Non-resectable colorectal liver metastases (KRAS mutant type)
Conditions
Interventions
Induction chemotherapy (mFOLFOX6 + bevacizumab) 4-12 courses plus additional mFOLFOX6 1 course, followed by surgery, followed by post-operative chemotherapy (mFOLFOX6 + bevacizumab) 0-7 courses. *(In
Sponsors
Hepato-biliary-pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients with histologically proven colorectal cancer (2) No prior local therapy for liver metastases and presence of measurable lesion in the liver (RECIST Ver.1.1) (3) A) Non-resectable or more than 5 liver limited metastases B) Non-resectable or more than 5 liver metastases with resectable extrahepatic metastases (except for peritoneal dissemination) C) Initial or recurrent liver metastases are permitted if liver metastases are metachronous (4) Resectable primary lesion and extrahepatic metastases except as noted below; A) Primary lesion : Patients with imminent risk of obstruction or significant bleeding B) Extrahepatic metastases : Patients with peritoneal dissemination (5) Metastatic colorectal cancer with KRAS mutant type (6) Age over 20 years (7) ECOG Performance Status(PS): 0-1 (8) No prior chemotherapy for colorectal cancer (9) Patients have enough organ function for study treatment - neutrophil count: >=1,500/mm3 - platelet: >=100,000/mm3 - serum bilirubib level: <=1.5mg/dL - serum creatinine level: <=1.5mg/dL - AST: <=100IU/L - ALT: <=100IU/L - albumin: >=3.0g/dL - Urinary protein: 1+<= - PT(INR): <1.5 (10)Life expectancy of more than 3 months (11)Written informed consent
Exclusion criteria
Exclusion criteria: (1) Prior local therapy for liver metastases (2) Severe comorbidity (3) A past history of drug allergy (needs continuation therapy) (4) A past history of Interstitial lung disease (5) A past history of hemoptysis (6) Patients who has not recovered from previous cancer treatment to less than Grade 1 toxicity (7) Fully recovered from surgical treatment within 4 weeks before registration (8) Received widespread radiation therapy within 6 weeks before registration (9) Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval (10) Severe infectious disease (11) Pleural effusion, ascites fluid and the pericardial fluid needing treatment (12) Watery diarrhea (watery colostomy output without trouble during patient's daily living is allowed) (13) Chronic systemic treatment of corticosteroid (14) Bleeding tendency, coagulation disorder, abnormality of coagulation factor, or administered anticoagulant (15) HBsAg positive, HCV-Ab positive or HIV positive (16) Women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test (17) Psychological disorder (18) Considered not appropriate for surgery (19) Patients who are judged inappropriate for the entry into the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver metastases R0 resection rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety(AE), All R0 resection rate, Liver metastases R0+R1 resection rate, Central review of resectability, Tumor reduction rate, Response rate, Disease-free survival, Progression-free survival, Overall Survival, Histopathologic assessment | — |
Countries
Japan
Contacts
Public ContactKiyoshi Hasegawa, Masaru Oba
The University of Tokyo Hepato-biliary-pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine
Outcome results
None listed