kobe, Hyogo, Japan, 650-0017
        • Kobe University Graduate School of Medicine
    • Ibaraki
      • 6528,Koibuchi,Tomobemachi,Nishi-ibarakigun, Ibaraki, Japan, 309-1793
        • Ibaraki Kenritsu Chuo Hospital & Cancer Center
    • Iwate
      • 1-4-1,Ueda,Morioka, Iwate, Japan, 020-0066
        • Iwate Prefectural Central Hospital
    • Kanagawa
      • 1-1-2,Nakao,Asahi-ku,Yokohama, Kanagawa, Japan, 241-0815
        • Kanagawa Cancer Center
      • 2-1-1,Asamizodai,Sagamihara, Kanagawa, Japan, 228-8520
        • Kitasato University East Hospital
      • 4-57,Urafunecho,Minami-ku,Yokohama, Kanagawa, Japan, 232-0024
        • Yokohama City University Medical Center
      • 56,Okazawa-cho,Hodogaya-ku,Yokohama, Kanagawa, Japan, 240-8555
        • Yokohama Mucipical Citizen's Hospital
    • Kochi
      • 2125-1,Ike,Kochi, Kochi, Japan, 781-8555
        • Kochi Health Science Center
    • Kumamoto
      • 5-16-10,Honjo,Kumamoto, Kumamoto, Japan, 860-0811
        • Kumamoto Regional Medical Center Hospital
    • Kyoto
      • 54,Syogoinkawara,Sakyo-ku,Kyoto, Kyoto, Japan, 606-8507
        • Kyoto University Hospital
    • Miyagi
      • 1-1,Seiryo-machi,Aoba-ku,Sendai, Miyagi, Japan, 980-0874
        • Tohoku University Hospital
    • Nagano
      • 197,Usuda,Saku, Nagano, Japan, 384-0301
        • Saku Central Hospital
    • Osaka
      • 2-7,Daigakucho,Takatsuki, Osaka, Japan, 569-0801
        • Osaka Medical College
    • Saitama
      • 38,Morohongo,Moroyama-machi,Iruma-gun, Saitama, Japan, 350-0495
        • Saitama Medical School Hospital
      • 818,Komuro,Ina,Kita-adachi, Saitama, Japan, 362-0806
        • Saitama Cancer Center
    • Shizuoka
      • 1007,Shimonagakubo,Nagaizumi-cho,Sunto-gun, Shizuoka, Japan, 411-8777
        • Sizuoka Cancer Center
    • Tochigi
      • 4-9-13,Yohnan,Utsunomiya, Tochigi, Japan, 320-0834
        • Tochigi Cancer Center
    • Tokyo
      • 1-5-8,Hatanodai,Shinagawa-ku, Tokyo, Japan, 142-8666
        • Showa University School of Medicine
      • 3-10-6,Ariake,Koto-ku, Tokyo, Japan, 135-8550
        • Cancer Institute Hospital
      • 5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital
    • Yamagata
      • 1800,Aoyagi,Yamagata, 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. histologic confirmation of gastric adenocarcinoma
  2. inoperable metastatic disease or recurrent metastatic disease after surgery
  3. disease with peritoneal metastasis
  4. 20 years or more but less than 75 years
  5. performance status 2 or less on the Eastern Cooperative Oncology Group scale
  6. no prior treatment for gastric carcinoma except for surgery and adjuvant chemotherapy
  7. no prior chemotherapy or radiotherapy for other disease except for gastric cancer
  8. adequate bone marrow function, adequate liver function, and adequate renal function
  9. no prior transfusion for anemia
  10. provision of written informed consent

Exclusion Criteria:

  1. Massive pleural effusion
  2. brain metastasis with symptoms
  3. severe diarrhea
  4. other severe medical conditions (infection, diabetes, hypertension, acute myocardial infarction, unstable angina, liver cirrhosis, intestinal pneumonia, pulmonary fibrosis)
  5. other active malignancies

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
toxicity
oral intake

Collaborators and Investigators

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

Sponsor

Japan Clinical Oncology Group

Collaborators

Ministry of Health, Labour and Welfare, Japan

Investigators

  • Study Chair: Kuniaki Shirao, MD,PhD, Gatrointestinal Oncology Division, National Cancer Center Hospital

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, 2002

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimate)

September 8, 2005

Study Record Updates

Last Update Posted (Estimate)

February 3, 2009

Last Update Submitted That Met QC Criteria

February 2, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JCOG0106-MF
  • C000000123

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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