Resectable liver metastasis from colorectal cancer
Conditions
Interventions
A: Within 56 days after surgery, patients receive infusional oxaliplatin and oral capecitabine. Patients receive infusional bevacizumab as from second course. Treatment repeats every 21 days for 8 cou
Sponsors
Hiroshima Surgical study group of Clinical Oncology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed adenocarcinoma 2) Four or less liver metastasis or maximum size of 5cm or less 3) Liver metastasis curable within 60% liver resection 4) No extrahepatic disease 5) Primary colorectal lesion curable or after curative resection 6) No prior radiofrequency ablation or cryotherapy for liver metastasis 7) No prior chemotherapy or radiotherapy 8) Child-Pugh class A 9) No evident bleeding or obstruction due to colorectal cancer 10) Patient age is 20 or more and 80 or less. 11) PS: 0, 1 12) Organ function is kept 13) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Multiple cancer patients 2) Pregnant or lactating woman 3) Steroid administration 4) Patients must use flucytosine, phenytoin or warfarin potassium 5) Uncontrollable hypertension or diabetes mellitus 6) Diarrhea or peripheral neuropathy greater than grade 1 7) Portal vein embolization 8) Clinically significant pulmonary disease, coagulopathy or thrombosis. 9) Clinically significant gastrointestinal bleeding, obstruction or ulcer. 10) Clinically significant abdominal, pleural or pericardial effusion. 11) Presence of psychological or central nervous system disorder. 12) Major abdominal or thoracic surgery within 4 weeks. 13) Presence of non-healing bone fracture 14) Hepatitis B virus infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment compliance (phase II) Progression-free survival (phase III) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Time to treatment failure, Response rate, Mode of recurrence, Resection rate, Incidence of adverse events, Morbidity, Pathological liver injury | — |
Countries
Japan
Contacts
Public ContactTsuyoshi Kobayashi
Hiroshima University Hospital Gasroenterological Surgery
Outcome results
None listed