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Expiratory randomized phase II trial for optimizing treatment dose and duration of adjuvant S-1 plus oxaliplatin in patients with stage III colon cancer

Phase 2
Conditions
colon cancer
Registration Number
JPRN-UMIN000013825
Lead Sponsor
Yokohama City University Medical Center
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up continuing
Sex
All
Target Recruitment
163
Inclusion Criteria

Not provided

Exclusion Criteria

1) Tumor located below the peritoneum. 2) history of another malignancy within 5 years 3) Severe postoperattive complication (such as severe infection, severe anastomoitc leakage, intestinal bleeding) 4) Severe concurrent disease such as poorly controlled hypertension, poorly controlled diabetes, interstitial pneumonia or pulmonary fibrosis, severe chronic pulmonary emphysema, heart failure, renal failure, hepatic failure. 5) Severe sensory disorder 6) Severe diarrhea 7) history of severe drug hypersensitivity 8) administration of flucytosine 9) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males who are currently attempting to produce a pregnancy 10) Severe psychiatric disorder 11) Physician concludes that the patient's participation in this trial is inappropriate.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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