Phase II study of cetuximab with mFOLFOX6 therapy in patients with KRAS wild-type advanced colorectal cancer which has unresectable liver metastases
- Conditions
- colorectal cancer
- Registration Number
- JPRN-UMIN000008473
- Lead Sponsor
- Yokohama City University Hospital Clinical Oncology division
- Brief Summary
early termination of clinical trial because of less saple size
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 7
Not provided
1)Severe drug allergy 2)Metastatic focus out of the liver 3)Active double cancer 4)Active infection 5)Intestinal paralysis, intestinal obstruction 6)Severe complications (interstitial pneumonia or pulmonary fibrosis, heart failure, kidney failure, liver failure, it is difficult to control hypertention, diabetes etc.) 7)Pleural effusion, ascites 8)Diarrhea (watery stool) 9)Brain metastases 10)Pregnant and lacting women 11)A bleeding tendency, coagulation disorder or the case with the abnormal clotting factor 12)Mental disorder 13)Patients who receive steroid continuously are excluded 14)Patients who have past histories of cerebral infarction, cardiac infarction and / or pulmonary infarction are excluded 15)History of the organ transplantation to need an immunosuppressive drug 16)The patient that a study responsibility physician judged to be inappropriat
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate
- Secondary Outcome Measures
Name Time Method Safety Resection rate of liver metastatis resion R0 liver resection rate Relapse-free survival Overall survival Treatment completion rate