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

Phase 3

Completed

• Conditions: Gastric Cancer; Neoplasm Metastasis

• Registration Number: NCT00149201
• Lead Sponsor: Japan Clinical Oncology Group

Brief Summary

To develop effective chemotherapy regimen against gastric cancer with peritoneal metastasis

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 Timeline

• Study Start: 2002-11
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-08
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-02
• Last Update Posted: 2009-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
overall survival

Secondary Outcome Measures

Name	Time	Method
oral intake
toxicity

Trial Locations

Locations (34)

National Cancer Center Hospital East; 🇯🇵 6-5-1,Kashiwanoha,Kashiwa, Chiba, Japan

Kyushu University Hospital; 🇯🇵 3-1-1,Maidashi,Higashi-ku, Fukuoka, Japan

Nagoya Medical Center; 🇯🇵 4-1-1,Sannomaru,Naka-ku,Nagoya, Aichi, Japan

Aomori Prefectural Central Hospital; 🇯🇵 2-1-1,Higashitsukurimiti,Aomori, Aomori, Japan

Sizuoka Cancer Center; 🇯🇵 1007,Shimonagakubo,Nagaizumi-cho,Sunto-gun, Shizuoka, Japan

Yamagata Prefectural Central Hospital; 🇯🇵 1800,Aoyagi,Yamagata, Yamagata, Japan

Aichi Cancer Center Hospital; 🇯🇵 1-1,Kanokoden,Chikusa-ku,Nagoya, Aichi, Japan

Kobe University Graduate School of Medicine; 🇯🇵 7-5-2,Kusunoki-cho,Chuo-ku,Kobe, Hyogo, Japan

Cancer Institute Hospital; 🇯🇵 3-10-6,Ariake,Koto-ku, Tokyo, Japan

National Hospital Organization Shikoku Cancer Center; 🇯🇵 13,Horinouchi,Matsuyama, Ehime, Japan

National Kyushu Cancer Center; 🇯🇵 3-1-1,Notame,Minami-ku,Fukuoka, Fukuoka, Japan

Osaka Medical College; 🇯🇵 2-7,Daigakucho,Takatsuki, Osaka, Japan

Tochigi Cancer Center; 🇯🇵 4-9-13,Yohnan,Utsunomiya, Tochigi, Japan

Showa University School of Medicine; 🇯🇵 1-5-8,Hatanodai,Shinagawa-ku, Tokyo, Japan

Chiba Cancer Center Hospital; 🇯🇵 666-2,Nitona-cho,Chuo-ku,Chiba, Chiba, Japan

Asahi General Hospital; 🇯🇵 I-1326,Asahi, Chiba, Japan

Federation of national public service personnel mutual aid associations Tonan Hospital; 🇯🇵 kita 1 nishi 6,Chuo-ku,Sapporo, Hokkaido, Japan

Iwate Prefectural Central Hospital; 🇯🇵 1-4-1,Ueda,Morioka, Iwate, Japan

Kitasato University East Hospital; 🇯🇵 2-1-1,Asamizodai,Sagamihara, Kanagawa, Japan

Kochi Health Science Center; 🇯🇵 2125-1,Ike,Kochi, Kochi, Japan

Aichi Cancer Center,Aichi Hospital; 🇯🇵 18,Kuriyado,Kake-machi,Okazaki, Aichi, Japan

Hokkaido University Hospital; 🇯🇵 North-14 West-5 Kita-ku,Sapporo, Hokkaido, Japan

Hyogo Medical Center for Adults; 🇯🇵 13-70,Kitaouji-cho,Akashi, Hyogo, Japan

Yokohama City University Medical Center; 🇯🇵 4-57,Urafunecho,Minami-ku,Yokohama, Kanagawa, Japan

Kumamoto Regional Medical Center Hospital; 🇯🇵 5-16-10,Honjo,Kumamoto, Kumamoto, Japan

Saitama Medical School Hospital; 🇯🇵 38,Morohongo,Moroyama-machi,Iruma-gun, Saitama, Japan

Ibaraki Kenritsu Chuo Hospital & Cancer Center; 🇯🇵 6528,Koibuchi,Tomobemachi,Nishi-ibarakigun, Ibaraki, Japan

Saitama Cancer Center; 🇯🇵 818,Komuro,Ina,Kita-adachi, Saitama, Japan

Kanagawa Cancer Center; 🇯🇵 1-1-2,Nakao,Asahi-ku,Yokohama, Kanagawa, Japan

Yokohama Mucipical Citizen's Hospital; 🇯🇵 56,Okazawa-cho,Hodogaya-ku,Yokohama, Kanagawa, Japan

Kyoto University Hospital; 🇯🇵 54,Syogoinkawara,Sakyo-ku,Kyoto, Kyoto, Japan

Tohoku University Hospital; 🇯🇵 1-1,Seiryo-machi,Aoba-ku,Sendai, Miyagi, Japan

Saku Central Hospital; 🇯🇵 197,Usuda,Saku, Nagano, Japan

National Cancer Center Hospital; 🇯🇵 5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan