Multicenter Phase II Study of FOLFIRI and biweekly Cetuximab combination chemotherapy as First Line Therapy in Patients with Wild Type KRAS Metastatic Colorectal Cancer. ( FIRBIC )
- Conditions
- Colorectal Cancer
- Registration Number
- JPRN-UMIN000006819
- Lead Sponsor
- Kanagawa Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 45
Not provided
(1)Severe bone marrow suppression (2)History of severe allergy (3) Active infection (include type B , C a hepatitis carrier) (4)Wattery diarrhea (5)Paralytic or mechanical bowel obstruction (6)Massive pleural effusion or ascites (7)Severe heart failure (8) Uncontrolled DM (9)Comorbidity or history of interstitial lung disease or pulmonary fibrosis (10)Jaundice (11) Multiple bone metastasis (12)Simultaneous or metachronous double cancers (Carcinoma in situ is eligible). (13)Patients who is receiving Atazanavir Sulfate (14) Mental disorder, central nervous system disorder or severe cerebrovasculara disease (15) Radiotherapy to target lesion (Adjuvant radiation therapy before and after the curative resection ) (16) Pregnant or lactating women or women of childbearing potential or men who are planning family (17)Severe complications (18)Symptomatic brain metastasis (19) Active bleeding or blood transfusion within two weeks. (20) Not appropriate for the study at the physician's assessment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate
- Secondary Outcome Measures
Name Time Method Progression-free survival, Overall survival, According to part response rate, Disease control rate, Safety profile, R0 resection rate, waterfall plot analysis, Cumulative response rate (30%), Effective reduction ratio (ROC), Cytoreductive ratio and duration for the liver