Multicenter randomized phase ll study of XELOX plus bevacizumab or XELIRI plusbevacizumab as first-line chemotherapy for metastatic or recurrent colorectal cancer
- Conditions
- Colorectal cancer
- Registration Number
- JPRN-UMIN000007547
- Lead Sponsor
- Chubu Clinical Oncology Group (CCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 100
Not provided
(1)Uncontrolled infection. (2)Patient with symptomatic cardiovascular disease or asymptomatic disease but have been treated (3)Previous history of thoromboembolitic disease,or necessity for antithrombotic drug. (4)Severe lung disease.(Interstitial lung disease or pulmonary fibrosis.) (5)Severe liver disease. (6)Severe renal failure. (7)Previous history of severe drug-induced allergy (8)Intestinal bleeding, ileus, bowel obstruction or uncontrolled peptic ulcer. (9)History of gastrointestinal perforation within 1 year. (10)Uncontrolled severe complications(DM, hypertension, diarrhea, et al.) (11)History of active double cancer. (12)Massive pleural effusion or ascites that required drainage. (13)Brain metastasis (14)Patients with psycho-neurological disease,central nervous system damage,cerebrovascular disorder (15)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. (16)Patient with untreated traumatic bone fracture. (17)Diathesis of bleeding (history of hemoptysis,including cavitation and/or necrosis in lung metastasis confirmed by imaging),coagulopathy. (18) Systemic administration of antiplatelet drug (19)Patient who have peripheral nerve disorder (20)Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers. (21)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 ORR; Overall response rate
- Secondary Outcome Measures
Name Time Method PFS; Progression free survival DDC;Duration of disease control TTF; Time to treatment failure OS; Overall survival Safety