lower rectal cancer
Conditions
Interventions
S-1: Medication for 4 weeks of 5-day administration followed by 2-day washout at the dose of 80mg/m2 Oxaliplatin: Infusion for 2 hours at the dose of 50mg/m2 on day1, 8, 15, 22 Bevacizumab: Infusion
Sponsors
Tokushima University Hospital Dept. of Digestive and Pediatric Surgery
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histopathologically confirmed rectal cancer 2) By CT or ultrasound endoscope, the depth of invasion is resectable cases of N0-N3 and T2-T4 3) Main lesion of the tumor is located at lower rectal cancer (Rb, P) 4) Patients with measurable disease 5) Patients without peritoneal metastasis 6) Patients without distant metastases 7) Age of 20 to under 80 years 8) Performance status (ECOG basis) of 0-2 9)Sufficient organ function as below: White blood cell count: 3,000/mm3 or more to 12,000/mm3 Neutrophil count:1,500/mm3 or more Platelet count:100,000/mm3 or more Hemoglobin amount:9.0g/dL or more GPT and serum GOT:2.5 times or less than upper limit of normal Total bilirubin:1.5mg/dL or less Serum creatinine:1.2mg/dL or less Creatinine clearance value:60mL/min or more(Estimated or measured) 10) No prior therapy for rectal cancer(chemotherapy, radiaotherapy and surgery) 11) Written informed consent 12) Ingestible cases
Exclusion criteria
Exclusion criteria: 1) Cases of obvious abnormality in the chest X-ray or interstitial pneumonia, pulmonary fibrosis with clinical symptoms or history of these disease 2) Patients with body cavity effusion requiring treatment 3) Patients with active double cancer, or curatively treated double cancer that have been no-treatment and disease-free interval for 5 years or less (However, skin cancer or carcinoma in situ is excluded) 4) Patients with primary lesions having severe stenosis that endoscope does not pass (However, cases of colostomy can be registered) 5) Cases with confirmed peritoneal metastasis on the image 6) Cases with infection, paralysis of the intestinal tract, intestinal obstruction 7) Cases with diarrhea (watery diarrhea). 8) Cases with uncontrolled diabetes 9) Cases with uncontrolled high blood pressure 10) Cases with complications (heart failure (cardiac dysfunction), liver failure, renal failure, etc.) that are judged to lead to serious trouble 11) Patients with history of thrombosis, cerebral infarction, myocardial infarction, pulmonary infarction and hemoptysis 12) Cases with intraperitoneal inflammation 13) Cases with perceived failure or severe paresthesia with dysfunction 14) Cases with symptomatic brain metastases 15) Cases with congenital bleeding diathesis orthe coagulation system abnormalities 16) Cases with inappropriate study entry due to psychosis or psychiatric symptoms 17) Cases with pregnant women, the intention or possibility of pregnant women and nursing mothers 18) Patients who had experienced severe allergic drug reactions 19) Cases corresponding to the contraindication to each drug of this study 20) Patients with a history of hypersensitivity to each drug 21) Patients receiving systemic administration(intravenous or oral) of continued steroids 22) Patients receiving anticoagulant 23) Any other cases who are regarded as inadequate for study enrollment by physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological Complete Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate(RR) Relapse free survival (RFS) Overall survival (OS) Safety(rate of adverse events, rate of complications) Rate of local recurrence Completion rate of preoperative chemoradiotherapy R0 resection rate Down-staging rate | — |
Countries
Japan
Contacts
Public ContactJun Higashijima
Tokushima University Hospital Dept. of Digestive and Pediatric Surgery
Outcome results
None listed