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Phase II study of Amrubicin in patients with Small-Cell Lung Cancer that is refractory or relapsed within 90 days of completing previous treatment (JCOG0901)

Phase 2
Conditions
Refractory relpased small-cell lung cancer
Registration Number
JPRN-UMIN000002763
Lead Sponsor
Japan Clinical Oncology Group(JCOG)
Brief Summary

See the datails via "URL releasing results" above. Also the details can be seen in the JCOG website: http://www.jcog.jp/en/trials/index.html

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
80
Inclusion Criteria

Not provided

Exclusion Criteria

1) active concomitant malignancy 2) active infection 3) fever 4) pregnancy or lactation 5) serious psychiatric illness 6) steroid treatment 7) massive pleural or pericardial effusion 8) symptomatic brain metastasis 9) interstitial pneumonia or severe pulmonary emphysema 10) ileus 11) myocardial infarction within 6 months or unstable angina 12) uncontrollable hypertension 13) uncontrollable diabetes mellitus

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
response rate
Secondary Outcome Measures
NameTimeMethod
overall survival, progression-free survival, adverse events
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