Resectable lower rectal cancer
Conditions
Interventions
S-1 day1-5,8-12,15-19,22-26,65-80mg/m2 orally Oxaliplatin day1,8,15,22,dose of 40-60mg/m2 iv bevacizumab day1,15,dose 5mg/kg iv Radiotherapy 2Gy/day day1-5,8-12,15-19,22-26,total 40Gy surgery aft
Sponsors
Tokushima University Hospital Dept. of Digestive and Pediatric Surgery
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically confirmed Rectal Cancer 2)T1N1-T4(by CT or EUS) 3)Tumor reached lower rectal 4)with target lesion by RECIST 5)No evidence of peritoneal metastasis 6)No evidence of distant metastasis 7)Age of 20-75years old 8)PS(ECOG):0-2 9)Adequate organ function 10)Without prior anti-cancer therapy 11)written IC 12)Adequate oral intake
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MTD,RD | — |
Secondary
| Measure | Time frame |
|---|---|
| pCR rate,response rate,safety | — |
Countries
Japan
Outcome results
None listed