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A phase II study of Oxaliplatin Reintroduction in patients pretreated with Oxaliplatin and Irinotecan for Advanced Colorectal Cancer

Phase 2
Conditions
Metastatic colorectal cancer
Registration Number
JPRN-UMIN000004884
Lead Sponsor
Japanese foundation for cancer research
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
33
Inclusion Criteria

Not provided

Exclusion Criteria

1.Severe peripheral neuropathy. 2.History of the serious hypersensitivity for drugs. 3.Active infection. 4.Complications (Evidence of interstinal lung disease, emphysema, pulmonary fibrosis, paralytic or mechanical bowel obstruction, uncontrolled hypertension, uncontrolled diabetes mellitus, cirrhosis, active cardiovascular disease, or past or current history (within 3 months) of myocardial infarction, uncontrolled angina pectoris or arrythmia. 5.Multiple primary cancer within 5years. 6.Need to drain pleural effusion, ascites or pericardial effusion. 7.Uncontrolled diarrhea. 8.Radiological evidence of brain cancer. 9.Clinically significant mental or psychological disease. 10.Other conditions not suitable for this study.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Disease control rate after 12 weeks of treatment.
Secondary Outcome Measures
NameTimeMethod
Adverse Effect Response Rate Progression-Free Survival Overall Survival
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