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A feasibility study of adjuvant therapy with FOLFOX plus Ca/Mg for the patient with colorectal cancer

Phase 4
Conditions
Colorectal Cancer
Registration Number
JPRN-UMIN000003708
Lead Sponsor
Kyushu Study group of Clinical Cancer
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
48
Inclusion Criteria

Not provided

Exclusion Criteria

1.Patients who had received blood transfusion, blood products, or hematopoietic growth factors such as granulocyte-colony stimulating factor within 7 days prior to registration. 2.History of the severe hypersensitivity. 3.Sensory neuropathy. 4.Active other malignancies. 5.Active infection 6.History of mental disorder,central nerve disorder. 7.Watery stools or Grade 2 or more diarrhea 8.Requiring steroid drug 9.Pregnant or lactating woman 10.Co-mobility, such as interstitial lung disease, lung fibrosis, intestinal paralysis, ileus,uncontrolled diabetes, liver cirrhosis, viral hepatitis type B ,kidney failure, uncontrolled hypertension, history of cardiac infarction 11.History of the internal organ transplant 12.Hypercalcemia ,renal calculus 13.Requiring cardiac glycoside 14.High probability of recurrence 15.Not appropriate for the study at the physician's assessment

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
the rate of completion of treatment as planned
Secondary Outcome Measures
NameTimeMethod
Safety (especially peripheral neuropathy, digestive symptom ) Quality of life Disease free survival Overall survival
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