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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
overall survival

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
toxicity
oral intake

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Japan Clinical Oncology Group

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministry of Health, Labour and Welfare, Japan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2002

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 7, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2005

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 3, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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