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

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: NCT00149201
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : February 3, 2009
Ministry of Health, Labour and Welfare, Japan
Information provided by:
Japan Clinical Oncology Group

Brief Summary:
To develop effective chemotherapy regimen against gastric cancer with peritoneal metastasis

Condition or disease Intervention/treatment Phase
Gastric Cancer Neoplasm Metastasis Drug: 5-FU continuous infusion Drug: MTX + 5-FU sequential therapy Phase 3

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  (Clinical Trial)
Enrollment : 160 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 (5FUci) Versus MTX+5-FU Sequential Therapy (MF) in Gastric Cancer With Peritoneal Metastasis (JCOG0106-MF, MF/5FU)
Study Start Date : November 2002
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. overall survival

Secondary Outcome Measures :
  1. oral intake
  2. toxicity

Information from the National Library of Medicine

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

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

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): NCT00149201

Aichi Cancer Center Hospital
1-1,Kanokoden,Chikusa-ku,Nagoya, Aichi, Japan, 464-8681
Aichi Cancer Center,Aichi Hospital
18,Kuriyado,Kake-machi,Okazaki, Aichi, Japan, 444-0011
Nagoya Medical Center
4-1-1,Sannomaru,Naka-ku,Nagoya, Aichi, Japan, 460-0001
Aomori Prefectural Central Hospital
2-1-1,Higashitsukurimiti,Aomori, Aomori, Japan, 030-0911
National Cancer Center Hospital East
6-5-1,Kashiwanoha,Kashiwa, Chiba, Japan, 277-8577
Chiba Cancer Center Hospital
666-2,Nitona-cho,Chuo-ku,Chiba, Chiba, Japan, 260-8717
Asahi General Hospital
I-1326,Asahi, Chiba, Japan, 289-2511
National Hospital Organization Shikoku Cancer Center
13,Horinouchi,Matsuyama, Ehime, Japan, 790-0007
Kyushu University Hospital
3-1-1,Maidashi,Higashi-ku, Fukuoka, Japan, 812-8582
National Kyushu Cancer Center
3-1-1,Notame,Minami-ku,Fukuoka, 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
13-70,Kitaouji-cho,Akashi, Hyogo, Japan, 673-8558
Kobe University Graduate School of Medicine
7-5-2,Kusunoki-cho,Chuo-ku,Kobe, Hyogo, Japan, 650-0017
Ibaraki Kenritsu Chuo Hospital & Cancer Center
6528,Koibuchi,Tomobemachi,Nishi-ibarakigun, Ibaraki, Japan, 309-1793
Iwate Prefectural Central Hospital
1-4-1,Ueda,Morioka, Iwate, Japan, 020-0066
Kanagawa Cancer Center
1-1-2,Nakao,Asahi-ku,Yokohama, Kanagawa, Japan, 241-0815
Kitasato University East Hospital
2-1-1,Asamizodai,Sagamihara, Kanagawa, Japan, 228-8520
Yokohama City University Medical Center
4-57,Urafunecho,Minami-ku,Yokohama, Kanagawa, Japan, 232-0024
Yokohama Mucipical Citizen's Hospital
56,Okazawa-cho,Hodogaya-ku,Yokohama, Kanagawa, Japan, 240-8555
Kochi Health Science Center
2125-1,Ike,Kochi, Kochi, Japan, 781-8555
Kumamoto Regional Medical Center Hospital
5-16-10,Honjo,Kumamoto, Kumamoto, Japan, 860-0811
Kyoto University Hospital
54,Syogoinkawara,Sakyo-ku,Kyoto, Kyoto, Japan, 606-8507
Tohoku University Hospital
1-1,Seiryo-machi,Aoba-ku,Sendai, Miyagi, Japan, 980-0874
Saku Central Hospital
197,Usuda,Saku, Nagano, Japan, 384-0301
Osaka Medical College
2-7,Daigakucho,Takatsuki, Osaka, Japan, 569-0801
Saitama Medical School Hospital
38,Morohongo,Moroyama-machi,Iruma-gun, Saitama, Japan, 350-0495
Saitama Cancer Center
818,Komuro,Ina,Kita-adachi, Saitama, Japan, 362-0806
Sizuoka Cancer Center
1007,Shimonagakubo,Nagaizumi-cho,Sunto-gun, Shizuoka, Japan, 411-8777
Tochigi Cancer Center
4-9-13,Yohnan,Utsunomiya, Tochigi, Japan, 320-0834
Showa University School of Medicine
1-5-8,Hatanodai,Shinagawa-ku, Tokyo, Japan, 142-8666
Cancer Institute Hospital
3-10-6,Ariake,Koto-ku, Tokyo, Japan, 135-8550
National Cancer Center Hospital
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan, 104-0045
Yamagata Prefectural Central Hospital
1800,Aoyagi,Yamagata, Yamagata, Japan, 990-2292
Sponsors and Collaborators
Japan Clinical Oncology Group
Ministry of Health, Labour and Welfare, Japan
Study Chair: Kuniaki Shirao, MD,PhD Gatrointestinal Oncology Division, National Cancer Center Hospital

Additional Information:
Responsible Party: Japan Clinical Oncology Group Identifier: NCT00149201     History of Changes
Other Study ID Numbers: JCOG0106-MF
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: February 3, 2009
Last Verified: February 2009

Keywords provided by Japan Clinical Oncology Group:
gastric cancer
peritoneal metastasis
randomized trial

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Stomach Neoplasms
Neoplastic Processes
Pathologic Processes
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs