Randomized phase II study of best available 5-FU versus low-dose Paclitaxiel in gastric cancer with peritoneal metastasis refractory to 5-FU containing regimen(JCOG0407)

UMIN ID: C000000138

Registered date:08/09/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: gastric neoplasm
• Date of first enrollment: 2005/09/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

A: Best available 5-FU In the best available 5-FU arm, 5-FU continuous infusion (5-FUci) regimen or sequential methotrexate (MTX) and 5-fluorouracil (MTX/5-FU) regimen is selected according to patients' prior chemotherapy: If the prior chemotherapy included 5-FU bolus infusion or MTX, 5-FUci regimen will be selected. The other cases select MTX/5-FU regimen. The 5-FUci regimen consists of 5-FUci (800 mg/m2/day, days 1 through 5), every 4 weeks. The MTX/5-FU regimen consists of MTX bolus infusion (100 mg/m2/day, day 1), 5-FU bolus infusion (600 mg/m2/day, day 1) after MTX, and l-leucovorin administration by oral or infusion (10 mg/m2/6 hour, days 2 through 3), which are repeated weekly.
B: Low dose paclitaxel The low-dose paclitaxel regimen consists of 1-hour paclitaxel infusion (80 mg/m2/day, days 1, 8, and 15) every 4 weeks.

Outcome(s)

• Primary Outcome: overall survival
• Secondary Outcome: adverse events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: (1) diabetes mellitus, uncontrolled or controlled with insulin (2) unstable angina, or myocardial infarction within 6 months prior to the study (3) arrhythmia, needing medical intervention (4) hypersensitivity to alcohol (5) HBs antigen or their HCV antibody are positive (6) massive pleural effusion (7) Grade 3-4 diarrhea (CTCAE ver3.0) (8) synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ (9) pregnant or lactating women (10) severe mental disease (11) not appropriate for the trial at the physician's assessment

Related Information

• Primary Sponsor: Japan Clinical Oncology Group(JCOG)
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare