Resectable colorectal liver metastases
Conditions
Interventions
Neoadjuvant chemotherapy with SOX plus Bevacizumab followed by surgery
Sponsors
Nagoya Surgical Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histopathologically confirmed adenocarcinoma of colorectal cancer 2)Resectable liver metastases from colorectal cancer except extrahepatic metastases 3)Age:20-79 years at registration 4)Confirmed liver metastases by chest,abdominal and pelvic CT and EOB-MRI, and no extrahepatic metastases 5)Performance status(PS)0-1 6)Without prior chemotherapy (including hepatic artery infusion) or RFA for liver metastases 7)Oral intake is possible 8)Adequate organ function (within 14 days before chemotherapy): 9)Alife expectancy greater than 3 months 10)Written informed consent
Exclusion criteria
Exclusion criteria: 1) Active double cancer 2) Active infection 3) Fever of >= 38 degrees Celsius 4) Pregnant or nursing females. Males who are planning partners' pregnancy. 5)Severe mental disorder 6)Systemic administration of corticosteroids 7)Serious complications 8)Abnormal in electrocardiogram within 28 days before chemotherapy or clinically significant heart disease 9)Neuropathy 10)Uncontrolled diarrhea 11)Massive pleural or abdominal effusion 12)Brain metastases 13)History of thromboembolism, cerebral infarction, pulmonary infraction or interstitial pneumonia 14)Surgery within 28 days before chemotherapy 15)History of hypersensitivity for Oxaliplatin 16)History of hypersensitivity for TS-1 17)History of hypersensitivity for Bevacizumab 18)Under treatment with fluoropyrimidine except TS-1 19)Under treatment with flucytosine 20)Pretreatment with TS-1, Oxaliplatin or Bevacizumab 21)High grade stenosis at the primary tumor 22)Massive peritoneum dissemination 23)Bleeding (Congenital hemorrhagic disease) or coagulation disorder 24)Under treatment with anticoagulant 25)History of gastrointestinal perforation within 6 months before registration 26)History of hemoptysis 27)Not suitable for participation with any other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS, Responce rate, adverse event rate, Relative dose intensity (RDI) | — |
Countries
Japan
Contacts
Public ContactKeisuke Uehara
Nagoya University Graduated School of Medicine Division of Surgical Oncology
Outcome results
None listed