A Phase II trial of SOX plus bevacizumab or cetuximab as neoadjuvant chemotherapy in patients with locally advanced rectal cancer (OITA-trial II)
- Conditions
- locally advanced rectal cancer
- Registration Number
- JPRN-UMIN000012856
- Lead Sponsor
- Department of Gastroenterological and Pediatric Surgery, Oita University faculty of medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 70
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method