A multicenter randomized phase II/III trial of preoperative versus postoperative chemotherapy with XELOX plus bevacizumab in patients with resectable colorectal liver metastasis.
Phase 2
- Conditions
- Resectable liver metastasis from colorectal cancer
- Registration Number
- JPRN-UMIN000003783
- Lead Sponsor
- Hiroshima Surgical study group of Clinical Oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 81
Inclusion Criteria
Not provided
Exclusion Criteria
1) Multiple cancer patients 2) Pregnant or lactating woman 3) Steroid administration 4) Patients must use flucytosine, phenytoin or warfarin potassium 5) Uncontrollable hypertension or diabetes mellitus 6) Diarrhea or peripheral neuropathy greater than grade 1 7) Portal vein embolization 8) Clinically significant pulmonary disease, coagulopathy or thrombosis. 9) Clinically significant gastrointestinal bleeding, obstruction or ulcer. 10) Clinically significant abdominal, pleural or pericardial effusion. 11) Presence of psychological or central nervous system disorder. 12) Major abdominal or thoracic surgery within 4 weeks. 13) Presence of non-healing bone fracture 14) Hepatitis B virus infection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment compliance (phase II) Progression-free survival (phase III)
- Secondary Outcome Measures
Name Time Method Overall survival, Time to treatment failure, Response rate, Mode of recurrence, Resection rate, Incidence of adverse events, Morbidity, Pathological liver injury