Pre-operative chemotherapy with FOLFOX4 in potentially resectable liver metastases from colorectal origin. Pilot phase II study

UMIN ID: UMIN000000740

Registered date:22/06/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: patients with liver metastasis from colon cancer
• Date of first enrollment: 2004/10/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Registration – (2 weeks) - FOLFOX4 4 courses – (4-7 weeks) - Surgical operation FOLFOX4 Day 1 1. L-OHP 85mg/m2 is diluted by 250 ml of 5%glucose (A) 2. l-LV 100mg/m2 is diluted by 250 ml of 5% glucose (B) 3. A and B is mixed by connecting Y tube and infused by 2 hours. 4. 5-FU 400mg/m2 is infused by 15 minutes. 5. 5-Fu 600 mg/m2 is infused by 2 hours. Day 2 1. l-LV 100mg/m2 is infused by 2 hours. 2. 5-FU 400mg/m2 is infused by 15 minutes. 3. 5-Fu 600 mg/m2 is infused by 2 hours.

Outcome(s)

• Primary Outcome: Resection rate on the liver
• Secondary Outcome: Rate of completion on preoperative chemotherapy Adverse events Response rate Time to progression

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1. cavity fluid which should be taken out 2. with double cancer and/or multiple cancer which excludes carcinoma in situ 3. with peripheral nerve disorder 4. with infectious disease 5. under the condition of diarrhea (watery diarrhea) 6. with psychological disorder which disturb the entry to the study 7. under continuous steroids therapy 8. with other severe diseases (pulmonary fibrosis, cardiac failure, liver dysfunction, renal dysfunction, intestinal paralysis/obstruction or uncontrolled DM) 9. pregnant and/or nursing women 10. with allergic history against medicines 11. doctors' stop not to register to the study

Related Information

• Primary Sponsor: OGSG
• Source(s) of Monetary Support: NPO Osaka Chinical Study Supporting Organization