on-resectable colorectal liver metastases of KRAS mutant type treated with oxaliplatin, fluorouracil and l-leucovorin plus bevacizumab induction toward liver R0 resection trial
- Conditions
- on-resectable colorectal liver metastases (KRAS mutant type)
- Registration Number
- JPRN-UMIN000009530
- Lead Sponsor
- Hepato-biliary-pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Not provided
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method iver metastases R0 resection rate
- Secondary Outcome Measures
Name Time Method 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