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)
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
overall survival
Kuniaki Shirao, MD,PhD
Study Chair
Gatrointestinal Oncology Division, National Cancer Center Hospital
Japan: Ministry of Health, Labor and Welfare
JCOG0106-MF
NCT00149201
November 2002
April 2008
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