Multicenter Phase II sequential study of S-1/Oxaliplatin (SOX) and Bevacizumab as first line therapy followed by S-1/Irinotecan (IRIS) and Cetuximab as second line in patients with metastatic colorectal cancer. : A SOBIC study
- Conditions
- Metastatic Colorectal Cancer
- Registration Number
- JPRN-UMIN000004011
- Lead Sponsor
- Hyogo Colorectal Cancer Study Group
- Brief Summary
The median second progression-free survival was 24.2 months (95% confidence interval [CI] 17.7 35.2). The response rate after first- and second-line chemotherapy was 46.7% and 20%, respectively. The median overall survival was 35.2 months (95% CI: 27.8 to not reached). The main grade 3,4 adverse events were sensory neuropathy (18%), fatigue (10%), and anorexia (8%). There were no treatment-related deaths among patients administered the first-line and second-line regimens.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 52
Not provided
(1) History of the serious hypersensitivity for Fluorouracil, oxaliplatin or bevacizumab (2) Pregnant or lactating women or women of childbearing potential. (3) Severe infectious disease (4) Serious complication (e.g. interstitialpneumonia, or pulmonary fibrosis, kidney injury, hepatic failure, uncontrolled diabetes mellitus, uncontrolled hypertension) (5) Comorbidity or history of heart failure (6) Peptic ulcers (7) Severe dysesthesia or sensory abnormality with functional disorder (8) Severe diarrhea (9) Massive pleural effusion or ascites. (10) Obstruction or disorder on digestive tract due to peritoneal metastasis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method