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

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

Summary

To develop effective chemotherapy regimen against gastric cancer with peritoneal metastasis

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Japan Clinical Oncology Group
• Collaborator: Ministry of Health, Labour and Welfare, Japan
• Treatments: Fluorouracil

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