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
toxicity
oral intake

Trial Locations

Locations (34)

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

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

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

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Aichi Cancer Center Hospital

🇯🇵1-1,Kanokoden,Chikusa-ku,Nagoya, Aichi, Japan