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Phase II study of FOLFOX4 in patients with advanced/recurrent colorectal cancer previously treated with 5FU (OGSG 0503)

Phase 2
Conditions
advanced/recurrent colorectal cancer
Registration Number
JPRN-UMIN000000734
Lead Sponsor
OGSG
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

Excluding Criteria 1. cavity fluid which should be taken out 2. with double cancer and/or multiple cancer which excludes carcinoma in situ 3. with peripheral nerve disorder 4. with infectious disease 5. under the condition of diarrhea (watery diarrhea) 6. with psychological disorder which disturb the entry to the study 7. under continuous steroids therapy 8. with other severe diseases(pulmonary fibrosis, cardiac failure, liver dysfunction, renal dysfunction, intestinal paralysis/obstruction or uncontrolled DM) 9. pregnant and/or nursing women 10. with allergic history against medicines 11. doctors' stop not to register to the study

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Response Rate
Secondary Outcome Measures
NameTimeMethod
Incidence of Adverse Events,Feasibility,Survival Time, Relative Dose Intensity
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