Multicenter Phase II Study of FOLFOX/XELOX and Erbitux as First Line Therapy in Patients with Wild Type KRAS/BRAF Metastatic Colorectal Cancer.
- Conditions
- Colorectal Cancer
- Registration Number
- JPRN-UMIN000003253
- Lead Sponsor
- Epidemiological and Clinical research Information Network (ECRIN)
- Brief Summary
Results: The response rates in the FOLFOX + Cmab (n = 37) and XELOX + Cmab (n = 25) groups were 64.9 % (24/37) and 72.0 % (18/25), respectively. The median PFS in the FOLFOX + Cmab and XELOX + Cmab groups was 13.1 months (95 % confidence interval [CI] 12.1-17.5) and 13.4 months (95 % CI 10.1-17.9), respectively. Neutropenia was the most frequent grade 3/4 adverse event in both groups (33.9 %), followed by anorexia, acneiform eruption, skin fissure and paronychia. A waterfall plot of tumor diameter showed prominent shrinkage of the tumors in 88.7 % of patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 57
Not provided
(1)Severe bone marrow suppression (2)Severe infectious disease (3) Severe dysesthesia or sensory abnormality with functional disorder (4) History of psychiatric disorder, central nervous system disorder or cerebrovascular accident (5)Comorbidity or history of heart failure (6)Comorbidity or history of interstitial lung disease or pulmonary fibrosis (7) Radiotherapy to target lesion ( Perioperative Adjuvant Radiotherapy is eligible ) (8)History of severe allergy (9)Pregnant or lactating women or women of childbearing potential (10)Severe comorbidity (renal insufficiency, hepatic failure, hypertension, hypercalcemia etc) (11)Symptomatic brain metastasis (12)Simultaneous or metachronous double cancers (13)Any other cases who are regarded as inadequate for study enrollment by the investigator.
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, Disease control rate, Safety profile, Dose intensity, Conversion rate of nonresectable liver metastases to resectable