A phase II trial of FOLFOXIRI+Bevacizumab as preoperative chemotherapy for locally advanced lower rectal cancer
- Conditions
- ower rectal cancer
- Registration Number
- JPRN-UMIN000031028
- Lead Sponsor
- Kobe University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Not provided
1. Previously treated with systemic chemotherapy, radiotherapy, hormone therapy, or immunotherapy for the present disease 2. Severe drug intorelance 3. Peripheral neuropathy (>= Grade 1) 4. Infectious disease to be treated 5. Uncontrollable hypertension 6. Uncontrollable diabetes mellitus 7. Severe heart disease such as congestive heart failure, pectoris, and myocardial infarction. 8. Severe pulmonary disease 9. Severe mental disease 10. Active bleeding from the intestine 11. Currently treated by Phenytoin, Warfarin, or Flucytosine. 12. Diarrhea(>= Grade 2) 13. Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal carcinoma 14. Women during pregnancy, possible pregnancy or breast-feeding 15. Liver chirrhosis or hepatitis 16. UGT1A1*6/*6, UGT1A1*28/*28, or UGT1A1*6/*28 17. Attending physician determines that the case was inappropriate as the subject of this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method pathological complete response (pCR) rate
- Secondary Outcome Measures
Name Time Method Feasibility, Response rate, Pathological response rate, Proportion of operative complication, Proportion of adverse events, R0 resection rate, Proportion of anus-preservation, 3 years progression free survival, 3 years overall survival