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Amrubicin at a dose of 45mg/m2 with pegylated granulocyte-colony stimulating factor support in patients with previously treated small-cell lung cancer - A prospective observational study

Not Applicable
Conditions
small-cell lung cancer
Registration Number
JPRN-UMIN000034657
Lead Sponsor
Tottori University Hospital Division of Medical Ontology and Molecular Respirology Tottori University Faculty of Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
17
Inclusion Criteria

Not provided

Exclusion Criteria

1.Transfusion and administration of hematopoietic factor preparations within 14 days before registration. 2.Serious renal dysfunction, or urine protein 2+ or higher in tests registered within 14 days. 3.Serious drug allergy. 4.Duplicate cancer of active. 5.Infections requiring systemic treatment. 6.Fever above 38 degrees Celsius. 7.Significant electrocardiogram abnormality or clinically problematic heart disease. 8.Severe lung disease. 9.Fresh bleeding from the gastrointestinal tract, intestinal palsy, intestinal obstruction or peptic ulcer. 10.Pleural effusion, ascites and pericardial effusion requiring removal of body cavity fluid by drain. 11.Defective thromboembolism. 12.Symptomatic brain metastasis. 13.Serious psychiatric disorders, central nervous disorders or cerebrovascular disorders. 14.Control poor hypertension or diabetes. 15.Severe bone marrow suppression. 16.Pregnant women, lactating women or women with a positive pregnancy test. A woman without intention to contraception. A woman wishing to become pregnant or breastfeeding. A man who is willing to conceive. 17.Cases the attending physician determines that inappropriate to participate in the test.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Overall Response Rate
Secondary Outcome Measures
NameTimeMethod
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