locally advanced rectal cancer
Conditions
Interventions
S-1 80 mg/m2 p.o. (day1-14) L-OHP 130 mg/m2(day 1) [ KRAS-MT ] bevacizumab 7.5mg/kg(day 1) to be repeated every 3 week until 3 course or to meet discontinuation criteria
S-1 80 mg/m2 p.o. (day
Sponsors
Department of Gastroenterological and Pediatric Surgery, Oita University faculty of medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed rectal cancer (Ra, Rb, P) 2) Histologically confirmed adenocarcinoma 3) Clinical stage T3-4, N0-2(UICC 7th edition) 4) Age of 20 to 80 years old 5) PS(ECOG) 0-1 6) Confirmed KRAS status 7) Previously untreated rectal cancer (including chemotherapy, radiotherapy, hormonal therapy, or surgery) 8) be able to take oral drugs 9) Required baseline laboratory parameters (within 14 days before registration): WBC >= 3000 ,< 12000/mm3 Neu >= 1,500/mm3 Plt >= 100,000/mm3 Hb >= 9.0g/dl T-Bil <= 2.0mg/dl AST,ALT <= 100U/L Cre <1.5mg/dl Ccr >= 60mL/min 10) Appropriate for the study at the physician's assessment 11) Written informed consent
Exclusion criteria
Exclusion criteria: 1) History of serious drug hypersensitivity or a history of drug allergy 2) Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration of 5 years or less) 3) Patients with contraindication to each drugs 4) Serious complication ( ex. intestinal paralysis, ileus, interstitial pneumonitis, pulmonary fibrosis, serious diabetes, serious hypertension cardiac failure, renal failure, or liver failure) 5) Previous history of serious lung disorder ( ex. interstitial lung disease or fibrosis, serious emphysema ) 6) Pleural effusion, peritoneal fluid that needs treatment 7) Positive for HBs antigen 8) Patients who have bleeding from GI tract, intestinal paralysis, intestinal obstruction, peptic ulcer 9) Patients who need flucytosine, phenytoin or warfarin potassium. 10) History of thromboembolism, cerebral infarction or pulmonary infarction 11) Hemorrhagic diathesis, coagulation disorder 12) Requiring anti-thrombogenic therapy to prevent thrombosis 13) History of hemoptysis 14) Requiring consecutive systemic administration of steroid drug 15) Pregnant or lactating woman 16) Man who hope for Partner's pregnant 17) High-grade stricture 18) Not appropriate for the study at the physician's assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate | — |
Secondary
| Measure | Time frame |
|---|---|
| DFS, OS, Response rate, pathological Response, Safety, Rate of complete treatment | — |
Countries
Japan
Contacts
Public ContactMasafumi INOMATA
Oita University faculty of medicine Department of Gastroenterological and Pediatric Surgery
Outcome results
None listed