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A Phase II Clinical Trial of Nedaplatin and Amurubicin Therapy for Advanced and Recurrent Squamous Cell Lung Cancer.

Phase 2
Conditions
squamous cell Lung carcinoma
Registration Number
JPRN-UMIN000007587
Lead Sponsor
agasaki Thoracic Oncology Group
Brief Summary

Partial response was observed in seven of 21 cases (ORR, 33.3%; 95% confidence interval [CI], 14.5-52.2). Disease control rate, which includes stable disease, was 71.4%. Median OS and PFS was 14.6 and 4.1 months, respectively.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
21
Inclusion Criteria

Not provided

Exclusion Criteria

1)Symptomatic or apparent interstitial pneumonia/lung fibrosis on X-ray image findings. 2)Patients wth uncontrollable fever. 3)Severe complications, such as cardiac. failure, uncontrollable diabetic or hypertension. 4)uncontrollable pleural effusion, pericardial effusionor ascites. 5)Active concomitant malignancy. 6)Severe drug allergies or history of drug hypersensitivity. 7)With active infection. 8)mental disorder. 9)Pregnant, lactating or women of child-bearing potential. 10)The case that is judged to be inadequacy for this study.

Study & Design

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