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Validation Study of the S-1 dosage formula based on renal function (SCHOLAR Study: Part 2)

Not Applicable
Conditions
Patients with cancer scheduled to have S-1 monotherapy
Registration Number
JPRN-UMIN000023880
Lead Sponsor
Keio University School of medicine
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) pulmonary fibrosis and interstitial pneumonia 2) diarrhea 3) active infection 4) require blood transfusion within 14 days 5) severe complications 6) dialysis 7) massive abdominal and pleural effusion 8) Being treated with flucytosine. 9) mental disease 10) hypersensitive to 5-FU 11) Any patients judged by the investigator to be unfit to participate in the study.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To confirm AUC of 5-FU was valid when S-1 calculated by B-B formula was administered
Secondary Outcome Measures
NameTimeMethod
To evaluate safety when S-1 calculated by B-B formula was administered
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