patients with liver metastasis from colon cancer
Conditions
Interventions
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
Sponsors
OGSG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) colorectal cancer, cytologically and/or histologically (2) without prior L-OHP therapy or without any other prior chemotherapy within 8 weeks (3) with measurable lesions in the liver (4) resectable lesions in the liver (5) Expected function is enough on the remnant liver (6) Age: 20 years old =< and =>75 years old (7) Performance Status: 0-1 in ECOG criteria (8) Longer than 12 weeks of expected survival (9) sufficient function in the important organs WBC 4,000<= and =< 12,000 mm3/dl Neutrocyte >= 2,000/mm3 Platelet 100,000/mm3 <= Hemoglobin >= 8.0 g/dl Total bilirubin within 1.5 times of normal range of each institute AST, ALT within 2.5 times of normal range in each institute Serum creatinin within normal range of each institute %PT or HPT >= 70% ECG normal range 10) written informed consents
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Resection rate on the liver | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of completion on preoperative chemotherapy Adverse events Response rate Time to progression | — |
Countries
Japan
Contacts
Public ContactFurukawa Hiroshi
Sakai City Hospital Director
Outcome results
None listed