Observational study of XELOX in combination with bevacizumab for advanced or recurrent colorectal cancer
- Conditions
- advanced and recurrent colorectal cancer
- Registration Number
- JPRN-UMIN000004971
- Lead Sponsor
- Kyoto Prefectural University of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Not provided
1)Contraindication of bevacizumab oxaliplatin and capecitabine 2)Brain tumors or brain metastasis 3)Presence of cerebrovascular disease or symptoms less than 1 year prior to entry 4)Any surgical treatments oncluding skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week 5)Non-healing bone fracture 6)Uncontrolled peptic ulcer 7)Uncontrolled hypertension 8)the internal organ transplant 9)Interstitial pneumonitis, pulmonary fibrosis 10)Uncontrolled Infection 11)Renal failure to be treated, 1+ or higher proteinuria within 1 weeks prior to entry 12)History of adverse events related to DPD loss 13)Daily treatment wit high-dose aspirin (>=325/day) or non-steroidal anti-inflammatory medications 14)Pregnant women, nursing mothers, possibly pregnant women 15)Perforation of gastrointestinal tract less than 1 year prior to entry 16)Clinically significant (i.e. active) cardiovascular disease (>= Grade 2 according to the Common Toxicity Criteria of the National Cancer Institute, version 4), clinically important echocardiographic findigs, or past or current history (within the last 1 year) of myocardial infarction 17)Peripheral neuropathy of at least grade 1 18)Uncontrolled pleural and/or peritoneal effusion 19)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
- Secondary Outcome Measures
Name Time Method