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Evaluation of the reintroducing FOLFOX or XELOX +/- BV in relapsed colorectal cancer patients treated with oxaliplatin as adjuvant chemotherapy.(REACT study)

Phase 2
Conditions
Colorectal Cancer
Registration Number
JPRN-UMIN000006523
Lead Sponsor
Hyogo College of Medicine, Department of Surgery
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up continuing
Sex
All
Target Recruitment
30
Inclusion Criteria

Not provided

Exclusion Criteria

1)Blood transfusion, administration of hematopoietic factor (human blood products or G-CSF, etc). 2)Serious drug allergy. 3)Peripheral sensory neuropathy >= Grade 2. 4)Active synchronous malignancies. 5)Massive pleural or pericardial effusion ,or ascites. 6)Infection of clinical issue or fever suspicious of infection. 7)Brain metastasis. 8)Cardiac disease complications (congested heart failure, symptomatic coronary artery disease, uncontrollable cardiac dysrhythmia or history of myocardial infarction within 12 months, etc). 9)Lung disease of clinical issue. 10)Bleeding that requires medication or transfusion. 11)Uncontrolled diarrhea. 12)Ileus or bowel obstruction. 13)Clinically significant mental or psychological disease. 14)Insulin-treated diabetic patients. 15)Women who are pregnant or breast-feeding. 16)Other patients who are unfit for the study as determined by the attending physician.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
response rate disease control rate
Secondary Outcome Measures
NameTimeMethod
safety progression free survival time to treatment failure overall survival relative dose intensity
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