A phase II study of alternate-day administration of S-1, oral leucovorin, oxaliplatin, and bevacizumab combination as first-line treatment in patients with metastatic colorectal cancer.
- Conditions
- Colorectal cancer
- Registration Number
- JPRN-UMIN000020439
- Lead Sponsor
- Aichi Cancer Center Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 25
Not provided
(1) Active multiple malignancy (2) History of severe drug-induced hypersensitivity (3) Symptomatic brain metastasis (4) Active infection (5) Interstitial pneumonia or pulmonary fibrosis (6) Serious complications (renal failure, liver failure, severe cardiac disease, uncontrolled diabetes, uncontrolled hypertension, ileus) (7) massive pleural, abdominal, or pericardial effusion (8) Administration of phenytoin or flucytosine (9) Systemic administration of steroid (10) Thromboembolism (grade 3 or higher) within 6 months before enrollment (11) Any major surgery or open biopsy within 4 weeks before scheduled date of treatment (14) Bleeding diathesis or tendency (13) Active peptic ulcer (14) History of gastrointestinal perforation within 1 year before enrollment (15) Clinically significant mental disorder (16) Positive for HBs antigen (17) Women who are pregnant or patients who are unwilling to avoid pregnancy (18) grade 2 or higher peripheral neuropathy (19) previous treatment with oxaliplatin (20) Patients who are inappropriate for the study in the opinion of the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective response rate as assessed by independent ragiologic review
- Secondary Outcome Measures
Name Time Method Objective response rate as assessed by investigators Progression free survival Time to treatment failure Overall survival Disease control rate The efficacy according to RAS status R0 resection rate Safety Relative dose intensity