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A phase I/II trial of concurrent thoracic radiotherapy with the combination of cisplatin and nab-pacliaxel for locally advanced non-small cell lung cancer

Phase 1
Conditions
locally advanced non-small cell lung cancer
Registration Number
JPRN-UMIN000012531
Lead Sponsor
Department of Medical Oncology, Kindai University, Faculty of Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
25
Inclusion Criteria

Not provided

Exclusion Criteria

1) Pulmonary disorder (idiopathic pulmonary fibrosis, interstitial lung disease, pneumoconiosis, active radiation pneumonia, etc.). 2) SVC syndrome 3) With active infection 4) With active double cancer. 5) With other serious disease condition (bleeding, cardiac diseases, poorly controlled diabetes, etc.) 6) Clinically significant drug allergy 7) Patients with steroid treatment. 8) Uncontrolled psychiatric disease. 9) Pregnancy or lactating patients 10) Positive serum HBs antigen or HCV antibody 11) Others

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
phase 1:determine the recommended dose phase 2:2year survival rate
Secondary Outcome Measures
NameTimeMethod
phase 1:safety, response rate, 2year survival rate, progression free survival, completion rate of chemoradiotherapy phase 2:safety, response rate, progression free survival, completion rate of chemoradiotherapy
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