A randomized phase II study of XELOX plus Bevacizumab versus XELIRI plus Bevacizumab for advanced colorectal cancer with or without mitochondrial transcription factor A (mtTFA) expression.
- Conditions
- nresectable advanced/recurrent colorectal cancer
- Registration Number
- JPRN-UMIN000005060
- Lead Sponsor
- Fukuoka University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Not provided
1)Administering transfusion/ hematopoietic factor or G-CSF and antithrombotic drug within 7 days. 2)Serious liver and renal dysfunction. 3)Serious drug hypersensitivity or a history of drug allergy. 4)Peripheral neuropathy. 5)Active double cancer. 6)Severe infectious disease. 7)High blood pressure and diabetic that cannot be controlled. 8)Symptomatic or asymptomatic but treated heart disease. 9)History of interstitial pneumonitis, pulmonary fibrosis or high-grade pulmonary emphysema. 10)History of mental disturbances or cerebrovascular accident. 11)Fresh hemorrhage from digestive tube, intestines tube paralysis, intestinal obstruction and peptic ulcer. 12)Current or previous (within one year) history of GI perforation. 13)Pleural effusion, peritoneal fluid and pericardial fluid. 14)Symptomatic brain metastasis. 15)Water solubility diarrhea. 16)Under coutinuous steroid therapy. 17)Any surgical treatments including skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week. 18)Anti-platelets therapy.(including aspirin and NSAIDS) 19)History of organ transplantation. 20)Traumatic fracture of unrecovery. 21)Bevacizumab used previous chemotherapy. 22)Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers. 23)Other conditions not suitable for this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate with or without mtTFA expression
- Secondary Outcome Measures
Name Time Method Progression free survival with or without mtTFA expression Overall survival with or without mtTFA expression Safety