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Phase I/II study of the combination of Oxaliplatin and S-1 in patients with advanced/recurrent colorectal cancer

Phase 1
Conditions
unresectable advanced/recurrent colorectal cancer
Registration Number
JPRN-C000000443
Lead Sponsor
Outpatient Oncology Unit Kyoto University Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
42
Inclusion Criteria

Not provided

Exclusion Criteria

1) during flucytosine medication 2) Active infection or inflammation 3) Uncontrolled severe Diabtes 4) patient severe medical condition 5) patient with interstitial pneumonitis or the history 6) patient with active gastrointestinal bleeding 7) patient with severe neurotoxicity 8) patient with active chicken pox 9) patient with metastasis of CNS 10) patient with other concurrent malignancy affecting on survival or adverse events 11) pregnant or nursing patient or with intent to bear baby 12) patient with allergic history to drug 13) patient with massive effusion of massive ascites 14) patient evaluated to be inadequate by a attending doctor

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Step1:safety;adverse events Step2:Disease control rate
Secondary Outcome Measures
NameTimeMethod
Step1:Eficacy (response rate(CR+PR),disease control rate, survival Step2: Safety, Response rate, survival
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