NCT00149201

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

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (planned)
• Sponsor: Japan Clinical Oncology Group · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	5-FU continuous infusion
DRUG	MTX + 5-FU sequential therapy

Timeline

• Start date: 2002-11-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2005-09-08
• Last updated: 2009-02-03

Locations

34 sites across 1 country: Japan