Patients with liver-only metastases from colorectal cancer
Conditions
Interventions
L-OHP 130mg/m2 i.v. (day1) Cmab 250mg/m2 i.v. (only the first time Cmab 400mg/m2) S-1 80mg/m2 (day1-14) to be repeated every 3 weeks for 4 cycles. Surgery was planned after SOX+Cetuximab the
Sponsors
Kyushu Study group of Clinical Cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Written informed consent 2.Appropriate for the study at the physician's assessment 3.Histopathology confirmed colorectal cancer. 4.KRAS wild-type. 5.With measurable lesions in the liver only. 6.degree of liver metastases: H2, H3 7.No prior therapy 8.ECOG performance status of 0-1. 9.Aged 20<= years. 10.considered to survive for more than 3 months. 11Required baseline laboratory parameters (within 14 days before registration): WBC >= 3000 ,<12000/mm3 Neu >= 1,500/ mm3 Plt >= 100,000/ mm3 Hb >= 9.0g/dl T-Bil <= 2.0mg/dl AST,ALT<= 200U/L Cre <1.5mg/dl Ccr >= 50mL/min 12.be able to take oral drugs
Exclusion criteria
Exclusion criteria: 1.Prior liver or pulmonary resection. 2.Administering antithrombotic drug within 7 days. 3.History of serious drug hypersensitivity or a history of drug allergy 4.Peripheral neuropathy 5.Active other malignancies. 6.Active infection. 7.Serious complications (renal failure or hepatic failure) 8.High blood pressure and diabetic and hypercalcemia that cannot be controlled 9.symptomatic or asymptomatic but treated heart disease 10.interstitial pnumonitis, pulmonary fibrosis or high-grade pulmonary emphysema 11.histry of mental disturbances, central nervous system disorder or cerebrovascular attack 12.Fresh hemorrhage from digestive tube, intestines tube paralysis, intestinal obstruction and peptic ulcer 13.Pleural effusion peritoneal fluid and pericardial fluid 14.Symptomatic brain metastasis 15.Watery stools or diarrhea 16.under continuous steroid therapy 17.Requiring flucytosine, phenytoin, Warfarin Potassium. 18.Infection with hepatitis B or C virus 19.Pregnant or lactating woman 20.No birth-control 21.Not appropriate for the study at the physician's assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver resection rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver resection rate in patients with H2 metastases Liver resection rate in patients with H3 metastases Progression Free Survival Overall Survival Response rate Safety R0 resection rate Response rate in liver metastases Pathological response rate | — |
Countries
Japan
Contacts
Public ContactKSCC
Clinical Research Support Center Kyushu KSCC
Outcome results
None listed