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Randomized phase 2 study of mFOLFOX6 plus bevacizumab versus modified OPTIMOX plus bevacizumab for metastatic colorectal cancer

Phase 2
Conditions
colorectal cancer
Registration Number
JPRN-UMIN000003477
Lead Sponsor
Chiba Cancer Center Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
80
Inclusion Criteria

Not provided

Exclusion Criteria

1) contraindication to 5-FU, oxaliplatin, UFT, calcium folinate, or bevacizumab. 2) moderate/severe pleural effusion, ascites or pericardial effusion. 3) brain metastases. 4) history of active other malignancies. 5) neuropathy. 6) history of thoromboembolitic disease. 7) uncontrollable Diabetes Mellitus or hypertension 8) interstitial lung disease, pulmonary fibrosis or severe pulmonary emphysema. 9) intestinal bleeding, ileus, bowel obstruction or uncontrolled peptic ulcer. 10) clinically significant infectious disease (body temperature more than 38.0 degrees) 11) urinary protein (more than 1+) 12) uncontrolled watery diarrhea. 13) pregnant or lactating women, women who are capable of pregnancy or intend to get pregnant. 14) Any other cases who are regarded as inadequate for study enrollment by the attending doctors.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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