liver metastases from colorectal cancer
Conditions
Interventions
mFOLFOX6Cetuximab Neoadjuvant 6course Adjuvant 6course Cetuximab loading dose 400mg/m2 weekly 250mg/m2/week LOHP 85mg/m2/day1 lLV 200mg/m2/day1 bolus 5FU 400mg/m2/da
Sponsors
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) histhopathological proven adenocarcinoma of colorectal cancer 2) liver metastases without extra hepatic metastases excep hilar LNs 3) marginal resectable defined following criteria (i)maximum diameter >5cm (ii)the number of liver metastases >4 (iii)primally N factor >N3 (iv)major vesseles invasion 4) No prior chemotherapy except adjuvant chemotherapy before more than 6 months 5) no prior treatment for liver metastases within 28 days of registration 6) 20 years old or older 7)ECOG Performance Status <2 8) adequate organ function following (i)WBC=or>3,000/mm3 (ii)ANC=or>1,500/mm3 (iii)Plt=or>100,000/mm3 (iv)Hb=or>9.0g/dl (v)AST (GOT), ALT (GPT)<5 times ULN (vi)T-bil<1.5times ULN (vii)Cre<ULN 9) measurable lesion in RECIST criteria 10) KRAS wild type 11) written IC form
Exclusion criteria
Exclusion criteria: 1) No severe heart disease 2) No past history of AMI within 6 months 3) Not pregnant 4) Uncontrolled infectious disease 5) No systemic steroids or immunosupressant 6) No severe drug allergy 7) No psychological, familial, social, or geographical condition that would preclude study compliance 8) No symptomatic effusion collection 9) No severe peripheral neuropathy 10) No watery diarrhea 11) No other significant disease that would preclude study participationr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate, safety, DFS, OS | — |
Countries
Japan
Contacts
Public ContactEiji Shinozaki
Cancer Institute Hospital of Japanese Foundation for Cancer Research Dept. of Medical Oncology
Outcome results
None listed