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Phase I–II study of TS-1 and Carboplatin in advanced Non Small Lung Cancer

Not Applicable
Conditions
non small cell lung cancer
Registration Number
JPRN-C000000054
Lead Sponsor
Department of Medical Oncology, Kinki University School of Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Sex
All
Target Recruitment
25
Inclusion Criteria

Not provided

Exclusion Criteria

1) History of active other malignancy 2) Severe heart disease (uncontrolled angina pectoris , myocardial infarction, heart failure within 3 months 3) Uncontrolled diabetes 4) Severe complication (infection, bowel obstruction, or hemorrhage etc.) 5) Intestinal pneumonia or lung fibrosis 6) Severe diarrhea 7) Massive pleural, cardiac, or abdominal effusion 8) Regular use of fenitoin, warfarin or frucitocin 9) Symptomatic brain metastasis 10) History of severe drug allergic reaction 11) History of bone marrow plantation or self peripheral blood stimulated transportation 12) Pregnant women or women willing child-bearing 13) Inadequate condition diagnosed by primary physician

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Decision of the recommended dose of TS1 and carboplatin
Secondary Outcome Measures
NameTimeMethod
Determination of dose limited toxicity and response and safety of the combination of TS1 and carboplatin
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