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Mechanism and prediction of bevacizumab-induced hypertension and proteinuria

Not Applicable
Conditions
Colorectal cancer
Registration Number
JPRN-UMIN000002560
Lead Sponsor
Saitama medical university
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
50
Inclusion Criteria

Not provided

Exclusion Criteria

1) Current severe infeciton, or suspicious of severe infection with fever greater than 38 degrees centigrade. 2) Sensory neuropathy. 3) Uncontrollable diabetes 4) Uncontrollable hypertension 5) Severe abnormality in electrocardiogram, or cardiovascular disease (e.g., heart failure, angina) with clinical symptom 6) Severe pulmonary disease (e.g., interstitial pneumonia, pulmonary fibrosis, severe pumonary emphysema) 7) Severe systemic disease(e.g., ileus, renal failure, hepatic failure) 8) Clinical or radiographic evidence of brain metastases 9) History of thromboembolism(e.g, myocardial infarction, cerebral infarction, deep venous thromboembolism, pulmonary thrmboembolism) 10) Uncontrollable gastrointestinal ulcer 11) Carcinomatous peritonitis controlled with drainage 12) Any surgery within 4weeks prior to randamization(the exception of implanted port system) 13) Clinical evidence or potential of dysfunction of coagulation 14) Current daily treatment with warfarin 15) Active synchronous cancer 16) Current known infection with HBV or HCV 17) Pregnant or lactating women, or men and women without wanting pregnancy 18) Severe psychiatric disorder 19) Current daily treatment with corticosteroid 20) Severe hypersensitivity to medicine(hypersensitivity to platinum, fluorouracil or 5-HT3 receptor antagonist is ineligible)

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To identify whether the biomarkers in blood or urine predict bevacizumab associated hypertension and proteinuria.
Secondary Outcome Measures
NameTimeMethod
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