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

NCT ID: NCT00149201

Last Updated: 2009-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-11-30
• Study Completion Date: 2008-04-30

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.

Conditions

Gastric Cancer; Neoplasm Metastasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

5-FU continuous infusion

Intervention Type: DRUG

MTX + 5-FU sequential therapy

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Labour and Welfare, Japan

OTHER_GOV

Sponsor Role: collaborator

Japan Clinical Oncology Group

OTHER

Sponsor Role: lead

Responsible Party

Japan Clinical Oncology Group

Principal Investigators

Kuniaki Shirao, MD,PhD

Role: STUDY_CHAIR

Gatrointestinal Oncology Division, National Cancer Center Hospital

Locations

Aichi Cancer Center Hospital

1-1,Kanokoden,Chikusa-ku,Nagoya, Aichi-ken, Japan

Aichi Cancer Center,Aichi Hospital

18,Kuriyado,Kake-machi,Okazaki, Aichi-ken, Japan

Nagoya Medical Center

4-1-1,Sannomaru,Naka-ku,Nagoya, Aichi-ken, Japan

Aomori Prefectural Central Hospital

2-1-1,Higashitsukurimiti,Aomori, Aomori, Japan

National Cancer Center Hospital East

6-5-1,Kashiwanoha,Kashiwa, Chiba, Japan

Chiba Cancer Center Hospital

666-2,Nitona-cho,Chuo-ku,Chiba, Chiba, Japan

Asahi General Hospital

I-1326,Asahi, Chiba, Japan

National Hospital Organization Shikoku Cancer Center

13,Horinouchi,Matsuyama, Ehime, Japan

Kyushu University Hospital

3-1-1,Maidashi,Higashi-ku, Fukuoka, Japan

National Kyushu Cancer Center

3-1-1,Notame,Minami-ku,Fukuoka, Fukuoka, Japan

Federation of national public service personnel mutual aid associations Tonan Hospital

Kita 1 Nishi 6,Chuo-ku,Sapporo, Hokkaido, Japan

Hokkaido University Hospital

North-14 West-5 Kita-ku,Sapporo, Hokkaido, Japan

Hyogo Medical Center for Adults

13-70,Kitaouji-cho,Akashi, Hyōgo, Japan

Kobe University Graduate School of Medicine

7-5-2,Kusunoki-cho,Chuo-ku,Kobe, Hyōgo, Japan

Ibaraki Kenritsu Chuo Hospital & Cancer Center

6528,Koibuchi,Tomobemachi,Nishi-ibarakigun, Ibaraki, Japan

Iwate Prefectural Central Hospital

1-4-1,Ueda,Morioka, Iwate, Japan

Kanagawa Cancer Center

1-1-2,Nakao,Asahi-ku,Yokohama, Kanagawa, Japan

Kitasato University East Hospital

2-1-1,Asamizodai,Sagamihara, Kanagawa, Japan

Yokohama City University Medical Center

4-57,Urafunecho,Minami-ku,Yokohama, Kanagawa, Japan

Yokohama Mucipical Citizen's Hospital

56,Okazawa-cho,Hodogaya-ku,Yokohama, Kanagawa, Japan

Kochi Health Science Center

2125-1,Ike,Kochi, Kochi, Japan

Kumamoto Regional Medical Center Hospital

5-16-10,Honjo,Kumamoto, Kumamoto, 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

Osaka Medical College

2-7,Daigakucho,Takatsuki, Osaka, Japan

Saitama Medical School Hospital

38,Morohongo,Moroyama-machi,Iruma-gun, Saitama, Japan

Saitama Cancer Center

818,Komuro,Ina,Kita-adachi, Saitama, Japan

Sizuoka Cancer Center

1007,Shimonagakubo,Nagaizumi-cho,Sunto-gun, Shizuoka, Japan

Tochigi Cancer Center

4-9-13,Yohnan,Utsunomiya, Tochigi, Japan

Showa University School of Medicine

1-5-8,Hatanodai,Shinagawa-ku, Tokyo, Japan

Cancer Institute Hospital

3-10-6,Ariake,Koto-ku, Tokyo, Japan

National Cancer Center Hospital

5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan

Yamagata Prefectural Central Hospital

1800,Aoyagi,Yamagata, Yamagata, Japan

Countries

Japan

Related Links

http://www.jcog.jp/

Related Info

Other Identifiers

C000000123

Identifier Type: -

Identifier Source: secondary_id

JCOG0106-MF

Identifier Type: -

Identifier Source: org_study_id