A phaseI trial of S-1 Oxaliplatin and Bevacizumab in combination with Radiotherapy for Neozdjuvant Therapy of Locally advanced lower rectal cancer
- Conditions
- Resectable lower rectal cancer
- Registration Number
- JPRN-UMIN000006937
- Lead Sponsor
- Tokushima University Hospital Dept. of Digestive and Pediatric Surgery
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 15
Not provided
1)With interstitial pneumotitis or pulmonary fibrosis 2)With ascites for need to cure 3)Prior or synchronous invasive malignancy(expect carcinoma in situ or superfivcial carcinoma which is able to eradicate by local therapy)unless disease free for a minimun of 5 years 4)With infection,bowel paralysis or bowel obstruction 5)With severe watery diarrhea 6)With uncontrolled diabetic mellitus 7)With uncontrolled hypertension 8)With Heart disease,hepatic failure,renal failure which is difficult to enroll 9)With brain metastasis 10)Pregnant or lactating and woman with childbearing potential who lacked effective contraception 11)Previous history of sever drug-induced allergy 12)Previous history of drug-induced allergy with Testing drugs 13)Evidence of psychiatric disability interfering with enrollment to clinical trial 14)Need systemic administration of corticosteroids 15)Evidence of thorombisis,cerebral infarction,myocardial infarction,pulmonary infarction 16)With peritonitis 17)With congenital bleeding tendency or coagulopathy 18)Need anti-coagulability drugs 19)Evidence of spit blood 20)Evidence of sever sensory disturbance 21)Previous history of sever drug-induced allergy with plutina-drugs 22)Patients judged inappropriate for this study by the physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MTD,RD
- Secondary Outcome Measures
Name Time Method pCR rate,response rate,safety