A phase II study of Perioperative FOLFOX4 plus Bevacizumab for initially unresectable Advanced Colorectal Cancer.
- Conditions
- colorectal cancer
- Registration Number
- JPRN-UMIN000005572
- Lead Sponsor
- Japanese foundation for cancer research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 49
Not provided
1.Malignant coelomic fluid. 2.Radiological evidence of CNS metastases or brain cancer. 3.Multiple primary cancer within 5 years. 4.Complication of cerebrovascular disease or symptoms within 1 year. 5.Any surgical treatments including skin open biopsy, trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week. 6.Planned surgery during chemotherapy. 7.Administering antithrombotic drug within 10 days. 8.Need to administrate or having anti-platelets therapy (including Methotrexate aspirin and NSAIDS). 9.Evidence of bleeding diathesis or coagulopathy. 10.Active gastrointestinal ulcer 11.Current or previous (within the last 1 year) history of GI perforation 12.Non healing fracture 13.Renal failure to be treated, 2+ or higher proteinuria within 2 weeks prior to entry 14.Uncontrolled Hypertension 15.Clinically significant (i.e. active) cardiovascular disease, or past or current history (within the last 1 year) of myocardial infarction 16.History of the serious hypersensitivity for Fluorouracil, leucovorin calcium or platinum agents. 17.Dihydropyrimidine Dehydrogenase Deficiency. 18.Uncontrolled diarrhea. 19.Evidence of interstinal lung disease, or pulmonary fibrosis. 20.Evidence of peripheral neuropathy. 21.CV access system implanted within 7 days before chemotherapy. 22.History of organ transplantation 23.Uncontrolled Active infection. 24.Other conditions not suitable for this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Completion rate of neoadjuvant chemotherapy. Possibility of curative surgery.
- Secondary Outcome Measures
Name Time Method