Phase II trial of Bevacizumab with XELOX as an adjuvant treatment after resection of colorectal liver metastases
- Conditions
- Colorectal liver metastases
- Registration Number
- JPRN-UMIN000004352
- Lead Sponsor
- Tohoku University Graduate School of Medicine Division of Integrated Surgery and Oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 45
Not provided
1.Recurrence of chemotherapy of capecitabine, oxaliplatin and bevacizumab less than 6 months 2.Active multiple cancers (within 5 years) 3.Histry of hyper sensitivity against bevacizumab, oxaliplatin and capecitabine 4.Serious infections 5.Serious complications 6.Serious alteration or paresthesia interfering with function 7.Pregnancy woman, or woman with suspected pregnancy 8.Histry of organ recipient 9.Surgery, biopsy, specimen with section or sutures within the past 2 weeks. Fine needle aspiration biopsy within 1 week 10.Thrombosis with present or history of thromboembolism within the past 1 year 11.Administrated with Aspirin (>=325mg/day) or steroid for RA and chronic inflammatory disease 12.Untreatment of traumatic bone fracture 13.Require treatment of renal dysfunction, or urine protein >+2 within 2 weeks 14.Uncontrollable hypertension 15.Uncontrollable diarrhea 16.Uncontrollable peptic ulcer disease 17.Severe pulmonary disease (Interstitial pneumonitis or pulmonary fibrosis) 18.Cardiac disease (over grade2 by CTCAE v4.0).Or histry of myocardial infarction within 1 year 19.Doubting dihydropyrimidine dehydrogenase (DPD) deficit 20.Any subject judged by the investigator to be unfit for any reason to participate in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method disease free survival
- Secondary Outcome Measures
Name Time Method Overall survival 2-year DFS rates Relapse-free survival Safety Treatment continuation rate 5 courses 8 courses