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A phase II study to evaluate the effect on the combination chemotherapy of CPT-11 and S-1 for advanced/recurrent colon cancer which combines genetic analysis on adverse events (OGSG 0405)

Phase 2
Conditions
Patients with advanced and/or recurrent colon cancer
Registration Number
JPRN-UMIN000000855
Lead Sponsor
OGSG
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

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

Not provided

Exclusion Criteria

1. without interstitial pneumonia or pulmonary fibrosis on X-ray examination And/or clinical signs 2. Cavity fluid which needs drainage 3. with active double cancer except ca. in situ 4. with intestinal paralysis or obstruction 5. under watery diarrhea 6. with uncontrolled DM 7. with ischemic cardiac disease 8. with mental disorder which disturbs registration to this study 9. with infectious disease which needs treatment 10. patients who receive steroids treatment 11. Cardiac failure, liver dysfunction, or renal dysfunction which disturb Registration to this study 12. with brain metastasis and the symptom due to the metastasis 13. pregnant women or women who like to be pregnant 14. history of severe allergy against drug 15. doctor's dicision not to be registered to this study

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Response Rate
Secondary Outcome Measures
NameTimeMethod
adverse events, survival time, Relative Performance, Genomic instability
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