Assessment of clinical efficacy and safety in capecitabine plus intermittent oxaliplatin (intermittent CapeOx)together with Bevacizumab as the first-line therapy for patients with advanced colorectal cancer; multicenter phase II trial
- Conditions
- advanced colorectal cancer
- Registration Number
- JPRN-UMIN000005732
- Lead Sponsor
- Surgical Oncology Association in Chiba (SOAC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Not provided
(1)History of the severe hypersensitivity for capecitabine, oxaliplatin or bevacizumab. (2)CNS metastases or brain cancer confirmed by imaging. (3)Cerebrovascular disease or its symptoms within 1 year. Prior abdominal irradiation for colorectal cancer. History of suspected complication of arterial thromboembolism such as cerebrovascular disease or experienced thromboembolism once within a year or twice bore. (4)History of gastrointestinal perforation within 1 year. (5)Synchronous malignant coelomic fluid that required drainage. (6)Uncontrolled peptic ulcer. (7)Uncontrolled diarrhea. (8)Uncontrolled infection. (9)Diathesis of bleeding (history of hemoptysis, including cavitation and/or necrosis in lung metastasis confirmed by imaging), coagulopathy or abnormality of coagulation factor as INR>=1.5. (10)Uncontrolled hypertension. (11)Necessity for antithrombotic drug or drugs affected to coagulation and fibrinolytic system within 14 days before enrollment(Expect for low-dose of aspirin). (12)History of active double cancer within 5 years. (13)Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers. (14)Patient receiving surgical procedure or such as skin-open biopsy, trauma surgery, or other more intensive surgeries within 4 weeks or aspiration biopsy within a week. (15)Patient with symptomatic cardiovascular disease or asymptomatic disease but have been treated (>=Grade 2 according to NCI-CTCAE ver.4). History of myocardial infarction within a year. (16)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 progression free survival (PFS)
- Secondary Outcome Measures
Name Time Method Safety time-to-treatment failure response rate 1 (RR 1) progression free survival 2 (PFS 2) response rate 2 (RR 2) resection rate in